Frequently Asked Questions

In the interest of full transparency, recipients should err on the side of disclosure. Researchers should consult with HMS Office of Research Administration at International_Collaborations@hms.harvard.edu. NIH requires complete and accurate reporting of all sources of research funding, in-kind support, personnel and affiliations, both foreign and domestic, that provide any support to your research efforts.

All resources available to an investigator in direct support of their research endeavors should be disclosed on NIH Other Support Pages including: Active and Pending Projects, In-Kind Resources; Positions & Scientific Appointments; and Other Resources (including sponsored research personnel). HMS Office of Research Administration has developed a detailed guide and template for NIH Other Support pages which can be accessed here: https://researchadmin.hms.harvard.edu/policies-guidance (scroll down to NIH Other Support link).

No, at this time, gifts do not need to be disclosed as Other Support.

Prizes do not need to be disclosed as Other Support.

Yes. See the HMS ORA NIH Other Support template for examples of how to list this type of support.  Remember that all externally supported researchers should be listed on a faculty Other Support Page, even if they are not working on the specific project supported by this grant application/JIT/RPPR.

Visiting scientists, scholars and researchers should also be evaluated for Restricted Party status. Contact the Office of Research Administration, Export Control Administrator at international_collaborations@hms.harvard.edu

Outside Activities and Consulting Activities do not need to be reported on Other Support; however, if activity provides a resource that is used by the faculty member as part of their research endeavors, the resource should be disclosed (e.g. grant funding, in-kind support, a position or appointment or other resources available).

If the fellowship recipient is working on one or more of the PI’s research projects, and their fellowship stipend supports their effort on that project, then it would be considered a type of in-kind support, which should be listed on the Other Support page. 

Space and capitalized equipment are typically not uniquely available to a researcher and therefore should be reported in the Facilities & Other Resources section and not the Other Support Page. If a faculty or department thinks that an unusual circumstance exists where facilities or capital equipment grants funds are being given in unique support of a PI, please talk with the Office of Research Administration at international_collaborations@hms.harvard.edu.

Yes. While you may not receive monetary compensation or salary, your access to lab space, materials, and staff are resources made available to you in support of and/or related to your research efforts. As outlined in NOT-OD-19-114 any outside appointment must be reported as Other Support. NIH requires applicants to list all positions and scientific appointments both domestic and foreign held by senior/key personnel that are relevant to an application including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).

You should not accept an appointment at any institution outside Harvard (or its affiliated hospitals/research institutes) without first consulting with the Office for Research Administration and/or the Office for Academic and Research Integrity. 

Yes. Other Support includes domestic research collaborations that directly benefit the researcher’s research endeavors. 

Yes. Available resources in support of and/or related to an investigator’s research endeavors should be disclosed even if they relate to work that is performed outside of a researcher’s appointment period. 

In July 2019, NIH issued NOT-OD-19-114 which clarified NIH’s requirements that “other support includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes resource and/or financial support from all foreign and domestic entities, including but not limited to, financial support for laboratory personnel, and provision of high-value materials that are not freely available (e.g., biologics, chemical, model systems, technology, etc.).”

You should keep the template intact and simply write “None” below any section under which you have no disclosures. This way, ORA and NIH are aware that you did not leave any information out by mistake.

Yes; however, we do not require other institutions to use our template. It is up to those institutions and faculty to disclose fully to the sponsor.

The NIH requires senior/key personnel to list all positions and scientific appointments both domestic and foreign held that are relevant to an application including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).

For awards where HMS is the prime awardee/PTE, the portion of the total award amount allocated for subawards may be deducted from the total costs represented on Other Support, as each subrecipient PI will report on their subaward amount in their Other Support.

When you are a Co-PI on a larger project, you should only list what is available to your research program.

NIH hasn’t defined this any further than the few examples listed in NOT-OD-19-114: “high-value materials that are not freely available (biologics, chemical, model systems, technology, etc.)”

Does this mean that every plasmid or reagent needs to be listed? Per above, the materials should only be disclosed if the department considers them to be high-value materials that are not freely available to other researchers.

No. You should not disclose discretionary funds received from HMS or Harvard on your Other Support Page.

Yes, awards from Harvard internal award/grant programs need to be disclosed as Other Support.

Yes, you may include the application under review within the list of pending projects. Including the current application is referable, as it places the proposed effort in context with other active and pending projects, and will show the full picture for overlap assessment.

You are welcome to share the HMS template with subaward institution and suggest they retain the headings and write in “NONE” if the investigator has no resources to report for that section.  That way, ORA won’t need to ask whether the individual is following the latest guidance. If the subrecipient(s) do not want to use the HMS Other Support template or headers, ask them to confirm in writing (email) that the investigator has included all applicable resources on their Other Support pages, and upload that email to the GMAS proposal/request.  

Yes, your pre-award officer should always review the Other Support information before it is emailed to the prime institution, even if the prime doesn’t require an institutional signature.

Yes, they must all be disclosed. Should your PI have nothing to report for one or more of the categories, please write ”NONE” under the section header. That way both ORA and NIH can see the category was not left out by mistake.

No, gifts and prizes do not need to be included on Other Support.

Yes, institutional (or internal) awards that support research must be included in the Active and Pending Projects/Awards section of the Other Support pages.

In-Kind support in the form of employees or trainees with outside funding (e.g., non-NIH fellowships) who contribute to the PI’s research grants should be listed by name and funding source. Effort per project does not need to be included.  

No, only include Active Awards (including any that have been awarded since the last submitted Other Support for the project) and Inactive Awards (awards that have terminated since last submitted Other Support for the project). The Inactive Awards must be clearly marked as such.

The Biosketch includes selected Positions and Honors that are relevant to the project. Other Support should list all domestic and foreign positions and appointments. This includes both paid and unpaid titled academic, professional, or institutional appointments, whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).

Consulting and scientific advisory board positions do not need to be reported as Other Support if they do not involve your performance of research activities. For example, providing input on the design of a study that will be conducted by other individuals would not trigger Other Support reporting requirements.

If, however, the investigator’s role as a consultant provides resources available to support his/her research (e.g., access to research funding, in-kind access to lab space or staff, access to high-value materials not generally available to other researchers, etc.), it should be disclosed as Other Support.

No, they are considered training awards which are not disclosed on Other Support. 

Reimbursed travel expenses for a talk that does not further the PI’s research do not require disclosure as Other Support.

The amount listed should reflect what is available to your PI to support their research activity on the award. Include both 1) the total costs (Direct + Indirect) for the entire award period, and 2) the direct costs for the current year.

Space and capitalized equipment are typically reported in a project application through the Facilities & Other Resources section.  If they are included in the application’s Facilities page, , they do not need to be included again in Other Support.  Additionally, if the lab or building is used to support other researchers (i.e, it is not uniquely available to your PI alone), it does not need to be reported as other support.

You should include 1) the total costs (Direct + Indirect) for the entire award period, and 2) the direct costs for the current year.  The directions in NIH’s NOT-OD-19-114 notice require us to report the total costs for the entire award period.  However, the directions on NIH’s other support format page ask for annual direct costs.  Therefore, HMS recommends supplying both amounts for awards listed on other support.   

Foreign Component is the performance of a significant scientific element of the NIH-supported project outside of the United States.  Once a recipient determines that a portion of the project will be conducted outside of the U.S., the recipient then will need to determine if the activities are considered significant. If both criteria are met, there is a foreign component.

Activities that meet this definition include, but are not limited to, (1) the involvement of human subjects or animals, (2) extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country.

The NIH must be notified of and approve a foreign component in advance.  Consult with the HMS Office of Research Administration (ORA) if you believe that you have a foreign component: nternational_collaborations@hms.harvard.edu.

The recipient institution is obligated to evaluate the element of the project that is being conducted outside of the United States within the context of the project as a whole to determine whether the element is “significant”. Some examples of activities that may be considered a significant element of the project include, but are not limited to:

• collaborations with investigators at a foreign site anticipated to result in co-authorship
• use of facilities or instrumentation at a foreign site
• receipt of financial support or resources from a foreign entity

Please use the Evaluating a Foreign Component Guide to assist you in determining if a foreign collaboration meets the criteria of Foreign Component.

Researchers should consult with HMS Office of Research Administration (ORA) to discuss the collaboration and its significance to the project. ORA can be reached at: international_collaborations@hms.harvard.edu. NIH requires complete and accurate reporting of all sources of research support, financial interests and affiliations, both foreign and domestic.

Harvard requires Provostial approval of research proposals that pose management challenges and/or reputational risk. 

Projects with any of the following international components must receive Provostial review, regardless of whether the funding is NIH or any other sponsor:

1. The project has an aggregate budget of more than $10 million for U.S.-based projects, or is an international program whose annual budget is greater than $5 million for HMS or $1 million for HSDM.
2. The project supports the establishment of any new international site. For this purpose, "new international site" refers to:
   • real estate, including offices and research space, outside the U.S. that is leased for Harvard use for a period of six months or longer;
   • a project outside the U.S. to which two or more Harvard faculty members, employees, staff members of an affiliated entity, independent contractors, post-doctoral fellows, or students are assigned and placed for a period of six months or longer; or
   • a project that involves significant work in, or the posting of a Harvard faculty member, employee, staff member of an affiliated entity, an independent contractor, post-doctoral fellow, or student to, countries or regions identified as 'High Risk' by Harvard's Global Support Services.    
3. The project is international and involves human subjects research that requires IRB expedited or full review.

     NOTE: If a proposal meets this criterion and no other criterion, it can be reviewed at the time of         award rather than at the time of submission.

Researchers should consult with HMS Office of Research Administration (ORA) to discuss the collaboration and its significance to the project. ORA can be reached at: international_collaborations@hms.harvard.edu. NIH requires complete and accurate reporting of all sources of research support, financial interests and affiliations, both foreign and domestic.

With very few exceptions, HMS Faculty and research staff must list ALL outside activities in the OAIR that are broadly relevant to the individual’s institutional role, including uncompensated activities.  This includes funds paid directly to an investigator from an institution of higher education or the government of another country in support of his or her salary and/or research training in the United States (e.g., sponsored trainee support).  This also includes relevant interests held by a partner/spouse and dependent children.

You should report all activities broadly related to your Harvard responsibilities. This should be thought of in the broadest sense including your academic, administrative, research and teaching responsibilities. HMS has a zero dollar reporting threshold so you should report activities even if there is no financial compensation. 

The only activities that do not need to be disclosed on the Outside activities Report are:

• Financial interests or uncompensated activities from a charitable institution of higher education located in the United States.
• Financial interests in or uncompensated activities with federal, state or local government        agencies (U.S. only!).
• Sponsored research support issued through HMS or an HMS affiliated institution.
• Salary support or other income paid by HMS, an affiliated institution or any other academic teaching hospital, medical center, or a research institute that is affiliated with a charitable institution of higher education (U.S. only!).
• UNLESS… Payments from above are made on behalf of a commercial entity that would otherwise be disclosed.

Each journal will have its own criteria for what they require authors to disclose. You should follow each journal’s requirements carefully. Please keep in mind that funders review acknowledgements, COI and funding disclosures in articles and publications. You should ensure that you are consistent with your disclosures to journals, HMS and funding sponsors.

HMS’s Outside Activities and Conflict of Interest team are available to support you with questions related to Outside Activities.

They can be reached at: Phone: (617) 432-1343; outside_activities@hms.harvard.edu. When in doubt, please err on the side of disclosure.

Disclosure should occur through the Outside Activities & Interests Reporting portal (https://oair.harvard.edu/).  Interests should be updated frequently, but, at a minimum, within thirty (30) days of acquiring any new Significant Financial Interest (as defined by policy) with updates made at least annually.

HMS’s Outside Activities and Conflict of Interest team are available to support you with questions related to Outside Activities disclosures. They can be reached at: Phone: (617) 432-1343; outside_activities@hms.harvard.edu. When in doubt, please err on the side of disclosure.

The following lists some examples of terms and conditions that should be further vetted if they arise in an Outside Activity agreements. If you see any of the following, please consult with the HMS Outside Activities and Conflicts of Interest team (Phone: (617) 432-1343; outside_activities@hms.harvard.edu) before signing the agreement.

Potentially problematic terms and conditions may include, but are not limited to:

• Serving in any employment position that is responsible for a material part of the operation or management of a business engaged in commercial or research activities of a biomedical nature
• Contractual prohibitions on disclosing the activity or relationship to third parties, including Harvard
• Use of Harvard resources, use of Harvard name or insignia, or including Harvard as a party to your personal agreement
• Requirements for effort beyond the 20% outside activities time allowance for full-time Faculty (20% is the cumulative time allowed across all outside activities in total)
• Requirements for making Harvard-based training opportunities available, including exchange of trainees or scholars to work in Harvard labs or participate in Harvard academic programs
• Requirements for the exchange of Harvard owned IP or unpublished data
• Being named as an employee or being asked to do employment activities: hiring, supervising, financial/budget responsibility
• Requirements or suggestions for grant submission/sponsored research activities, being named investigator on a grant or dedicating commitment to any grant that is not awarded through Harvard (or an affiliated institution)
• Overly broad IP ownership requirements
• Academic appointments
• Mentions of Talents Program
• Agreements with unusual compensation terms or methods of payment (including through third party payors) or payment in excess of Fair Market Value
• Use of third-party intermediaries to facilitate payments or activities

As a general rule, no more than 20% of a full-time Faculty member’s total professional effort may be directed to outside work.  This means that faculty should spend no more than an average of one day per seven-day week on all outside activities.  If you think the amount of time you spend on outside activities may exceed 20% of your professional effort then you should discuss this with your Chair in order to ensure that your outside activities do not impede your ability to uphold your teaching and research obligations as an HMS faculty member and to adjust if necessary.

EH&S is available to assist with the transport and shipping of research materials. EH&S can be reached at: Phone: (617) 496-3797

EHS_ResearchTransport@harvard.edu. You may need a Material Transfer Agreement (MTA); to confirm whether an MTA is needed, please reach out to The Office of Technology Development at: Phone: (617) 432-3845 or visit the OTD Material Transfer website or email them at:  hms_materialtransfer@harvard.edu.

If you are shipping internationally, please also contact international_collaborations@hms.harvard.eduto request a review of the materials and end user to determine whether an export control license is required.

Data transfers should be accompanied with a Data Use Agreement. To initiate a Data Transfer and Use Agreement, contact the Office of Research Administration at SPAContracts@hms.harvard.edu or enter a record in the Agreements-DUA system. HMS Information Security may also need to participate in the transfer of sensitive, high-risk or large data files. HMS IS can be reached at: itservicedesk@hms.harvard.edu; Phone: (617) 432-2000 or enter a record in the Data Safety system.

The US Federal Government maintains various lists for individuals and companies who are prohibited from participating in certain Federal programs. US entities that receive Federal funding should be aware if any individuals are named in any of the exclusion or debarment lists and must be cautious of engaging with them in business transactions and services.

Yes. Foreign Visiting Scientists and Visiting Scholars should also be evaluated for Restricted Party status. Contact your departmental Visual Compliance user or the Office of Research Administration, Export Control Administrator at international_collaborations@hms.harvard.edu to screen incoming individuals.

The Office of Academic and Research Integrity, Research Compliance Office can direct you to the correct person or department to support you, depending on your question or concern. Please reach out to them at:  ari@hms.harvard.edu; Phone: (617) 432-4408.