Common Rule Revision – The Ethics Police Fight Back

It’s different when people are involved … Here Claude Shannon introduces his famous electronic rodent Theseus to a maze. (Image courtesy of Computer History Museum)

As might have been expected, the proposed revisions to the Common Rule regulating research ethics in federally funded research in the U.S. have not gone unchallenged.

The proposals are contained in a long and complex document. Even those of us who take a close interest in these things have struggled to assimilate 500 pages of dense prose. It is not, then, unreasonable that the consultation period has been extended by another 30 days. However, it is important that scholars who basically support the proposals take advantage of this to express positive views – because it is clear that there is a determined push back.

As I outlined in a previous blog, these revisions would mean that most social science research would be excluded from IRB review.

Any research involving standardized testing, surveys, interviews, or observations, including audio and video recording, of public behavior, including behavior online, will be able to proceed without further review. Certain types of experimental work will also be excluded, where participants experience ‘benign interventions [which are] brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact…[or to be] offensive or embarrassing.’ These studies may include an element of deception provided the participant agrees to this in advance. Oral history, journalism, biography and historical scholarship about named individuals can proceed solely with reference to the disciplines’ own codes of ethics. The secondary analysis of administrative data, including many health and criminal justice records, even in identifiable form, will be excluded from review provided it complies with data protection legislation. Some research with children would still require review: standardized tests and non-participant observation would be excluded but not surveys, interviews and participant observation.

Investigators would simply be required to complete an online form and file this with their IRB. Job done.

It was probably too much to expect this to go through without opposition. While the proposals envisage an expansion of review in some areas of biomedical research, this loss of control has produced predictably negative reactions from communities whose interests would be affected. Conveniently many of these come together in an article on the NPR website. This reports remarks by the prominent bioethicist, Ruth Macklin, which have been widely quoted. She regards the exclusion of most social science projects from review as “… a major step backwards that, as far as I’m concerned, takes us back into the dark ages.” While these kinds of studies “are not physically invasive… they may be intrusive…There are forms of harm that are not just physical harm.” Probing people about sensitive subjects, such as whether they’ve had an abortion or have been physically or sexually abused as children, can trigger strong emotional reactions, potentially causing psychological distress.

Macklin’s response exemplifies a common view among bioethicists that any imagined harm is a justification for regulation, regardless of the proportionality between the risk and the intervention or, in this case, the implied lack of respect for the human subjects involved.

The Common Rule revisions recognize that there is an important distinction between those risks where there is a real asymmetry of knowledge between research participants and investigators and those where the participants are making the sorts of judgments that they make in everyday life. If a biomedical researcher is injecting a volunteer with possibly toxic green stuff, it is desirable that their assessment of the toxicity and their presentation of the risk to the participant are reviewed by someone independent. It is unrealistic to expect biomedical research participants to be familiar with cutting edge physiology, pharmacology, biochemistry, radiation physics, etc.

If I want to ask someone whether they were abused as a child, they are better placed to assess the risk of distress than I am. This is their story and their decision about whether to tell it. They have not embarked on something that is not easily reversible: once green stuff is in the body, that’s it. If I start asking distressing questions, they can stop answering. I am not a police officer or a homeland security agent. I cannot compel anyone to answer my questions. Moreover, the chance of encountering those questions is a chance in everyday life. 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.

In acknowledging this, the Common Rule revisions also accept one of the key tenets of U.S. bioethics, namely its high valuation of autonomy. As far as social science research is concerned, an important element of the revision is its acknowledgement of the competence of members of supposedly ‘vulnerable groups’ to determine their own participation. Bioethical thinking is generally hostile to professional paternalism – except, apparently, when paternalism is exercised in the name of ethics. The Common Rule revisions respect human subjects, even prisoners or people with cognitive disabilities. They create space for all participants to assess risks for themselves and to make their own decisions. It is the kind of empowerment that bioethicists routinely advocate in other contexts.

For the social sciences, the Common Rule revisions are a big step forward in eradicating the evils introduced by the IRB system to their fields of study. The regulation of social science research has imposed societal costs from the obstruction of innovation, from the systematic creation of no-go areas of ignorance, and from the infantilization of research participants. The proposed changes will create important international precedents. They deserve – and need – the support of the social science research community.