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+Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXAll patients or their legal guardians (if the patient is < 18 years old) or durable power of attorney (DPA) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study; when appropriate, pediatric patients will be included in all discussions in order to obtain verbal assentXx_NEWLINE_xXSigned informed consent according to institutional guidelines must be obtainedXx_NEWLINE_xXAble and willing to sign informed consent/assentXx_NEWLINE_xXPatients 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 Step 1 registration of patients who have not yet submitted specimens for the Oncotype DX Breast Cancer Assay, the appropriate consent form is the Step 1 Consent Form; for both Step 1 and Step 2 registration of patients whose Recurrence Score is already known and is 25 or less, the appropriate consent form is the Step 2 Consent FormXx_NEWLINE_xXPROCUREMENT: Patient able to give informed consentXx_NEWLINE_xXTREATMENT: Patient able to give informed consentXx_NEWLINE_xXA medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulationsXx_NEWLINE_xXPatients must consent to be in the study and must have signed and dated an approved consent form, which conforms to federal and institutional guidelinesXx_NEWLINE_xXThe patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXSigned 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 studyXx_NEWLINE_xXWillingness to sign the healthy volunteer informed consent formXx_NEWLINE_xXMedical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselvesXx_NEWLINE_xXPatients who do not consent for PK studies to be performed (alternatively: patients who initially consent to be on study but withdraws consent for PK study will be taken off study and replaced)Xx_NEWLINE_xXDiagnostic 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 obtainedXx_NEWLINE_xXCognitive impairment, history of medical or psychiatric disease, other uncontrolled intercurrent illness, active substance abuse, or social circumstances, which in the view of the principal investigator (PI), would preclude safe treatment or the ability to give informed consentXx_NEWLINE_xXAble to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit; if the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enrollXx_NEWLINE_xXAll patients and/or their parent or legal guardian must sign a written informed consentXx_NEWLINE_xXPatients must NOT suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities; this includes uncontrolled intercurrent illness including, but not limited to ongoing or active infectionXx_NEWLINE_xXAbility 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 performedXx_NEWLINE_xXPatient or appointed surrogate decision-maker or legally authorized representative must have ability to understand the purpose and risks of the study and willingness to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXInability to understand and inability to provide informed consentXx_NEWLINE_xXThe patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXThe patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document, inclusive of assent where appropriate, according to institutional guidelinesXx_NEWLINE_xXINCLUSION CRITERIA FOR STRATUM C: The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document, inclusive of assent where appropriate, according to institutional guidelinesXx_NEWLINE_xXDiagnostic 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 agreesXx_NEWLINE_xXSigned, written informed consentXx_NEWLINE_xXOther uncontrolled, concurrent illness that would preclude study participation; or, psychiatric illness or social challenges that would entail unreasonable risk or preclude informed consent or compliance with study proceduresXx_NEWLINE_xXInability to understand and sign informed consentXx_NEWLINE_xXWritten informed consent (IC) for trial participation must be signed and dated by the patient and the investigator prior to enrollmentXx_NEWLINE_xXWritten consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trialXx_NEWLINE_xXAny perceived inability to directly (and without the means of a legal guardian) provide informed consentXx_NEWLINE_xXMedical or psychiatric illness or social situations that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselvesXx_NEWLINE_xXRECURRENT/ PROGRESSIVE DIPG (STRATUM 1): The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelinesXx_NEWLINE_xXNON-PROGRESSED DIPG (STRATUM 2): The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelinesXx_NEWLINE_xXPatients must be able to understand and sign an informed consent formXx_NEWLINE_xXThe patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXSigned, dated informed consentXx_NEWLINE_xXThe patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelinesXx_NEWLINE_xXDiagnostic 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 agreesXx_NEWLINE_xXVoluntary 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 careXx_NEWLINE_xXThe patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXPatients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary; patients must be made aware of their other treatment optionsXx_NEWLINE_xXHave been informed of other treatment optionsXx_NEWLINE_xXParticipant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedureXx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the studyXx_NEWLINE_xX
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