Regulatory paradox: A review of enforcement letters issued by the office for human research protection

INTRODUCTION Writing in 2001, the National Bioethics Advisory Commission (NBAC) complained that Institutional Review Boards (IRBs) were overwhelmed not only by high workloads and limited resources but also by regulatory system that often distracts from rather than focuses on key ethical issues.1 NBAC blamed emphasis by regulators on for contributing to atmosphere in which of research becomes an exercise in avoiding sanctions and liability rather than in maintaining appropriate ethical standards and protecting human participants.2 The procedure-prone regulator of greatest concern to NBAC was the federal Office for Human Research Protection (OHRP). OHRP is the primary government agency responsible for enforcing the federal human subject protection regulations, known as the Common Rule,3 at the nearly 10,000 federally funded institutions in the country.4 NBAC judged that OHRP 's focus on paper evidence of procedural compliance was frustrating IRBs and researchers trying to focus on ethical principles.5 IRBs might properly review research in accordance with an appropriate focus on ethical behavior, but nonetheless run into trouble at OHRP, where are ultimately held responsible primarily for procedure and documentation.6 NBAC identified the fundamental challenge for a system of protecting human subjects that embeds reflection on ethical principles in a set of mandated regulatory procedures. The logic of philosophical ethics is opentextured deliberation about how general principles illuminate unique cases, conducted with an appreciation of ambiguity and the value of differing viewpoints. The logic of hierarchical regulation is rigorous compliance with general rules, carefully and uniformly documented, with serious sanctions for non-compliance. The two logics could conceivably coexist with some degree of coherence in some situations. In the case of the human subject protection system, however, observers have persistently noted a tendency towards formal bureaucratic enforcement and compliance largely unrelated and possibly detrimental to ethical behavior.7 IRBs are required, on behalf of universities and other research institutions, to ensure that research on human subjects comports with indeterminate standards of beneficence, justice, and autonomy, a task which in turn requires IRBs to make fine judgments about small or unknown risks and benefits. Because the quality of an IRB 's deliberations, let alone the accuracy of its ethical decisions, cannot readily be verified, institutional compliance with federal regulations is measured almost entirely by of records and consent forms. The metric, in turn, drives the compliance priorities of the regulated institutions. In this Article, we examine OHRP 's enforcement activities since the NBAC report. Part I describes OHRP' s work and the methods we used to study it. In Part II, we present our results, which show that OHRP continues to promote ethics by requiring paperwork in just the way NBAC decried. The discussion (Part III) explains why it is too easy to blame the agency, which in many ways seems to be performing in model regulatory fashion. The heart of the problem is the paradoxical scheme of embedding virtue in federal regulations, and then constructing an enforcement system that purports to encourage reflection and deliberation but must in practice enforce procedural diligence and paperwork. The OHRP 's regulatory impact is just one of many issues roiling the enterprise of human research subject protection. In 1966, the New England Journal of Medicine published Henry Beecher's damning catalogue of human research subject abuses in medical research, which galvanized the movement to regulate research with human subjects.8 In 2004, it published Tu and his colleagues' account of a failed effort to create a national stroke registry in Canada, a failure they attributed to the requirement that each person included in the registry give informed consent. …

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