[Cross-posted from the Institutional Review Blog, as part of the Bill of Health’s symposium on the 2015 notice of proposed rulemaking (NPRM) on human subjects regulations.]
The notice of proposed rulemaking (NPRM) promises long-sought relief for historians, journalists, and biographers. For these groups, the goal will be to ensure that the proposed rules are enacted as currently written.
Organizations representing anthropologists, sociologists, political scientists, and other social scientists have largely tried to make peace with IRB regulations, often counseling members to submit to IRB review and serve on IRBs. Historians, by contrast, have been almost uniform in our opposition to regulation, and since 2000, we have argued that our work should not be subject to rules written for “generalizable research.” In 2003, OHRP endorsed that position, but then distanced itself at the first challenge from IRB offices.
Now, the NPRM promises to eliminate the ambiguity. As it explains, it
outlines eleven specific types of activities that will be outside the scope of the regulations. These activities will therefore not have to satisfy any regulatory requirements, nor is it expected (unlike exempt research) that they will undergo any type of review process to determine this status. The exclusions will eliminate uncertainty regarding some activities that are not research, and identify some activities that arguably might be judged to be research, but whose contribution to public welfare is so imperative that they should proceed without having to satisfy the regulatory requirements. The exclusions also identify certain research activities that are sufficiently low- risk and nonintrusive that the protections provided by the regulations are an unnecessary use of time and resources, whereas the potential benefits of the research are substantial.
History makes this first set of exclusions, concerning the “some activities that are not research.” As the NPRM explains,
While the NPRM does not propose to modify the definition of “research”, it does propose to explicitly exclude oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information or biospecimens is collected. In the kinds of activities referred to here, the ethical requirement is to provide an accurate and evidence-based portrayal of the individuals involved, and not to protect them from public scrutiny. Therefore, the protections afforded to individuals by the Common Rule seem unhelpful in furthering the aforementioned ethical goal in this context. Additionally, these fields of research have their own codes of ethics, according to which, for example, consent is obtained for oral histories. It is believed that because of these reasons, explicit exclusion of these activities from the scope of the Common Rule is appropriate.
The specific provision states that among those activities “deemed not to be research … for the purposes of this regulation” are “Oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.”
This is tremendous news. The reference to “public scrutiny” may be the first time U.S. regulators have acknowledged that ethical research may be, in the words of Canada’s TCPS2, “legitimately critical and/or opposed to the welfare of those who are the focus of the research, and may cause them some harm.” And the reference to historians’ “own codes of ethics” is a nice nod to the work of oral historians and others, some of it predating the Belmont Report.
The NPRM dilutes this understanding a few pages later, when it states that “All investigators performing excluded studies are expected to act in a way that is consistent with the principles outlined in the Belmont Report, even if the Common Rule does not impose requirements on excluded work.” As I’ve noted, the Belmont Report makes no acknowledgement of the goal of public scrutiny, and is thus a poor guide for historians and journalists. But Tom Beauchamp himself told me that “the principles outlined in the Belmont Report” are really just “headings,” so I suppose historians can find a way to live with them.
More worrisome are two questions that follow the section describing the exclusions:
12. Public comment is sought regarding whether some or all of these activities should be exemptions rather than exclusions.
13. Public comment is sought regarding whether these exclusions should be narrowed such that studies with the potential for psychological risk are not included. Are there certain topic areas of sensitive information that should not be covered by this exclusion? If so, please provide exemplary language to characterize such topic areas in a manner that would provide clarity for implementing the Rule.
Either one of these could nullify any progress. As the NPRM itself notes later, “Institutions, if they so choose, could continue to have [exempt] determinations made by an individual who is knowledgeable about the exemption categories and who has access to sufficient information to make an informed and reasonable determination.” In other words, exempt could still mean non-exempt.
As for “psychological risk,” the SBS White Paper of 2011 noted that
There is considerable ambiguity in the discussion of psychological risk in 45CFR46 creating a danger that IRBs will misjudge the nature of possible psychological harms and overestimate their likely magnitudes and risks. The result will be unneeded reviews and unnecessary regulation of important but low risk SBS research. Among the negative psychological risks labeled “psychological harms” that human subjects may experience are such emotions as boredom, worry, frustration, annoyance, stress, upset, guilt, and loss of self confidence. These may be minor in magnitude or transitory and may even stimulate new levels of personal insight or self awareness.
Thus, the concept of potential psychological risk is so fluid that an alarmist IRB staffer could easily decide that any oral history interview poses such risk.
Historians, journalists, and biographers need exclusion from human subjects regulations, with no ifs, ands, or buts. The language of exclusion, with no qualifier about psychological risk, should be adopted as it appears in the proposed rule.