In their comments on the NPRM, SACHRP and PRIM&R oppose the proposed exclusion of “Research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators” (§ ll.101(b)(2)(i)); they want such research to be moved from the excluded to the exempt category. But they differ in what they think the consequences of such a move would be; SACHRP thinks that researchers would face low barriers, while PRIM&R sees a chance for its members to continue to exert more control than is authorized by regulations. Both groups fail to represent the researchers most likely to conduct these kinds of studies.
Fears of interview trauma
Since the exclusion would only apply to research with a low risk of privacy breach, either because the subjects could not be identified or because the information they share is not sensitive, PRIM&R and SACHRP attack it on the grounds that risks other than privacy are at stake.
PRIM&R’s draft comments explicitly worry that interviews are traumatic:
Comprehensive ethics review of the sort envisioned in the Belmont Report requires thoughtful and experienced individuals to weigh the benefits and harms of each research project in terms of beneficence, justice, and respect for persons. Consider, for instance, a study in which college-aged victims of sexual trauma suffering from post-traumatic stress disorder are interviewed about their experience. Under the proposal at §__.101(b)(2)(i), this study may not be subject to the regulatory requirements of the Common Rule if the data are not recorded in an identifiable manner or if the researcher determines that disclosure of “responses outside the research would not reasonably place the subject at risk of criminal liability or be damaging to the subject’s financial standing, employability, reputation, educational advancement, or reputation” [§__.101(b)(2)(i)]. However, research only involving “interviews” often raises ethical questions beyond these privacy concerns, such as whether subjects will be recruited in a setting and in a manner that enables them to decline study involvement, whether subjects will receive sufficient information about the nature of research interview before being asked to make a decision to participate, whether the interviewers are appropriately trained to work with victims of sexual violence, whether there is a plan in place to address imminent risk associated with depression, substance use, or suicidal ideation if it emerges during the course of the interview, and whether the research is designed in a way that ensures its results will be useful.
SACHRP’s comments (inexplicably submitted anonymously to the HHS docket, and not posted on SACHRP’s website) are vaguer. In calling for “educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators” to be moved from “excluded” to “exempt,” SACHRP notes only that “there may be issues involved beyond privacy and confidentiality concerns.”
The December 2015 SACHRP meeting, however, suggests that SACHRP too is fretting about people made to feel bad by talking. As David Forster explained the reasoning of the relevant subcommittee, “there’s more risk involved in these types of research studies than just a confidentiality breach. There might be psychological harm, other types of harm that would not be considered under the application of the privacy act or HIPAA.” (SACHRP meeting, 4 December 2015, about 1:42).
These are not wholly fantastic concerns. As Michael McDonald, Susan Cox, and Anne Townsend note in their chapter, “Toward human research protection that is evidence based and participant centered,” interviews can leave participants sad or upset, even without any risk to their privacy.
There is scant evidence, however, that these risks are much greater than those encountered in daily life. As Robert Dingwall notes, “Distress may be as easily provoked by a drama, a novel, a movie or a conversation overheard on a bus. A former colleague with a long and unsuccessful history of struggle with her own lack of fertility once told me how she was distressed every day by walking past the campus nursery and by the department’s celebrations of new babies born to younger faculty members. This is recognized by the reform. Regulation is disproportionate when it does not add to a participant’s own experiences of managing everyday psychological challenges.”
Failure to consider the consequences
In calling for interviews to be “exempt,” rather than excluded, SACHRP seems not to have considered the full impact of its recommendations. At the December meeting, SACHRP members, Nancy M. P. King in particular, seemed to believe that making an activity “exempt” would simply require a researcher to spend a few minutes online completing the determination tool. I doubt she has considered the conundrum this poses for ethnographers, for whom all of life may be one rolling interview. Should they complete the determination tool each morning, before brushing their teeth?
PRIM&R at least offers a more realistic assessment of the difference between exclusion and exemption under the proposed rule. Excluded would mean exempt, while exempt might well continue to mean non-exempt. As PRIM&R explains:
Currently, research projects like [the hypothetical “study in which college-aged victims of sexual trauma suffering from post-traumatic stress disorder”] may be eligible for an exemption under 45 CFR 46.101(b)(2). At most institutions, this means that an experienced IRB staff person will review the study to determine whether it meets the exemption criteria and to weigh any other regulatory or ethical considerations that the research may raise. Through this process, many of the considerations outlined above, as well as those related to ensuring subject privacy, are evaluated and institutional oversight is established. If the reviewer determines that the research raises significant concerns, it may be subject to further consideration or oversight …
PRIM&R … believes that, as is current practice, exempt research should be subject to some level of institutional review and oversight.
In other words, PRIM&R admits that IRB staff members, many of them certified by PRIM&R, are regularly subjecting exempt research “to further consideration or oversight,” that is, to make it non-exempt, delaying it for days, weeks, or months; imposing heavy burdens, and reducing participation. I can’t say I’m surprised; in recent years, PRIM&R has been generally dismissive of exemptions. But I’m not sure I’ve seen so bald a statement of its position that IRB staff should be able to demand oversight of projects that are eligible for exemption.
Unsurprisingly, PRIM&R offers no evidence that IRB staff or members are any good at training investigators or helping devise reasonable plans, and it ignores the harms of IRB review, such as stunted research, reinforced stereotypes, exaggerated fears of interview trauma, and the denial of opportunity to people who would benefit from conversation. PRIM&R claims to advocate “evidence-based revisions” to the regulations. But where is the evidence to support its own recommendations or current practices?
Ethical imperialism at work
Both sets of comments show the problem, now half a century old, of denying one set of researchers a voice in recommendations about their methods of research. HHS has repeatedly failed to appoint an ethnographer to SACHRP, so when a well-meaning bioethicist like King starts talking about exemption as if it were no barrier to research, there is no one in the room to point out to her the effect her recommendation would have on ethnography, participant observation, and the like, or to relate the horror stories that the existing system generates. And PRIM&R’s Public Policy Committee, which prepared the NPRM comments, of course does not include any qualitative social scientists or scholars in the humanities. Because it’s PRIM&R.
Robert Levine, who served as a consultant to the National Commission, has lamented that that body had failed to consider the rights and responsibilities of social scientists. “Sociology, anthropology, education and other vast areas of research were left out,” he told an interviewer. “The Commission made some passing statements that have been interpreted as being relevant to social and behavioral research, but they did not look into it thoroughly.” Forty years later, as a member of the PRIM&R policy committee, he is making the same mistake.