National Evaluation of Policies on Individual Financial Conflicts of Interest in Canadian Academic Health Science Centers
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Conflicts of interest (COI) in research are an important emerging topic of investigation and are frequently cited as a serious threat to the integrity of human participant research.
To study financial conflicts of interest (FCOI) policies for individual investigators working in Canadian academic health centers.
Survey instrument containing 61 items related to FCOI.
All Canadian academic health science centers (universities with faculties of medicine, faculties of medicine and teaching hospitals) were requested to provide their three primary FCOI policies.
Number of all centers and teaching hospitals with policies addressing each of the 61 items related to FCOI.
Only one item was addressed by all 74 centers. Thirteen items were present in fewer than 25% of centers. Fewer than one-quarter of hospitals required researchers to disclose FCOI to research participants. The role of research ethics boards (REBs) in hospitals was marginal.
Asking centers to identify only three policies may not have inclusively identified all FCOI policies in use. Additionally, policies at other levels might apply. For instance, all institutions receiving federal grant money must comply with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
Canadian centers within the same level (for instance, teaching hospitals) differ significantly in the areas that their policies address and these policies differ widely in their coverage. Presently, no single policy in any Canadian center informs researchers about the broad range of individual FCOI issues. Canadian investigators need to understand the environment surrounding FCOI, be able to access and follow the relevant policies and be confident that they can avoid entering into a FCOI.
KEY WORDSinvestigator financial conflicts of interest academic health science centers
We acknowledge John Hoey and David Streiner for their assistance in the development of this project. We would like to thank Peter Anderson and Marie-Eve Couture for their help in this project. Marie-Eve Couture assisted with the data abstraction of all French language policies.
Source of funding
This project was funded by a Canadian Institutes for Health Research (CIHR) Grant entitled the Evaluation of the Integrity of Clinical Research in Canada EIC - 77338. The sponsor did not play any role in the design, analysis, or publication of this study.
Joel Lexchin (Apotex - 2006) has been retained by a law firm acting for Apotex, a Canadian generic manufacturer, to provide information relevant to two court cases involving the proposed launch of generic equivalents.
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