International Research

International Projects and Collaboration (ICA)

 

Overview

Harvard strongly values its international connections and considers the free exchange of ideas among students and scholars across the globe to be paramount to the University’s mission. Nevertheless, the accurate identification and review of research projects that include international components is necessary to ensure compliance with the numerous regulatory and administrative requirements that can arise from international collaborations. Our federal and non-federal sponsors have varying levels of interest and scrutiny relative to the University’s international footprint and associated compliance processes. However, regardless of how wide or narrow of a view any particular sponsor may take with respect to required disclosures, Harvard must be able to aggregate data with respect to and, at times, report on all forms of its international activities in order to effectively manage the associated administrative and compliance obligations.

The key objectives of the International Collaborations and Activities Approval are to: (i) provide a consolidated means of collecting and systematizing information regarding Harvard’s international sponsored activities; (ii) establish better internal controls related to such activities; and (iii) enable the University, when needed, to report on its international sponsored activities both internally and externally, including in accordance with applicable sponsor requirements. In addition, by tracking international sponsored activities on a comprehensive scale, the University is better positioned to accommodate future revisions to regulatory and policy requirements, and to address any related changes in compliance and disclosure best practices. Aggregating this information will further enable the University to respond to international emergencies in a more effective and informed manner, as needed.

Background

In recent years, the U.S. federal government has expressed increased interest in the impacts and potential influence of foreign involvement on federally-sponsored research. This has included the issuance of guidance reiterating the significance of certain required disclosures and prior approvals, as well as project-based scrutiny on the involvement of foreign nationals, the use of facilities and performance of other research activities outside of the U.S., and the receipt of foreign resources in support of research aims. As Universities have worked to refine existing processes and adopt more comprehensive compliance regimes in response to such heightened interest, efforts have necessarily been balanced against Harvard’s and our peer institutions’ commitment to not only supporting, but encouraging international collaboration. 

As a result, the International Collaborations and Activities Approval finds its basis in federal agency requirements surrounding international activities, in particular, those promulgated by the National Institutes of Health (NIH), the National Science Foundation (NSF), the Department of Energy (DOE) and the National Aeronautics and Space Association (NASA), among other agencies. However, as inquiries exist even outside the plain letter of such agency requirements, Harvard must be positioned to not only understand, but substantiate its international research activities, regardless of sponsoring agency. We further anticipate that other federal and non-federal sponsors will adopt requirements similar to, for example, the “Foreign Component” prior approval stipulated by NIH. Accordingly, this process is necessarily designed to reflect the practical necessities of compliance and policy interests, while being adaptable to a rapidly evolving regulatory environment. 

Scope

This document outlines the process for the identification, collection and review of International Components in GMAS to assist Principal Investigators, Grants Managers, Central Reviewers and other University administrators in implementing and maintaining appropriate procedures relevant to Harvard’s international sponsored activities. The International Collaborations and Approval is intended, not to replace, but to supplement existing reviews and approvals applicable to international activities as well as sponsored projects, including those conducted by the Office of the Vice Provost for Research (OVPR), the Harvard International Office, Global Support Services, the University Committee on International Projects and Sites, and local Export Control Administrators. Further, this process does not eliminate or otherwise change the obligations of Principal Investigators and key personnel with respect to required disclosures in accordance with applicable sponsor requirements, including those of our federal agency sponsors.

Key Definitions

International Component

For purposes of the International Collaborations and Activities Approval, an International Component is any element of a Project which takes place outside of the U.S.; involves the receipt of funding, in-kind support, or other resources (including personnel) from a foreign organization or collaborator; includes the issuance of funds or resources to a foreign organization or collaborator in support of Project aims; or that may have an impact on U.S. foreign policy. The specific International Components addressed under the International Collaborations and Activities Approval in GMAS are listed below under International Component Definitions

Project

The sponsored project in connection with which information on International Components is being requested. Entry and confirmation of such information is required at various points during the Project lifecycle, including prior to submission of the initial proposal and upon award. 

Sponsor Requirements

The applicable regulations and administrative requirements of the organization funding the Project. While the International Collaboration and Activities Approval is grounded in disclosures required by U.S. federal agency sponsors, non-federal sponsors may also require certain disclosures and prior approvals with respect to International Components.

International Component Definitions

International Sponsor

A non-U.S. organization that is the named sponsor or prime sponsor of the Project. While the Project may involve other sources of funding or resources, this International Component refers to the organization to which Harvard’s obligations under the sponsored award flow, whether in the University’s capacity as the award recipient or as a subrecipient to another pass-through-entity. 

International Subaward

An agreement (subaward) that flows down Project funding and prime award terms to a non-U.S. organization (subrecipient) for the performance of substantive, programmatic work on the Project, including the design or conduct of research.

International Travel

Travel outside of the U.S. for any purpose in support of Project aims, whether by a member of the Project team or by another individual who is contributing to the completion of the Project (paid or unpaid, Harvard-affiliated or otherwise).

International Collaborator

Any individual (other than a formal subrecipient) who (a) is employed or engaged by a non-U.S. organization, or, as in the case of an independent contractor, otherwise operates outside of the US; and (b) will be performing work in support of Project aims, regardless of whether or not such organization or individual receives funding from the Project or Harvard. 

Establishment of a New International Site

This International Component may comprise the use of Project funds to purchase or lease real estate outside of the U.S., a Project scope that requires significant research abroad (e.g., personnel relocating to a foreign country for multiple months at a time), or a combination of such activities. All activities that meet the definition for “New International Site” set forth under the Criteria and Procedures for Provost’s Review of New Projects or Grants (Provostial Review Criteria) should be disclosed under this International Component.

Use of International Facilities/Instrumentation at an International Site

Any use of facilities and/or instrumentation outside of the U.S. by Harvard personnel, or by a collaborator, vendor/service provider or subrecipient, in connection with the Project. Any payment to individuals or entities in support of such use (excluding under a formal subaward), or for similar services essential to the Project, including via a services/vendor agreement, should likewise be captured under this International Component. 

Foreign National

An individual who is a citizen of any country other than the United States. This includes individuals working at Harvard while on a student, scholar, or work visa. Note that individuals who hold U.S. permanent residency status (i.e. holders of a green card) or who have been deemed “protected individuals” as defined in 8 U.S. Code § 1324b(a)(3) (e.g. refugees or persons seeking asylum) are not considered foreign nationals for the purposes of this International Component.

International Shipment/Transfer/Exchange of Research Materials, Data and/or Equipment

Any (I) shipment or transfer of equipment, software, or technology, (ii) sharing of data (other than through publication), or (iii) shipment of biological, chemical or radioactive samples, in each case, to or from an international collaborator or site in connection with the Project.

International Human Subjects and/or Animal Research

The conduct of research involving human or animal subjects outside of the U.S in connection with the Project, whether by Harvard, or by any of its collaborators or subrecipients. 

Impact on US Foreign Policy

Any activity in connection with the Project that may have an impact on foreign policy through the involvement in the affairs or environment of a foreign country.

Roles & Responsibilities

Central Reviewer

The individual within the School or Central Administration responsible for reviewing the proposal and/or award documentation, including the information entered into GMAS as part of the International Collaborations and Activities Approval. The Central Reviewer is expected to be familiar with the scope and requirements of the International Collaborations and Activities Approval, as well as any applicable Sponsor Requirements relating to international activities identified in connection with the Project. The Central Reviewer may engage, or advise the Grants Manager/Principal Investigator to engage, ancillary reviewers in connection with a Project, including by adding OVPR as a Project signatory in GMAS. The Central Reviewer signs off on all Project requests in GMAS and serves as the Authorized Organizational Representative with respect to proposal and award documentation submitted to sponsor in accordance with Sponsor Requirements.

Export Control Administrator

Jenifer Neira is responsible for providing export control review as needed in connection with the Project. While this role does not serve as a GMAS signatory or otherwise provide any required reviews prior to a Project being awarded, they may be consulted by the Central Reviewer, Grants Manager, Principal Investigator and/or the Provost Reviewer to assess the export control implications of any International Components associated with the Project. Such Export Control Administrators may further utilize the data in GMAS to monitor and otherwise support compliance operations across the University as they relate to export control issues under sponsored awards.

Grants Manager 

The department administrator (or individual acting in such capacity) responsible for supporting preparation and entry of the proposal into GMAS, including the information required under the International Collaborations and Activities Approval, and managing the resulting award at the local level. This individual may assist the Principal Investigator in identifying International Components in connection with the Project, and is responsible for facilitating information gathering, updates, and subsequent disclosures with respect to any International Components identified, as may be required throughout the life of the Project. The Grants Manager may be added as a local signatory for the Project proposal in GMAS, depending on School practices. 

Principal Investigator

The individual designated in GMAS as the Principal Investigator on the Project. This individual is responsible for the integrity of the information both included in the proposal and entered into GMAS, and for certifying through the GMAS signature process that the responses to each of the International Collaborations and Activities Approval questions are accurate. The Principal Investigator is further responsible for ensuring that those International Components that require prior approval or disclosure under the applicable Sponsor Requirements are appropriately reflected in the proposal, at just-in-time and award stage, and in subsequent progress reports (e.g., RPPRs) throughout the life of the Project. Note that when Harvard is acting as a subrecipient, the individual overseeing Harvard’s portion of the work typically serves in the Principal Investigator role, notwithstanding that they may not be a named Principal Investigator or Co-Investigator on the prime award. 

Provost Reviewer

The individual within the OVPR responsible for providing Provostial review and acting as a GMAS signatory for those Projects involving International Components that satisfy the Provostial Review Criteria, where indicated, or activities in a “country of concern,” as designated by OVPR. The Provost Reviewer may coordinate with the Central Reviewer, Grants Manager, Export Control Administrator, other School or department leadership, and/or the Principal Investigator to gather additional information and address compliance concerns related to a particular International Component.

Process Steps

Entering International Components in GMAS

Prior to the proposal being "locked and routed" in GMAS, the Principal Investigator will be asked to confirm the presence of, and provide details with respect to, each of the International Components included under the International Collaborations and Activities Approval as they relate to the Project. (Note that for both the International Sponsor and International Subaward components, GMAS will auto-populate the responses for the Principal Investigator’s review based on the proposal information entered in GMAS.)

Screenshot of International Collaborations and Activities Approval in GMAS, showing list of international components.Each International Component includes information regarding the intended scope of the question as well as examples of subject activities, where appropriate. As outlined in the Toolkit for Grants Managers, the Grants Manager should assist the Principal Investigator with the identification and entry of such information. The Principal Investigator and Grants Manager should consult with the Central Reviewer as necessary to address any uncertainty as to whether a specific International Component may be applicable to their Project.

If the Principal Investigator indicates that a particular International Component applies to their Project, they will be asked to supply supporting information via a dropdown menu or text box.

Screenshot of International Travel question in GMAS including activities encompassed.

Screenshot of country and activity selection for International Travel question in GMAS.

The Principal Investigator will first be asked to identify the country or countries in which the activities associated with the particular International Component will take place, and then to indicate, either via a checklist of activity types or an open comments field, depending on the component, the specific activities that will occur in that country. This process should be completed for each country identified by the Principal Investigator and under each International Component, as applicable. 

The Grants Manager should work with the Principal Investigator to ensure that each International Component question has been answered to the best of the Principal Investigator’s knowledge at the time of proposal. The Principal Investigator will be responsible for certifying in GMAS that the responses provided are complete and accurate as of the time the proposal is being submitted, and for ensuring that those International Components that require prior approval or disclosure under the applicable Sponsor Requirements are appropriately reflected in the proposal documentation.

Review of International Components at Proposal

Once the Principal Investigator’s responses have been entered into GMAS and prior to submission of the proposal to the sponsor, the Central Reviewer will review the information provided for each International Component in accordance with the Work Instruction for Central Reviewers, and coordinate or otherwise provide guidance to the Grants Manager and Principal Investigator with respect to any required follow up. For those International Components that involve a “country of concern” or otherwise require review pursuant to the Provostial Review Criteria, the Provost Reviewer should be added as a Project signatory in GMAS and provided with all relevant supporting information.

The Central Reviewer is expected to review the responses provided for each International Component against both the proposal documentation and the other International Component responses. Given the interrelation between many international activities, it is critical that International Components be validated in conjunction with each other, and not reviewed only as stand-alone activities. For example, if the Principal Investigator indicates that the Use of Instrumentation/Facilities at an International Site will be taking place in furtherance of the Project, the Central Reviewer is tasked with questioning and reviewing by whom and for what purpose such use is taking place, and ensuring any associated International Components have likewise been captured (e.g., if samples will be shipped for testing at a foreign facility, International Shipment/Transfer/Exchange of Research Materials, Data and/or Equipment should also have received a “Yes” response and completed with supporting details). The Central Reviewer will further compare any International Components indicated against the description of such activities in the proposal documentation to confirm each has been captured appropriately in accordance with Sponsor Requirements. 

The Central Reviewer will notify the Grants Manage of any inconsistencies, and request supplemental information and/or require that updates to the Approval responses to be entered as appropriate. To the extent that the responses entered by the Grants Manager/Principal Investigator require substantive revisions, the Central Reviewer should retract the proposal or otherwise ask the Grants Manager to facilitate entry of the appropriate updates in GMAS prior to proposal submission. The Central Reviewer may further direct the Principal Investigator to update the proposal to accurately reflect the International Components disclosed. 

For those proposals where the Provost Reviewer has been added as a signatory, the Provost Reviewer may require the Grants Manager/Principal Investigator to provide additional information and/or receive Provostial approval for the Project prior to proposal submission. In all cases, any questions or inconsistencies are expected to be resolved to the satisfaction of the Central Reviewer and/or OVPR prior to the proposal being submitted to the sponsor.

Review of International Components at Award

Upon the logging of an award notice, GMAS will generate a requirement for the Grants Manager to confirm with the Principal Investigator that the information entered at proposal under the International Collaborations and Activities Approval remains current.

Screenshot of segment page in GMAS showing that the International Collaborations and Activities Approval "needs review" prior to award setup.

If there have been no changes to the International Components since the proposal was submitted, the Grants Manager will be prompted to confirm that the information remains correct. To the extent the anticipated scope of International Components has changed since the proposal was submitted, the Grants Manager will be directed to enter a new International Collaborations and Activities Approval request in GMAS to facilitate the necessary updates to the information previously provided. 

All revisions will be reviewed by the Central Reviewer against the International Components previously disclosed, the award documentation, and the applicable Sponsor Requirements. Material changes should be communicated to the sponsor, along with any required updates to the sponsor documentation or prior approval requests, before the award is accepted. In all cases, any updates to the International Collaborations and Activities Approval, and any outstanding ancillary reviews in connection with the Project, including by the Provost Reviewer, must be finalized prior to account set up. 

Entering and Reviewing Changes/Revisions after Award

The Central Reviewer should continue to review progress reports and continuation requests, as applicable, against the International Collaborations and Activities Approval information throughout the life of the award. As changes to the scope of international activities occur during the course of the Project, the Principal Investigator and Grants Manager are expected to ensure that the International Components identified in GMAS remain complete and up to date. Should revisions need to be entered, the Grants Manager will initiate a new request in GMAS to update the International Collaborations and Activities Approval. To the extent such revisions require prior approval by, or other formal disclosure to, the sponsor, the Grants Manager and Principal Investigator will work with the Central Reviewer to communicate such prior approval requests and/or disclosures. The Provost Reviewer may be added as a signatory in GMAS or otherwise consulted depending on the activities and countries identified for any International Component updated after award. 

Additional Resources

Agency Information:

NIH

NSF

NASA

Institutional Resources

    Hosting Foreign Visitors

    Visitor Participation Agreements

    Harvard’s research policies cover all individuals who perform work under the University’s auspices, including visitors.  Thus, in addition to the Participation Agreement, there are several forms of Visitor Participation Agreements.  For information on who should sign which form, see the PA and VPA Guidance. Once signed, the Visitor PA should be scanned and linked to the visitor’s personnel record in GMAS.  If no such record exists (i.e., if the visitor will not receive an appointment with a Harvard ID number and card), you may wish to create one for the limited purpose of archiving the Visitor PA, so that it can be retrieved when needed.

    Because visitors may be differently situated with respect to pre-existing obligations that may relate to their research, alternative forms of the Visitor PA, as described and made available for download below, have been designed to accommodate their various needs, depending on the type of organization, if any, from which they are visiting Harvard.

     

    Click on the Visitor type that best describes your visitor for the appropriate form:

     

    TYPES OF VISITORS

    From For-Profit Organizations (U.S. and foreign)

    For visitors from companies or other for-profit organizations anywhere in the world, you may view and download the “HARVARD UNIVERSITY VISITOR PARTICIPATION AGREEMENT for visitors from for-profit organizations (U.S. and foreign) by clicking here.

    From Foreign Non-Profit Institutions/Unaffiliated Individuals

    For visitors from foreign non-profit institutions OR for visitors who are not affiliated with any university, research institution, hospital, company or other organization, i.e., who are self-employed or unemployed, you may view and download the “HARVARD UNIVERSITY VISITOR PARTICIPATION AGREEMENT for visitors from foreign non-profit institutions and for unaffiliated individuals by clicking here.

    From U.S. Non-Profit and Governmental Institutions

    For visitors from U.S. non-profit and governmental institutions, except for medical centers affiliated with Harvard Medical School,* you may view and download the “HARVARD UNIVERSITY VISITOR PARTICIPATION AGREEMENT for visitors from U.S. non-profit and governmental institutions OTHER THAN the Harvard-affiliated medical centers by clicking here.

    From Harvard-Affiliated Medical Centers

    For visitors from one of the medical centers affiliated with Harvard Medical School, you may view and download the “HARVARD UNIVERSITY VISITOR PARTICIPATION AGREEMENT for visitors from Harvard-Affiliated Medical Centers” by clicking here.

    From U.S. Government Agencies/Institutions

    For visitors employed by the U.S. Government, you may view and download the “HARVARD UNIVERSITY VISITOR PARTICIPATION AGREEMENT for Visitors employed by the U.S. Government” by clicking clicking here.

     

    RELATED GUIDANCE

    PA and VPA Guidance

    Intellectual Property Policy

     

    Acknowledgement of Risk and Release of Claims

    In addition to the VPA, non-Harvard personnel who visit Harvard laboratories where certain hazards (e.g. chemical, radioactive, biological agents or heavy machinery) may be present may also be required by the lab to complete the “Acknowledgement of Risk and Release of Claims” form.  Not all visitors who sign a VPA are required to complete this form.  Only visitors to labs where certain hazards are present who are NOT:

    Completion of the form confirms that the visitor understands the nature of the risks and indicates that they have health insurance of their own and will release Harvard from any claims in the event they are injured as a result of working in Harvard laboratories.

     

    RELATED RESOURCES

    Acknowledgement of Risk and Release of Claims

    Provostial Review of International Activities

    What’s Essential

    Harvard values the global nature of its community, and reveres its relationships with international researchers and institutions, and continues to actively work to protect longstanding principles of openness in research and collaborative exchange of ideas. Researchers and staff must be aware that certain engagements involving international collaborations and funding require heightened scrutiny, and should be cognizant of the shared obligation to safeguard the integrity of University research, and to protect funds, intellectual property, and sensitive data and information developed by or managed at Harvard.

     

    How to Comply

    The University has developed criteria outlining specific types of international projects and research that require central review by the Office of the Vice Provost for Research (OVPR), and may also require decanal review, and/or review by additional offices and committees. Additionally, for sponsored research, there are specific project components that must be reviewed at the school level, and recorded in GMAS in the International Collaborations and Activities Approval section. Depending on the scope of work, these international activities may require review by OVPR and other relevant offices. It is important to include as much context and detail as possible when submitting such projects, otherwise the process will be delayed while school-level and central reviewers attempt to collect pertinent information.

     

    Why it’s Important

    Funders, especially federal sponsors, require that certain activities be disclosed in proposals and other documentation, or directly to a program officer, depending on the activity and timing, and it is imperative grant managers and reviewers have the opportunity to work with researchers to ensure all appropriate information is provided. In a small number of cases, international collaborations and activities, if not managed properly, may result in loss of funding, violation of export control laws, or legal jeopardy to the University and its researchers. Accordingly, the University encourages all researchers and administrators to take steps to ensure that documentation and information submitted to funders is both transparent and in full compliance with relevant policies and regulations.

     

    Resources

     

    Committee

    Any proposals not submitted to a sponsored programs, IRB, or gifts office may be sent directly to Ara Tahmassian (617-495-9797), Rachel Talentino (617-495-9829), and Todd Washburn (617-496-5974) before the proposal is filed with potential funders. Certain proposals may require review by the University Committee for Special Review of Sensitive Collaborations.