Policies & Procedures

Conflict of Interest and Clinical Research Policy - Questions and Answers

Question: If I have previously conducted and concluded research studies or clinical trials involving human subjects, with the financial sponsorship of a private company and the results of the research have been published, can I establish new financial relationships with the same company?
Answer: Yes. The policy is not meant to include financial arrangements with companies either prior to the initiation of the sponsored study or after its publication: what needs to be avoided are financial relationships whose value might be influenced by the conduct and outcome of a particular study. Therefore, faculty/staff can have financial interests in a company that sponsored his/her research after the study has been published or before the company begins to sponsor the research.
Question: How does the policy apply to an individual who has been involved in the design phase of a clinical research project sponsored by a company and has a financial interest in the company, but is not involved in research study?
Answer: The policy only applies to faculty/staff who are actively involved in the conduct of research studies or clinical trials involving human subjects. The policy does not apply to faculty/staff whose involvement in the study ceases at the design phase.
Question: If I have stock options in a company, which at present have no established market value, should I disclose this and is the stock option subject to the inclusive limit of $10,000?
Answer: Yes, all stock options must be disclosed regardless of value. Although it may not be possible to ascertain market value, the value of the options may be sharply influenced by positive or negative research results. Hence, stock options pose potentially the most serious conflict of interest issues and must be disclosed.
Question: Is the $10,000 limit described in the policy a per-year maximum or cumulative over the life of the research?
Answer: The $10,000 is a per-year maximum. Stock options, regardless of value, must be disclosed annually.
Question: What should I do if my financial interests already exceed the limit described in the policy?
Answer: Re-disclose the financial interests using the financial disclosure form found on the web site.
Question: What administrative steps should I take to seek exceptions to this policy?
Answer: Faculty/staff should use the financial disclosure form to disclose the conflict to the Disclosure Review Committee, for appropriate disclosure and management. The Committee may elect to recommend an exception or defer the decision to the Dean of the appropriate school and Vice Chancellor for Research for a management strategy, if any is possible.