On 18 January 2017, sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects. As I noted earlier, this marks a huge victory for historians, who have spent the last 20 years working to end the inappropriate interference of IRBs with oral history research.
No biospecimens overhaul; less controversy
The final rule “does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.” This was the target of the greatest criticism from groups like the National Academies of Sciences, Engineering, and Medicine and SACHRP. So while this change has little direct bearing on the work of social scientists and scholars in the humanities, it will likely reduce the controversy surrounding the regulatory reform as a whole.
The abandonment of the biospecimens proposal could also reduce opposition to reform by conservatives. The House Freedom Caucus opposed a new Common Rule on the grounds that it would cost $13.334 billion over 10 years. This figure seems to have been drawn from the NPRM’s quantified costs of $13.342 billion (using a 3 percent discount rate), and ignored the NPRM’s quantified benefits of $2.6 billion. If all the Freedom Caucus cares about is money, it may like the final rule a lot more. Of the $13.3 billion estimated costs, $12.2 billion came from complying with the new rules on secondary use of biospecimens (80 FR 54021). The new estimate is that changes will have benefits of $1.9 billion over 10 years and costs of only $528 million (at a 3 percent discount rate, which is where the $13.3 billion figure came from). If Republicans can consider benefits as well as costs (as the House Freedom Caucus has so far failed to do), perhaps the jettisoning of those rules will reduce hostility to the overall reform.
Agencies continue to ignore statutory limits
Like previous versions of 45 CFR 46, this final rule claims as its statutory authority 42 U.S.C. 289, which applies to “biomedical and behavioral research,” yet it fails to restrict its provisions to such activities. The announcement explains:
Regarding the concerns expressed that the Common Rule departments and agencies are not authorized to regulate humanities and social science research, this challenge had been asserted previously against the 1981 HHS protection of human subjects regulations, as well as the 1991 Common Rule, and in each case the regulatory agencies concluded that the regulation of humanities and social science research is justified. We continue to assert the authority to regulate humanities and social science research that falls within the scope of the final rule.
Note the verb “assert.” Not find, show, explain, reason. No statutory analysis. Just raw assertion of power.
The announcement cites the 1981 and 1991 Federal Register announcements, neither of which states that “the regulatory agencies concluded that the regulation of humanities and social science research is justified.” I know of no such formal finding.
Similarly, the final rule abandons the NPRM’s proposal to impose review on clinical trials “regardless of the funding source of the specific clinical trial” without reference to the statute. Rather than concede that HHS lacks the statutory authority for such a requirement—something it did concede in 1981 (46 FR 8369)—it claims, “our proposal for extending the Common Rule to currently unregulated clinical trials would benefit from further deliberation.”
Oral history is clear; ethnography is still regulated
As I noted in my previous post, the new definition of research includes a provision [ §__.102(l)(1)] explicitly excluding “Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.” This is a big deal not only for historians and journalists, but also for literary critics, law professors, and political scientists who do on-the-record interviews.
The final rule eliminated the special exemption for research with public officials on the grounds that it is no longer needed. Now, if you are running a low-risk survey of public officials, you seek clearance under the exemption for low-risk surveys, while if you want to “hold specific elected or appointed officials up for public scrutiny,” you aren’t doing research under the revised definition of research. This strikes me as an improvement, since it provides the same clearance for research about corporate executives, rock stars, lobbyists, and other public figures as it does for the more narrow category of officials and candidates.
Unfortunately, the new rule continues to cover ethnography:
Activities described in §__.102(l)(1) may sometimes be performed in the fields of anthropology or sociology, but not all activities characteristic of these fields are outside of the rule. Studies using methods such as participant observation and ethnographic studies, in which investigators gather information from individuals in order to understand their beliefs, customs, and practices, and the findings apply to the studied community or group, and not just the individuals from whom the information was obtained, fall within the scope of the definition of research of the final rule.
How exactly ethnographers are supposed to do their work is another question. At the 20 October 2015 Town Hall, OHRP officials could not figure out how the NPRM would govern ethnography. And I’m not sure the final rule is any clearer.
Changes to ethnography and surveys
The final rule does make some changes that may affect ethnography and surveys, perhaps to the good.
- Easier to talk with prisoners, pregnant women, and the disabled
For ethnography and other social science work that still falls under the definition of research, but that is exempt, it will be possible to maintain that exemption if the population studies “only incidentally includes prisoners.” And “pregnant women or ‘handicapped’ or physically disabled individuals” are now considered able to think for themselves, so no special review of research involving them is required.
- Modified exemption for interviews and surveys
(2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §__.111(a)(7).
The addition of “by the investigator” in part (i) is helpful. If a participants wants to take notes, that doesn’t affect the researcher’s exemption. The addition of part (iii) allows another path to exemption not present before. At some point in the future, HHS will issue guidance explaining what privacy procedures qualify a study for this exemption.
- No more checking the box
HHS “plan[s] to implement the proposed nonregulatory change to the assurance mechanism to eliminate the voluntary extension of the FWA to nonfederally funded research.” The final rule explains:
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.
Conceivably this could help ethnographers win exemption.
- Modified consent rules
I confess that I haven’t been able to digest the complex new rules about obtaining consent. I do note that the final rule allows IRBs to waive the requirement for a signed informed consent form if
the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
The regulations have, since 1981, allowed waivers of consent forms for “procedures for which written consent is normally required outside of the research context,” like talking with people. (Whether IRBs have heeded this provision is another matter.) So I’m not sure that the addition of distinct groups here will change anything for ethnographers.
Delayed changes to “minimal risk,” exemption determination, and privacy protections
The final rule abandons some NPRM proposals in favor of buying time by reducing them to matters of guidance. These include:
Changing the definition of minimal risk. HHS may still develop a list of examples of minimal-risk activities, but it will do so outside of the regulatory track.
Creating an “exemption determination tool,” which researchers could use to determine if their proposals were exempt from review. Like the list of minimal-risk activities, this is something that HHS can continue to work on without a regulatory change.
Privacy protections. “Rather than promulgate a regulation that lacked sufficient specificity, we determined it would be preferable to maintain the requirement that IRBs review research studies to ensure that appropriate privacy and security safeguards are in place to protect research subjects, but include a commitment that the Secretary of HHS will issue guidance to assist IRBs in appropriately protecting subjects’ privacy and confidentiality. This guidance would take into consideration, among other things, the level of identifiability and sensitivity of the information being collected.”
Limited restraints on IRBs
The final rule states that “An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under §__.104 for which limited IRB review is a condition of exemption.” It does not explicitly forbid IRB review of exempt research. And since the big problem with exempt research has been jumping through hoops erected by IRB staff, it’s not clear how much of a difference this will make either way.
IRBs now must document their reasons for escalating review:
The final rule includes the NPRM proposal that IRBs document decisions to require continuing review or full board review even in circumstances when such review is not required because we believe it is important to document why an IRB is making a determination that differs from the regulatory baseline. This also helps to promote the principle of justice (as applied to IRB operations). Note that nothing in these regulations prevents an institution from authorizing an IRB to apply standards that exceed those in the regulations, if indeed the institution has chosen to do so.
Beyond that, there’s scant due process protections in the final rule. No guaranteed appeals, for instance. No requirement that IRBs base their decisions on evidence.
In sum, the final rule is great news for researchers whose work will no longer be subject to IRB oversight. I’m less sure it will significantly help those still subject to regulation.