...subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. (a) Basic...elements of informed consent. When appropriate, one 01 more of the following elements of i» formation shall also be provided U each subject: (1) A statement...

...subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. (a) Basic...benefits to which the subject is otherwise entitled. (to) Additional elements of informed consent. When appropriate, one or more of the following elements...

...subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. (a) Basic...benefits to which the subject is otherwise entitled. 16 CFR CM. 11(1-1-94 subjects unless the requirements of this policy have been satisfied. 81028.123...

...subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. (a) Basic...otherwise entitled, and the subject may discontinue parló CFR Ch. It (1-1-98 Edffion) ticlpation at any time without penalty or loss of benefits to which...

...that participation IE voluntary, refusal to participate will involve no penalty or loss of benefits tc which the subject is otherwise entitled and the subject...elements of informed consent. When appropriate, one 01 more of the following elements of Information shall also be provided tc each subject: (1) A statement...

...treatments are available if injury occurs and, if so, what they consist of, or where further information nay be obtained; "(7) An explanation of whom to contact...benefits to which the subject is otherwise entitled." Specific points regarding gene therapy that follow from or relate to these general requirements are:...

...subjects' rights, and whom to contact in the event of a researchrelated injury to the subject; and (h) a statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled. Additional information must be provided, when appropriate: (a) A statement that the particular treatment...

...discomforts," "any benefits to the subject or other which may reasonably be expected," and to include a statement that "participation is voluntary, refusal...benefits to which the subject is otherwise entitled." (HHS 45 CFR 46.116) The Task Force concurs that information disclosed for Phase I must include a statement...

...discomforts," "any benefits to the subject or other which may reasonably be expected," and to include a statement that "participation Is voluntary, refusal...benefits to which the subject Is otherwise entitled." (HHS 45 CFR 46.116). The Task Force concurs that information disclosed for Phase 1 must include a statement...

...regulations do both. In obtaining informed consent, the prospective subject must be provided with: 1. A statement that the study involves research, an...loss of benefits to which the subject is otherwise entitled.36 An IRB may "approve a consent procedure that does not include, or which alters, some or...