and reduce IRB and investigator burden, delay, and ambivalence (Emanuel and Menikoff, 2011; Fisher et al., 2013, p. 4). The committee strongly supports these aims.

This chapter considers critical issues related to how best to ensure (a) that the definition of “minimal risk” is appropriate for the full range of current social and behavioral science research; (b) that IRBs and investigators have adequate guidance for avoiding underestimation and overestimations of minimal risk; and (c) that categories of research that may be reviewed through an expedited review adequately reflect the broad spectrum of social and behavioral science research. The committee’s proposed approach to assessing and minimizing participant risk adheres to the Belmont Report’s principles of beneficence, respect, and justice (U.S. Department of Health and Human Services, 1979) and to established canons of scientific and professional knowledge.

In response to the ANPRM, the Society for Research in Child Development (SRCD) convened the SRCD Task Force on Proposed Changes to the Common Rule (hereafter, “SRCD Task Force”). In its published report and commentary on the ANPRM, which addresses many of the issues also addressed in this report, the SRCD Task Force viewed research as “a moral endeavor that seeks to ensure that the welfare, autonomy and privacy rights of infant, child and adolescent research participants are adequately protected and that such protections do not prevent them from equitable sharing of the burdens and benefits of research” (Fisher et al., 2013, p. 4). The committee believes its approach is consistent with this view of research, expanded to apply to all research participants.

DEFINING MINIMAL RISK

As defined at 45 C.F.R. § 46.102(i), “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” The ANPRM should be applauded for asking the research community to consider whether this definition of “minimal risk” needs revision. In the past 10 years, a number of ethics committees and scholars have grappled with how minimal risk should be delineated, and some consensus has developed (Meyer, 2013; Resnik, 2005; Rid et al., 2010; Wendler et al., 2005). While it is probably impossible—and in fact may be unwise—to completely eliminate variation in interpretation of the term, the regulations and guidance should be revised to reflect the developing consensus.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement