Prior to participation of an individual in a research study relating to HIV or AIDS, both of the following requirements shall be met:
(a) The informed consent of each research subject shall be obtained in the method and manner required by Section 46.116, (a) and (b), of Part 46 of Title 45 of the Code of Federal Regulations and be documented in accordance with Section 46.117 of that part.
(b) Each research subject shall be provided with an explanation in writing, in language understandable to the research subject, of the rights and responsibilities of researchers and research subjects under this chapter.
(Amended by Stats. 2006, Ch. 20, Sec. 11. Effective April 17, 2006.)
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