title: Is conflict of interest becoming a challenge for institution-based institutional review boards?
abstract: Expansion of business relationships between academic institutions and their leaders and industry have become a reality, whereas media attention regarding conflict of interest (COI) at academic institutions has raised concerns about possible erosion of public trust. The Institutional Review Board (IRB) should collaborate with institutional COI committees to ensure that research with human subjects is in compliance with various applicable federal regulations. The IRB and COI committee should take additional independent action as necessary under their separate mandates to protect the welfare, safety, and rights of human subjects and to include limits on protocols affected by significant financial interests of the institution or its decision makers. If unable to review research due to an intrainstitutional conflict, the local IRB should consider transferring the study review and oversight to an external unaffiliated institutional or central IRB. A process for involvement of an executive institutional IRB is proposed.
authors.affiliation: Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. rfreedma@mdanderson.org
authors.forename: Ralph S
authors.initials: RS
authors.lastname: Freedman
authors.forename: Ross
authors.initials: R
authors.lastname: McKinney
mesh_terms: D000047:Academies and Institutes / Q000191:economics / Q000331:legislation & jurisprudence; D003132:Commerce; D016265:Conflict of Interest; D017277:Drug Approval; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence; D006801:Humans; D012106:Research / Q000191:economics*