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Protecting Human Subjects and Preserving Academic Freedom: Prospects at the University of Chicago

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Protecting Human Subjects and Preserving Academic Freedom: Prospects at the University of Chicago RICHARD A. SHWEDER University of Chicago Protecting human subjects and preserving academic freedom: Prospects at the University of Chicago ABSTRACT The basic policies of the University of Chicago include complete freedom Within the terms of the federal regulatory scheme of research and the unrestricted dissemination of information. requiring institutional review board (IRB) oversight of federally funded research with human subjects, —University of Chicago Articles of Incorporation, Bylaws and Statutes, p. 44 projects that are not federally funded are not mandated for IRB review. Eighty percent of We regret to inform you that IRB approval for your research Protocol has social-science projects at the University of Chicago expired. Please note that research related activities (including interaction are not federally funded. This article is a critique of with human subjects, data collection, and/or data analysis) may not con- the overextension of federal regulations by tinue or be initiated until the IRB has approved the continuation of this university and college administrators and provides research. some suggestions for reform. [academic freedom, —Official communication from the University of Chicago Social and IRB, human-subjects protection, research ethics] Behavioral Science Institutional Review Board to the faculty spon- sor of a personally funded research project, September 2005 he federal regulatory scheme specifically requiring institutional re- view board (IRB) oversight of federally funded research at U.S. uni- versities and colleges (Department of Health and Human Services [DHHS] “Code of Federal Regulations, Title 45 ‘Public Welfare,’ Part 46 ‘Protection of Human Subjects’ ” [2005] rules and definitions, Talso known as the “Common Rule”) was initiated by an act of Congress in 1974 and is currently enforced by the Office for Human Research Protec- tions (OHRP). The original act of Congress was motivated by concerns over perceived ethical violations in biomedical research conducted by the Pub- lic Health Service, and its aim was to make sure that all federally sponsored research is ethically sound and respectful of the rights of the human beings involved in the research. Within the terms of those federal regulations, re- search that is not federally funded is not mandated for “Common Rule” reg- ulation. Alternatively stated, within the terms of the 45 CFR 46 regulations, the scope and depth of OHRP enforcement is limited to federally funded projects; it is legally possible for academic research institutions to shield and protect privately funded, personally funded, and unfunded projects from the reach of the IRB surveillance and research licensing process (and its AMERICAN ETHNOLOGIST, Vol. 33, No. 4, pp. 507–518, ISSN 0094-0496, electronic ISSN 1548-1425. C 2006 by the American Anthropological Association. All rights reserved. ⃝ Please direct all requests for permission to photocopy or reproduce article content through the University of California Press’s Rights and Permissions website, www.ucpress.edu/journals/ rights.htm. American Ethnologist ! Volume 33 Number 4 November 2006 various definitions, rules, and regulations) while at the same academic administrators) for the wholesale application of time assuring by other means that all research with human the DHHS regulations to the vast majority of social scien- subjects is guided by ethical principles. In this article, I pro- tists, humanists, and legal scholars who conduct research vide a brief account of the overextension of the 45 CFR 46 without a reliance on federal funds. regulations by university and college administrators, a pro- That there is no federally mandated legal requirement cess of overregulation that has been labeled “mission creep” to universalize the 45 CFR 46 regulations (or any of their sub- (University of Illinois Center for Advanced Study 2005). I also parts) beyond federally funded projects has been a well-kept defend a defining proposition associated with the tradition secret among academic administrators, most of whom have of academic freedom at the universities and colleges of the done very little to educate their faculty in this regard or to United States, namely, that a university is a place where the bring the matter forward for appropriate deliberation and a life of the mind of individual scholars is granted very high vote; but it is also welcome news, especially for researchers degrees of autonomy; hence, proposed restraints (even well- in the social sciences, humanities, and law, in which many intended ones) on faculty and student research and other scholarly projects involving other human beings are not fed- suggestions for regulating, monitoring, controlling, or con- erally funded. At the University of Chicago, for example, stricting scholarship that are not mandated by law should nearly 80 percent of all research projects reviewed by the So- be viewed with a very skeptical eye and resisted, rather than cial and Behavioral Science IRB are either personally funded, uncritically embraced, by members of the academy. A mon- privately funded, or unfunded. Indeed, the news might be umental (even if small) first step in that direction, restricting viewed as an eye-opening invitation to faculty ruling bod- the legally required range of application of the 45 CFR 46 reg- ies around the country to scrutinize their own institutions’ ulations to federally funded projects, has been taken at my history of administrative decision making concerning IRB own academic home, the University of Chicago, as I describe policy and to reform their internal procedures for the pro- below. motion and maintenance of research ethics. A first step in that direction has been taken at the Uni- The news: The limited scope of IRB authority versity of Chicago. The occasion was the most recent three- year renewal of the university’s ethical-oversight agreement The news that research with human beings that is not fed- with DHHS and OHRP,which went into effect on January 1, erally funded is not federally mandated for IRB oversight 2004. All U.S. universities and colleges that receive federal will probably come as a surprise to many scholars in the research funding enter into this type of contract or agree- United States. Until rather recently, academic administra- ment, which was previously known as the Multiple Project tors at almost all U.S. research universities have voluntarily Assurance (MPA) and is currently titled the Federalwide As- signed away and (as I suggest in this article) unwisely sur- surance (FWA). From the point of view of the federal funding rendered their legal rights to restrict the IRB regulations to agencies, it is the FWA agreement that legally enables them federally funded research and to create their own alternative to sponsor and support research involving human volun- ethical-oversightproceduresforresearchthatisnotfederally teers at research institutions that are not part of the federal funded. government. By means of its FWA form (in the section on Typically, this discretionary extension of the DHHS reg- “Statement of Principles”), DHHS and OHRP offer research ulations to all research (regardless of funding source) has institutions the option to either adopt the DHHS Belmont been done without the benefit of an open and robust de- Report (a document written largely by bioethicists that high- bate about its implications for academic values or research lights various moral ideals: respect for persons, beneficence, performance. Indeed, at many (perhaps most) colleges and justice, and informed consent [National Commission for the universities today, the decision to extend the regulations Protection of Human Subjects of Biomedical and Behavioral has been taken by academic administrators without the full Research 1979]) as the ethical standard governing research knowledge, involvement, and direct consent of faculty ruling or else propose an alternative set of ethical guidelines to gov- bodies.Ithasbeenacompletelyelectiveinternaladministra- ern research at that institution. By means of that assurance tive action: voluntary endorsement of an optional clause in a form, DHHS and OHRP inform a university that all federally formal contract with DHHS and OHRP agreeing to subject all funded research must be reviewed and approved by an IRB researchers to the ethical licensing system tied to federally applying the 45 CFR 46 regulations, rules, and definitions. supported projects, including federal definitions of exempt Quitecrucially,theFWAform(inthesection“Applicabil- research and the authority of an IRB to demand and evalu- ity”) also offers a university the option to either agree or not ate project proposals and dispense or withhold permission agree to legally bind itself to apply the IRB process to all re- to do research. Consequently, many research scholars, in- search regardless of funding source. Thus, the FWA form of- cluding those social scientists who grumble about the IRB ficially and explicitly asks university administrators whether and trade horror stories, appear to be totally unaware that they would like to retain their legal right to apply the IRB they have no one to blame but themselves (and their own process only to federally funded research. For almost three 508 Protecting human subjects and preserving academic freedom ! American Ethnologist decades following the creation of the IRB system, almost all that universities and colleges have a legal right to decide for academic institutions voluntarily renounced their legal right themselves how to uphold
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