Secretive

Compared to previous stages in the regulation of human subjects research, the process that produced the newest Common Rule was remarkably obscure. The first 45 CFR 46, issued in 1974, followed extensive hearings in both the House of Representatives and the Senate. The second version, issued in 1981, followed four years of public meetings of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Both of those phases had their problems, particularly when it came to defining the scope of the research to be regulated. But at least everyone understood the impetus for the process: the public disclosure of the abuses of the Tuskegee Syphilis Study, as well as other ethically dubious research documented by Henry Beecher.^{Reference Beecher6}

By contrast, the latest round started quietly. At some point in 2009, the Office of Management and Budget directed staff at the White House and DHHS to begin work on an ANPRM to reform human subjects regulations.^{Reference Baumann, Emanuel and Menikoff7} Without better documentation, we know little about why that happened. Was Ezekiel Emanuel, who had long called for reform before joining the Obama administration, the prime mover? If so, what led him to believe that now was the moment for Common Rule reform? Would he have made the same proposals in prior years? Or were there recent events, like the 2010 publication of The Immortal Life of Henrietta Lacks? (If so, that would perpetuate a pattern of writing regulations in an effort to stop practices that had already ended decades previously.)^{Reference Conley8} We did get one glimpse behind closed doors when, in 2014, Public Citizen posted a series of emails it had “obtained” through unspecified means. As noted below, those documents offers some tantalizing glimpses of the process of regulatory revision, such as the role of the National Science Foundation.^{Reference Carome9} Still I am not speaking from the kind of documentary authority I would prefer as a historian.¹⁰

At no point in the multiyear revision process did the federal government hold official hearings comparable to the congressional hearings of the early 1970s or the commission hearings of the late 1970s, during which experts were invited to testify. Experts in all fields, including biomedical research, were left to organize their own conferences and publications in the hopes of influencing policy.

Spasmodic

The process was also rushed in ways reminiscent of the haste of previous efforts. It might sound strange to label as “hasty” a process that took six and a half years in public, and presumably a fair amount of preparation out of sight before then. But the process, or at least its public elements, ran in fits and starts, leading to a great deal of hasty work.

When they promoted the ANPRM in July 2011, Ezekiel Emanuel and Jerry Menikoff warned that “If this reform effort fails, 20 years from now, someone might … bemoan the fact that the Common Rule has undergone essentially no change in 40 years.”¹¹ Yet their agencies released the original ANPRM in the middle of the summer, when academics are least in touch with each other, and gave citizens only 60 days to respond to its 74 questions. They said, in effect, respond in 60 days or lose your chance for 20 or 30 years. When scholarly and advocacy organizations begged for 120 days, DHHS lengthened the deadline to a still-hasty 90 days. Such deadlines precluded careful deliberation.

Similarly, when the National Research Council appointed a Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, it could not know how long it had to issue recommendations before it would be overtaken by events. It therefore wrote a “fast-track” report, released in January 2014.^{Reference Fiske12} As it turned out, the committee could have worked more deliberately, since the regulators were not close to a proposed rule.

In between these spasms of activity, we faced long stretches of silence. In February 2013, 15 months after the close of comments on the ANPRM, Tom Puglisi of the Office of Research Oversight in the Department of Veterans Affairs wrote that “proposals to modify the Common Rule have become stalled, at least for the foreseeable future, if not permanently. Given the current political climate and the often divergent interests of the seventeen agencies that adhere to the rule, meaningful systemic modernization of the Common Rule is not likely to occur any time soon.”^{Reference Puglisi13} The next month, Greg Koski, former director of OHRP, said of the reform process, “I think it's dead, pretty much.”^{Reference Basken14} Philip Rubin, who held posts at the National Science Foundation and the Office of Science and Technology Policy, recalls that little progress was made between January 2012 and February 2014. At that point he created a Common Rule Modernization Working Group to push for a proposed rule.¹⁵

For those of us outside the closed rooms, the wait lasted even longer: all of 2012, 2013, and 2014, and most of 2015. After a 90-day official comment period, we endured a 1407-day period of unofficial inaction. During that time, the National Research Council did its work, and the Petrie-Flom Center at Harvard Law School organized and ran a conference, edited the papers, and published them in a volume, all before any suggestion that a proposed rule was on its way. In late 2014, we started getting teasers that work was progressing after all. “I can assure you that this continues to be an HHS priority,” said a spokesperson, “and all the relevant parties are still working very hard on this.”^{Reference Shea16} Then nearly another year more of silence.

If officials had been more forthcoming about their thinking during this nearly three-year period, the hundreds of researchers, subjects' advocates, and other interested parties could have been more helpful. For instance, perhaps early on, federal officials rejected the idea of using the Health Insurance Portability and Accountability Act (HIPAA) to define “individually identifiable information,” which could have saved people the bother of arguing against that idea.¹⁷ Or experts would have known to be especially active. Acting in secrecy for five of the eight Obama years kept most citizens out of the loop.

Only in September 2015 did we see an NPRM. Then, more haste. Not only were comments limited to 90 days, but everyone knew that time was now running out on the Obama administration. There was no more time for bold ideas, just everyone grab what you can on the way out of the burning building. Finally, a new rule was announced on January 18, 2017, with only 51 hours left in the Obama presidency. At least this team beat the record of their 1981 predecessors, who didn't get their rule into the Federal Register until six days after the end of the Carter administration. Still, I suspect that the rush was responsible for some rough spots in the final rule, which regulators eventually judged to require two years, rather than one, to implement.

The rush at the end was the result of the initial decision to try to overhaul the entire Common Rule in a single leap. I rarely agree with Public Responsibility in Medicine and Research (PRIM&R), an organization that often defends the IRB status quo. But I concur with its analysis that “the best, evidence-based revisions will not emerge from a process that tries to make all needed revisions at once. By perpetuating the view that regulations cannot be revised when needed, the current approach risks locking in place for another 25 years a number of provisions in the NPRM that even its most enthusiastic supporters admit are flawed in important ways.”^{Reference Capron, Strauss and Hurley18}

It doesn't have to be this way. Canada issued the first Tri-Council Policy Statement in 1998, revised it in 2000, 2002, 2005, released a second edition in 2010, and revised the second edition in 2014.¹⁹ Australia published its National Statement on Ethical Conduct in Human Research in 1999, promising to review it at least every five years.²⁰ U.S. policy should be equally steady, and equally open.

Unrepresentative

From what occurred in public and was leaked, we can say that social science, including qualitative social science, enjoyed some chances to make itself heard, perhaps slightly more than was the case during the previous revision, from 1974 to 1981. However, the process never approached the National Research Council's 2003 suggestion that “Any committee or commission established to provide advice to the federal government on human research participant protection policy should represent the full spectrum of disciplines that conduct research involving human participants.”²¹

Such a system has been in place since 2001 in Canada, where human subjects guidelines (the Tri-Council Policy Statement) are set by a body called the Interagency Advisory Panel on Research Ethics, representing the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council. Neither the Canadian process nor the rules it has produced is perfect, but the presence of representatives from the social sciences and humanities has led to major reforms in Canadian guidelines. So far as I can tell, U.S. policymakers almost wholly ignored the lessons from Canada and other countries.²²

By contrast, United States official bodies governing and advising on human subjects protections tend to exclude social scientists, especially qualitative researchers. Social scientists have been denied seats on most of the various presidential commissions formed to discuss this area since 1974. Most recently, the Presidential Commission for the Study of Bioethical Issues claimed to have made “attempts to understand the full range of human subjects research conducted or supported by the federal government,” but it discussed only medical research in its 2011 report, Moral Science.²³

Similarly, the Secretary's Advisory Committee on Human Research Protections (SACHRP) enjoys official status within DHHS, and OHRP officials always attend its meetings. Officially, its members “shall be selected from among individuals possessing demonstrated experience and expertise in any of the several disciplines and fields pertinent to human subjects protection and/or clinical research.”²⁴ In practice, SACHRP rarely if ever includes members with expertise outside of biomedical and psychological research, even as OHRP imposes its decisions on a much broader range of disciplines. In December 2015, for instance, SACHRP consisted solely of members with expertise in health and bioethics, and it conceded that it had “insufficient expertise” to address some elements of the NPRM. Yet it recommended a “comprehensive re-write of the NPRM,” a process that could have doomed reforms desperately sought by scholars whose disciplines it did not represent.²⁵

OHRP, the lead agency on the regulations, also lacks humanists and qualitative social scientists. As Gorey explained, “no one from OHRP was willing to put forth themselves as an expert in the field of ethnography.” I suspect that would be equally true for other forms of interview research — such as folklore, linguistics, and oral history — and for much observational and survey research as well.

Instead, here's what qualitative social scientists in the United States got:

1. 1. Acknowledgment of grievances. The ANPRM warned that “Over-regulating social and behavioral research in general may serve to distract attention from attempts to identify those social and behavioral research studies that do pose threats to the welfare of subjects and thus do merit significant oversight,” and it cited some criticism of the old system by scholars in the social sciences and humanities, myself included.²⁶ It's nice when people listen.

2. 2. The chance to send comments over the transom. Thanks to the Administrative Procedure Act of 1946, all “interested persons” had the chance to participate, and more than a thousand individuals and organizations did so. These included dozens of individual scholars in the social sciences and humanities, as well as organizations representing their interests. White House staff do read these comments carefully.²⁷ However, regulators are not required to respond to such comments.

3. 3. Half a seat on the National Research Council's Panel on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. Despite the NRC's 2003 recommendation, the panel formed in late 2012 included six doctorates in psychology, two in economics, and one each in social epidemiology and sociology, plus an M.D. and a J.D. One of the economists and the lawyer specialized in health issues. When first formed, it had no anthropologists, communication scholars, folklorists, geographers, historians, journalists, or linguists, and no one primarily interested in ethnography, interviewing, participant observation, or action research.²⁸ Only after the panel had been working for some months did the chair appoint anthropologist Rena Lederman. Given her long experience and eagerness to speak for all humanistic social sciences, Lederman was a superb choice, but she was still grossly outnumbered on the panel, and because of the rules, anyone could veto her suggestions.²⁹

4. 4. Possibly some advocates within the federal government. The emails released by Public Citizen show that in October 2014, the White House asked the National Science Foundation “to ensure that the ‘non-biomedical science perspective’ is covered” in the forthcoming Notice of Proposed Rulemaking (NPRM), revising the Common Rule.³⁰ That's important; as the Common Rule agency most likely to fund social science research, the NSF has played an important moderating role since the 1970s. But it also has a lot of biomedical and behavioral research in its portfolio, and is only one of a dozen and a half players in Common Rule negotiations. Moreover, as Rubin explains, “HHS really is the big gorilla here, and the interagency stuff is kind of at the margin of things.”³¹

All told, qualitative researchers occupied pretty much the same marginal position they had during earlier rounds of regulation. From the regulators' perspective, the key debates concerned biospecimens and, perhaps, single IRB review for multisite studies. Experimental behavioral science and quantitative social science were a sideshow, and qualitative research in the humanities and social sciences were a sideshow to a sideshow. Yet the outcomes mattered greatly for those of us who work in those fields. As it turned out, those outcomes were mixed.

Freedom for Oral History and Related Disciplines

Speaking as a historian, I can say objectively that the most wonderful thing to come out of the entire reform process is the deregulation of “oral history, journalism, biography, literary criticism, legal research, and historical scholarship,” done “in order to resolve longstanding debate and uncertainty about whether these activities are considered research in the sense of the regulatory definition.”³² As a nice bonus, the announcement of the final rule explained that historians and other researchers may not want to protect the subjects of their research from “public scrutiny” and may even appropriately lower their subjects' reputations.

Fewer Restrictions on Psychological Experimentation

Psychologists cheered a new exemption for “research involving benign behavioral interventions,” provided that subjects know they may be deceived during the course of the experiment.^{Reference Riley and Akbar33}

A More Sensible Definition of “Vulnerable”

The previous regulations had given special attention to researching involving “a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons.”³⁴ This provision bizarrely suggested that competent adults might be denied the right to participate in surveys or interviews because of pregnancy or a disability. The new rule instead refers to “individuals with impaired decision-making capacity,” without assuming that pregnant women or people with disabilities are so impaired.³⁵

While this is an improvement, the redefinition of “vulnerable” did not go far enough. In his comments on the ANPRM, Tom Boellstorff, editor-in-chief of American Anthropologist, warned that “the notion of ‘economically or educationally disadvantaged persons' is so broad so as to include a majority of the world's population under its scope. The mere fact of being disadvantaged does not mean someone is ‘vulnerable’ with respect to social science research that carries only informational risk.”^{Reference Beollstorff36} This aligns with other studies suggestion that IRBs do poor jobs predicting who is vulnerable to what risks, and open to what benefits, in interview research.^{Reference Opsal37} The National Research Council report called for scrapping the language about vulner-ability to coercion and undue influence.³⁸ Yet the final rule retains the objectionable requirement of “additional safeguards” for “economically or educationally disadvantaged persons.”³⁹

No Regulation of Unfunded Research

The ANPRM considered imposing Common Rule regulation on “all research that is not Federally funded that is being conducted at a domestic institution that receives some Federal funding for research with human subjects from a Common Rule agency.”⁴⁰ I don't think the National Research Act of 1974 provides this authority, and neither did the DHHS General Counsel in 1981.⁴¹ Its imposition would be both unjust and unwise, and I'm glad to see it dropped in the final rule.

No Reliance on HIPAA

The ANPRM imagined relying on the 18 identifiers in the HIPAA Privacy Rule to determine what research needed IRB review. I don't think any researchers in any field thought this was a good idea, and it was dropped.

No Requirements for Re-Consent

The ANPRM proposed to ban the practice of “telling the subjects, during the initial research consent, that the data they are providing will be used for one purpose, and then after stripping identifiers, allowing it to be used for a new purpose to which the subjects never consented, would not be allowed.”⁴² It made clear that the authors were thinking of biospecimens here, but since the language covered “data,” it could have devastated the research based on longitudinal studies of a broader range of datasets.

No Recognition of Statutory Limits

Not only does the announcement of the final rule ignore the limits of the statutory authority underlying the regulation, it flat-out lies about the history of statutory analysis, claiming that in 1981 and 1991, “the regulatory agencies concluded that the regulation of humanities and social science research is justified.”⁴³ I see no such justification in the Federal Register announcements cited for that claim.

Exempt is Still Not Exempt

For social scientists, the great irony of human subject regulation is that the regulations, as written, have been pretty good since 1981. When DHHS released the revised 45 CFR 46 that year, it included a series of exemptions which, it promised, would allow the vast majority of social science research to proceed unhindered. And that worked until 1995, when regulators recommended that researchers not be allowed to determine whether their projects were exempt, and instead “check with the IRB or other designated authorities.”⁴⁴ This led to a bizarre regulatory world in which exempt did not mean exempt; most U.S. universities required social scientists to submit formal proposals to be reviewed by IRBs or human protections staff before beginning their research.

The ANPRM recognized the problem and proposed to remedy it with a system in which “researchers would file with their institution or IRB a brief registration form (about one page long) that provides essential information about the study,” and then proceed, greatly reducing the current burden of applying for exemptions.⁴⁵ That proposal died in the final rule, though the 2017 announcement suggests that it might come back in the future.⁴⁶ OHRP continues to advise that “investigators not be given the authority to make an independent determination that human subjects research is exempt.”⁴⁷ In 2017, Susan Fiske, who had chaired the National Research Council study, claimed that the revised regulations “clarify[ied] that exempt means exempt from IRB review.”^{Reference Fiske and Rivard48} Yet as of February 2019, the IRB at her home institution, Princeton University, still insists that “exempt studies must be submitted to the IRB for an exempt determination. Investigators are not authorized to make this determination.”⁴⁹ A systematic survey of current university policies is beyond the scope of this essay, but I expect that Princeton's policy is typical.^{Reference Loe, Winkelman and Robertson50}

A Failure to Deregulate “Two People Talking”

As the exchange between Gorey and the anthropologists showed, the federal government is still regulating some conversations between autonomous adults for the research it funds. As the final rule announcement makes clear, “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.”⁵¹ Folklore is ignored once again, despite folklorists' please for deregulation.

I think this is a mistake, and I maintain that the goals of the ANPRM would be better served by the adoption of the formula devised by E. L. Pattullo in 1979: “These regulations do not apply to research using legally competent subjects that involves neither deceit nor intrusion upon the subject's person nor denial or withholding of accustomed or necessary resources.”^{Reference Peltason52}

Insufficient Expertise in Qualitative Social Science

In 2002, Emanuel co-authored a paper noting that “A single IRB often reviews research on a wide variety of scientific topics and research settings, some of which are not aligned with the scientific expertise of the board members … Under these circumstances, IRBs can make poor decisions about the permissibility of a study that can sometimes result in avoidable harms to participants.”^{Reference Wood, Grady and Emanuel53} This has been a particular problem for qualitative researchers. Even when facing a so-called “social science” IRB, their work will be judged by scholars used to experiments and quantification, who have scant understanding of the practices and ethics of qualitative fields. The revised Common Rule does not solve this problem.

Nor does it solve it at the agency level. If I understand the final rule announcement, the work of drafting new guidance and revising old guidance will fall to “three staff people at the GS–14 level” within OHRP. Since OHRP is an agency of DHHS, which focuses on health, these staffers will presumably be experts primarily in the medical fields on which OHRP has traditionally concentrated.⁵⁴

No Provision for Empirical Research

In his 2011 appearance before the Presidential Commission for the Study of Bioethical Issues, Emanuel complained of IRBs' reliance on what he termed “gut reactions … which is worthless.”^{Reference Opsal55} Similarly, in 2014 the NRC warned of IRBs' “subjectively judging research as having a greater than minimal risk” when in fact the probability of harm was very low, or the magnitude very small.⁵⁶ Obviously, the old regulations did not instruct IRBs to rely on worthless gut reactions, but neither did they provide any mechanism for restraining IRBs that preferred such gut reactions to the hard work of ethics review.

Emanuel stressed his wish for “a learning process that would be constant and dynamic to reflect actual risk,” which I took to be a reference to a proposal, in the ANPRM, for a new database collecting “adverse events and unanticipated problems.”^{Reference Emanuel57} The National Research Council report picked up this idea, calling for research on “the probability and magnitude of harms and discomfort in daily life and the nature of age-indexed, routine medical, psychological, or educational examinations, tests, or procedures of the general population” and “appropriate algorithms for determining whether the calculus of probability and magnitude of harms and discomfort meets minimal-risk criteria.”⁵⁸

The NPRM abandoned this proposal, noting that most commentators opposed the central database as burdensome and impractical. The NPRM and the final rule after it substituted no other means for IRBs to learn or any requirement that they base their decisions on evidence.⁵⁹

No Appeals Process

An appeals process could have been another mechanism to force IRBs to base their decisions on evidence, by giving researchers the chance to challenge gut reactions. An appeals process was supported by many of the commentators during the revision process, including the National Research Council report.⁶⁰ But it did not make it into the final rule, nor did any other comparable mechanism.

Murkiness Around Generalizability

The revised Common Rule perpetuates a strategy, begun in the late 1990s, of using the concept of “generalizability” as a safety valve to deregulate research, especially interviews, that they don't think should be regulated. I have written elsewhere at greater length why I think this is a poor choice of tools.^{Reference Schrag61} Here I will note that the unreliability of the concept showed itself yet again in June 2018, when OHRP released a video claiming that while “a historical study about the life of a specific civil rights leader, and only about that individual” would escape review, “a historical study about the societal impacts of the Civil Rights Movement and how it was driven by specific leaders in that movement, would qualify as research, under the regulatory definition.”⁶² The video seems to distinguish between a singular individual and multiple specific individuals, despite the Federal Register's announcement that research on “specific individuals” (plural) would not trigger review.⁶³ Fifteen months after OHRP promised to “resolve long-standing debate and uncertainty,” it muddied those waters once again.

No Recognition of Freedom as a Fundamental Value

The Universal Declaration of Human Rights guarantees “freedom to hold opinions without interference and to seek, receive and impart information and ideas,” and the International Covenant on Economic, Social and Cultural Rights (signed though not ratified by the United States) seeks to “to respect the freedom indispensable for scientific research and creative activity.”⁶⁴ Canada's Tri-Council Policy Statement recognizes both the importance of academic freedom and the “corresponding responsibility on the part of institutions to defend researchers in their efforts to uphold academic freedom and high ethical, scientific and professional standards.”⁶⁵

In creating the new Common Rule, the United States has failed to acknowledge this need for balance. The January 2017 Federal Register announcement of the final rule is the most official statement of what regulators were hoping to achieve with this reform. Including the final rule itself, it is around 125,000 words long. None of those words is “freedom.” Once again, regulators have failed to consider freedom to be a fundamental value, worth protecting alongside such other values as respect, beneficence, and justice.