What are the elements of consent that must be provided to subjects?
The following elements of consent are required by the Federal regulations (45 CFR 46.116(a)). The first set lists the requirements for all research. The second set is required only if deemed appropriate or applicable by the IRB. (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,
