Jonathan Kimmelman1. 1. Department of Social Studies of Medicine, Clinical Trials Research Group, Biomedical Ethics Unit, McGill University Faculty of Medicine, Montreal, QB, Canada. jonathan.kimmelman@mcgill.ca
Abstract
CONTEXT: The Bayh-Dole Act and renewed emphasis on translational research have stimulated patenting activities at universities. PURPOSE: To examine how different institutions manage possible patent-related conflicts of interest in human subjects research, and to provide an ethical analysis and recommendations. METHOD: Policies of nine major professional organizations, 13 of the largest recipients of federal biomedical funding in the United States and Canada, and 17 biomedical journals were canvassed. Disagreements in policies were used as the basis for analyzing the ethics of inventorship in clinical trials. RESULTS: Policies varied along three lines. First, some policies did not define patent inventorship as a potential conflict of interest. Second, some of those that did define it as such used licensing as a trigger for conflict of interest management. Third, several policies imposed presumptive restrictions on an investigator's participation in a trial involving his or her invention. CONCLUSIONS: The author defends on ethical grounds restrictive policies on patent holding in clinical trials and rejects objections to restrictive policies. The author recommends five policies: (1) any related patent holding should always be disclosed to IRBs and research subjects, (2) investigators who hold conflicting patents should be presumptively barred from certain activities in a study, (3) institutional interests in patents should be managed and disclosed to research subjects, (4) IRBs should also be informed of an investigator's filed (not just held) patents on an experimental agent, and (5) the stringency of policies should be adjusted according to a patent's earning potential and the risk associated with a study.
CONTEXT: The Bayh-Dole Act and renewed emphasis on translational research have stimulated patenting activities at universities. PURPOSE: To examine how different institutions manage possible patent-related conflicts of interest in human subjects research, and to provide an ethical analysis and recommendations. METHOD: Policies of nine major professional organizations, 13 of the largest recipients of federal biomedical funding in the United States and Canada, and 17 biomedical journals were canvassed. Disagreements in policies were used as the basis for analyzing the ethics of inventorship in clinical trials. RESULTS: Policies varied along three lines. First, some policies did not define patent inventorship as a potential conflict of interest. Second, some of those that did define it as such used licensing as a trigger for conflict of interest management. Third, several policies imposed presumptive restrictions on an investigator's participation in a trial involving his or her invention. CONCLUSIONS: The author defends on ethical grounds restrictive policies on patent holding in clinical trials and rejects objections to restrictive policies. The author recommends five policies: (1) any related patent holding should always be disclosed to IRBs and research subjects, (2) investigators who hold conflicting patents should be presumptively barred from certain activities in a study, (3) institutional interests in patents should be managed and disclosed to research subjects, (4) IRBs should also be informed of an investigator's filed (not just held) patents on an experimental agent, and (5) the stringency of policies should be adjusted according to a patent's earning potential and the risk associated with a study.