As of August 24, 2012, Public Health Service (PHS) regulations on the “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) have been revised. Any Institution applying for or receiving NIH funding from a grant or cooperative agreement must be in compliance with the requirements of the new regulations, which mandate, in part, that all individuals responsible for the design, conduct or reporting of PHS-funded research awarded through Harvard Medical School (HMS) or the Harvard School of Dental Medicine (HSDM) report to institution any personal financial interests that may be deemed relevant to the individual’s institutional role with HMS or HSDM. HMS policy covering these regulations can be found on the Integrity in Academic Medicine website at the following link: http://hms.harvard.edu/content/integrity-academic-medicine.
To ensure both compliance with these regulations and the public’s continued trust in the integrity of our research endeavors, HMS requires that all HMS and HSDM postdoctoral fellows report, at the time of hire and annually thereafter, their relevant outside activities and financial interests to HMS. An update within thirty (30) days of receiving a new interest is also required. New hires MUST complete this report prior to commencing research activities at HMS/HSDM.
How do I report to HMS?
Access to report: You can access the online Outside Activities Reporting portal by clicking on: outsideactivities.hms.harvard.edu/OAR. You can return to the link at any time to update your reports or submit additional reports.
Questions or access difficulty following log-in?
If you require further assistance, please contact Cindi-Ann Hirst at 617-432-1343 or firstname.lastname@example.org.
As you prepare to submit your required outside activity report, please keep in mind the following:
• Trainings. As part of the regulatory requirements, all HMS/HSDM investigators, including postdoctoral fellows, are required to complete an additional training component through the Citi platform. This training will orientate you to the requirements of the PHS regulations and Conflict of Interest Policy and what constitutes a conflict. This training is required every four years and should be completed at the time of on-boarding. Directions for accessing this training can be found at:
A CITI account is required to access the training, and you should use your existing account. If you do not have an account, this link will also allow you to create an account. Please register with your HMS email address and provide your HUID.
When registering, please select Harvard Medical School and Harvard School of Dental Medicine from the list of participating institutions.
2) You will need to enroll in the CITI Conflict of Interest Course. To enroll:
• Please select “Conflicts of Interest” when it asks which category or categories of courses you need to take
3) The “Conflict of Interest – Stage 1” Course will be displayed in the “My Courses” section. Click on “Enter” to begin.
4) To access the course content, you will need to sign the Integrity Assurance Statement. Once acknowledged, you’re now able to begin the Conflict of Interest Training modules.
5) Complete all three COI Training modules:
a) Financial Conflicts of Interests
b) Institutional Responsibilities
c) Mandatory PHS Required Training on Research Conflicts of Interest at Harvard Medical School.
You will need a score of 80% or higher on Modules 1 and 2, to successfully complete the training and receive credit. If you do not score 80% or higher, you will need to re-take the quiz portion of the relevant module until you reach 80%. There is no quiz for module 3.
To confirm you have completed each module, you can find your results by clicking on “See a list of all modules completed” located in the main menu.
Content of report
You are required to report:
• All outside professional income, royalties and equity holdings relevant to your role as a HMS/HSDM investigator.
• The reporting requirement is independent of whether your financial interests represent potential, perceived or actual conflict of interest.
• You are required to report each entity with which you have an outside fiduciary relationship and/or a financial interest.
• In addition, any PHS investigator is required to disclose the occurrence of any reimbursed or sponsored travel related to your postdoctoral responsibilities. It does not apply to travel that is reimbursed or sponsored by the following:
o A U.S. federal, state, or local government agency,
o An U.S. institution of higher education,
o An academic teaching hospital, a medical center, or a research institute that is affiliated with an U.S. institution of higher education.
A link for tracking and reporting sponsored travel on an ongoing basis is available through the Outside Activities reporting interface. Please contact the Office for Professional Standards and Integrity if you have questions about this requirement.
YOU ARE NOT REQUIRED TO REPORT SALARY, TRAVEL OR OTHER COMPENSATION OR BENEFIT THAT YOU RECEIVE FROM HMS/HSDM UNDER A GRANT, SPONSORED AWARD OR OTHER CONTRACT WITH HMS/HSDM.