By Gary Evans, Medical Writer

As this story was filed, the originally planned finalization and implementation of the revised Common Rule in January 2018 was subject to possible delay along with other pending federal regulations paused for review by the Trump administration.

Perhaps that is just as well for social scientists, behavioral researchers, and their respective IRBs. They find themselves in the midst of a somewhat complicated debate about how and to what extent the Common Rule changes affect or exempt oversight of their endeavors by the Office of Human Research Protections (OHRP).

Some behavioral and social science researchers see a great opportunity. Low-risk social science research that is not federally funded remains exempt from IRB review, and if finalized as currently written it will be much easier to exempt low-risk social science research of all stripes, says Richard A. Shweder, PhD, a professor in the department of comparative human development at the University of Chicago.

“The OHRP has basically put out an invitation to universities to figure out how to handle research that is not federally funded,” he says. “They encourage flexibility and have made it clear that there is no regulation saying how you exempt something, and you can be creative about that. I think there is an onus on all of us to demonstrate that any alternative systems we set up actually produce the right outcome.”

On the other hand, some social science researchers see an opportunity missed.

“The 2011 Advance Notice of Proposed Rulemaking [ANPRM] was exciting, in part because of its title, which called for ‘reducing burden, delay, and ambiguity for investigators,’” says Zachary M. Schrag, PhD, professor of history at George Mason University in Fairfax, VA. “This marked an unusual acknowledgment by regulators that IRB problems start with flawed regulations, not bad acts by institutions. And the ANPRM itself cited important empirical scholarship that demonstrated the arbitrariness of many IRB decisions. Unfortunately, the ANPRM offered relatively timid proposals to address these problems.” (For more information, see related story in this issue.)

Buck Stops With IRB

IRB Advisor asked William T. Riley, PhD, director of the Office of Behavioral and Social Sciences Research at OHRP, if he could clarify some of the revised regulations in this area.

“The revised Common Rule does not specifically exempt behavioral and social science studies, but [it] does expand the research that is exempt from IRB review, some of which clearly relates to behavioral and social sciences research,” Riley says. “For example, the revised Common Rule expands the exemption for secondary research — data regulated under HIPAA, conducted for or by the federal government for non-research purposes. Two new exemptions require limited IRB review for secondary data [with] broad consent obtained, and for storage and maintenance of this information.”

Riley was the lead author of a recently published article that said, “under the pre-2018 Common Rule, many laboratory-based studies that manipulated an independent variable (e.g., studies of cognition, attitudes, learning) would have required IRB review...but these studies can now be exempt from IRB review.”1

Riley notes in the paper that “the new and most relevant exemption for behavioral and social scientists is the exemption for research involving benign behavioral interventions on adult subjects, in which the subject prospectively agrees to the intervention and information collection. … The rule defines benign behavioral interventions as ‘brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects.’”

Could some of this be interpreted to mean that researchers and IRBs can take the default position that certain categories of social research are exempt?

“This is the exemption for ‘benign behavioral interventions’ on adult subjects,” he says. “It is still standard practice that researchers submit protocols for any research that they believe to be exempt to the IRB for the IRB to determine if it meets the exempt criteria. For these benign behavioral interventions, [that means] if the ‘intervention’ is brief in duration, harmless, painless, not physically invasive, and not likely to have a significant adverse lasting impact. Therefore, many lab-based studies of learning, memory, attention, cognition, or effect might be exempt if they meet these criteria for being benign, even though these studies may be manipulating an independent variable. In the past, if you manipulated an independent variable, however benign that manipulation may have been, it would require IRB review — not be exempt.”

This exemption also may apply to some systems-level interventions, he adds. For example, an intervention to encourage physical activity in the workplace using signs encouraging people to take the stairs, advocating the benefits of standing desks, or using prompts to remind people to move about after periods of sedentary activity.

“[That] might be considered exempt if the investigator and IRB agree that it meets the criteria [we discussed],” Riley says. “Exempted behavioral and social sciences research is still ‘regulated’ by the revised Common Rule. All research involving humans is regulated by the Common Rule and revised Common Rule — it is just that it is regulated by being considered exempt from IRB review. The determination of exempt status by IRBs is typically a rapid process, but IRBs still need to determine that it is exempt.”

Bottom line: The buck stops with the IRB. “IRBs are responsible for implementing the Common Rule for their institution, and will provide additional guidance, documentation, and materials to assist investigators in determining which research is exempt from IRB review and the documentation required to request an exemption from IRB review,” Riley says.

Removing the Check Box

Another key development is the elimination of the “check box” formerly used to designate whether the human research rules would apply to trials funded by non-federal sources. In the preamble to the new IRB regulations in the Jan. 19, 2017, Federal Register, OHRP states:

“The prior option that enabled institutions with an active Federalwide Assurance (FWA) to ‘check the box’ is being eliminated. Importantly, institutions could, if they so desire, continue for purposes of their own internal rules to voluntarily extend the regulations to all research conducted by the institution, but this voluntary extension will no longer be part of the assurance process and such research will not be subject to OHRP oversight. We expect this change to have the beneficial effect of encouraging some institutions to explore a variety of flexible approaches to overseeing low-risk research that is not funded by a Common Rule department or agency, without reducing protection of human subjects, thus furthering the goal to decrease inappropriate administrative burdens.”

Removing the box is a good idea because, over time, institutions that didn’t check it came to regulate research as if they did, Shweder says.

”If you checked the box, you were saying, ‘we agree that we will apply these [regulations] to everyone regardless of funding source,’” he notes. “But there was no regulation or compulsion to check the box. Ultimately, a lot of universities stopped checking the box because they reasoned, ‘why should we bind ourselves unnecessarily to the OHRP?’ But then almost all of them voluntarily continued to apply the OHRP regulations to everybody. So, it ended up that the current situation is one in which almost all universities have, at their discretion, done that. And in doing that, they have not taken seriously the legitimate interest of the many faculties at those universities who do low-risk research in social sciences and the humanities [by] applying [review protocols] which were designed and tailored for research that is not low-risk.”

In addition to emphasizing that change in the rule, the onus is on individual researchers — and IRBs, to some extent — to communicate this change and also develop tools or some method of documentation and assessment of the level of risk in order to clarify what is exempt.

“Some kind of simple checklist — as the OHRP has proposed — could be used to exempt out low-risk social science research, with the document being filed within the department with the understanding the IRB can review it if it wishes,” Shweder says.

Universities can work out their own ways of doing that. “OHRP has made a proposal, and we put that forward as a perfectly reasonable way to start reforming the system,” he says. “The idea is to identify certain kind of cases which are clearly exempt. Have a checklist that a researcher can go down, answering certain kinds of questions — and as a result of that, if it comes out saying you are exempt, you simply submit the checklist to your department. If the local IRB wants to look at that and say something about that, they can, but the default is that you start doing your research on things that are low risk.”

These would be things like interviewing an “autonomous adult” one-on-one with confidentiality procedures in place, he says. Other examples would be performing observations of public behavior or sending out a survey.

“The idea would be you go down a checklist, determine that you are exempt, you start your research, you file, and you probably submit it with a paragraph describing it,” Shweder says. “There are a lot of decisions to be made about where you submit, but you could submit it to your department. If you’re a student, it could be a thesis proposal committee and you submit it at the time of the hearing. There are lots of ways you could do this that basically involve self-determination.”

The matter may end up with policies and protocols developed on an institution-by-institution basis, particularly given the kind of “self-exemption” Shweder argues should be granted to a broad swath of low-risk science research give some IRBs pause.

“Some IRB heads seem to think that you can’t have ‘self-exemption,’ but the OHRP has been quite clear that there is no specific regulation saying how you can go about exception determination,” Shweder says. “In any case, I’m not suggesting that everything be exempt. One wants to have [appropriate] human subjects research going on, but it seems to me that there are other ways we can address ethical questions.”

For example, Shweder cites the case of a colleague who has been waiting for months to get permission to interview federal judges, who would not seem to meet the definition of an at-risk population.

“Why should that be?” he says. “Why shouldn’t a faculty researcher at a university — let’s say, who is a legal scholar — be able to have a conversation with any federal judge who is willing to talk to him? Under the Common Rule, even if it was federally funded, that ought to be exempt.”

As evidenced by advocacy articles entitled with such phrases as “don’t squander this opportunity,”2,3 Shweder urges researchers to be proactive in clearing the thicket of past protocols and opening social science research to broader exemptions.

“Unless faculties are proactive, this is unlikely to result in big reform,” he says. “Entrenched systems are entrenched systems, and all sorts of people either have some stake in keeping them going, or it’s just easier to keep them going than to change them. Look, have you read through all those [Common Rule] regulations — it’s like a new form of torture. Having people being heroic and willing to make a commitment to reform this is going to be a real challenge. If people are complaining about the current system and they want it changed, the onus is on them to get involved.”

REFERENCES

  1. Riley WT, Akbar F. Revision to the Common Rule: Implications for Behavioral and Social Sciences Research. Observer 2017: http://bit.ly/2s0KavB.
  2. Shweder RA, Nisbett RE. Don’t Let Your Misunderstanding of the Rules Hinder Your Research. Chronicle Higher Education 2017: http://bit.ly/2r1GvbY.
  3. Shweder RA, Nisbett RE. Long-Sought Research Deregulation Is Upon Us. Don’t Squander the Moment. Chronicle Higher Education 2017: http://bit.ly/2n6w8VV.