title: Protecting participants in family medicine research: a consensus statement on improving research integrity and participants' safety in educational research, community-based participatory research, and practice network research.
abstract: Recent events that include the deaths of research subjects and the falsification of data have drawn greater scrutiny on assuring research data integrity and protecting participants. Several organizations have created guidelines to help guide researchers working in the area of clinical trials and ensure that their research is safe and valid. However, family medicine researchers often engage in research that differs from a typical clinical trial. Investigators working in the areas of educational research, community-based participatory research, and practice-based network research would benefit from similar recommendations to guide their own research. With funding from the US Office of Research Integrity and the Association of American Medical Colleges, we convened a panel to review issues of data integrity and participant protection in educational research, community-based participatory research, and research conducted by practice-based networks. The panel generated 11 recommendations for researchers working in these areas. Three key recommendations include the need for (1) all educational research to undergo review and approval by an institutional review board (IRB), (2) community-based participatory research to be approved not just by an IRB but also by appropriate community representatives, and (3) practice-based researchers to undertake only valid and meaningful studies that can be reviewed by a central IRB, rather than separate IRBs for each participating practice.
authors.affiliation: Department of Family Medicine, Medical University of South Carolina, 295 Calhoun Street, PO Box 250192, Charleston, SC 29425, USA. huestowj@musc.edu
authors.forename: William J
authors.initials: WJ
authors.lastname: Hueston
authors.forename: Arch G
authors.initials: AG
authors.lastname: Mainous
authors.forename: Barry D
authors.initials: BD
authors.lastname: Weiss
authors.forename: Ann C
authors.initials: AC
authors.lastname: Macaulay
authors.forename: John
authors.initials: J
authors.lastname: Hickner
authors.forename: Roger A
authors.initials: RA
authors.lastname: Sherwood
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D016265:Conflict of Interest; D004501:Education, Medical / Q000592:standards*; D005194:Family Practice / Q000193:education / Q000592:standards*; D006801:Humans; D007258:Informed Consent; D010349:Patient Compliance; D010358:Patient Participation; D011787:Quality of Health Care; D012107:Research Design / Q000592:standards*; D035842:Research Subjects