Protecting Participants in Family Medicine Research: A Consensus Statement on Improving Research Integrity and Participants' Safetyin Educational Research, Community-based Participatory Research,and Practice Network Research

摘要

Recent events that include the deaths of research subjects and the falsification of data have drawngreater scrutiny on assuring research data integrity and protecting participants. Several organizationshave created guidelines to help guide researchers working in the area of clinical trials andensure that their research is safe and valid. However, family medicine researchers often engage inresearch that differs from a typical clinical trial. Investigators working in the areas of educationalresearch, community-based participatory research, and practice-based network research wouldbenefit from similar recommendations to guide their own research. With funding from the US Officeof Research Integrity and the Association of American Medical Colleges, we convened a panel toreview issues of data integrity and participant protection in educational research, community-basedparticipatory research, and research conducted by practice-based networks. The panel generated11 recommendations for researchers working in these areas. Three key recommendations includethe need for (1) all educational research to undergo review and approval by an institutional reviewboard (IRB), (2) community-based participatory research to be approved not just by an IRB but alsoby appropriate community representatives, and (3) practice-based researchers to undertake onlyvalid and meaningful studies that can be reviewed by a central IRB, rather than separate IRBs foreach participating practice.