A proposal and prototype for a Research Risk Repository to improve the protection of research participants

Abstract

A Research Risk Repository has the potential to significantly improve the consistency and accuracy of the evaluation of research risks. However, currently available data are generally insufficient for this purpose. Future collection and maintenance of data on the risks posed by research interventions will help to ensure that research participants receive appropriate protection and promote important research consistent with adequate subject protection.

Minimal Risk in Pediatric Research: A Philosophical Review and Reconsideration

“…In part, this would require that IRBs have as much relevant information available to them as is possible. Thus, we support prior suggestions to better empirically characterize the risks of research interventions and comparator activities and to establish a research risk repository to facilitate IRBs’ access to this information (Wendler et al 2005, Rid and Wendler 2011b). However, having access to relevant information is not just a function of empirical research; it is also a function of IRB representation and procedures.…”

“…There are numerous possible explanations for this variability, but one of them is that IRBs often operate without robust empirical information about the nature and probability of harms posed by research interventions or comparator activities. In response to the preceding problem, some scholars have undertaken the task of gathering empirical information about the risks that individuals face in daily life or from research interventions (Wendler et al 2005, Rid and Wendler 2011b), and this focus might give the impression that improving research risk assessment is primarily an empirical matter. Such empirical data can undoubtedly aid in applying the current federal regulations, but we should not expect more comprehensive empirical information to fully settle debates about risk magnitude.…”

“…As well, the extent to which IRB meeting minutes are used to guide future meetings—as opposed to being filed away—is unclear, but such records of justification could provide a helpful resource for future deliberation by the committee. If suitably anonymized, IRB deliberations about particular research interventions or comparator risks could also be made a publicly available resource, analogously to a proposed research risk repository (Rid and Wendler 2011b). …”

Evaluating the Risks of Clinical Research: Direct Comparative Analysis

“…More frequently, IRBs have some data on the risks posed by the research intervention, but are unsure whether these risks qualify as minimal or greater than minimal risks. For example, it may be known that a ''punch'' skin biopsy typically poses a 1 per 100 risk of bleeding that will require another clinical visit, as well as a 1-10 per 1000 risk of infection that can require treatment with oral antibiotics (Rid and Wendler 2011). In these cases, protecting children without inadvertently blocking valuable research requires IRBs to determine whether the risks are minimal or greater than minimal.…”

The value of evidence-based risk assessments

“…Inherent in both movements is the recognition that quality data are essential in improving the safety, efficacy, and cost of medical care. The proposal by Rid and Wendler [1] in this volume to create a formal process to assess the risks of common research interventions exemplifies these contemporary trends. As such, the proposal is welcome and should be subject to further discussion and development.…”