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THE SYSTEM IN THE UNITED STATES FOR PROTECTING HUMAN PARTICIPANTS IN RESEARCHengages 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.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 ...

We describe the development, testing, and formative evaluation of nine role-play scenarios for teaching central topics in the responsible conduct of research to graduate students in science and engineering. In response to formative evaluation surveys, students reported that the role-plays were more engaging and promoted deeper understanding than a lecture or case study covering the same topic. In the future, summative evaluations will test whether students display this deeper understanding and retain the lessons of the role-play experience.

Without any systematic data or evidence of a problem, or even a thoughtful analysis of costs and benefits, the application of the human participant review system within universities is overreaching at the same time that some risky experimentation on humans outside of universities is unregulated. This article questions the purpose, feasibility, and effectiveness of current IRB approaches to most "2 people talking" situations and proposes scaling back the regulatory system to increase respect accorded it by researchers and its ability to protect human participants of research from real versus imagined harms. In too many cases, the focus is on form over ethical substance: counting what can be counted, rather than focusing instead on what counts. Some disciplines--oral history and journalism, for example--simply do not belong within the scope of institutional review board jurisdiction. Others, such as survey research, informational interviews, and informal interactions, call for a shift from centralized review to more departmentally based (i.e., rooted in disciplinary ethics) oversight, and clearer guidelines on what requires advance review as opposed to provision of post hoc complaint systems.

Institutions have a central role in protecting the integrity of research. They employ researchers, own the facilities where the work is conducted, receive grant funding, and teach many students about the research process. When questions arise about research misconduct associated with published articles, scientists and journal editors usually first ask the researchers' institution to investigate the allegations and then report the outcomes, under defined circumstances, to federal oversight agencies and other entities, including journals. 1 Depending on institutions to investigate their own faculty presents significant challenges. Misconduct reports, the mandated product of institutional investigations for which US federal dollars have been spent, have a wide range of problems. These include lack of standardization, inherent conflicts of interest that must be addressed to directly ensure credibility, little quality control or peer review, and limited oversight. Even

The single most important component in an institutional culture of research integrity is institutional leadership committed to ethical conduct. If the institution's leaders are committed to integrity in research and act on that commitment, the campus will follow that lead; conversely, if the perception develops that the leaders pay only lip service to ethical conduct, the campus will adopt the same attitude. An institution must pay attention to both prevention and education, and many are developing codes of conduct. Further, institutions must establish a misconduct review process that can render objective, fact-based decisions untainted by personal bias and conflicts of interest. In developing such a process, leaders must be aware of probable pitfalls, create an accessible structure, and provide for consistent assessment of allegations and complaints, focusing on facts, not personalities. Increased demands for accountability and a heightened public interest in ethical issues portend increasing pressures on institutions to monitor the conduct of their members. The institution that builds effective, credible structures for preventing and resolving ethical issues will be well equipped to cope with these external pressures. Ultimately, however, institutional structures for such monitoring accomplish far more than preserving institutional autonomy: they protect the principle of scholarly and scientific inquiry that is at the core of the institution's mission.

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 crisis has been caused by what we call mission creep, in which the workload of IRBs has expanded beyond their ability to handle effectively. Mission creep is caused by rewarding wrong behaviors, such as focusing more on procedures and documentation than difficult ethical questions; unclear definitions, which lead to unclear responsibilities; efforts to comply with unwieldy federal requirements even when research is not federally funded; exaggerated precautions to protect against program shutdowns; and efforts to protect against lawsuits. We recommend collecting data. We also call for refinements to our regulatory system that will provide a set of regulations designed for non-biomedical research. This will enable IRBs to direct attention to the areas of greatest risk while intentionally scaling back oversight in areas of lesser risk. We recommend removing some kinds of activity from IRB review altogether. Our system, if not broken, is seriously straining at the seams. It is imperative that we have a respected and effective system in place to protect human research subjects, so that much-needed research into the causes and prevention of disease and other research expanding the boundaries of knowledge can proceed. We hope 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.