Wednesday, May 11, 2016

NSF Officer Misstates Belmont and Common Rule Standards

In the final contribution to the PS symposium, Lee Demetrius Walker, currently serving as program officer for the Political Science Program at the National Science Foundation, acknowledges the problems of applying a biomedical review system to social science. But he misstates the Belmont and Common Rule standards for assessing research.

[Lee Demetrius Walker, “National Science Foundation, Institutional Review Boards, and Political and Social Science,” PS: Political Science & Politics 49, no. 02 (April 2016): 309–12, doi:10.1017/S1049096516000263.]

Walker notes that

On the one hand, IRB evaluations for experimental social science will be much like IRB evaluations for biomedical and behavioral sciences. In short, IRBs apply the Belmont principles to experimental social-science research with the same rigor as for biomedical and behavioral-science research.

On the other hand, this extension of biomedical-level evaluation to experimental social science creates several problems: (1) the IRB review may be too severe because it is conducted by individuals who generally review more intrusive experimental research; (2) the IRB may assign social-science reviewers who are more comfortable with nonexperimental social-science methodologies; and/or (3) the IRB may extend the experimental protocols to social-science research that uses nonexperimental approaches. These problems may lead to delays that threaten completion of the research or to denial of proposed research because IRB reviewers are unfamiliar or uncomfortable with political science methods.

He calls on researchers to cooperate with their local IRBs, since “NSF program officers can neither waive the applicability of the Common Rule to research activities nor impose less oversight than the institution’s IRB requires.”

Walker unfortunately misstates the requirements of both the Belmont Report and the Common Rule. He writes,

The fundamental principle of human-subjects protection is that people should not be involved in research without their informed consent and that subjects should not incur increased risk of harm from their research involvement.

In fact, while the Belmont Report states that “in most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information,” even this includes the qualifier, most,“ suggesting that some persons can be involved in research without their informed consent. This is made explicit in §46.101 of the Common Rule, which exempts several categories of research from the standards of IRB review, including informed consent. Moreover, the Common Rule states that an institution’s ”statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research … need not be applicable to any research exempted or waived under §46.101(b) or (i)."

As for risks, neither the Belmont Report nor the Common Rule demand that “subjects should not incur increased risk,” since such a standard would make most research impossible. As the Belmont Report explains, “Risk can perhaps never be entirely eliminated,” and so it recommends merely that “Risks should be reduced to those necessary to achieve the research objective.” This standard is encoded in §46.111 of the Common Rule, which demands that “Risks to subjects are minimized” (not eliminated) and that “Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result,” not that they be zero.

The NSF has done good work explaining the application of the Common Rule to social science research, so it is disappointing that Walker, writing as the foundation’s representative, has misinformed his readers about these important points.

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