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

Rid A, Wendler D (2011): A Proposal and Prototype for a Research Risk Repository to Improve the Protection of Research Participants. Clinical Trials 8: 705-715

Editorial by Jeffrey Botkin (2011): The value of evidence-based risk assessments. Clinical Trials 8: 685-686 (.pdf )

Abstract

Background Accurate and consistent risk assessment is vital for the protection of research participants. Yet, current evaluation of the risks of research interventions often does not take into account the relevant empirical data. This approach raises concern that current practice may not be protecting research participants adequately, or that it may be thwarting acceptable research.

Purpose To propose and evaluate the possibility of creating and maintaining a Research Risk Repository which would make empirical data on the risks of research interventions available to institutional review boards, investigators, funders, and others.

Methods Analysis of the usefulness of a Research Risk Repository and evaluation of whether currently available empirical data are sufficient to establish such a repository.

Results Creation of a Research Risk Repository would provide a vital resource for systematically and accurately evaluating the risks of biomedical research. Realizing this goal requires data that have at least 4 characteristics: (1) trustworthy: to ensure credibility to all stakeholders; (2) robust: to support confident risk determinations; (3) inclusive: to cover all potential harms of the interventions under review; and (4) comprehensive: to determine which factors influence the risks of the interventions under review. Evaluation of existing data reveals that they satisfy these requirements for only a few research interventions and, even in those cases, only to a limited extent. Gaps in the currently available evidence highlight the need for systematic collection and maintenance of data on the risks posed by research interventions.

Limitations Creation and maintenance of a Research Risk Repository would be costly and require regular updating as new data are collected, and new practices and interventions emerge.

Conclusions 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.