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MODELS OF ACCREDITATION 59 it is not the most direct solution to the problem and cannot replace investigation and enforcement activities. Educating Investigators In 1995 ACHRE completed a report that built on a thorough historical and ethical analysis. It concluded: It is not clear to the Advisory Committee that scientists whose research involves human subjects are any more familiar with The Belmont Report today than their colleagues were with the Nuremberg Code forty years ago. . . . No one in the scientific community should be able to say âI didn't knowâ or ânobody told meâ about the substance and importance of research ethics (ACHRE, 1995, pp. 817â818). Many, perhaps most, of the serious problems that arise in human research arise from the actions of investigators, so policies that deal directly with investigators are at least as important as improving the review of research protocols in an HRPPP. The policies that most directly affect investigators include the following: educating them about their roles and responsibilities in the ethical conduct of research, increasing the capacity to monitor ongoing research approved by an IRB, the investigation of infractions, and the enforcement of regulations. Among these, education seems to be the one most likely to have the desired results with the least level of intrusion and the greatest direct impact on overall norms. In a background paper written for NBAC, Charles McCarthy, drawing on two decades of direct experience with federal oversight of protection of human participants in research, argued that the measure most important to improving the ethical conduct of research is educationâof investigators, IRB members, IRB staff, and those working at research institutions (McCarthy, forthcoming). The devotion of resources to education led to fewer problems down the road. Incidents requiring investigation and the need for intervention increased when budgets for education decreased, and increased attention to education seemed to reduce the numbers of untoward incidents. McCarthy's observation is corroborated by the observations of ACHRE (Mastroianni and Kahn, 1998). Henry Beecher, in a seminal 1966 New England Journal of Medicine article, argued against establishing an oversight bureaucracy for medical research, asserting that the key was instead to elevate norms of research ethics among investigators (Beecher, 1966). The present committee concurs with that position. Although accreditation can reinforce education programs at accredited institutions, education on the ethical conduct of research and the ethical responsibilities of investigators are matters of central importance regardless of accreditation and will be taken up in greater depth as the committee continues its work.
