3.4.1 Institutional Conflicts of Interest
Trudo Lemmens, LicJur, LLM, DCL
- To understand the concept of Institutional Conflict of Interest
- To understand the potential impact of institutional COI
- To learn how to deal with institutional COI
Dr. X is an expert on the treatment of colon cancer. She is also the vice president (VP) of research at one of Canada's major research-oriented hospitals, the General Hospital of Bancroft. Nearly three years ago, a pharmaceutical company, Lanaflux Inc., signed a contract with Dr. X and her institution for a multisite, three-year study on the efficacy and safety of a new medication for the treatment of colon cancer. The research contract is now coming to an end.
The company, apparently happy with the work delivered so far, proposes to establish a closer collaboration with the General Hospital and with the University of Central Bancroft, to which the General Hospital is attached. It will provide a $10 million fund for research on colon cancer to a specialized cancer research unit. It will also fund a research chair in colon cancer, the Lanaflux Chair. The research chair will be for a two-year probationary period, with possible renewal for subsequent three-year periods. Dr. X will probably be the chair holder. Lanaflux Inc. will have a priority right over the commercialization of any research findings coming out of the specialized research unit during the period of funding. In exchange, the General Hospital will receive 25% equity shares in the company. Researchers who have been involved in a study that has its findings commercialized will receive a total of 15% in equity, to be divided among those involved.
- What is a conflict of interest (COI)?
- What is an institutional COI?
- Why is it important to deal with COIs in research?
- What regulatory and policy options are available to deal with COIs?
- How do trial registration and results reporting help us to deal with some aspects of COI?
In the presented case, the collaboration established between the institution and the sponsor clearly creates COIs. At a minimum, an independent, arms-length COI committee should be established by the institution with the mandate to review the potential impact of these institutional interests on the conduct of research. The institution should also ensure that proper procedures are in place to safeguard the independence of its investigators. It should establish a complaints procedure that will allow individual investigators to report potential negative issues that arise from the significant interests at stake.
The COI committee should document its evaluations, make recommendations about how to deal with the COIs and make these recommendations publicly available. It should ensure proper communication with the REB.
The university should, in my view, resist the temptation to accept the chair offered by the company. Renewable contracts create a situation of dependence. It speaks for itself that people who receive the chair (with its accompanying significant financial benefits and prestige), knowing that the renewal of this chair depends on the satisfaction of a pharmaceutical sponsor, may be less critical of the sponsor's products. They would certainly be perceived to lack independence.
Even if the chair holder is not driven to skew data, present study results prepared by the sponsor as their own or sign a paper written by a ghost author, they may not be in a position to stand up to the sponsor if issues of interpretation and results reporting arise. Alternatively, they may simply avoid talking about the sponsor's products if they think the products are inferior or when safety issues arise. They lack the necessary independence to be seen as fully independent academic researchers.
In this particular case, the fact that the VP of research has a close connection to this important research sponsor—and that she is also the person who will receive the chair—indicates significant institutional confusion of roles. The VP of research should not be involved in negotiating this contract and should remove herself from such personal COIs.
The institution should, at a minimum, be able to convince the pharmaceutical sponsor to donate a fixed amount of money to be used for an endowment that does not depend on the yearly goodwill of the sponsor. Not all problems will be solved by this approach. Indeed, the expectation that future funding may be coming can clearly influence an institution's behaviour. However, if such funding is deemed acceptable then I would expect to see at least the creation of a buffer between the institutional interests and the day-to-day research and teaching activities of the staff. The institution should also implement policies to strengthen the independence of its oversight bodies, in line with the recommendations above. The presented case clearly shows why the COI committee and the REB should not report to the VP of research in this institution.
The institution should ensure that all research contracts within the institution are verified to ensure that researchers are free to publish the results of the study and to share the data with other investigators. It should implement policies to ensure compliance with several other initiatives to promote transparency and accountability of research, including trial registration and registration of results.
The institution should further ensure that researchers who have direct financial interests in the outcome of the research are not involved in the study. Following this approach, the chair holder should not be involved in any research funded by this industry sponsor. It would also seem appropriate, following the recommendations of the AAMC, to see if the research sponsored by Lanaflux Inc. can take place in another institution that does not have such a significant equity share in the company.
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