...manner. (Approved by the Office of Management and Budget under control number 9999-0020) S 745.116 General requirements for informed consent. Except...benefits to which the subject is otherwise entitled. (to) Additional elements of informed consent. When appropriate, one or more of the following elements...

...subparts, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective...information shall also be provided to each subject: (1)A statement that the particular treatment or procedure may involve risks to the subject (or to the...

...consent of the subject or the subject's legally authorized repre16 CFR Ch. II (1-1-93 Edition) sentative. An investigator shall seek such consent only under...information shall also be provided to each subject: (DA statement that the particular treatment or procedure may involve risks to the subject (or to the...

...section, In seeking informed consent the following information shall be provided to each subject: '!> A statement that the study involves research, an explanation...information shall also be provided to each subject: (1)A statement that the particular treatment or procedure may involve to the subject (or to the embryo...

...of the purposes of the research and the expected duration of the subject's par§1230.116 ticipation, a description of the procedures to be followed, and...information shall also be provided to each subject: (1)A statement that the particular treatment or procedure may involve risks to the subject (or to the...

...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...information shall also be provided to each subject: (DA statement that the particular treatment or procedure may involve risks to the subject (or to the...

...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...

...and, U so, what they consist of, or where further information may be obtained; (7) An explanation oí whom to contact for answers to pertinent questions...information shall also be provided to each subject: (DA statement that the particular treatment or procedure may involve risks to the subject (or to the...

...information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions ibout the research and research subjects' rights, and whom...information shall also be provided to each subject: (DA statement that the particular treatment or procedure may involve risks to the subject (or to the...