Author
Matthew W. Finkin
Other affiliations: University of Illinois at Chicago, Southern Methodist University, University of Illinois at Urbana–Champaign
Bio: Matthew W. Finkin is an academic researcher from West Virginia University College of Law. The author has contributed to research in topics: Labour law & Academic freedom. The author has an hindex of 13, co-authored 94 publications receiving 846 citations. Previous affiliations of Matthew W. Finkin include University of Illinois at Chicago & Southern Methodist University.
Papers published on a yearly basis
Papers
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TL;DR: The University of Illinois white paper addresses the problems of mission creep and offers possible solutions, including the exemption from IRB oversight of some activities that have ethical standards of their own, distinct from the biomedical tradition.
Abstract: The system in the United States for protecting human participants in research engages the earnest efforts of thousands of scientists, community volunteers, and administrators. Through untold hours of service on Institutional Review Boards (IRBs), they watch over the safety of human research subjects. Unfortunately, much of that effort is increasingly misdirected as the system succumbs to “mission creep” that could compromise its central goals. Our IRB system is endangered by excessive paperwork and expanding obligations to oversee work that poses little risk to subjects. The result is that we have simultaneous overregulation and underprotection.
IRBs were established after the 1979 Belmont Report from the Department of Health, Education, and Welfare, with the goal of protecting human subjects involved in potentially risky medical and behavioral research. But IRBs' burdens have grown to include studies involving interviews, journalism, secondary use of public-use data, and similar activities that others conduct regularly without oversight. Most of these activities involve minimal risks—surely less than those faced during a standard physical or psychological examination, the metric for everyday risk in the federal regulations. And IRBs are pressured to review an expanding range of issues from research design and conflicts of interest to patient privacy. These are beyond the scope of research protection and are best left to others.
The IRB system is being overwhelmed by a focus on procedures and documentation at the expense of thoughtful consideration of the difficult ethical questions surrounding the welfare of human subjects, especially as complex clinical trials burgeon. Their work is afflicted by unclear definitions of terms such as “risk,” “harm,” and “research.” Because ethical behavior is difficult to measure, many IRBs rely on stylized documentation over substantive review, out of concern that one case in a thousand could slip through and generate bad publicity or penalties, or potentially shut down research. The result is that many protocols receive exaggerated review, and the paper piles up. Society loses as potentially productive research is discouraged or self-censored.
Ironically, this obsession with paperwork and mechanical monitoring may undermine protection of human subjects. IRB members spend too much time editing documents, marking typos, and asking for more details. One researcher, 10 years into a longitudinal study, was asked by an IRB to remove the term “anemia” from consent forms because participants might not understand it. Such actions, about which we hear frequently, carry a serious risk: They reduce trust in the guidance of IRBs and may alienate some researchers enough to turn them into scofflaws.
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CREDIT: ROYALTY-FREE/CORBIS
Oversight of the IRB process by federal agencies reinforces these tendencies. “Poor or missing ‘Standard Operating Procedures'” and “poor minute-keeping” account for about half of all U.S. Food and Drug Administration citations, and quorum failures for another 13%, according to one review. In seeking compliance, universities have multiplied the number of IRBs, depleting the supply of willing and competent faculty. All this has generated a trend in which researchers increasingly think of IRBs as the “ethics police.” In fact, all researchers must take primary responsibility for professional, ethical conduct. Our systems should reinforce that, not work against or substitute for it; the IRB should be a resource, not the source, for ethical wisdom. All compliance systems require the buy-in and collaboration of the regulated, and it will be a sad day if scholars come to see human protection in research as the source of frustrating delays and expensive paperwork.
What can be done? Our University of Illinois white paper,[*][2] based on 2 years of study after an interdisciplinary conference of researchers and IRB leaders, addresses the problems of mission creep and offers possible solutions. Our recommendations include the exemption from IRB oversight of some activities that have ethical standards of their own, distinct from the biomedical tradition. We also support gathering information in a national clearinghouse that supports IRBs and researchers alike. This would provide examples of good and poor practices rooted in disciplinary standards, and help IRBs make priority determinations about what constitutes risk and harm in different human research settings.
The IRB system is in trouble, and that means trouble for the safety and efficacy of research on human subjects. We should refocus our efforts on the core issues and stop expanding the mission into less productive territory.
[1]: pending:yes
[2]: #fn-1
119 citations
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TL;DR: It is hoped that this White Paper will further the discussion about what reasonable procedures can be instituted to help get IRBs back on track and do what they were originally meant to do—protect the rights and welfare of human subjects while allowing the research enterprise to progress and its benefits to society to accrue.
Abstract: This White Paper reports on two years' work by a group convened by the Center for Advanced Study at the University of Illinois, following an invitational, national, interdisciplinary conference Human Subject Policy Conference: An Examination of the Interaction Between Human Subject Protection Regulations and Research Outside the Biomedical Sphere. We describe the pernicious effects of mission creep on the work of Institutional Review Boards, which is diverting the attention of some IRBs from critical ethical oversight in favor of often-meaningless paperwork. We make recommendations to help the IRB system focus its efforts on those research projects most in need of careful ethical review to protect human subjects of and participants in research. The recommendations include the idea that some methodologies do not need advance review and approval by IRBs and that there are procedural changes that can strengthen the core missions of IRBs. We hope that this paper will further the discussion about what reasonable procedures can be instituted to provide improved ethical protection for people who participate in research projects.
113 citations
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TL;DR: Our system of research self-regulation as discussed by the authors, designed to provide internal checks and balances for those who participate in research involving human subjects, is under considerable stress. Much of this c...
Abstract: Our system of research self-regulation, designed to provide internal checks and balances for those who participate in research involving human subjects, is under considerable stress. Much of this c...
93 citations
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21 Apr 2009TL;DR: Finkin and Post as discussed by the authors discuss the four primary dimensions of academic freedom: research and publication, teaching, intramural speech, and extramuralspeech, and argue that academic freedom protects the capacity of a faculty to pursue the scholar's profession according to the standards of that profession.
Abstract: Debates about academic freedom have become increasingly fierce and frequent. Legislative efforts to regulate American professors proliferate across the nation. Although most American scholars desire to protect academic freedom, they have only a vague and uncertain apprehension of its basic principles and structure. This book offers a concise explanation of the history and meaning of American academic freedom and it attempts to intervene into contemporary debates by clarifying the fundamental functions and purposes of academic freedom in America. Matthew Finkin and Robert Post trace how the American conception of academic freedom was first systematically articulated in 1915 by the American Association of University Professors (AAUP) and how this conception was in subsequent years elaborated and applied by a Committee of the AAUP. The authors discuss the four primary dimensions of academic freedom: research and publication, teaching, intramural speech, and extramural speech. They carefully distinguish academic freedom from the kind of individual free speech right that is created by the First Amendment. The authors strongly argue that academic freedom protects the capacity of a faculty to pursue the scholar's profession according to the standards of that profession.
31 citations
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01 Jan 2014
TL;DR: In this paper, Cardozo et al. proposed a model for conflict resolution in the context of bankruptcy resolution, which is based on the work of the Cardozo Institute of Conflict Resolution.
Abstract: American Bankruptcy Institute Law Review 17 Am. Bankr. Inst. L. Rev., No. 1, Spring, 2009. Boston College Law Review 50 B.C. L. Rev., No. 3, May, 2009. Boston University Public Interest Law Journal 18 B.U. Pub. Int. L.J., No. 2, Spring, 2009. Cardozo Journal of Conflict Resolution 10 Cardozo J. Conflict Resol., No. 2, Spring, 2009. Cardozo Public Law, Policy, & Ethics Journal 7 Cardozo Pub. L. Pol’y & Ethics J., No. 3, Summer, 2009. Chicago Journal of International Law 10 Chi. J. Int’l L., No. 1, Summer, 2009. Colorado Journal of International Environmental Law and Policy 20 Colo. J. Int’l Envtl. L. & Pol’y, No. 2, Winter, 2009. Columbia Journal of Law & the Arts 32 Colum. J.L. & Arts, No. 3, Spring, 2009. Connecticut Public Interest Law Journal 8 Conn. Pub. Int. L.J., No. 2, Spring-Summer, 2009. Cornell Journal of Law and Public Policy 18 Cornell J.L. & Pub. Pol’y, No. 1, Fall, 2008. Cornell Law Review 94 Cornell L. Rev., No. 5, July, 2009. Creighton Law Review 42 Creighton L. Rev., No. 3, April, 2009. Criminal Law Forum 20 Crim. L. Forum, Nos. 2-3, Pp. 173-394, 2009. Delaware Journal of Corporate Law 34 Del. J. Corp. L., No. 2, Pp. 433-754, 2009. Environmental Law Reporter News & Analysis 39 Envtl. L. Rep. News & Analysis, No. 7, July, 2009. European Journal of International Law 20 Eur. J. Int’l L., No. 2, April, 2009. Family Law Quarterly 43 Fam. L.Q., No. 1, Spring, 2009. Georgetown Journal of International Law 40 Geo. J. Int’l L., No. 3, Spring, 2009. Georgetown Journal of Legal Ethics 22 Geo. J. Legal Ethics, No. 2, Spring, 2009. Golden Gate University Law Review 39 Golden Gate U. L. Rev., No. 2, Winter, 2009. Harvard Environmental Law Review 33 Harv. Envtl. L. Rev., No. 2, Pp. 297-608, 2009. International Review of Law and Economics 29 Int’l Rev. L. & Econ., No. 1, March, 2009. Journal of Environmental Law and Litigation 24 J. Envtl. L. & Litig., No. 1, Pp. 1-201, 2009. Journal of Legislation 34 J. Legis., No. 1, Pp. 1-98, 2008. Journal of Technology Law & Policy 14 J. Tech. L. & Pol’y, No. 1, June, 2009. Labor Lawyer 24 Lab. Law., No. 3, Winter/Spring, 2009. Michigan Journal of International Law 30 Mich. J. Int’l L., No. 3, Spring, 2009. New Criminal Law Review 12 New Crim. L. Rev., No. 2, Spring, 2009. Northern Kentucky Law Review 36 N. Ky. L. Rev., No. 4, Pp. 445-654, 2009. Ohio Northern University Law Review 35 Ohio N.U. L. Rev., No. 2, Pp. 445-886, 2009. Pace Law Review 29 Pace L. Rev., No. 3, Spring, 2009. Quinnipiac Health Law Journal 12 Quinnipiac Health L.J., No. 2, Pp. 209-332, 2008-2009. Real Property, Trust and Estate Law Journal 44 Real Prop. Tr. & Est. L.J., No. 1, Spring, 2009. Rutgers Race and the Law Review 10 Rutgers Race & L. Rev., No. 2, Pp. 441-629, 2009. San Diego Law Review 46 San Diego L. Rev., No. 2, Spring, 2009. Seton Hall Law Review 39 Seton Hall L. Rev., No. 3, Pp. 725-1102, 2009. Southern California Interdisciplinary Law Journal 18 S. Cal. Interdisc. L.J., No. 3, Spring, 2009. Stanford Environmental Law Journal 28 Stan. Envtl. L.J., No. 3, July, 2009. Tulsa Law Review 44 Tulsa L. Rev., No. 2, Winter, 2008. UMKC Law Review 77 UMKC L. Rev., No. 4, Summer, 2009. Washburn Law Journal 48 Washburn L.J., No. 3, Spring, 2009. Washington University Global Studies Law Review 8 Wash. U. Global Stud. L. Rev., No. 3, Pp.451-617, 2009. Washington University Journal of Law & Policy 29 Wash. U. J.L. & Pol’y, Pp. 1-401, 2009. Washington University Law Review 86 Wash. U. L. Rev., No. 6, Pp. 1273-1521, 2009. William Mitchell Law Review 35 Wm. Mitchell L. Rev., No. 4, Pp. 1235-1609, 2009. Yale Journal of International Law 34 Yale J. Int’l L., No. 2, Summer, 2009. Yale Journal on Regulation 26 Yale J. on Reg., No. 2, Summer, 2009.
1,336 citations
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TL;DR: In this article, the authors present a review of the history of institutional change in Germany, focusing on five sectors: institutional change, capitalist development, social policy, public finance, industrial bargaining, and disorganization.
Abstract: Introduction: Institutional Change, Capitalist Development PART I: GRADUAL CHANGE: FIVE SECTORAL TRAJECTORIES 1. Five Sectors 2. Industry-wide Collective Bargaining: Shrinking Core, Expanding Fringes 3. Intermediary Organization: Declining Membership, Rising Tensions 4. Social Policy: The Rise and Fall of Welfare Corporatism 5. Public Finance: The Fiscal Crisis of the Postwar State 6. Corporate Governance: The Decline of Germany Inc. PART II: SYSTEMIC CHANGE: PATTERNS AND CAUSES 7. Systemic Change: Five Parallel Trajectories 8. From System to Process 9. Endogenous Change: Time, Age, and the Self-Undermining of Institutions 10. Time's Up: Positive Externalities Turning Negative PART III: DISORGANIZATION: BRINGING CAPITALISM BACK IN 11. Disorganization as Liberalization 12. Convergence, Non-convergence, Divergence 13. 'Economizing' and the Evolution of Political-Economic Institutions 14. Internationalization 15. German Unification 16. History 17. Bringing Capitalism Back In
493 citations
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TL;DR: This article reviewed two theories that emphasize deprofessionalization and proletarianization of the professions and concluded that the available evidence does not support either theory sufficiently to make them analytically useful; instead, they advanced an alternate theory that emphasizes the formalization of professional social control.
Abstract: The traditional view of the professions is that they are largely free of the hierarchical forms of social control characteristic of other kinds of occupations; instead, they are self-regulating, subject only to informal collegial control. As a result of events in the past few decades in the United States, analysts now believe that the traditional autonomy of professions is eroding. This paper reviews two theories that emphasize this process, one focusing on deprofessionalization and the other on proletarianization. It concludes that the available evidence does not support either theory sufficiently to make them analytically useful; it advances an alternate theory that emphasizes the formalization of professional social control. This third viewpoint is based on the finding that the professions—as corporate bodies—have remained relatively autonomous. Antitrust decisions, political pressure to exercise more control over errant members, and the administrative requirement of greater accountability in large org...
482 citations
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TL;DR: The implications for labor markets of contracts to avoid hold-up of investments are assessed in this article, where the authors assess the implications of employment contracts for avoiding hold up of investments.
Abstract: The implications for labor markets of contracts to avoid hold-up of investments are assessed. Employment at will protects the returns on a firm's general and specific investments without wages increasing with tenure. With turnover costs, fixed but renegotiable wages can protect general investments by both firm and employee, and generage wage stickiness without adversely affecting employment. Employment contracts that induce efficient specific investments by both firm and employee are problematic so it makes sense, wherever possible, for one side to make all such investments. With private information, fixed wages may induce fewer inefficient separations than employment at will.
332 citations