450:1-11-7 - Informed consent

450:1-11-7. Informed consent

Except where specifically waived or altered by the ODMHSAS IRB under 45 C.F.R. § 46.101(i), 46.116(c) & (d), or 46.117 (c) of all research for which the ODMHSAS IRB is responsible requires written informed consent, in nonexculpatory language understandable to the subject (or subject's legally authorized representative), including the following basic elements per 45 C.F.R. § 46.116(a) & (b):

(1) Identification as research; purposes, duration, and procedures; procedures which are experimental;

2) Reasonable foreseeable risks or discomforts;

(3) Reasonable expected benefits to the subject or others;

(4) Alternative procedures or treatments, if any, that might be advantageous to the subject;

(5) Extent of confidentiality to be maintained;

(6) Whether compensation or medical treatment are available if injury occurs (if more than minimal risk);

(7) Whom to contact for answers to questions about the research, subjects' rights, and research-related injury;

(8) Participation is voluntary; refusal to participate, or discontinuation of participation, shall involve no penalty or loss of benefits to which subject is entitled; and

(9) When appropriate, additional elements per 45 C.F.R. § 45.116.

Added at 23 Ok Reg 1941, eff 7-1-06

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