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Protecting Research from the Risk of Bias Caused by Conflicts of Interest

JHU policy sets limits on investigators' financial interests in human subjects research.

Q. A colleague at another institution started a company to develop his idea for a device that permits dialysis without activating immune responses that can adversely affect other organ systems. I began consulting for the small, privately held firm when it was founded several years ago and have been paid in stock that likely has no value. Now, the company has asked me to be the lead surgeon and principal investigator of a feasibility study that will implant the device in humans. Can I perform both roles?

A. Your proposal must be reviewed by the School of Medicine Committee on Outside Interests, the group which evaluates situations like yours under the JHU Policy on Financial Interests and Financial Conflicts of Interest in Research. The committee weighs the potential benefits of translational research against the possible risks that an investigator's financial interests pose to the objectivity and safety of the research. Studies that pose risks to human research subjects get special consideration.

In the process of translating ideas into commercial products, researchers often earn fees and acquire equity or royalty interests. Although financial interests are not inherently "bad," they can bias a researcher, even subconsciously, in a manner that may affect the recruitment of subjects, the consent process, the conduct of the study, and data collection and analysis.

The JHU policy sets limits on the size of the financial interests an investigator can have in human subject research. Generally in such studies, an investigator cannot have:

  • Income of $25,000 or more per year;
  • Ownership of publicly traded stock that exceeds $25,000 in value;
  • Ownership of any stock in a privately held entity;
  • Service in a fiduciary role (e.g., as a board of directors member); and
  • Potential or actual royalty income.

Regarding the scenario you describe, the policy prohibits your participation in the research because you own stock in the device manufacturer. (Although you do not know the stock's value, a positive study could dramatically increase it.)

However, if you are uniquely qualified to conduct the implant procedure — and a disinterested expert confirms that you do have unique skills — the committee may recommend to the Institutional Review Board that you be allowed to have a limited role in the study, for example, that you implant the device in a small number of subjects until another surgeon is trained to conduct the procedure safely. The committee may also decide to restrict you from seeking informed consent from prospective subjects and analyzing study data. You will certainly be required to disclose your stock interests in all consent forms, presentations and publications. In light of your limited role, it is unlikely that you can be principal investigator.

This approach should ensure that translational research can proceed safely, protected from the risks of potential bias. It will also allow for proper disclosure of your interests to those who may be affected by this work.

The JHU Policy on Individual Financial Interests and Financial Conflicts of Interest in Research is available online, and more information is available on the Office of Policy Coordination website

 

 
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