A conflict of interest occurs whenever an investigator at a research site has personal or financial interests which compromise, or appear to compromise, the investigator’s independent professional judgment in any aspect of the conduct of a clinical research study, including the protection and rights of the human subjects involved.
“Investigator” includes the PI/QI, all Sub-I’s and research staff involved in the research study, as well as their spouses and dependent children. The Board considers research staff involved in the design, conduct and/or reporting of the research and their immediate families to be subject to disclosing conflicts of interest. It is the responsibility of the institution to identify those individuals that are considered involved in the design, conduct and/or reporting of the research, for example those that may have influence on subjects or the data.
Schulman’s policy requires each PI/QI to identify financial and non-financial conflicts of interest related to the research on behalf of all applicable investigators at the research site, including all research staff involved in the design, conduct and/or reporting of the research and their immediate families, for each study submitted. A financial interest is “related to the research” when the financial interest is in the sponsor, product or service being tested, or competitor of the sponsor or product or service being tested.
Additional definitions to assist in determining when financial interests are to be disclosed:
Ownership Interest: Equity ownership or stock options held for the referenced company.
Value: Publicly traded prices (if the company is publicly traded) or other measure of fair market value.
Proprietary Interest: Property or other financial interest including, but not limited to, a patent, trademark, copyright or licensing agreement.
Significant Payment of Other Sorts: Payments by the company to support activities of the investigator that have a monetary value of more than $5,000 exclusive of the costs of conducting the research study, such as retainers for ongoing consultation or honoraria, during the course of the study and when aggregated for the immediate family.
Compensation Affected by the Outcome of the Study: Compensation that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result; Compensation in the form of an equity interest in the company; or Compensation tied to sales of the product, such as royalty interest.
If, at any point during a study, any “investigator” has a potential conflict of interest regarding the study, complete and submit the Conflict of Interest Disclosure Form. The Board will determine whether the conflict of interest is allowable for the particular study.