| Administrative law - 1990 - 460 pages
...obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the...the subject's participation, a description of the proce§50.20 Food and Drug Administration, HHS dures to be followed, and identification of any procedures... | |
| Administrative law - 1995 - 886 pages
...section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research, an explanation...identification of any procedures which are experimental; (2) A | foresees subject! (3) A the sub] sonablj (4) A native ment, tageous (5) Al tent, if I recordsl maintaj... | |
| Administrative law - 1998 - 688 pages
...section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research, an explanation...identification of any procedures which are experimental; (2) Л description of any reasonably foreseeable risks or discomforts to the subject; (3) A description... | |
| Administrative law - 1994 - 708 pages
...section, in seeking informed consent the following information shall be provided to each subject: (1) A statement that the study involves research, an explanation...Identification of any procedures which are experimental; §11.116 (2) A description of any reasonably 'oreseeable risks or discomforts to the tubject; (3) A... | |
| Administrative law - 1992 - 464 pages
...(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information...research and the expected duration of the subject's par§1230.116 ticipation, a description of the procedures to be followed, and identification of any... | |
| Administrative law - 1991 - 712 pages
...section, in seeking informed consent the following information shall be provided to each subject: (DA statement that the study involves research, an explanation...description of the procedures to be followed, and identifica49 CFR Subtitle A (10-1-91 Edition) tion of any procedures which are experimental; (2) A... | |
| Curtis L. Meinert, Susan Tonascia - Clinical trials - 1986 - 502 pages
...General elements of an informed consent • A statement that the study involves research, an explanation of the research and the expected duration of the subject's...be followed, and identification of any procedures that are experimental • A description of any reasonably foreseeable risks or discomforts to the subject... | |
| |