[c09aa8]: / clusters / 3009knumclusters / clust_167.txt

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All patients and/or their parents or legal guardians must sign a written informed consent
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Subject has given written informed consent
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines; for step 1 initial registration, the appropriate consent form is the step 1 consent form
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; the appropriate consent form for this registration is the step 2 consent form
STEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; the appropriate consent form for this registration is the step 2 consent form
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
REGISTRATION STEP 2-RANDOMIZATION: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Patient must have given written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent.
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
All patients and/or their parents or legal guardians must sign a written informed consent
Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
All patients and/or their parents or legal guardians must sign a written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
All patients and/or their parent or legal guardian must sign a written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
Each patient’s parents or legal guardians must sign a written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
Written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
All patients and/or their parents or legal guardians must sign a written informed consent
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
ALL PATIENTS: Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legal guardians must sign a written informed consent
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Voluntary written informed consent
Patients with mental deficits or psychiatric conditions that preclude them from giving informed consent or following protocol
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separately; consent and HIPPA authorization must be obtained prior to any screening procedures
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Written informed consent which is consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation.
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must have signed an authorization for the release of their protected health information
All patients and/or their parents or legal guardians must sign a written informed consent
Informed consent must be obtained according to St. Jude guidelines before enrollment into study
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Signed and dated voluntary written informed consent before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Any HSCT within 6 months prior to signing informed consent
Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH GCP Guidelines and applicable local regulations.
At least 18 or older of age on day of signing informed consent
Documented informed consent
Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
Patients must give informed consent prior to initiation of therapy
Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
Subject must have a brain scan performed during Screening or within 3 months prior to signing informed consent;
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Any perceived inability to directly (and without the means of a legal guardian) provide informed consent
SAFETY RUN-IN: Signed written informed consent in accordance with regulatory and institutional guidelines
RANDOMIZED PHASE II CLINICAL TRIAL: Signed written informed consent in accordance with regulatory and institutional guidelines
Potential subject must have the ability to understand (as judged by the treating physician) and willingness to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately; written informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures
Patients have voluntarily agreed to participate by giving written informed consent.
Voluntary written informed consent
Informed consent/assent
Execute an informed consent.
Voluntary written consent must be signed before performance of any study related procedure not part of standard medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care
Subjects unable to comprehend and give informed consent are excluded.
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care
Written and voluntary informed consent.
Written informed consent
Voluntary written informed consent before performance of any study-related procedure not part of routine medical care with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Written informed consent
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent; in patients who are not able to consent to the trial due to medical circumstances, the next of kin or power of attorney may consent for the study
Provided informed consent
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients will be given a copy of the consent form
Patients must agree, as part of the informed consent, to provide blood for pharmacokinetics analysis
The subject or subject's medical power of attorney has provided written consent to participate in this study.
Ability to give informed consent.
Have mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.
Subject is ? 18 years of age at the time of signing the informed consent form (ICF).
Be capable, willing, and able to provide written informed consent/assent. For patients < 18 years of age, their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
A patient must be capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject’s behalf
Legal incapacity/limited legal capacity for providing informed consent.
Ability to understand the nature of this study and give written informed consent.
Ability to give informed consent; all subjects >= 18 years of age must be able to give informed consent; for subjects < 18 years old their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 7 years of age, when appropriate
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Ability to understand and the willingness to sign an informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Informed consent cannot be obtained either from the patient or legal representative
Documented informed consent of participant and/or legally authorized representative
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Written informed consent has been obtained
Informed and must sign and give written informed consent in accordance with institutional and federal guidelines
Provided written informed consent and HIPAA authorization for release of personal health information, approved by an Institutional Review Board (IRB). NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Any mental or medical condition that prevents the subject from giving informed consent or participating in the trial.
Patients must have the psychological ability and general health that permits informed consent, completion of the study requirements, and required follow up
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Written informed consent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) guidelines
Inability or unwillingness of legal guardian/representative to give written informed consent
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Provision of informed consent
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
For inclusion in optional genetic research, the patient must provide a written informed consent for genetic research.
Written informed consent prior to any procedure.
Patient must sign an informed consent document indicating that they are aware of the investigational nature of this study, which includes an authorization for the release of their protected health information
Patient and/or legal guardian must sign informed consent for HSCT.
Ability to understand and the willingness to sign a written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Patients with mental deficits and/or psychiatric history that preclude them from giving informed consent or from following protocol
Subjects or their legally authorized representative must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and federal guidelines
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
The patient has given written informed consent after the nature of the study and alternative treatment options have been explained
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Informed consent provided
Provides written informed consent on the approved informed consent form
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Patient or parent/guardian capable of providing informed consent
Patient or parent/guardian capable of providing informed consent
All subjects must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the NCI, POB screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agrees
Paediatric patients aged 2 years to <18 years at the time of informed consent
Patients, parents/guardian(s), legally authorized representative (LAR), or durable power of attorney must be able to give consent and sign the informed consent document; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 7 years of age, when appropriate
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Patients must give voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization before performance of any study-related procedure not part of normal medical care with the understanding that consent maybe withdrawn by the subject at any time without prejudice to future medical care
ELIGIBILITY FOR SCREENING: Informed consent (and assent as applicable) obtained from patient/guardian
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Voluntary written consent must be given before performance of any study-related procedures not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
No written consent of the patient or his/her parents or legal guardian
Informed consent must be obtained from all patients prior to beginning therapy, including consent for mandatory tissue submission for ERCC1 staining (and p16 staining if not locally conducted); patients should have the ability to understand and the willingness to sign a written informed consent document
Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients or their guardians will be given a copy of the consent form
All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care
Written informed consent provided.
All participants and/or their parents or legal guardians must sign a written informed consent
Unwillingness to give written informed consent
Patient must be at least 18 years old at the time of consent.
Must be capable of giving consent to participate in the study
Patients who give a written informed consent obtained according to local guidelines
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Provided written informed consent
Has provided written informed consent for participation in this trial
Cognitively impaired patients who cannot give informed consent and do not have a legal guardian
Subject has provided written informed consent
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
The patient or their legal guardian must give their informed consent
Willing to give informed consent\r\n* A parent or guardian must be available for giving consent for pediatric subjects under 18 years of age
Ability to understand and the willingness to sign a written informed consent document. Patients with Impaired Decision Making Capacity (IDMC) can have a Legally Authorized Representative sign on their behalf. Documentation, such as a Power of Attorney, must be presented in order for a substitute decision maker to be allowed
Willing and able to provide written informed consent (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment.
Inability or unwillingness or research participant or legal guardian/representative to give written informed consent
Ability to give written informed consent
Have the capacity to give informed consent
All subjects must have the ability to understand and the willingness to sign a written informed consent; they are to give voluntary written informed consent before performance if any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care; cognitively impaired subjects will be included only if their guardian or legal representative agrees to sign the written informed consent
Signed written informed consent: voluntary written consent must be given before performance of any study-related procedure not part of standard medical care
Subjects given written informed consent
Give informed consent
Refuses to give informed consent
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the Unites States of America [USA] only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Subjects must be willing and able to provide informed consent. For patients < 18 years of age, their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document; for subjects < 18 years old their legal guardian must give informed consent; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 7 years of age, when appropriate
Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Unable to give informed consent
For inclusion in the optional PGx research, patients must provide informed consent for the genetic sampling and analyses.
Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
Men and women ?18 years old on the day of signing informed consent.
Written informed consent and authorization for release of personal health information obtained according to local laws.
Provision of written informed consent
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. This will be assessed by the consenting physician using general questions as outlined in Etchell’s 1999 publication titled Assessment of Patient Capacity to Consent to Treatment. These are general conversation based questions that assess the patient’s ability to understand the medical problem, proposed treatment, alternatives to proposed treatment, and understand the consequences of the medical choices
The subject (or legally acceptable representative if applicable) provides written informed consent for the trial. The subject may also provide consent for future biomedical research. However the subject may participate in the main trial without participating in future biomedical research.
Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation.
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Ability to understand the nature of this trial and give written informed consent.
All patients >= 18 years of age must sign a written informed consent; for patients < 18 years old, the patient’s parents or legal guardians must sign a written informed consent, unless the patient is an emancipated minor; childhood assent, when age appropriate as per institutional guidelines, should be signed by the participating patient
Informed consent for participation
Written informed consent must be obtained from the patient.
Documented informed consent of participant and/or legally authorized representative
Written informed consent.
All patients and/or a legal guardian must sign institutionally approved written informed consent and assent documents
Written informed consent and authorization obtained from the subject/Health Insurance Portability and Accountability Act (HIPAA)-appointed legal representative prior to performing any protocol-related procedures including screening evaluations
Patient has a psychiatric illness that would prevent the patient or legal guardian or representative from giving informed consent and/or assent.
Have the capacity to give informed consent
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks and benefits of the study; all patients and/or their parents or legal guardians must sign a written informed consent
Have provided written informed consent
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
Patients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Patients must be capable of understanding and providing a written informed consent
Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy.
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
Informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information obtained
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
Subject is 1 to < 21 years of age at the time of signing the Informed Consent Form/Informed Assent Form (ICF/IAF).
Subjects must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and federal guidelines.
At least 18 years old at the time of informed consent
All participants and/or their parents or guardians must sign a written informed consent.
Must have provided written informed consent prior to participating in any study-related activity.
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
Written informed consent in accordance with federal, local, and institutional guidelines
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
Subjects must give informed consent according to the rules and regulations of the individual participating sites.
Written informed consent.
Understand and able to willingly provide voluntary written informed consent, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
Patient is ? 18 years old at the time of informed consent.
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Written informed consent
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information
Have provided written consent for protocol directed biopsies
Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation
Patients or appropriate legally authorized representatives must possess the ability to give informed consent
Documented informed consent of the participant or legally authorized representative
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Inability to understand or give an informed consent
Voluntary written consent
DONOR: Documented informed consent per local, state and federal guidelines
Written, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) guidelines
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Patients must be informed of investigational nature of this study and must be willing to give written informed consent in accordance with institutional and federal guidelines. Patients must be able to comply with the requirements and assessments of the study protocol
Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. However, the Investigator should not repeat procedures that are performed as part of standard of care (SOC), if they are within the screening window and are done prior to signing the informed consent form (ICF)
Voluntary signed informed consent before performance of any study related procedure not part of normal medical care indicating that the patient is aware of the investigation and nature of this study in keeping with institutional policies and with the understanding that the consent may be withdrawn with the subject at any time without prejudice to future medical care
Written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of protected health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Have provided written informed consent.
Ability to give informed consent
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; provision of informed consent prior to any study procedures\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Signing of the Informed Consent Form
Psychiatric disorder that would preclude patients from signing an informed consent
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
PRE-SCREENING: Written informed consent for prescreening
FULL STUDY INCLUSION CRITERIA: Written informed consent for full study
Ability to give informed consent and comply with the protocol
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information. Patients must be registered prior to treatment on study.
Provision of genetics research informed consent
All patients must be capable to voluntarily sign an informed consent indicating that they are aware of the investigational nature of this study prior to registration
Voluntary written consent
Patient, or patient's authorized representative, must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements
Inability to give voluntary informed consent
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the subject/legal representative prior to performing any protocol-related procedures
Provide informed consent for genetic sampling and analyses
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
All participants will undergo standard written informed consent procedures as dictated by the City of Hope Human Research Protections Office prior to performing any screening procedures that are not part of standard-of-care; informed consent will be obtained by the principal investigator, collaborating investigators, or other Institutional Review Board (IRB) designated personnel who will meet the training requirements established by the IRB; with the support of research personnel, he/she will explain the nature, duration, purpose of the study, potential risks, alternatives and potential benefits, and all other information contained in the informed consent document; in addition, they will review the experimental subject's bill of rights and the Health Insurance Portability and Accountability Act (HIPAA) research authorization form; prospective research participants will be informed that they may withdraw from the study at any time and for any reason without prejudice; prospective research participants will be afforded sufficient time to consider whether or not to participate in the research
CELL PROCUREMENT: Written informed consent for procurement signed by subject or legal guardian of a pediatric subject and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
LYMPHODEPLETION: Written informed consent for the main study signed by subject or legal guardian of a pediatric subject
Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Documented informed consent of the participant and/or legally authorized representative
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Documented informed consent of the subject and/or legally authorized representative
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Ability to understand and the willingness to sign a written informed consent that is consistent with International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) guidelines
Voluntary written informed consent
Subject or subject's legally acceptable representative has provided informed consent.
Written informed consent obtained prior to biopsies and blood samples
Written informed consent obtained prior to biopsies and blood samples
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Patients must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of 8 weeks of their last dose of ixazomib in the parent study or as agreed by the Millennium clinician/designee.
Willingness to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
Provision of written informed consent to participate in this investigational study
Subjects must have the ability to understand and the willingness to sign a written informed consent document and Health Insurance Portability and Accountability Act (HIPAA) consent document; voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Written informed consent must be obtained prior to enrolling in the rollover study and receiving the study treatment. If consent cannot be expressed in writing, then the consent must be formally documented and witnessed, ideally via an independent trusted witness
Must be capable of providing informed consent
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate will be obtained according to institutional guidelines
Inability to give informed consent
Patients who give a written informed consent obtained according to local guidelines
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the study specific informed consent or another consent, such as the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agrees
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Patient and/or legal guardian must sign informed consent for BMT
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
All patients must have provided informed consent for correlative studies
Written informed consent obtained prior to any study-related procedure being performed.
Signed written informed consent including Health Insurance Portability and Accountability Act (HIPAA) according to institutional guidelines
Legal guardians must sign an informed consent indicating that they are aware of this study, the possible benefits, and toxic side effects; legal guardians will be given a signed copy of the consent form
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Patients must give documented informed consent to participate in this study
Subject/parental/guardian permission (informed consent), and child assent for subjects >= 7 years
PART 2 GROUP 1 INCLUSION CRITERIA: All subjects or a parent/guardian must sign written informed consent
PART 2 GROUP 2A INCLUSION CRITERIA: All subjects or a parent/guardian must sign written informed consent
PART 2 GROUP 3 INCLUSION CRITERIA: All subjects or a parent/guardian must sign written informed consent
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Patients or parents/legal guardian must be able to give informed consent
mCRPC EXPANSION COHORT: Patient must be capable of understanding and complying with protocol requirements and is willing to give informed consent
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Written informed consent
Written informed consent for transplant
Unable to give informed consent
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All subjects must have the ability to understand and the willingness to sign a written informed consent; they are to give voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Any psychiatric disorder that prohibits obtaining informed consent
Informed consent
Patients or their legally authorized representative must have the ability to understand and provide signed informed written consent
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
The subject must be deemed competent to give informed consent
The subject is cognitively impaired, and unable to give informed consent
ability to consent
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Patient must willingly provide written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
PRIOR TO CELL PROCUREMENT: Informed consent explained to, understood by and signed by the patient or legal guardian for pediatric patients; patient and/or legal guardian given a copy of informed consent form for procurement
PRIOR TO LYMPHODEPLETION: Informed consent explained to, understood by and signed by the patient or legal guardian for pediatric patients; patient and/or legal guardian given a copy of informed consent form
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Has given written consent to participate in the study.
Voluntary written consent before any research related procedures or therapy
Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Subject has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital
Voluntary written consent
Patients unable to comprehend and give informed consent are excluded
Ability for patient (and if applicable parent or legal guardian) to understand and the willingness to sign a written informed consent document, or for a parent or legal guardian to give assent for those cases where a very young patient is unable to understand or sign the consent
Gives voluntary informed consent
Subject is capable of understanding the informed consent process
Written informed consent is given
All participants and/or their parents or legally authorized representatives must sign a written informed consent; assent will be obtained for all participants under the age of 18 years
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Ability to give informed consent
The subject has been fully informed about the study and has signed the informed consent form and, where appropriate, Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Patient has given written informed consent.
Unwilling or inability to give informed consent
Inability to obtain informed consent from patient or surrogate
Patients must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Informed consent
Written and voluntary informed consent
Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved
Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
Have signed an informed consent indicating that the patient is aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, possible alternative therapies, potential benefits, side effects, risks, and discomforts
Written informed consent
Written informed consent from patient or legal representative
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration; NOTE: HIPAA authorization may be included in the informed consent or obtained separately; subject must have the ability to understand and willingness to sign the written informed consent document
Sign Subject Information Sheet and Informed Consent Form
Capable of understanding and complying with the protocol requirements and has signed the informed consent document; voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
Patient, or the patient’s legal representative, has voluntarily agreed to participate by giving written informed consent
DONOR: Written informed consent
Patients must have the ability to give informed consent
Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines; patient must sign an informed consent document indicating that they understand the purpose of and procedures required for the study, and are willing to participate in and comply with the guidelines of the study
Inability to understand or give an informed consent
All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patient
Cognitive impairment that precludes a patient from acting as his or her own agent to provide informed consent
Subjects unable to give informed consent
Subject has provided informed consent
Have the ability to understand, and have given written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients must be informed of the investigational nature of this study and must sign and\\ give written informed consent in accordance with institutional and federal guidelines
Written and signed informed consent from the parent(s) or legal representative (guardian) and assent from the minor participant. Written informed consent from subjects ?18 years.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Ability to give written informed consent
Patient understands the nature of the procedure, is willing to comply with associated follow–up evaluations, and provide written informed consent prior to the procedure
Age ? 18 years with the capacity to give written informed consent
Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent will be obtained, when appropriate, according to institutional guidelines
All subjects and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Ability to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
A written informed consent MUST be obtained from the patients and/or their parents/legal guardians prior to enrollment indicating their awareness of investigational nature of this study
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Ability to give informed consent
Subjects must be willing and able to provide written informed consent for the trial and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of protected health information\r\n* NOTE: HIPPA authorization may be included in the informed consent or obtained separately
Voluntary written consent with appropriate parent/guardian consent and minor information sheet for participants < 18 years of age
Unable to give informed consent
Has any mental or medical condition that prevents the patient from giving informed consent
All patients and/or their parents or legally authorized representatives must sign a written informed consent.
Ability to consent to treatment - patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
Patients must give informed consent
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Subjects must give written informed consent to participate in this trial
Patient and/or parents or authorized legal representative have signed a written informed consent/assent per institutional guidelines
Patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent obtained
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
Ability to understand and the willingness to sign a written informed consent document and consent to the serial nature of the proposed Personalized ANtibodies for Gastro-Esophageal Adenocarcinoma (PANGEA) treatment with first, second and third line therapy as tolerated
Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
Provision of written informed consent
Consent: all patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
All research participants must have the ability to understand and willingness to sign a written informed consent or age appropriate assent for pediatric patients\r\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
All subjects must have the ability to understand and the willingness to sign a written informed consent\r\n* Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
All research participants must have the ability to understand and the willingness to sign a written informed consent\r\n* Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent in processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Inability to give informed consent or lacks decision making capacity
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Willing to sign an informed consent form, indicating awareness of the investigational nature of this study that is in keeping with the policies of the institution.
Written voluntary informed consent
Patient has voluntarily agreed to participate by giving written informed consent/assent for the trial
Patients must have the ability to give informed consent
Participant has the ability and the willingness to sign the informed consent document (for adults only, for participants with mild cognitive abilities may use a legally authorized representative)
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care
Patient or patient’s legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant’s age is at least seven and less than eighteen years
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
Patients must have the ability to understand the study, its risks, side effects, potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
The recipient and/or the recipient's legal guardian must have been informed of the investigational nature of this study and have signed a consent form which is in accordance with Federal guidelines
Capable of providing informed consent
Ability to comprehend and willing to sign an informed consent, assent obtained from minors
Patients must be aware of the investigational nature of the therapy and provide written informed consent
Written informed consent is given
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study
Patient capable of giving informed consent
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written voluntary informed consent
Clinical performance status of ECOG 0-2 within 30 days of signing informed consent (Turnstile II)
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Patient capable of giving informed consent
Patient or patient’s legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant’s age is at least seven and less than eighteen years
RECIPIENT: Ability of subject or legally authorized representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study or written informed consent obtained from parent or legal guardian if subject is a minor
Written, informed consent according to institutional guidelines
Subjects given written informed consent
Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients or their guardians will be given a copy of the consent form
Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Capable of informed consent
Written informed consent obtained prior to enrolling in roll-over study and receiving study medication • If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness
Legal guardians must sign an informed consent indicating that they are aware of this study, the possible benefits, and toxic side effects; legal guardians will be given a signed copy of the consent form; note: for inclusion on biology studies after enucleation, the patient or his/her legal guardian, as appropriate, must provide written informed consent for SJRET6 protocol within 60 days of the removal of the tissue (eye) sample
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Written informed consent in accordance with federal, local, and institutional guidelines
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
Ability to give informed consent
Patient has voluntarily agreed to participate by giving written informed consent
Patients must be aware of the investigational nature of the therapy and provide written informed consent
Patients must be able to give informed consent; parent or legal representative will be asked to consent for patients younger than 18 year old
Patients must give documented informed consent to participate in this study
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of MD Anderson Cancer Center (MDACC)
All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
Patient should be able to provide signed written informed consent; before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel; written consent will include a Health Insurance Portability and Accountability Act (HIPAA) form according to institutional guidelines
There will be no upper age limit for eligibility; elderly patients will be eligible for participation provided they are competent to provide informed consent, or written consent can be provided by their duly appointed healthcare proxy
Patients must voluntarily sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
Patients unable to give informed consent for the study will be excluded
Capability of providing informed consent
Inability to grant informed consent
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must have signed an authorization for the release of their protected health information at all sites except the National Institutes of Health (NIH)
Inability to understand or give an informed consent
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; Note: HIPAA authorization may be included in the informed consent or obtained separately
Have mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.
All patients must have a surgical and medical oncology consult prior to signing informed consent
Inability to obtain informed consent
Ability to understand and the willingness to sign a written informed consent document; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Provision of written informed consent
Written voluntary informed consent
Psychiatric disorder that would preclude patients from signing an informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
Subjects given written informed consent
Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients or their guardians will be given a copy of the consent form
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
Patients, parents/guardian(s), legally authorized representatives (LAR), or durable power of attorney must be able to give consent and sign the informed consent document; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 12 years of age, when appropriate
Recipient must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
Informed consent
Have provided informed consent
Ability to give informed consent
Written voluntary informed consent
Must have the capacity to give informed consent
Written informed consent by patients and/or their parents or legal guardians; assent for those patients inclusive of ages 12 to 17
Patients with psychiatric or addictive disorders that would preclude obtaining informed consent
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Inability to give informed consent or assent
Patients must be capable of informed consent
The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policies approved by the United States (U.S.) Department of Health and Human Services; informed consent must be signed prior to registration on study
Recipients will sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Psychological condition that renders the patient unable to understand the informed consent
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care
Subjects must sign a written informed consent in accordance with institutional guidelines
Patients must demonstrate the ability and willingness to give informed consent.
Subject (or legal guardian) must sign a written informed consent in accordance with institutional guidelines
Informed consent must be obtained
Ability to give informed consent
Signed informed consent form by patients and/or patients' parents/legal guardians and age appropriate assent form by the patients obtained before any study specific procedure
Subject must be >=18 years of at the time of signing the informed consent.
Informed consent: All participants and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines. Participants must be willing to comply with all aspects of the protocol.
Informed Consent
Written informed consent obtained prior to any study-related procedure being performed;
Voluntary written consent (adult or legally authorized representative; or parental/guardian)
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
Written informed consent for the trial
Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Provision of informed consent prior
Patients must give informed consent
Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Subject is ? 18 years of age at the time of signing the informed consent form (ICF)
Written informed consent prior to admission to this study
Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.
Patients must consent to be in the study and sign an approved consent form conforming with institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent that is consistent with International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice guidelines
Patients must give written informed consent prior to registration on the study
Inability to give informed consent
Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; note: HIPAA authorization may be included in the informed consent or obtained separately
Informed consent
Cognitive impairment such as to preclude informed consent
Patients must be capable of understanding of the nature of their disease and willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
Patients, or legal guardians, and donors must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects
Written informed consent
Written informed consent
Unwillingness or inability to given written informed consent.
Cases involving subjects who are minors, pregnant or require an authorized representative for informed consent
Subjects who are ?18 years of age on the date of written informed consent.
Subjects who have voluntarily agreed to participate by giving written informed consent.
All patients and/or their parents or legal guardians must sign a written informed consent
102 Age ? 18 at the time of informed consent.
Written informed consent and authorization for release of personal health information obtained according to local laws.
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Adults capable of giving informed consent.
Documented informed consent of the participant and/or the legally authorized representative
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
Ability to understand and the willingness to sign a written protocol specific informed consent for tissue harvest or a parental/guardian informed consent and pediatric assent when appropriate.
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Voluntary written consent
Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
Written informed consent in accordance with institutional guidelines.
Patient is capable of giving informed consent
Voluntary written consent
Documented informed consent of the participant and/or legally authorized representative
Voluntary written consent (adult or parental/guardian)
DONORS: Voluntary written consent prior to the performance of any research related procedure
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Written informed consent
Ability to consent
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration for protocol therapy\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Ability to give informed consent and comply with the protocol
Each patient must be aware of the nature of their disease and must willingly consent to treatment after being informed of alternatives, potential benefits, side effects, and risks
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Written informed consent according to institutional guidelines, and
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
Written informed consent provided
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for the release of personal health information \r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
Subjects or their legal guardian must sign a written informed consent in accordance with institutional guidelines
The subject must be deemed competent to give informed consent
The subject is unable to give informed consent
The subject is cognitively impaired, and unable to give informed consent
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
All patients or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All patients and/or their parents or legal guardians must sign a written informed consent
Patient has given voluntary written informed consent before performance of any study-related procedures not part of standard (non-investigational) medical care
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Informed consent and assent obtained as appropriate
All patients and/or their parents or legal guardians must sign a written informed consent
History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent (Note: Consent may not be obtained by means of a legal guardian)
Patients must give informed consent
Voluntary written consent
Inability to give voluntary informed consent or obtain a parent or guardian’s informed consent
Informed consent
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
All patients and/or their parents or legal guardians must sign a written informed consent
Written informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization for release of personal health information
Patients must sign an informed consent document that indicates they are aware of the investigative nature of the treatment in this protocol as well as the potential risks and benefits
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
Patient (or his or her legally accepted representative) has provided written informed consent to participate in the study
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Signed informed consent to participate in the study, including participation in the expansion cohort after safety of enzalutamide and gemcitabine and cisplatin have been established, must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information
All patients and/or their parents or legal guardians must sign a written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
Not willing to follow protocol requirements or to give informed consent
Ability to give written informed consent
Any history of HIV-1 associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)
All patients and/or their parents or legal guardians must sign a written informed consent
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Signed, written informed consent in accordance with federal, local, and institutional guidelines
All patients and/or their parents or legal guardians must sign a written informed consent
Written informed consent in accordance with federal, local, and institutional guidelines
Any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines; patients must be willing to comply with all aspects of the protocol
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Untreated psychiatric conditions preventing informed consent
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Voluntary written informed consent
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Capable of giving written informed consent
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
Unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent
DONOR: Donors able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
DONOR: Persons unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent
Voluntary written consent
Informed consent and assent (as applicable) obtained from parent/guardian and child
Signed written informed consent; patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Patients unable to comprehend and give informed consent are excluded
Ability to understand and willingness to provide informed consent, and the willingness to comply with the requirements of the protocol; informed consent may be obtained with the assistance of a medical translator according to institutional policies
Inability to understand or give an informed consent
Patients unable to comprehend and give informed consent are excluded
Subjects must be willing to give written informed consent per institutional guidelines and must be able to adhere to dose and visit schedules
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Ability to give informed consent; for subjects < 18 years old their legal guardian must give informed consent; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those >= 12 years of age, when appropriate
Voluntary written consent
Inability to understand the investigational nature of the study to provide informed consent
Ability and willingness to participate in the informed consent process and including signing a copy of the informed consent form
Patient’s written informed consent
Must sign informed consent, witnessed, and dated prior to entry
Ability to give informed consent; for patients < 18 years of age their legal guardian must give informed consent; pediatric patients will be included in age-appropriate discussion in order to obtain verbal assent\r\n* Durable power of attorney form completed (patients >= 18 years of age only)\r\n* Female patients (and when relevant their male partners) must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential
Patients must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules
Inability to obtain informed consent because of psychiatric or complicating medical problems
Subject must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
Subject must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
Ability to give voluntary informed consent and to comply with treatment and required tests
All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Ability to give written informed consent and willingness to comply with the requirements of the protocol
Patients must give documented informed consent to participate in this study
Inability to understand or give an informed consent
Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines
Patients must be informed of the investigative nature of the treatment, must give appropriate informed consent to protocol procedures and must sign an Informed Consent documentation form
Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients or their guardians will be given a copy of the consent form
Informed consent must be obtained from all subjects prior to beginning therapy
All participating patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota Committee on the Use of Human Subjects in Research
Ability to understand and the willingness to sign a written informed consent document; voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care
Inability to give informed written consent
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Unable to give informed consent
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for all patients the appropriate consent form for this registration is the Step 2 Consent
Inability to give informed written consent
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\r\n* Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Aged ?18 years at signing of informed consent.
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent prior to any study-related procedures in accordance with institutional and federal guidelines
Male or female is 1 to ? 18 years of age at the time of signing the Informed Consent Form / Informed Assent Form (ICF/IAF).
Venous thromboembolism within 6 months prior to signing Informed Consent Form.
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Lack of parents'/guardian's informed consent for children who are minors.
Patients must be able to provide voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Written informed consent
Written informed consent and/or assent from patient, parent or guardian.
Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines
Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Subject is male or female, ? 18 years old at the time of signing the informed consent form (ICF).
Aged ?18 years at signing of informed consent
Written informed consent
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document
Patients must have the ability to understand and sign an approved informed consent and authorization permitting release of personal health information
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Subject is ? 18 years of age at the time of signing the informed consent form (ICF)
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Able and willing to give voluntary, written and signed informed consent before any screening procedure and according to local guidelines
Ability to read and understand the informed consent form and willingness and ability to give informed consent and demonstrate comprehension of the trial before undergoing any trial activities
Mentally incompetent or unable or not willing to give written informed consent or meet study requirements
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Written Informed Consent
Subject is considered an adult according to local regulation at the time of signing informed consent.
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is less than 18 years old, an Assent form and parental/guardian Consent form (replacing \you will\ with \your child will\ will be required).
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Matched Related Donor: Capable of giving written, informed consent
Age ? 18 at time of informed consent
Patients must sign a written informed consent prior to entering the study.
Written informed consent for the transplant phase
Subject has voluntarily agreed to participate by giving written informed consent
Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
have undergone ASCT within the period ? 3 months prior to signing the informed consent form.
Subjects must be ?18 years of age at the time of signing the Informed Consent Form (ICF);
Written informed consent to participate in this study before the performance of any study-related procedure
Written informed consent
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Written, informed consent and assent following guidelines of the Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP)
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
All patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelines
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients and/or their parents or legal guardians must sign a written informed consent
Subject must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained; and
Voluntary written consent given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Informed Consent Signed informed consent according to institutional guidelines must be obtained. Assent, when appropriate, will be obtained according to institutional guidelines.
All subjects or their legally authorized representative must be informed of the investigational nature of the study and provide written informed consent and HIPAA authorization for release of personal health information before performance of any study related procedure not part of routine medical care. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
Patient is an adult male/female ? 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. Female patients must be postmenopausal.
Patient must give written informed consent
Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Written informed consent is given
Obtained written informed consent
Written informed consent must be obtained before any assessment is performed.
Able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for all patients, the appropriate consent form for this registration is the Step 2 Consent Form
Diagnosis of psychiatric or addictive disorders that would preclude obtaining informed consent
Written informed consent to participate in this study
Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Provided written consent
Inability to understand or give an informed consent
Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of University of Texas M.D. Anderson Cancer Center (UTMDACC)
Patient must give written informed consent
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Patient must be capable of understanding and complying with protocol requirements and is willing to give informed consent
Informed consent
Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects; patients or their guardians will be given a copy of the consent form
Written informed consent and HIPAA authorization for release of personal health information.
All patients and/or their parents or legal guardians must sign a written informed consent
All patients and/or their legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Documented informed consent
Written informed consent prior to any procedure
Autologous HCT < 3 months prior to the time of signing the informed consent form
MDS subjects may not receive RIC and must be < 50 years of age at the time of signing the informed consent form
Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
Subject is considered an adult according to local regulation at the time of obtaining informed consent.
Men and women ? 18 years of age, at the time of signing the informed consent form (ICF).
They or their legal guardian must give their informed consent
Written, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) Guidelines
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Ability to understand and willingness to sign a written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Capable of giving informed consent
Signed and dated written informed consent prior to admission to the study in accordance with international conference on harmonization (ICH)-good clinical practice (GCP) guidelines and to the local legislation
Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Patients must understand and willingly sign an approved informed consent, and authorization permitting release of personal health information
Ability to give informed consent
Written informed consent provided
Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Written informed consent and authorization obtained from the subject/Health Insurance Portability and Accountability Act (HIPAA)-appointed legal representative prior to performing any protocol-related procedures including screening evaluations
Patients must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care as noted above; with the exception of 1 cycle of chemotherapy based on current diagnosis and clinical condition, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Subject is ? 18 years of age or is considered an adult according to local regulation at the time of signing informed consent.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Signed, written informed consent in accordance with federal, local, and institutional guidelines
All patients and/or their parents or legal guardians must sign a written informed consent
Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Has any mental or medical condition that prevents the subject from giving informed consent or participating in the trial
Give informed consent
Refuses to give informed consent
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care
Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved
Be willing and able to provide written informed consent for the trial and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Subject has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
Any mental or medical condition that prevents the subject from giving informed consent or participating in the trial.
Written informed consent and HIPAA authorization for release of personal health information
Patient and his/her partner agree to use adequate contraception after providing written informed consent through 3 months after the last dose of PBI 05204, as follows:
Written informed consent obtained from the patient/legal representative;
All patients >= 18 years must sign a written informed consent; patients < 18 years old must provide assent, and the parent or legal guardian must sign the written informed consent
Unable to give informed consent
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Patient will read, understand and sign the informed consent and Health Insurance Portability and Accountability Act (HIPAA) agreement
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent prior to any screening procedures in accordance with institutional and federal guidelines
Subjects must give written informed consent to participate in this trial
Written informed consent must be obtained
Written informed consent
Written informed consent obtained from the patient/legal representative
Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines to ensure compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Written informed consent in accordance with federal, local, and institutional guidelines
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Written informed consent in accordance with federal, local, and institutional guidelines
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Patients must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation
Informed consent must be signed prior to the treatment; patients must willingly consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side effects, risks and\r\ndiscomforts; (human protection committee approval of this protocol and a consent form is required)
Ability to understand the nature of this study and give written informed consent.
Written informed consent in accordance with federal, local, and institutional guidelines
Voluntary written informed consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Written informed consent in accordance with federal, local, and institutional guidelines
Inability to give informed consent
Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Patients must have the ability to understand the study, its risks, side effects, potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
Written informed consent in accordance with federal, local, and institutional guidelines
Ability to understand and voluntarily give informed consent
All patients and/or a legal guardian must sign institutionally approved written informed consent document
Written informed consent
? 18 years at time of consent.
Psychiatric disorder that would preclude patients from signing an informed consent
Ability to understand and the willingness to sign a written informed consent document; voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Written, voluntary informed consent.
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Written informed consent and HIPAA authorization for release of personal health information. HIPAA authorization may be included in the informed consent or may be obtained separately. NOTE: Central pathology review may be conducted any time after definitive surgery. Consenting participants may be pre-registered to the study and proceed with central pathology review before full eligibility has been confirmed. However ALL of the eligibility criteria must be met and formal study registration completed prior to submission of the sample for sequencing.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Written informed consent.
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Written informed consent in accordance with federal, local, and institutional guidelines
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Voluntary written consent
Written informed consent must be obtained from all patients before entry into the study
All patients must be informed and must sign and give written informed consent in accordance with institutional and federal guidelines; patients who are unable to comply with study and/or follow-up procedures are ineligible
Provide written informed consent (Screen 1 and Screen 2)
Voluntary written consent
Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
Written informed consent
Signed written informed consent including Health Insurance Portability and Accountability Act (HIPAA) according to institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
All patients and/or their parents or legal guardians must sign a written informed consent
Patients must have the ability to understand the study, its risks, side effects, potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Willing and able to provide written informed consent and authorization for use and release of health and research study information (Health Insurance Portability and Accountability Act [HIPAA] authorization)\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Gives voluntary informed consent
Must be ? 18yrs at the time of signing informed consent.
Signed and dated written informed consent by start date of Screening visit in accordance with Good Clinical Practice (GCP) and local legislation.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients must be informed of the investigational nature of this study and must sign and give written consent in accordance with institutional and federal guidelines
Voluntary written consent
Ability to understand and voluntarily give informed consent
Patient must be capable of understanding and complying with protocol requirements and is willing to give informed consent
Patients must give voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Patient (or parents/guardians, in the case of minors) must sign an informed consent document indicating that they are aware of the investigational nature of this study, which includes an authorization for the release of their protected health information
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Informed consent
All patients must sign a consent form indicating that they are aware of the investigational nature of the study; the informed consent form will indicate that the patient has been made aware of all other appropriate therapies
Patient should be able to provide signed written informed consent:\r\n* Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel\r\n* Written consent will include a Health Insurance Portability and Accountability Act (HIPAA) form according to institutional guidelines
Signed written informed consent in accordance with federal, local, and institutional guidelines
Voluntary written consent
Ability and willing to give consent
? 18 years old at the time of informed consent.
Ability to give written informed consent and willingness to comply with the requirements of the protocol
Voluntary consent form
Written informed consent has been obtained
Voluntary written consent must have been given before performance of any study related procedure not part of standard medical care, with the understanding that consent may have been withdrawn by the participant at any time without prejudice to future medical care.
All patients and/or their parents or legal guardians must sign a written informed consent
Ability to give written informed consent and willingness to comply with the requirements of the protocol
Refusal or inability to give informed consent to participate in the trial
Ability to give written informed consent according to local guidelines
The patient must be willing and able to comply with all study protocol requirements. The patient or a legally authorized representative must fully understand all elements of the informed consent and have signed the informed consent according to institutional and federal regulatory requirements
Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Patient's Informed Consent. -
Written informed consent
Subject has no clinically significant co-morbidities (i.e. chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy. Subject has given written informed consent
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Able and willing to sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must be registered prior to treatment with study drug
Informed consent
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
Written informed consent
Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients must demonstrate the ability to understand the investigational nature of this study and must sign a written informed consent document in accordance with institutional and federal guidelines
Signed written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent
Written informed consent prior to registration on study
Voluntary written consent
Voluntary written consent
Inability to give informed consent
Ability to give informed consent; for recipients and donors < 18 years of age, their legal guardian must give informed consent; pediatric patients will be included in an age appropriate discussion in accordance with institutional guidelines
MATCHED RELATED DONOR: Age >= 2 and =< 60 years old and able to give consent or assent; for donors < 18 years old, the legal guardian must be able to provide informed consent and an evaluation by a licensed social worker (LSW) or psychiatric personnel will be needed to determine willingness to participate; pediatric patients will be included in an age appropriate discussion in accordance with institutional guidelines
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Written and voluntary informed consent
Patient must be capable of, and must voluntarily agree to participate by giving written informed consent
The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Inability to understand or give an informed consent
Has given written Informed Consent
Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information
Patients must give written informed consent
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved
Ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Voluntary written informed consent
Willing to provide voluntary written informed consent before performance of any study related procedure not part of normal medical care
Written, voluntary informed consent
Written informed consent in accordance with federal, local, and institutional guidelines; the patient must provide informed consent prior to the first screening procedure
Written informed consent
Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
Voluntary written consent
Subjects must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Psychiatric or addictive disorders that would preclude obtaining informed consent
Any medical condition, that would prevent the subject from signing the informed consent form.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Signed Written Informed Consent\r\n* Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel\r\n* Written consent will include a Health Insurance Portability and Accountability Act (HIPAA) form according to institutional guidelines
Written informed consent and assent as is age appropriate
Patient or parent/guardian capable of providing informed consent
Ability to understand the investigational nature of this study and to give informed consent
Written informed consent
Written informed consent according to institutional guidelines
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Inability to understand or give an informed consent
All patients must sign an IRB approved informed consent indicating their awareness of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
Ability to understand informed consent and signing of written informed consent document prior to initiation of protocol therapy
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital
Ability to give voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n*NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Inability to give voluntary informed consent or guardian’s informed consent
Subjects must be able to understand and be willing to sign the written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. A signed informed consent form (ICF) must be appropriately obtained prior to the conduct of any trial-specific procedure. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Ability to give informed consent
Written, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) guidelines
Inability or unwillingness or research participant or legal guardian/representative to give written informed consent
Written Informed Consent
Written informed consent must be provided.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Ability to give informed consent
Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks and benefits of the study. All patients and/or their parents or legal guardians must sign a written informed consent.
All subjects must have the ability to understand and the willingness to sign a written informed consent; they are to give voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Written informed consent/assent before any study-specific screening procedures. For pediatric patients, consent will be obtained from parent(s) or legal guardian(s) and the signature of at least 1 parent or guardian will be required. Investigators will also obtain assent of patients according to local, regional or national guidelines.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
Written informed consent in accordance with federal, local, and institutional guidelines
Able to give informed consent, or their legally authorized representative can give informed consent
Psychiatric disorder that would preclude patients from signing an informed consent
Any condition that may compromise the ability to give written informed consent or to comply with the study protocol.
Each patient must be aware of the nature of her disease process and must willingly consent to treatment after being informed of alternatives, potential benefits, side effects, and risks; eligibility testing that is considered standard of care may be done prior to informed consent but no immunotherapy related procedures or testing may occur without informed consent
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Competent to give informed consent
Study subjects must sign an approved informed consent and authorization permitting release of personal health information
Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).
Psychiatric conditions/diseases that impair the ability to give informed consent or to adequately co-operate
Patients must give documented informed consent to participate in this study
Written informed consent
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Patients must be informed of the investigational nature of this study and sign written informed consent in accordance with institutional and federal guidelines
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Patients must sign an informed consent form approved for this purpose by the IRB of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks
Must have provided informed consent for study participation.
Able and willing to sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Ability to understand the nature of this study and give written informed consent.
Patients must give informed consent
Ability to understand the nature of this trial and give written informed consent
Subject (and/or parent/guardian for subject who otherwise is unable to provide independent consent, if acceptable to and approved by the site and/or site's IRB) must be willing to give written informed consent and be able to adhere to dose and visit schedules.
Ability to give informed consent
Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines
Provision of written informed consent
Ability to give informed consent; for patients < 18 years of age their legal guardian must give informed consent; pediatric patients will be included in age-appropriate discussion in order to obtain verbal assent
Patient or patient’s legal representative, parent(s) or guardian able to provide written informed consent for the long-term follow-up gene therapy study 2006-0676
Written informed consent or assent
Voluntary, written informed consent.
Patients must have the ability to understand and voluntarily sign a written informed consent; if an unexpected non-English speaking patient or if an illiterate patient is encountered, current Institutional Review Board (IRB) guidelines on obtaining informed consent will be followed; a voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Has given written informed consent.
Patients must voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
Lack of ability or willingness to give informed consent
Voluntary written informed consent
Patients capable of providing written, informed consent
Written informed consent
Patient must understand and voluntarily sign an informed consent form, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care
The subject must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital.
Subjects must give written informed consent to participate in this trial
Voluntary written consent
Able to provide voluntary written informed consent, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients, or their legal guardians, must sign a written informed consent in accordance with institutional guidelines
Written informed consent to participate in this study before the performance of any study-related procedure
Patient (or legal representative where appropriate) must be capable of providing written informed consent.
Patient is capable of giving informed consent.
Patient is an adult, female ? 18 years old at the time of informed consent
Written informed consent which is consistent with International Conference on Harmonization, Good Clinical Practice (ICH-GCP) guidelines and local legislation.
Written informed consent and HIPAA authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
All patients and/or their parents or legal guardians must sign a written informed consent
Men and women ? 18-years-old on the day of signing informed consent.
Informed consent
Willingness to sign informed consent by patient or patient’s legal representative
Research participant or legal guardian/representative must be willing to give written informed consent
Willing and able to understand and provide written informed consent. For minors or those incapable of providing written informed consent (i.e., incapacitated), understood, written and informed consent must be provided by a parent or legal guardian or representative.
Patient or his or her legal representatives must give written informed consent and privacy authorization prior to participation in the study.
Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.
Ability to give written informed consent and willing to comply with the requirements of the protocol; and for Part 3, to give written informed consent for 2 cancer biopsy procedures
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study
Inability to give an informed consent
Patients must have the ability to give informed consent
Patients must have the ability to give informed consent
Written informed consent in accordance with federal, local, and institutional guidelines
Unable to give informed consent
Inability or unwillingness or research participant or legal guardian/representative to give written informed consent
Research participant or legal guardian/representative is able and willing to give written informed consent
Patient must have the ability to give written informed consent
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Written informed consent that is consistent with ICH-GCP guidelines and local regulations
Written informed consent;
REGULATORY CRITERIA: Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Provision of written informed consent
patient had given written informed consent.
All patients and/or their parents or legal guardians must sign a written informed consent
Written informed consent obtained before undergoing any study-related activities
Has provided written informed consent prior to any study related activities.
Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
Subject has provided informed consent or subject's legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
Has the subject given written informed consent?
Written informed consent provided.
The subject has read and understood the written informed consent form (ICF) and is willing and able to give informed consent, fully understands the requirements of the trial and is willing to comply with all trial visits and assessments, including completion of patient-reported measures. Consent must be given before any trial related activities.
Patient is an adult ? 18 years old at the time of informed consent.
Has provided written informed consent
Provision of informed consent
Voluntary signed informed consent before performance of any study-related procedure not part of normal medical care, indicating that that the patient is aware of the investigational nature of the study in keeping with the policies of MD Anderson Cancer Center (MDACC) and with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Eligible to give informed consent to participate in the study.
Voluntary written consent must be given before performance of any study-related procedure
Written informed consent has been obtained
Inability to give informed consent
Voluntary written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
Voluntary written consent must be given before performance of any study-related procedure
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients must be informed of the investigational nature of this study; patients or a legally authorized representative must sign and give written informed consent in accordance with institutional and federal guidelines
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Lack of ability or willingness to give informed consent.
Patients must sign an Informed Consent and Authorization indicating that they are aware of the investigational nature of this study and the known risks involved
All patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelines
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Willingness to consent to research biopsy
Patients who give a written informed consent
Written voluntary informed consent: the patient is capable of complying with the requirements of the written Informed Consent Form and complying with protocol requirements
Cognitive impairment sufficient to render the patient incapable of giving informed consent
Written informed consent in accordance with federal, local, and institutional guidelines
Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
Written informed consent - a signed informed consent and/or assent (as age appropriate) for study participation including PK sampling will be obtained according to institutional guidelines.
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines.
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients or their legal guardians (if the patient is < 18 years old); when appropriate, pediatric patients will be included in all discussions; this can be accomplished through one of the following mechanisms: a) the NCI, POB screening protocol, b) an Institutional Review Board (IRB)-approved institutional screening protocol or c) the study-specific protocol; documentation of the informed consent for screening will be maintained in the patient’s research chart; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for baseline values even if the studies were done before informed consent was obtained
Unable to give informed consent
All subjects must have the ability to understand and the willingness to sign a written informed consent; only lucid patients qualified to consent to neurosurgical procedure will be approached for participation in this study
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
Written informed consent in accordance with federal, local, and institutional guidelines.
Signed informed consent according to institutional guidelines must be obtained; assent, when appropriate, will be obtained according to institutional guidelines
Voluntary written informed consent before performance of any study-related procedure not part of routine medical care with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Voluntary written consent
Ability to give written informed consent.
Written informed consent.
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
Written informed consent which is consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation.
Subjects willing and able to give written informed consent to participate in the study and to adhere to the procedures stated in the protocol, or legally acceptable representative willing and able to give written informed consent on behalf of the subject for minors, unconscious adults and those incapable of consenting themselves due to their medical condition, or included as permitted by local regulatory authorities, IRB/IECs or local laws.
All patients and/or their parents or legal guardians must sign a written informed consent
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal regulations
Written informed consent in accordance with federal, local, and institutional guidelines
Capable of given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
The patient is >= 18 years of age at the time of signature of the first informed consent form.
Written informed consent and HIPAA authorization for release of personal health information.
Inability to give informed consent
Patient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen years
Patients must give written informed consent
Parental informed consent
Patient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen years
Because significant time will have elapsed between apheresis/tumor biopsy and the initiation of immunotherapy, all patients or their legal guardians (if the patient is < 18 years old) must sign a second informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility)
All patients or their legal guardians (if the patient is < 18 years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility; after confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility)
Inability or unwillingness of research participant or legal guardian or representative to give written informed consent
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must sign an authorization for the release of their protected health information
All patients must sign an informed consent document indicating that they are aware of the investigational nature of this study
Patient has given written informed consent which must be consistent with the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation.
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Written informed consent following institutional and federal guidelines
The patient is >= 18 years of age at the time of signature of the informed consent form.
Inability to give informed consent because of psychiatric problems, or complicated medical problems.
Provision of written informed consent.
Patients must be capable of signing an informed consent
Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from parent or legal guardian
Written informed consent obtained from subject or subject’s legal representative and ability for subject to comply with requirements of the study
Subjects must have given written informed consent to agree to participate
Documented informed consent of the participant and/or legally authorized representative
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Subjects must have given written informed consent
Informed consent and Health Insurance Portability and Accountability Act (HIPAA) signing
Voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients must be informed of the investigational nature of the study and standard alternative therapies; all patients must sign and give written informed consent in accordance with institutional and federal guidelines
Have the ability to give written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution’s policy)
Capable of providing informed consent
Women with cognitive impairment that precludes informed consent and those unable to provide consent in English
Providing informed consent
Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information \r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must sign an authorization for the release of their protected health information
PHASE I: For patients < 18 years, parents must give informed consent and patient must give assent; patients >= 18 must give informed consent
PHASE II: For patients < 18 years, parents must give informed consent and patient must give assent; patients >= 18 must give informed consent
Lack of ability to give informed consent
Ability to give informed consent
Patient must have given written informed consent according to Food and Drug Administration (FDA) guidelines
Patient or parent(s)/legal guardian(s) is able and willing to provide informed consent; assent will be obtained per local institutional policy; subjects who turn 18 during the course of the study will be consented at that time of their next visit by a member of the research staff
Informed consent
Subject has provided informed consent.
Patients must give voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Written informed consent and any locally required authorization
Subject (or legally authorized representative) has voluntarily agreed to participate by giving written informed consent in accordance with ICH GCP guidelines and applicable local regulations.
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
Ability to understand and/or the willingness of the patient (or parent or legally authorized representative, if minor) to provide informed consent, using an institutionally approved informed consent procedure
Subject understands and signs the Informed Consent
Capable of giving informed consent
Subjects given written informed consent.
Written, informed consent
Patients with obvious unresectable disease prior to signing informed consent
Written informed consent.
People unable to read and understand the informed consent document because of language difficulties
Inability or unwillingness of individual to give written informed consent
Subjects must be capable of giving informed consent
Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
Capable of giving informed consent
Subjects are capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject’s behalf
The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policies approved by the United States (U.S.) Department of Health and Human Services; informed consent must be signed prior to registration on study
Documented written informed consent of the participant
Unable to give informed consent
HSCT CGs: Able to give written informed consent
Ability to give informed consent.
Unable to give informed consent
Subjects who cannot give an informed consent
Cognitively unable to give informed consent
Patients that consent to participate
Has provided written informed consent
Receiving elotuzumab and/or other study drugs at the time of signature of informed consent
Treating oncologist consent
Patient must give informed consent for this new study
Not giving consent for study participation
DCG: Is capable of providing informed consent
Voluntary written consent
Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds)
Sign an informed consent indicating they are aware of the investigational nature of this study
Providing informed consent
Treating oncologist consent
Medical record documentation of cognitive impairment that would preclude the ability to provide informed consent
Written, informed consent
Subjects are capable of giving informed consent
Voluntary written consent
Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study
Refusal of informed consent
Must be able to give voluntary informed written consent to participate in the study; informed consent will be obtained prior to starting of remission IC (can be obtained even on the first day of remission IC if obtained before administration of chemotherapy) and before any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Voluntary written consent
Documented informed consent of the participant and/or legally authorized representative
Subjects are capable of giving informed consent.
Written informed consent
Must give written study consent
Any patient with cholestasis due to suspected MHO who provides written informed consent.
Ability to give informed consent
Each subject must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts
All patients and/or their parents or legal guardians must sign a written informed consent
This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent
Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent
Patients who are confused and unable to give informed consent
All subjects must have the ability to understand and the willingness to participate in the informed consent process, although a waiver of written informed consent is obtained for this study
Patients must give informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
Patients will have provided informed consent to participate, documented by their signature on the study consent form
All patients and/or their parents or legal guardians must sign a written informed consent
For donors < 18 years of age, their legal guardian must give informed consent, the donor must give written assent
All patients and/or their parents or legal guardians must sign a written informed consent
Written informed consent and assent as required by institutional guidelines
Able to provide informed consent or, if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (per institutional policies) must sign consent by the baseline visit
All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Properly obtained written informed consent
All patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Gives written informed consent
Gives written informed consent
Cannot give informed consent.
All patients must be informed of the investigational nature of this study and must sign and give written informed consent for aim 1 study activities in accordance with institutional and federal guidelines
Men and women with literacy as demonstrated by reading and signing informed consent form
Presence of relatively intact cognition defined by normal memorial delirium assessment scale (< 7/30); sign written informed consent
Neurocognitive deficits that impair ability to give informed consent
Inability to give informed consent
Inability to provide informed consent; potential participants will be identified by our collaborating physicians
All patients to give written informed consent to participate
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Has the ability to read and understand subject Informed Consent Form (ICF).
Ability to give informed consent
Written informed consent and Health Insurance Portability and Accountability Act of 1966 (HIPAA) authorization for release of personal health information.
Participants must be capable of understanding and complying with the protocol requirements and signing informed consent
Have the ability to understand, and have given written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Patients with psychiatric or addictive disorders that would preclude obtaining informed consent
Unable to give written informed consent
Capable of providing informed consent
Written informed consent obtained prior to any study-related procedure being performed;
Provision of written informed consent to participate in this investigational study
Patients must give informed consent according to the rules and regulations of the individual participating sites
Subjects must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules
Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q questionnaires
Written informed consent
Legally authorized representative consent
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients refusing to sign informed written consent for participation in research
All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution’s policy)
Diagnosis of dementia or unable to grant their own informed consent
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Willing to consent to participate
The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study, as has his/her responsible caregiver, if applicable
Patient must have adequate kidney function as measured by eGFR greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the PN; patient must be able to give written informed consent
Informed Consent: Each patient must be aware of the neoplastic nature of his/her disease process and must willingly sign a study-specific consent prior to randomization after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts (human protection committee approval of this protocol and consent form is required)
Adequately informed of the nature and risks of the study with written informed consent
All patients and/or their parents or legal guardians must sign a written informed consent
Written informed consent obtained in accordance with institutional policies approved by the United States (U.S.) Department of Health and Human Services
Incapable of giving informed consent
Parent or legal guardian consent
Give written informed consent
This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent
Subject or authorized representative has provided informed consent.
Participant/parent/legally authorized representative (LAR) unwilling to give written informed consent
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
Participants must be capable of providing written informed consent for study participation
People unable to read and understand the informed consent document because of language difficulties
Inability or unwillingness of individual to give written informed consent
Properly obtained written informed consent
Willingness to give informed consent
Patients unable to give informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Patients with obvious unresectable disease prior to signing informed consent
Capable of giving informed consent
Informed consent
Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
Ability to sign informed consent and understand the nature of a placebo-controlled trial
Subjects who are unable to give informed consent
Unable to give informed consent
Patients who are unable to give informed consent
Subjects capable of giving informed consent
Any patient/volunteer unable to give informed consent
Patients do not have the ability to give informed consent
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
All patients and/or their parents or legal guardians must sign a written informed consent
Patient or parent/legal guardian or representative has a psychiatric illness that would prevent the patient or parent/legal guardian or representative from giving informed consent and/or assent.
Patient or parent/legal guardian or representative lacks the full mental capacity to understand and sign a written informed consent.
Parent/legal guardian willing and capable of signing written informed consent
Written informed consent in accordance with institutional and FDA (food and drug administration) guidelines must be obtained from all subjects (or patients' legal representative).
DONOR: Ability to comprehend the investigational nature of the study and provide informed consent
Able to perform written, informed consent
Voluntarily agree to participate and read the informed consent documents
Written consent
Patients unable or unwilling to provide informed consent or sign a written informed consent document (ICD)
Signed written informed consent (patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent)
Written informed consent
Patient has been informed of the investigational nature of this study and has given written Informed Consent and is able to adhere to dosing and visit schedules and meet all study requirements
Patient or the patient's legally authorized guardian must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent in accordance with the institutional policies approved by the U.S. Department of Health and Human Services
Willingness to give informed consent
Given written informed consent (patient and donor)
Unwilling to give informed consent
A willingness to follow the study protocol, as indicated by provision of informed consent to participate
Voluntary written consent signed by the subject (or the subject’s legally authorized representative)
Subjects consent to participate in the trial
SMOKING CESSATION SUB-STUDY: Written informed consent will be obtained by trained study personnel from all participants
Written informed consent in accordance with institutional guidelines
Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them
Written signed informed consent; patients must be aware of their diagnosis and willingly consent after being informed of the investigational nature of the intervention, alternatives, potential benefits, side-effects, risks, and discomforts
Subjects who cannot give an informed consent
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
Willing to give written informed consent, adhere to the visit schedules and meet study requirements
Patients must give written informed consent to participate in this study before the performance of any study-related procedure.
Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
Subject must have provided written Informed Consent
Informed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
Written informed consent and authorization to use and disclose health information
Subject is ? 18 years of age at the time of signing the informed consent form (ICF).
Provision of informed consent by primary caregiver
Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines
Provision of informed consent
Patients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance within institutional and Food and Drug Administration (FDA) guidelines
Inability to give informed consent
Capable of informed consent
Written informed consent obtained from the subject.
Written informed consent obtained from the subject
Patients must have an ability to understand and the willingness to sign a written informed consent document; the patient is still eligible for this study even if she declines consent for her tissue to be used for any (or all) of the correlative studies described in this document and/or if she declines consent for her tissue to go into a tissue bank for future unspecified research
Signed informed consent by subject (age >= 18 years) or by parent/guardian (subject age < 18 years); information will be provided to potential subjects and their parents/guardians (as appropriate) by oral discussion with opportunity for question and answer and the written informed consent document; subjects less than 18 years of age capable of giving assent will be included in these discussions and will be asked for written assent on the same document as the parents/guardians give consent; if feasible, both parents (or guardians) will be included in these discussions and will be asked to sign the written consent document; if a second parent or guardian is unavailable, this will be explained in writing on the written consent document; if subjects age 18 years or older are unable to provide informed consent, then they will not be enrolled in this study
The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization
Inability to give informed consent
Individuals able to give informed consent, or a signature from a designated health care proxy or legal guardian
Ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent
Unable to give written, informed consent
Patients unable or unwilling to provide informed consent or sign a written informed consent document (ICD)
All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Ability to provide informed consent; all subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed
Patients must sign an informed consent, and be mentally responsible
Participant will be fully informed and has personally signed and dated the written informed Consent and Health Insurance Portability and Accountability Act (HIPAA) provisions
Be capable of signing and providing written consent in accordance with institutional and federal guidelines
Cannot consent for himself or herself
Patients must have signed an approved informed consent and authorization permitting release of personal health information; ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Ability to provide written informed consent in accordance with institutional policies
Subjects who refuse to participate, or demonstrate inability to give informed consent
All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Ability of the subject, or the legally authorized representative (LAR) if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, to understand, and the willingness to sign, a written informed consent.
Patients cannot give informed consent.
Patient provides written informed consent
Sign written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
Patient or legal parent/guardian unable to provide informed consent
Psychiatric or addictive disorders that preclude obtaining informed consent
Patients who cannot consent for themselves
Subject or legally authorized representative signs study-related informed consent document
Subject capable of giving informed consent and participating in the process of consent
Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study
Only individuals who can understand and give informed consent will be eligible to participate in this study
Subject capable of giving informed consent and participating in the process of consent
Unwilling to give informed consent
Written informed consent
CAREGIVER/PARENT: Caregivers (parents or legal guardians) must give informed consent
All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Inability to give informed consent
Patients unable or unwilling to provide informed consent or sign a written informed consent document (ICD)
Valid informed consent by subject or subject’s legally authorized representative (LAR)
Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent)
Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines
Informed consent
All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the cancer center
Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent
EXCLUSION CRITERIA FOR OPEN-ACCESS: Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent
All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Informed consent
Have the ability to give informed consent
Give written informed consent
All patients or their legal guardians (if the patient is < 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study; when appropriate, the minor patient will be asked for oral assent; the parent or guardian will sign the consent form on the designated line attesting to the fact that the minor has given assent
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* Note: HIPAA authorization may be included in the informed consent or obtained separately
Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;
Patient or patient's legally acceptable representative cognitively provides written informed consent
unwilling to give informed consent;
Patient provides written informed consent
Patient provides written informed consent
All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Psychiatric or addictive disorders that preclude obtaining informed consent
Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Patients must give written informed consent
Subjects who refuse to participate, or demonstrate inability to give informed consent
Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure
LOCALIZED RCC TREATED WITH PARTIAL NEPHRECTOMY:\r\nWritten informed consent available
ADVANCED RCC TREATED WITH RADICAL NEPHRECTOMY:\r\nWritten informed consent available
Women who cannot consent for themselves
All participants, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Inability to give informed consent
Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate
Provides written informed consent
Patients must be able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Patients who cannot consent for themselves
Patients who cannot give informed consent
Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of medical information
Patients will have provided informed consent to participate, documented by their signature on the study consent form
Patients will have provided informed consent to participate, documented by their signature on the study consent form
Inability to give informed consent
Written, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) guidelines
Ability to understand and willingness to sign a consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form
Provides written informed consent document
Are unwilling to give informed consent
Patients who have granted written informed consent for the study
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of University of Michigan (UM) hospital
Unable to give informed consent
Written informed consent will be obtained from patients
Subjects, or their legal guardian, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Subject has provided written informed consent with HIPAA authorization
Provides written informed consent
Written informed consent
All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Subjects incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders\r\n* Prisoners or other individuals deemed to be susceptible to coercion
Provides written informed consent
Patients incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, cognitive impairment, or psychiatric disorders\r\n** Patients scoring 14.5 or lower on the University of California at San Diego (UCSD) Brief Assessment of Consent Capacity (UBACC) Capacity to Consent Questionnaire will be excluded\r\n* Prisoners or other individuals deemed to be susceptible to coercion
Written informed consent
Subjects incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders\r\n* Prisoners or other individuals deemed to be susceptible to coercion
Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
Ability to provide informed consent; all subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed
Written informed consent
Patient having provided his/her written informed consent to participate in the trial prior to any study-related procedure being conducted
Inability to give informed consent
Provides written informed consent
Informed consent cannot be obtained either from the patient or legal representative
Provides written informed consent and willing to comply with protocol requirements
Ability of subject or legally authorized representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study
Provides written informed consent
Written informed consent
Inability to give informed consent in person
Informed consent was obtained.
All patients must give written informed consent
Patient gives informed or surrogate consent
Patient ability to read and comprehend the informed consent document
Written informed consent signed by all patients and/or their parents or legal guardians (both parents/guardians if reasonably available)
Written informed consent.
Ability to understand informed consent and signing of written informed consent prior to initiation of protocol therapy
Ability to give informed consent
Inability to give informed consent.
Valid informed consent by subject
Able to give voluntary written informed consent
Provides written informed consent
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Subject has provided written informed consent to participate in the study
Subject has provided written informed consent to participate in the study
Unable to give informed consent
Have the ability to understand and to give written informed consent as assessed by the participant’s primary care physician or medical oncologist
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Patients must have capacity to consent
Unable to give informed consent
Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure
Individuals who are unable to give informed consent
Informed Consent: Written informed consent must be obtained from subject or parent/legal guardian prior to enrollment. Assent, when appropriate, will be obtained according to institutional guidelines
Patients who have initiated treatment for unresectable or metastatic melanoma at\n medical practice (e.g. community-based, office-based, hospital-based, academic\n setting)within 21 days before informed consent for this study OR in the case where\n treatment has not yet been initiated, documentation that the treatment strategy was\n determined before informed consent for this study, and treatment must be initiated\n within 28 days after informed consent
Subjects incapable of giving informed written consent
Patients are capable of giving informed consent
Provision of written informed consent
Patients are capable of giving informed consent
Men and women ? 18 years of age, at the time of signing the ICD (Informed Consent Document).
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participants at any time without prejudice to future medical care.
Subjects participating in another clinical investigation at the time of signature of the informed consent.
Ability to understand the nature of this trial and give written informed consent.