3. The provisions of this act shall apply to medical research on persons with cognitive impairments, lack of capacity, or serious physical or behavioral conditions and life-threatening diseases that is approved and monitored by an institutional review board that holds an assurance with the United States Department of Health and Human Services and either:

a. offers the prospect of direct benefit to the individual subject, provided that the institutional review board has determined that the risk is justified by the anticipated benefits to the subject and that the relation of the anticipated benefit to the risk is at least as favorable to the subject as that presented by available alternative approaches. If a currently recognized treatment exists, the subject or his guardian or authorized representative, as applicable, shall be presented with the choice of the recognized treatment and the research protocol; or

b. does not offer the prospect of direct benefit to the individual subject, provided that the institutional review board has determined that it: (1) is likely to yield generalizable knowledge about the subject’s disorder or condition; (2) by its very nature cannot be conducted without the participation of decisionally incapacitated persons as subjects; and (3) involves no more than a minor increase over minimal risk.

For purposes of this section, “minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests.
L.2007, c.316, s.3.