...benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements...

...benefits to which the subject is otherwise entitled, and the subject may discontinue par-ticipation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements...

...benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements...

...which the subject is otherwise entitled, and that the subject may discontinue participation at ajny time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements...

...subject; and (8) A statement that participation is voluntary, refusal to participate will Involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which...

...subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which...

...benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled." Specific points regarding gene therapy that follow from or relate to these general requirements are:...

...benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Additional information must be provided, when appropriate: (a) A statement that the particular treatment...

...which the subject is otherwise entitled, 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 Regulation Comparison is available in the Dffice of Health Affairs, FDA. Current...

...and to include a statement that "participation Is voluntary, refusal to participate will Involve no penalty or loss of 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...