Showing papers by "Matthew W. Finkin published in 2006"

Mission creep in the IRB world.

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. ![Figure][1] 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

The Illinois White Paper - Improving the System for Protecting Human Subjects: Counteracting IRB Mission Creep

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.

Comparative Labour Law

Abstract: In 2006, Matthias Reimann and Reinhard Zimmermann edited the OXFORD HANDBOOK OF COMPARATIVE LAW, a comprehensive work of 42 chapters treating the development of comparative law, approaches to comparative law, and subject areas of comparative law. One of the latter, by this author, treated comparative labor law. A decade later the work has been revised and updated. This chapter discusses the taxonomy of the subject, the role of comparativism in national law, and the role of comparativism in the contemporary debate on the future of labor law. It dwells briefly on the future of comparative labor law itself.

Employee Privacy and the Theory of the Firm

Abstract: Bruce Kobayashi and Larry Ribstein apply the theory of the firm to worker privacy with specific application to the employer's ability to monitor employee performance and behavior. They take the theory to drive toward a much reduced role for law in favor of regulation by contract. This essay unpacks their theory. It faults the theory for its failure to come to grips with the possibility of monopsony in the labor market, its failure to appreciate the public goods nature of privacy policies and the related assumption that the employer's ability to adopt and apply privacy-invasive policies is invariably a product of a consensual arms-length bargain.

Shoring Up the Citadel (At-Will Employment)

Abstract: The third draft of parts three and four of the proposed Restatement of Employment Law was circulated in April, 2006. The draft was prefaced by a statement of the Executive Director of the American Law Institute explaining the project's purpose: to simplify the law, to clarify the doctrine underpinning it, and to bring the law into line with evolving economic and social developments. This essay takes a hard look at these two parts - governing contractual job security and discharge for reasons violative of public policy - from the perspective of these desiderata. It argues that the rules set out beg lots of questions, the doctrinal grounding is either incoherent or absent, and that no effort at all is made even to describe what the economic and social conditions are to which these rules ostensibly respond. It argues that if the rules prove as influential as the ALI hopes the result is a stultification of the growth of the law; and, consequently, that the project ought be abandoned.

Life Away from Work

Abstract: A number of states assure employees the right to consume a lawful product on their own time and off the employer's premises, and a very few states protect an employee's right to engage in all lawful activities away from work. These laws have recently been attacked as having no basis in public interest, as substituting a judicial for an employer's judgment of what serves business need - a decision the courts are ill-suited to make - and for eroding the at-will rule. This essay, given at a conference sponsored by the Louisiana Law Review on February 9-10, 2006, replies to that critique. It grounds these laws in the public interest; it explores the consequences of juridification of off-duty life by examination of decisions in France and Germany where such is protected; and, it argues that there is no reason why U.S. employees should not enjoy the same right to a life away from work as do their European counterparts.

Shoring Up the Citadel (At-Will Employment)

Abstract: In 2002, the American Law Institute announced a project to restate the law of employment: not all of the law—so weltered has it become by a thick network of hundreds upon hundreds of state statutes, some sweeping, some of exquisite narrowness—but only the corner occupied by the common law, of contract and tort, and not even all of that, not defamation, misrepresentation (by employers or employees, intentionally or negligently), negligent hiring or supervision, the intentional or negligent infliction of emotional distress, but only parts of it, the two most salient being the common law of job security and privacy. I found the project puzzling for the Institute had breathed no public hint of why these discrete choices were made or, more importantly, what end called for the effort. My puzzlement was compounded when the first albeit decidedly rough draft of the part on job security appeared. After touching upon what seemed the draft’s more problematic elements, two questions persisted: “What purpose does all this serve? What demonstrable need does it satisfy?” Now the redraft of that part has appeared, this time accompanied by