Harvard Medical School (HMS) researchers are actively engaged in research funded (sponsored) through various outside sponsored research awards from federal awarding agencies, research foundations, and industry. There are special conflict of interest (COI) requirements that apply to sponsored research, beginning at the time an investigator applies for funding from an awarding agency.
These requirements, outlined in the HMS/HSDM Policy on Financial Conflicts of Interest in Sponsored Research(Sponsored Research COI Policy).
The requirements are in addition to the rules set forth in the Faculty of Medicine Policy on Conflicts of Interest and Commitment and apply to all investigators on a research project for which an application for funding has been made through and/or granted to HMS. The requirements outlined in the Sponsored Research COI Policy apply to investigators who are planning to conduct or are conducting sponsored research (applied for and/or received through HMS) that is not otherwise prohibited by the Faculty of Medicine Policy on Conflicts of Interest and Commitment or other applicable requirements. In the event a research project would not be permitted to proceed pursuant to the Research Rules and other prohibitions outlined in the Faculty of Medicine Policy on Conflicts of Interest and Commitment, nothing in the Sponsored Research COI Policy alters that conclusion.
Disclosure and Review of Interests
All investigators conducting research for which a funding application has been made to an external funding agency or entity must disclose their outside activities and financial interests through the Outside Activities and Interests Reporting portal (https://oair.harvard.edu/) both annually and at the time of proposal submission. An investigator is anyone who is responsible for the design, conduct or reporting of a research project. HMS is required to review the investigator’s financial interests for potential conflicts of interest prior to the expenditure of funds under a sponsored research award. If a conflict of interest is identified, the Office of Academic and Research Integrity (ARI) will contact the faculty member to discuss whether elimination or management of the conflict is necessary. Determinations of whether a potential conflict exists will be informed by the recommendations of the HMS Financial Interest Review Committee, a faculty committee comprised of representatives across the HMS departments that apply for and/or receive grant funding through HMS.
All Investigators working on a Public Health Service (PHS) funded grant must complete mandatory conflict of interest training. This training is a regulatory requirement for any investigator working under a PHS award and HMS cannot release funding until it has been completed by all investigators on the research project. Training must be completed at least every four years following the initial training. When training is due, the Outside Activities and Interests Reporting system (OAIR) will automatically prompt investigators to complete the training in connection with their outside activities disclosure.
HMS is required to make certain financial conflicts of interest identified in connection with a Public Health Service (PHS) funded research project publicly accessible in order to comply with the PHS regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought [(42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94)].
HMS makes available the following information regarding financial conflicts of interest identified on and after August 24, 2012 of senior/key personnel on Public Health Service awards:
- Name of senior/key personnel with the financial conflict of interest;
- The individual’s title and role in the research project;
- The name of the entity in which the financial interest is held;
- The nature of the financial interest;
- The approximate value of the financial interest (in ranges).
To submit a request:
1. Complete the Public Request for Information Form for each financial conflict of interest for which you are seeking information.
2. Print, complete, and attach a scanned copy of the form, to an email. The title of the email should be “Public Request for Information”. Send the email with attachment to firstname.lastname@example.org. HMS will respond via email to the email address provided in the form.