Sponsored Research Review


HMS faculty members are actively engaged in research aimed at alleviating suffering caused by disease. Much of this research is externally funded (sponsored) through various outside grant awards, for example grants from government awarding agencies, research foundations, and private companies. There are special 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, are in addition to the rules set forth in the Faculty of Medicine Policy on Conflicts of Interest and Commitment.

ARI is responsible for the implementation of the HMS/HSDM Policy on Financial Conflicts of Interest in Sponsored Research. This policy outlines requirements applying to investigators applying for and receiving sponsored research awards. These requirements are in addition to the rules set forth in the HMS COI Policy and apply to all investigators in a research project for which an application for funding has been made through and/or granted to HMS.

Disclosure and Review of Interests

Under the policy, investigators, those responsible for the design, conduct or reporting or research, must disclose their outside activities to ARI through the Outside Activities Reporting portal (https://esupport.hms.harvard.edu/OAR) both annually and at the time of grant proposal. ARI will review all disclosed financial interests for potential conflicts of interests before the expenditure of funds under a sponsored research award. If a conflict of interest is identified, 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.

Training

Before working under a PHS funded grant, you must complete the mandatory CITI Training module “Mandatory PHS Required Training on Research Conflicts of Interest at Harvard Medical School”.  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. Training must be completed at least every four years following the initial training.  You are strongly encouraged to complete this training so that you avoid any delay in funding of the award.  The training can be accessed at the following link: www.citiprogram.org. 

Please follow this link for detailed instructions on completing the CITI training.

Public Accessibility

HMS is required to make investigator financial conflicts of interest related to Public Health Service (PHS) funded research 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)]Requests for information regarding financial conflict of interest related to PHS funded research may be made to ARI. ARI will provide a written response within five (5) business days upon receipt of a request.  .

 Requests request for information must meet the following criteria: 

  • The individual for whom information is sought, is identified by HMS in the grant application, progress report, or any other required report submitted to the NIH as a senior/key personnel on an active NIH grant or cooperative agreement for which a notice of award was issued on or after August 24, 2012;
  • The Significant Financial Interest (SFI)  is still held by the senior/key personnel for the NIH-funded research project;
  • A determination has been made that the SFI is related to the PHS-funded research; and
  • A determination has been made that the SFI is a Financial Conflict of Interest (FCOI). 

To submit a request:

1. Complete the Public Request for Information Form  for each SFI for which you are seeking information. 

 2. Print, sign, 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 outside_activities@hms.harvard.edu.

 3. Alternatively, you can print the completed form, sign, and send it by regular mail to: Director, Office for Academic and Research Integrity, Harvard Medical School, Gordon Hall, 25 Shattuck Street, Suite 407, Boston, MA 02115.

 4. HMS will respond via email to the email address provided in the form.  If a paper copy is required, please enclose a self-addressed postage paid envelope.  Mailed responses will be postmarked no later than five (5) business days after receiving a valid request (as detailed above) at the email address or mailing address provided above.