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Suggested Citation:"Improving Research Monitoring." Institute of Medicine. 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: The National Academies Press. doi: 10.17226/10085.
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Page 60

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MODELS OF ACCREDITATION 60 Improving Research Monitoring Research monitoring has emerged as a major problem, but policies have mainly focused on administrative compliance with federal regulations that emphasize informed consent and prospective review of written protocols. One reason is that the level of administrative compliance is much easier to measure and infractions are thus easier to document. For example, every research protocol must be reviewed, and informed-consent forms and minutes of IRB meetings can reflect specific actions. This creates a trail of documentation that can be audited (or can suggest a remedy when a trail of documentation is not maintained). Research monitoring, in contrast, is mainly concerned with the prevention of rare bad events. Research monitoring may be the more important function of the system, but effective monitoring is much harder to measure. The current HRPPP system attends to the functional equivalent of maintenance records by documenting informed-consent forms and IRB deliberations, but it appears to be less adept at identifying and investigating serious breaches or systematically detecting danger signals in ongoing research. In most cases, the trigger for an investigation has come from participants who make complaints, research staff who act as whistleblowers, or public media exposure and investigative journalism.13 If the oversight processes are working well, serious violations will be rare. Learning from such rare violations, however, is essential to improving the system, and the current system appears to be deficient in this function. The elements of the protection regime most amenable to accreditation, moreover, may not be the ones most likely to first identify serious infractions or problems. The oversight system could, however, become much more systematic about detecting problems by creating feedback mechanisms by which research participants and staff can report problems (and can link those reports to IRBs), by ensuring that means for the identification and reporting of serious and unexpected adverse events are built into the research process, and by strengthening linkages between programs for HRPPP review and programs for investigation of the serious problems that do arise. The relative roles of institutions conducting research, research sponsors, accreditation bodies, and OHRP and the FDA in investigating violations are not clearly spelled out. Historical cases suggest that research institutions are sometimes delegated primary responsibility for investigation (for example, the University of California at Los Angeles for the Cline case), and at times federal regulatory agencies take the lead (for example, the FDA for the Gelsinger case). 13The Tuskegee trial, Martin Cline's premature gene therapy experiments, and human radiation experiments were all first reported in the public media, with investigations occurring after public furor. The FDA had begun to investigate the death of Jesse Gelsinger when the case became public, but many of the details about financial conflict of interest and serious underreporting of adverse events became known mainly via investigative journalism. Investigations then followed.

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Amid increasing concern for patient safety and the shutdown of prominent research operations, the need to improve protections for individuals who volunteer to participate in research has become critical. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs considers the possible impact of creating an accreditation system to raise the performance of local protection mechanisms. In the United States, the system for human research participant protections has centered on the Institutional Review Board (IRB); however, this report envisions a broader system with multiple functional elements.

In this context, two draft sets of accreditation standards are reviewed (authored by Public Responsibility in Medicine & Research and the National Committee for Quality Assurance) for their specific content in core areas, as well as their objectivity and validity as measurement tools. The recommendations in the report support the concept of accreditation as a quality improvement strategy, suggesting that the model should be initially pursued through pilot testing of the proposed accreditation programs.

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