Friday, November 5, 2010

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.

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