...participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language...benefits to which the subject is otherwise entitled. (to) Additional elements of informed consent. When appropriate, one or more of the following elements...

...participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language...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...

...participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language...benefits to which the subject is otherwise entitled. 294 and the subject may discontinue participation at any time without penalty or loss of benefits to...

...description of any beceSta to the subject or to others which may reasonably be expected ftrxs. ~&t research; (4) A disclosure of appropriate alternative...benefits to which the subject is otherwise entitled. Cb) Additional elements of informed consent. When appropriate, one or more of the following elements...

...extent, If any, to which confidentiality of records identifying the subject will be maintained; (б) For research involving more than minimal risk, an...informed consent. When appropriate, one or more of the following1 elements of information shall also be provided to each subject: (1) A statement that the...

...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...

...rights, and whom to contact in the event of a researchrelated injury to the subject; and (8) A statenent that participation is voluntary, refusal to participate...and the subject may discontinue participation at any tine without penalty or loss of benefits to which the subject is otherwise entitled. A complete HHS/FDA...

...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...