8. What Financial Interests & Potential or Actual Conflict of Interests Must be Reported to the IRB?
In order to minimize actual or potential financial conflicts or non-financial conflicts of interest in human research, the MMC Human Research Protection Program requires all individuals involved in the design, conduct, or reporting of the research to report all conflicts related to the research to the IRB. A completed Conflict of Interest Financial Disclosure Form must be submitted with the Application for Human Subject Research. Of note, "all individuals involved in the design, conduct, or reporting of the research" is broader than principal investigators and co-investigators and may include study coordinators, research nurses, data coordinators, and other support staff. IRB SOP RR 802
Review the guidance document MMC HRPP and MMC IRB Human Research Guidance for Conflict of Interest Disclosure Requirements for Human Subject Researchers.
Submit the Conflict of Interest Financial Disclosure Form at the time of initial review and each subsequent continuing review. In addition, investigators must report any change(s) to this disclosure to the IRB within ten business days.
Important definitions are as follows:
Financial Interest Related to Research is defined as a financial interest in the sponsor, product or service being tested, or competitor of the sponsor. This covers anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options or other ownership interest); and intellectual property rights (e.g., patents, copyrights and royalties from such rights) for the purposes of this policy.
Disclosable Financial Arrangements are:
- Compensation made to the investigator in which the value of compensation could be affected by study outcome.
- A proprietary interest in the tested product, including but not limited to: a patent, trademark, copyright or licensing agreement.
- Any equity interest in the sponsor of a covered study, i.e., any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices.
- Any equity interest in a publicly held company. Payments of other sorts made by the sponsor of a covered study to the investigator or the investigator's institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for 1 year following completion of the study.
Non-Financial Interest Related to Research is defined as an interest in the sponsor, product or service being tested, or competitor of the sponsor which excludes financial interest. For the purposes of this policy, Disclosable Non-Financial Arrangements are:
- Having a Board or executive relationship related to the research, regardless of compensation.
- Have been involved, or plan to become involved in the design, conduct, or reporting of the research.