Mission creep in the IRB world.
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Biomedical subjects
Publications and source records attributed to C K Gunsalus.
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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.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
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.