Maintaining Research Integrity

Ethical integrity in the conduct of health care research is essential for maintaining the public trust and support of such activities. Institutional Review Boards (IRBs) play a critical role in maintaining the ethical integrity of research by reviewing research protocols to ensure, among other things, that research participants receive safe and ethical treatment and provide informed consent, and that the potential for a conflict of interest is minimized. The purpose of this review was to catalog the literature on issues pertaining to IRBs, to identify the issue with the greatest number of published studies which might inform VA policy, and to assess the evidence regarding that issue, which were conflict of interest policies and the activities of the IRB. Without research, health care cannot advance in a scientific fashion. But by definition, research that involves human participants necessitates that some aspects of their care are no longer being provided solely for their health benefit: research is meant to inform the care of future patients. Therefore, care provided as part of a research protocol always involves a risk of harm. Sometimes it is a direct health risk, as in the case of a new treatment of hoped-for-but-as-yet-unproven benefit with the potential for certain adverse events; or it may be less obvious, such as the risk of disclosure of sensitive information. The ethical management of risk is a primary focus of maintaining integrity in research. The goal of this review was to describe the evidence regarding areas of interest in the ethical conduct of research, with a particular focus on the IRB and quality improvement initiatives. Further discussions resulted in the following key questions: Key Question #1. What has been published regarding the IRB, and each of the following issues: Quality improvement initiatives as research, Conflict of interest, Studies requiring approval of multiple IRBs, Genetic issues. Key Question #2. What is the actual evidence regarding the issue with the largest literature which may inform VA policy?