A social scientist’s guide to the Final Rule

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.

In addition, the final rule includes several provisions of note to scholars in the humanities and social sciences. Here are some of them; I don’t claim it is a complete list.

NPRM: Escape for Many, Scant Relief for Those Left Behind

While the NPRM might do much to reduce the number of projects requiring IRB review, it would do little to improve the quality of review for those projects for which it is still required. This is a retreat from the more ambitious plans of the 2011 advance notice of proposed rulemaking.

[This post will be cross-posted to the Petrie-Flom Center's Bill of Health, which is conducting an online NPRM Symposium.]

Schrag Reviews Klitzman, Ethics Police?

Just in time for the NPRM comment period, Society has published my review of Robert Klitzman’s book, The Ethics Police?: The Struggle to Make Human Research Safe (New York: Oxford University Press, 2015). I note that “By offering the subjective worldview of IRB members, Klitzman shows how good intentions combine with ethical ineptitude to produce arbitrary decisions.”

Per my agreement with Springer, what follows is the accepted manuscript of the review. The final publication is available at Springer via http://dx.doi.org/10.1007/s12115–015–9935-x.

David Wright: OASH "is secretive, autocratic and unaccountable."

David Wright has resigned as director of the Department of Health and Human Services' Office of Research Integrity. In his letter of resignation, obtained by Science Insider, Wright blames a dysfunctional Office of the Assistant Secretary for Health (OASH), which also houses OHRP.

[Kaiser, Joceyln. "Top U.S. Scientific Misconduct Official Quits in Frustration With Bureaucracy." Science Insider, March 12, 2014.]

What Can One University Do?

A few weeks ago, a correspondent asked me what reforms individual universities can implement while awaiting systemic, regulatory reform. It's an excellent question, so here's a roundup from material previously covered on the blog.

No university has adopted all of these measures, and at least one of these measures has not been adopted by any. But most of them are in place already, and there's no reason they can't spread.

U of Sheffield REC Suspended Professor for Discussing Research

The Times Higher Education reports that in 2010, the director of research in the University of Sheffield Management School told Professor Stuart Macdonald to suspend his research, even though the professor had done nothing but mention another professor's research during a "discussion on research ethics and integrity."

[Paul Jump, "Found guilty until proven innocent over unapproved research claims," Times Higher Education, 25 October 2012.]

The story reports, "Fifteen days later, [Macdonald] received an email from the chair of the research ethics committee, Richard Jenkins, saying a 'misunderstanding' had occurred, although he was offered no apology or further explanation."

Macdonald filed a formal complaint about his treatment by the REC, but it was dismissed.

The case echoes the experience of Bernadette McCauley, who also received an order to suspend all research from an ethics committee that had no idea of what it was doing.

Can an IRB Ban a Researcher?

In July, the Sacramento Bee reported that the University of California, Davis, had ordered two doctors--J. Paul Muizelaar and Dr. Rudolph J. Schrot--"to halt all human research activity 'except as necessary to protect the safety and welfare of research participants.'" Schrot told the Bee that "To be banned from clinical research makes a career in academic medicine challenging, to say the least."

The Common Rule (45 CFR 46.113) empowers IRBs to "suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects," but it does not explicitly empower them to ban a researcher from all research.

Li Abandons Suit, But Brown University Still Ponders IRB Reform

Though it no longer faces a faculty lawsuit, Brown University is considering an outside review of its troubled IRB.

As readers of this blog may remember, Brown faculty have been complaining about the IRB since 2007, if not before.

In 2011, a Brown professor, Jin Li, took the highly unusual step of suing the university because of IRB interference in her work. In March, Li abandoned that effort, her attorneys agreeing to a dismissal with prejudice.

According to the Daily Herald, Brown faculty and administrators are discussing possible reforms, including an external review, broader disciplinary representation on the IRB, the creation of an additional IRB for non-biomedical human subject research, and "changing the charge of the IRB to make it not only a monitory board but also one that provides a more supportive and guiding role to research teams."

[Aparaajit Sriram, "IRB Likely to Undergo Review," Brown Daily Herald, 26 April 2012.]

The article does not mention the possibility of an appeals process, the lack of which was one of Li's complaints.

Could Retrospective Review End Nitpicking?

Robert Klitzman and Paul Appelbaum, both of Columbia University, suggest that shifting research oversight to the retrospective review of a subset of projects, rather than prospective review of proposals, could reduce the "variability and subjectivity across IRBs" that now characterizes ethics review.

[Robert Klitzman and Paul S. Appelbaum, "To Protect Human Subjects, Review What Was Done, Not Proposed," Science 335 no. 6076 (30 March 2012): 1576-1577,
DOI: 10.1126/science.1217225.]

Li and Brown Continue Negotiations

A correspondent asks for an update in the case of Jin Li, the Brown professor who sued her university after its IRB restricted her research.

I checked Public Access to Court Electronic Records (PACER) and found that on January 13, the parties jointly asked for an extension of the discovery deadline, telling the court "that they continue to negotiate a settlement of the claims. Due to the efforts made negotiating a settlement, only minimal discovery has been propounded so far. As such, if the parties are unable to settle, then the parties will need time to complete formal discovery."

I have posted the motion and other key documents on my IRB Documents page.

SBS White Paper Calls for Drastic Reform

Weighing in at 72 pages, the "Social and Behavioral Science White Paper" is the most detailed response to the ANPRM from scholars in the social sciences. The paper presents a grim picture of the state of IRB review and is generally supportive of the ANPRM's goal of reform. But it offers detailed, helpful warnings about the potential effects of the proposed "excused" category and the adoption of HIPAA as a model for confidentiality requirements. Though it shies away from the toughest questions about the IRB system, it is a good expression of the frustrations felt by so many researchers in the social sciences and humanities.

[American Educational Research Association et al., "Social and Behavioral Science White Paper on Advanced Notice for Proposed Rulemaking (ANPRM), Federal Register 44512-531 (July 26, 2011); ID Docket HHS-OPHS-2011-0005," 26 October 2011.]

Inside Higher Ed Reports on Li v. Brown University

Inside Higher Ed reports on the Brown University professor who is suing the university over IRB restrictions. The story quotes your humble blogger.

[Dan Berrett, "IRB Overreach?," Inside Higher Ed, 18 March 2011.]

Professor Sues Brown University Over IRB Mission Creep

Jin Li, Associate Professor of Education at Brown University, has sued the university in federal court for forbidding her from using data from a study she conducted with private funding.

[Alexandria D'Angelo, "Professor Says Brown U Has a Lot of Nerve," Courthouse News Service, 1 March 2011. Thanks to Illuminata for catching this.]

IRBs and Procedural Due Process

A law student finds that "current IRB regulations fail to provide procedural due process as guaranteed by the Fifth and Fourteenth Amendments of the United States Constitution."

[Daniel G. Stoddard, "Falling Short of Fundamental Fairness: Why Institutional Review Board Regulations Fail To Provide Procedural Due Process," Creighton Law Review 43 (June 2010): 1275-1327]

Stoddard notes a number of measures that might protect researchers against capricious IRBs but which are not currently required:

Federal IRB regulations are silent . . . regarding a number of specific aspects of IRB function including public attendance of IRB functions, a researcher's opportunity to hear and cross-examine information opposing that researcher's research, and a researcher's right to privacy with regard to an IRB's media interaction. IRB regulations additionally fail to address whether an IRB should base its decision exclusively on evidence presented to it, whether a researcher should have a right to a hearing before the IRB suspends research, whether a researcher has a right to judicial review of an IRB decision, and whether a researcher has a right to an attorney. Federal IRB regulations also fail to include a researcher's right to have informal communications with an IRB, a researcher's right to present further evidence to an IRB following a rejection, a researcher's right to consult with personnel opposing that researcher's research in an effort to understand and prepare to challenge them, and an IRB's obligation to evaluate its own functioning procedures periodically. (1290)

All of these measures could be helpful, but the question for Stoddard is whether their absence violates procedural due process. To answer that question, he turns to Mathews v. Eldridge (424 US 319 - Supreme Court 1976), a 1976 Supreme Court case named for the same HEW secretary who was sued for violating IRB procedures in Crane v. Mathews, 417 F. Supp. 532 - Dist. Court, ND Georgia 1976.

Mathews states that

the specific dictates of due process generally requires consideration of three distinct factors: First, the private interest that will be affected by the official action; second, the risk of an erroneous deprivation of such interest through the procedures used, and the probable value, if any, of additional or substitute procedural safeguards; and finally, the Government's interest, including the function involved and the fiscal and administrative burdens that the additional or substitute procedural requirement would entail.

Stoddard, it turn, argues that "The inability to contest or appeal an IRB decision is a substantial procedural shortcoming when evaluated under the three prong Mathews [v. Eldridge] balancing test."

The problem with this argument is that Mathews does not require the right to appeal, nor do other key precedents. In particular, Stoddard would be more persuasive had he addressed head-on what I take to be the federal court decision that most directly addressed due process and IRBs: Halikas v. University of Minnesota. Though Stoddard cites the district court's denial of a preliminary injunction to the plaintiff in that case, an aggrieved researcher, he does not analyze the court's reasoning behind that denial: "An IRB proceeding is, simply, not a federal criminal prosecution. Such a proceeding is governed by contracts and federal regulations which do not require, or provide, the full panoply of criminal procedural rights . . . Dr. Halikas voluntarily entered into an employment contract and conducted his research under the aegis of the University and its research-regulatory regime. He received the process which is his due." [Halikas v. University of Minnesota, 856 F. Supp. 1331; 1994 U.S. Dist.]

Nor does Stoddard analyze the final judgment in that case, which was not published. [Case number 4-94-CV-448, Federal District Court, Fourth Division, District of Minnesota; filed 18 May 1994; Judgment entered 9 June 1996. I am very grateful to Dr. Dale Hammerschmidt, one of the named defendants in the Halikas suit, for providing me with a copy of this document. I have posted it on my website (see previous link) so it will be easier to find in the future.]

In that judgment, the court found that "as the Eighth Circuit Court of Appeals has determined in similar cases, the Constitution requires only that Dr. Halikas receive: (1) clear and actual notice of the charges against him; (2) notice of the names of those bringing the charges and the specific nature and factual basis for the charges; (3) a reasonable time and opportunity to respond; and (4) a hearing before an impartial board or tribunal." It did not include the right to appeal as a component of procedural due process under the Constitution.

The "similar cases" which Judge James Rosenbaum used to reach this result were two cases in which employees of public universities contested their firing: Riggins v. Board of Regents of Univ. of Neb., 790 F. 2d 707, 712 (8th Cir. 1985) and King v. University of Minn., 774 F. 2d 224, 228 (8th Cir. 1985), cert. denied, 475 U.S. 1095 (1986).

This comparison casts doubt on Dr. Hammerschmidt's claim that Judge Rosenbaum "formally recognized the concept that the opportunity to conduct research upon human subjects is a privilege, rather than a right." ["'There is no substantive due process right to conduct human-subject research': The Saga of the Minnesota Gamma Hydroxybutyrate Study," IRB: Ethics and Human Research. 19 (May - Aug., 1997): 13-15. This is amplified in Steven Peckman, ["A Shared Responsibility for Protecting Human Subjects," in Institutional Review Board: Management and Function, ed. Robert J. Amdur, Elizabeth A. Bankert (Jones & Bartlett Learning, 2006), 17.]

To the contrary, Riggins specifically states that "Public employees may have a property right in continued employment." And King involved the dismissal of a tenured professor. By invoking these precedents, the Halikas decision suggests that while research is not a substantive due process right, researchers may have procedural due processs rights comparable to those enjoyed by public employees and tenured professors. Halikas makes no mention of research as a "privilege."

Though the Halikas judgment was sufficient to decide the case before the court, it left unanswered many questions about the rights of researchers who face IRBs. Are the procedural protections set forth in King and Riggins adequate to protect the right to research, academic freedom, or a property right in continued employment? Do professors in their capacity as researchers deserve more, less, or equivalent protections as professors in their capacity as teachers? What rights, if any, might student-researchers claim? Would Halikas or King have been decided differently had the plaintiffs offered free-speech claims? Does the "human research" in the judgment refer to social research as well as the medical research that was the subject of the IRB proceedings against Halikas? (The final judgment describes the IRB as a "medical research review body.") Does a board or tribunal have to be competent as well as impartial?

Halikas leaves all these questions unanswered. A careful analysis of that case would be a good starting place for further legal scholarship on the due process implications of IRB policies.