Documented informed consent Patients must give informed consent prior to initiation of therapy Informed consent/assent Execute an informed consent. Have the capacity to give informed consent Give informed consent Refuses to give informed consent Informed consent for participation Have the capacity to give informed consent Documented informed consent of the participant Informed consent Informed consent Patients must give informed consent Informed consent Must have the capacity to give informed consent Informed consent must be obtained Informed Consent Patients must give informed consent Informed consent Patients must give informed consent Informed consent Understand and give informed consent Informed consent Documented informed consent Understand and give informed consent Give informed consent Refuses to give informed consent Informed consent Patient's Informed Consent. - Informed consent Patients must give informed consent Informed consent Parental informed consent PHASE I: For patients < years, parents must give informed consent and patient must give assent; patients >= must give informed consent PHASE II: For patients < years, parents must give informed consent and patient must give assent; patients >= must give informed consent Informed consent Subjects who cannot give an informed consent Patient must give informed consent for this new study Patients must give informed consent Cannot give informed consent. Willingness to give informed consent DONOR: Willingness to give informed consent Informed consent Documented informed consent of the participant Willingness to give informed consent DONOR: Willingness to give informed consent Subjects who cannot give an informed consent Cannot consent for himself or herself Patients cannot give informed consent. Patients who cannot consent for themselves Informed consent Informed consent Women who cannot consent for themselves Patients who cannot consent for themselves Patients who cannot give informed consent Informed consent was obtained. Patients must have capacity to consent