Source share

(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:

(1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) a description of any reasonably foreseeable risks or discomforts to the subject;

(3) a description of any benefits to the subject or to others which may reasonably be expected from the research;

(4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;