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Faculty Disclosure Guidance

Policy Contacts

Katherine S. Godin
Research Compliance Officer, OVPR

Ara Tahmassian
Chief Research Compliance Officer, Harvard University

OVPR works closely with Harvard’s sponsored programs (OSP, ORA, and SPA) and other university colleagues to develop internal guidance and updated templates for our researchers and administrative staff that address changes in disclosure requirements.  For the most recent updates see the links below.

Update: NIH Submissions for Due Dates Before and After January 25, 2022

May 20, 2021 Research Management Meeting (PDF)

FAQs: Changes to NIH Biosketch and Other Support (PDF)

Foreign Component Guidance

This document assists researchers engaged in foreign collaborations on federally funded NIH projects.  They are based on the best available guidance from the agency and is not a substitute for a thorough review of the agency and Harvard policies and guidance. 

Agencies continue to issue updates, modifications, or clarifications to existing requirements. The Office of the Vice Provost for Research is continuing to monitor the communications from the agencies and will update this site and the FAQs as appropriate. 

NIH

(As of 2/22/2021)

NIH: The FOREIGN COMPONENT DECISION DOCUMENT is designed to assist researchers in identifying whether they need to request prior approval from the NIH to include a foreign collaboration or activity on an NIH funded project.

School Specific Information

For school specific information on faculty disclosures please visit the relevant site(s):
Harvard Chan School of Public Health
Harvard Faculty of Arts and Sciences
Harvard Kennedy School
Harvard Medical School

Faculty Disclosure & Intellectual Property Protection Guidance for Researchers 

 

Framework for Researchers at Harvard: 

Introduction

Recently federal funding agencies and congressional committees have expressed concerns regarding certain activities that threaten the integrity of the U.S. research enterprise. These concerns have been widely referred to as “Foreign Influence on U.S. Research” or “Foreign Influence on U.S. Academia”. The issues raising concern for agencies and federal funders can be summarized as:

Basic Principles

The following sets forth some guiding principles to help Harvard staff, faculty, and others conform to both federal expectations and Harvard University’s core values:

  1. Harvard University holds as paramount the open exchange of ideas among students and scholars from across the globe as one of its core values and welcomes all such exchanges as critical in advancing its mission as a global leader in the creation and dissemination of knowledge.
  2. Harvard University’s stewardship of research funding, both from federal government agencies and from private funders, is a core institutional responsibility, and Harvard has developed policies and adopted rules to ensure that its activities are conducted with integrity and with due regard for the health, safety, and privacy of everyone concerned.
  3. Harvard University recognizes its important role in the advancement of legitimate national security needs and the protection of the intellectual property developed as a result of its research and scholarly activities.

The following sections outline the regulatory requirements, expectations of research sponsors, and Harvard’s institutional policies and responsibilities, each of which informs best practices at Harvard.

A set of Frequently Asked Questions for Harvard Researchers (FAQs) can be found below and further elaborates on these suggestions. The FAQs are organized in accordance with the four main issues described in the Introduction (Section 1) above.

Note: Regulatory requirements and sponsor expectations change frequently; therefore, we strongly recommend that this and the FAQ sites be visited frequently to ensure that you are aware of all relevant updates.

Integrity of Peer Review Process

Confidentiality of information obtained during peer review is critical to the integrity of the review process. The Office of Research Integrity (ORI Introduction to RCR: Chapter 10. Peer Review) explains:

[I]nformation that is shared during peer review is shared confidentially, that is, with the understanding that it will not be shared with anyone else without permission. Confidentiality is generally required during grant reviews, manuscript reviews, and personnel reviews.

During grant and manuscript reviews, confidentiality helps protect ideas before they are funded or published. In personnel reviews, confidentiality is important to protect personal privacy.”

NIH’s Peer Review: Grants and Cooperative Agreements lists eight (8) core values of the peer review process:  expert assessment, transparency, impartiality, fairness, confidentiality, security, integrity, and efficiency. The Confidentiality section articulates this as follows:

“In order to protect confidential information, portions of NIH review meetings (initial peer review and Council) are closed or partially closed to the public if grant applications (and contract proposals) are being reviewed or discussed. Only Federal employees with a need to know, reviewers, and support contractors are allowed to attend NIH review meetings.

In addition, all discussions, application materials (except those in the public domain such as publications), and information about conflicts of interest and assignments of individual reviewers to particular applications are strictly confidential. In fact, reviewers must sign a confidentiality certification indicating that they have read and understand the confidentiality rules for NIH peer review, and do so under penalty of perjury, before access to applications is granted. The NIH may take steps in response to a violation of the confidentiality agreement, in order to preserve the integrity of the NIH review process. Depending on the specific circumstances, such steps may include but not be limited to: notifying or requesting information from a reviewer’s institution; terminating a reviewer’s service; Notifying the NIH Office of Management Assessment (OMA) with possible referral to the U.S. Department of Health and Human Services Office of Inspector General (OIG); pursuing a referral for government-wide suspension or debarment.”

Harvard expects that its community members will respect and abide by the confidentiality of all peer review processes.

Definitions

Current and Pending Support: A term generally used by all non-NIH federal sponsors and other types of funding entities to request the submission of information for key personnel’s active and pending review or awarded research funding. This information is submitted at the time of proposal. The format varies by sponsor. NSF and other sponsors tend to call this “Current and Pending” Support. NIH tends to refer to it as “Other Support.”

Collaborator: The general definition is “a person who works jointly on an activity or project; an associate”.

  • NIH’s Definition:

“Collaborators always play an active role in the research, and the position is sometimes defined interchangeably with co-investigator. As a loose guideline, think of a collaborator as a scientist whose distinct expertise complements your own while a co-investigator shares your area of expertise and therefore contributes in guiding the scientific direction of the overall project. One provides unique expertise, the other umbrella expertise”.

https://www.niaid.nih.gov/grants-contracts/consultants-collaborators-subawards

  • DoD/VA Handbook:

“Seeking a Collaborator: The first, critical step in any collaborative research project is to find an interested colleague within the other Department, someone with complimentary research interests whom you like and trust and who can devote the necessary time to the project. This person needs to work with you through the planning and implementation stages and will champion the project at their agency to ensure proper “buy in” and approvals”.

Export Control: The U.S. Government controls exports or transfer of sensitive equipment, information, software and technology as a means to promote our national security interests and foreign policy objectives. Through complicated network of federal agencies (e.g. U.S. Departments of State, Treasury, and Commerce) and number of inter-related regulations the U.S. governs such exports, these are collectively referred to as “Export Controls.

Foreign Component: Foreign component in an NIH funded requires approval from NIH before the collaboration can start. This is defined as: “the performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would 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. Examples of other grant-related activities that may be significant are:

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

Foreign travel for consultation is not considered a foreign component”.

Other Support: The term other support is specific to NIH and entails the submission of information regarding research funding that is either active (awarded) or pending review or award. The information needs to be submitted for all key personnel and needs to include all financial resources, whether Federal, non- Federal, commercial or organizational, foreign or domestic, available in direct support of an individual’s research endeavors, including, but not limited to, research grants, cooperative agreements, contracts, or organizational awards.

Progress Report: Funding agencies required periodic reports to be submitted by the recipient and used by the funder to assess progress and, except for the final progress report of a project period, to determine whether to provide funding for the budget period subsequent to that covered by the report. Funding requirements should be consulted to identify the frequency of required progress reports.

https://www.med.navy.mil/sites/nmcp/Dept/Shared%20Documents/CID/VA-DoD-Guidebook-2013.pdf

Guidance for Researchers at Harvard:

Transparency & Disclosure of Information

Transparency & Disclosure of Information regarding funding support, outside activities, and other matters (as of February 22, 2021)

The terms of Federal awards, as well as Harvard’s internal policies and procedures, require the disclosure of such information. As stated in 1.b above, failure to fully disclose all relevant information either in a proposal or in accordance with Institutional requirements is one of the major issues identified by federal agencies (e.g., NIH) as a concern. All Harvard researchers are responsible for meeting the obligations listed below to ensure the integrity of research, both at Harvard and in the broader scientific community. It is important to note that it is the responsibility of the individual researcher/PI to comply with these requirements.

The following is a brief summary of the major requirements and information that should be included in such disclosures.

  1. Outside/Professional Activity Report:Harvard University’s “Statement on Outside Activities of Holders of Academic Appointments” establishes the requirement that faculty must request permission to engage in certain outside activities and delegates to schools the requirements for reporting such activities Each School has developed a process by which faculty are required to submit annual disclosures of all their outside activities. Typically, these disclosures are made through academic/faculty deans’ offices. Through their respective disclosure processes, most schools collect information on the following activities (paid and unpaid):
  2. Teaching and advising activities both within and outside of the school.
  3. University service (e.g. committees, faculty mentoring, etc.).

iii. Research and Scholarship, including a list of publications, presentations, lectures, colloquia, contracts, and grants.

  1. Honors, awards, lectureships, or other significant recognition.
  2. Major accomplishments in the previous year.
  3. Outside professional activities such as participation in professional associations, journal editorial boards, panels and committees, companies (e.g.,boards of directors, scientific advisory committees, consulting, etc.), other academic institutions (e.g.,appointment-paid and unpaid, visiting or review committee members, honorary lectureships, etc.)

Faculty are expected to provide complete information on all outside activities as required by the School-specific disclosure form, ensuring that all domestic and foreign activities are included, and to update the information when substantial new activities are engaged in.

  1. Financial Conflicts of Interest: The “Harvard University Policy on Individual Financial Conflicts of Interest for Persons Holding Faculty and Teaching Appointments”” establishes the requirements for annual disclosure of faculty’s financial conflicts of interest. The implementation of the Policy is delegated to each School, and Harvard currently uses an electronic system, OAIR, (for all schools except for Harvard Law School and Harvard Business School) to gather and review disclosures under this Policy.

FCOI disclosure requirements include information on:

  1. Payments from any non-Harvard entity (e.g., non-profit and for-profit institutions, companies, professional societies, government or quasi-governmental organizations, etc.).
  2. ​​​​​​​Travel reimbursements that exceed a $5,000 threshold from a single entity, including from all non-profits and foreign entities. The only exception is from Institutions of Higher Education (IHE) in the Unites States (Note: travel reimbursements from foreign IHE are not exempt and must be reported).

iii. ​​​​​​​Ownership and/or payments for intellectual property (“IP”); equity in start-ups based on their IP.

  1. ​​​​​​​Licensing agreements on their IP; industry collaborations; equity in companies, public or private; etc.

For the avoidance of doubt, the requirement to disclose includes financial interests received from a foreign institution of higher education or the government of another country. This requirement is distinct from other support and foreign components.

All Persons Holding Faculty and Teaching Appointments must follow their School’s annual disclosure requirements and must update their disclosures when new conflicts are identified (e.g., a new consulting agreement, reaching the travel reimbursement threshold, etc.). The School’s designated official will review the disclosure and contact you if any additional information or a management plan is required.

Other individuals who are not “Persons Holding Faculty and Teaching Appointments” but who are listed as Key Personnel or otherwise deemed “investigators” in sponsored research funding applications may also be required (subject to funder policies) to disclose their financial conflict of interest. If required, they are expected to comply with the same disclosure requirements as above.

  1. ​​​​​​​Other Support or Current and Pending Support: These terms are generally used by federal sponsors and other funding entities to request information on key personnel’s active and pending projects and funding.  This includes the proposed project, ongoing projects, other proposals that are currently under consideration from another source of funding as well as additional resources that directly support the relevant work.  This information is submitted at the time of proposal. Depending on the funder, this section of the application may require information on sources of all financial resources, whether federal, non-federal, commercial or institutional, public or private foundations, industrial or other commercial organizations, foreign sources of funding, available in direct support of an individual’s research endeavors (US training awards, prizes or gifts are not included) and commitments of time, even if not receiving salary support.

It is important to provide all the relevant information in the proposal and to update the information whenever there are changes.  Current guidelines for NIH and NSF are outlined below.

NIH:  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 Harvard.  This includes resources 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.).  Such as:

  1. All active and pending grants, whether or not they are based at Harvard
  2. Internal awards in direct support of a research project
  3. In-kind resources (e.g. office/lab space, equipment, personnel, materials not freely available, etc.).  In-kind resources may not necessarily have a readily ascertainable monetary value
  4. Foreign support made to a trainee or fellow working in the lab (e.g. “sponsored fellow” supporting your laboratory’s research efforts)
  5. Positions, affiliations, and appointments that are related to a foreign talent (or similar type) program
  6. All other resources (domestic or foreign) available in direct support of your research endeavors

Additional details may be found in the 2019 Notice: NOT-OD-19-114 Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components and the supporting FAQs.  Further updates on this guidance will be provided to comply with the recent March 12, 2021 Notice: NOT-OD-21-073 Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021.

NSF:  NSF is currently reviewing proposals to change its requirements for Current and Pending Support and is expected to release new guidance soon.  Until this guidance is available, proposals should adhere to information in the June 1, 2020 guide: NSF20-1 Proposal and Award Policies and Procedures Guide, Chapter II.C.2.H and supporting FAQs.

Current and pending support information, for each individual designated as senior personnel on the proposal, must be provided in an NSF-Approved Format.  Current and pending support includes all resources made available to an individual in support of and/or related to all of his/her research efforts, regardless of whether or not they have monetary value.  This includes, but is not limited to:

  1. The currently proposed project
  2. All proposals currently under consideration from any source, irrespective of whether such support is provided through the proposing organization or is provided directly to the individual
  3. All projects, activities or in-kind contributions requiring a portion of the individual’s time or effort
  4. In-kind contributions (such as office/laboratory space, equipment, supplies, employees, students) not intended for use on the project being proposed.  (In-kind contributions intended for use on the proposed project must be included as part of the Facilities, Equipment, and Other Resources section of the proposal.)

NSF-Approved Formats for the preparation of current and pending support are available through NSF and may be produced with SciENcv or with a NSF fillable PDF form.

  1. Foreign Component and International Activities:International collaboration is a key element to scientific research and progress; and while this is recognized and supported by federal funders, like NIH and NSF, they are subject to certain limitations and disclosures.  This includes disclosure of foreign participation at the time of proposal submission and throughout the life of the grant.

NIH:  The addition of a Foreign Component to a NIH funded project requires NIH prior approval and must be disclosed at the time of proposal submission, or added to an ongoing NIH grant through a Prior Approval request.  A foreign component is defined as performance of any significant element or segment of the project outside the United States either by the grantee or by a researcher employed by a foreign institution, whether or not grant funds are expended.  To assist in the determination of whether or not a particular international activity or collaboration rises to the level of a Foreign Component, please use the “NIH Foreign Component Researcher Decision Guide”.

For an element or segment of a project to be considered a Foreign Component it would satisfy all of the following criteria:

  1. The project element or segment is performed outside of the United States
  2. The project element or segment is in support of the specific aims of an NIH funded project
  3. The project element or segment is considered significant (see below) toward the completion of the NIH project aims.

Applicants and recipients should first identify whether a portion of a project will be conducted outside of the U.S. before determining whether the activities are significant.  While NIH has not explicitly defined “significant”, the measure of significance is subjective and should be carefully considered.  Activities that should always be disclosed as a Foreign Component include, but are not limited to:

  1. The involvement of human subjects or animals residing in a foreign site,
  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.

Activities that may be considered a significant element of the project include, but are not limited to:

  1. Collaborations with investigators at a foreign site anticipated to result in co-authorship,
  2. Use of facilities or instrumentation at a foreign site, or
  3. Receipt of financial support or resources from a foreign entity

If you think that you may have an undisclosed Foreign Component associated with your NIH project(s), please contact your School’s grant submitting office for additional support or to make a Prior Approval request.

Additional details may be found in the 2019 Notice: NOT-OD-19-114 Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components and the supporting FAQs; the July 21, 2020 policy topic: Protecting U.S. Biomedical Intellectual Innovation; as well as the recent March 12, 2021 Notice: NOT-OD-21-073 Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021.  Requests for NIH prior Approval must be submitted through your School’s Grants office.

NSF:  NSF is currently reviewing proposals to change its requirements for International Activity and is expected to release new guidance soon.  Until this new guidance is available, proposals should adhere to information from the June 1, 2020 guide: NSF20-1 Proposal and Award Policies and Procedures Guide, Chapter II.D.8 and supporting FAQs.

At the time of proposal submission, applicants are required to indicate whether the proposal includes International Activity; after the award is received NSF prior approval is required if International Activity is planned.  International Activity is defined as research, training, and/or education carried out in cooperation with international counterparts either overseas or in the U.S. using virtual technologies.

If a proposal indicates that a Foreign Organization or an International Branch Campus of a US Institution of Higher Education (IHE) will be funded, either through a subaward or consultant agreement, the proposer must also enter the name of the applicable country(ies) in the International Activities Country Names box on the Cover Sheet.

If you think that you may have an undisclosed International Activity associated with your NSF project(s), please contact your School’s grant submitting office as soon as possible.​​​​​​​

  1. Biographical sketches:​​​​​​​Depending on the funder, biographical sketches may be required to include significant information on an individual’s activities, both domestic and foreign. These generally include educational background, positions and honors, appointments, contributions to science, research support and/or scholastic performance, publications, products (e.g., software, patents, and copyrights), synergistic activities (e.g., co-chair of academic conference, membership of the National Academy of Sciences, peer reviewer, organizer of summer workshop, service, service on editorial board of academic journal, etc.), scientific collaborations with or without funding, etc. It is critical to follow the funders’ guidelines and to include all relevant information. Generally, it is a good idea to include research collaborations or other activities that are not included in the Current and Pending Support, described above, in the biographical sketch.

NIH (Biosketch and SciENcv): NIH requires Biosketches in both competing applications and progress reports.  Instructions, blank format pages, and sample biosketches may be found on the NIH website; please note updates to the NIH Biosketch are described in the recent March 12, 2021 Notice: NOT-OD-21-073 Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021.  NIH supports the use of SciENcv: Science Experts Network Curriculum Vitae to help with biosketch development and formatting to be consistent with NIH requirements.

NSF (SciENcv):   NSF has partnered with the National Institutes of Health (NIH) to use SciENcv: Science Experts Network Curriculum Vitae as an approved format for use in preparation of both the Biographical Sketch and Current and Pending Support sections of a proposal.  SciENcv will produce an NSF-compliant PDF version of the documents which proposers can save and submit as part of their proposals via FastLane, Research.gov or Grants.gov.

NSF-Approved Formats for the preparation of current and pending support are available through NSF and may be produced with SciENcv or with an NSF fillable PDF form.

  1. Research Performance Progress Report (RPPR): ​​​​​​​The RPPR is used by grantees to report on the progress of their project, identify significant changes, report on personnel, and describe plans for the subsequent budget period or year. Agencies require that any administrative changes (e.g. new collaborations, appointments, funding, etc.) be included in the RPPR.

Typically, the RPPR requires the following information:

  1. Accomplishments
  2. Products

iii. Publications, conference papers, and presentations

  1. Website(s) or other internet site(s)
  2. Technologies and/or techniques
  3. Inventions, patent applications, and/or licenses

vii. Participants and other collaborating organizations including the addition of a foreign component (As a reminder, new foreign components require prior NIH approval through the relevant Harvard Submitting Offices)

viii. Actual or anticipated problems or delays and actions or plans to resolve them

  1. Changes that have a significant impact on expenditures
  2. Significant changes in effort
  3. Significant changes in use or care of human subjects, vertebrate animals, biohazards, and/or select agents

xii. Names of individuals who have worked on the project

In order to facilitate the use of RPPR in the disclosure review process, a copy of the RPPR must be uploaded into GMAS.

Note: See special requirements for DOE grants below.

  1. Collaboration Agreements: The term collaboration is used to define a broad range of agreements and is not just limited to those signed formally, as defined in the Negotiating and Signing Authority for Agreements Related to Research document. This requirement applies to all research collaboration agreements that are negotiated by the sponsored research offices (OSP, HMS ORA, SPH ORA), Dean’s Office, Departments or faculty, or the Office of Technology Development. Such agreements may be structured as formal inter-institutional agreements, Memoranda Of Understandings (MOUs) or letters of intent, or they may be informal (‘hand-shake’) arrangements to participate in joint research programs, with various levels of details on the nature of the collaboration, faculty involved, resource sharing, etc. As faculty discuss collaborations with their external colleagues, it is essential that they consult with their research administrators to identify any potential constraints on the proposed work or possible impacts on their research portfolio. For example, collaborations with investigators at a foreign site anticipated to result in co-authorship qualifies as a “foreign component” that requires notification of NIH (and inclusion in the International Collaborations and Activities page in GMAS); or the new DOE reporting requirement (see below) that require inclusion of additional information on the collaborators.

 

  1. U.S. Department of Energy (DOE) Requirements:​​​​​​​On February 1, 2019, DOE issued a new policy mandating that “DOE federal and contractor personnel fully disclose and, as necessary, terminate affiliations with foreign government-supported talent recruitment programs.” Further, as reported in its recent notices, the DOE requires that additional information be included in contractors’ and grantees’ quarterly reports. The following is a summary of the DOE’s new reporting requirements for senior or key personnel. These requirements (italicized and underlined), as listed below, are excerpted directly from the DOE terms:

“Include the following information on participants and other collaborating organizations during the reporting period:

  1. ​​​​​​​What individuals have worked on the project?

Provide the following information for: (1) Project director(s)/Principal investigator(s) (PDs/PIs); and (2) each person who has worked at least 160 hours on the project during the reporting period, regardless of the source of compensation. Please note that such reporting does not constitute a formal institutional report of effort on the project, but rather is used by agency program staff to evaluate the progress of the project during a given reporting period.

  1. ​​​​​​​Provide the name and identify the role the person played in this project.

Indicate the total number of months (including partial months) (Calendar, Academic, Summer) that the individual worked on this project. Using the project roles identified below, select the most senior role in which the person worked on the project for any significant length of time. For example, if an undergraduate student graduated, entered graduate school, and continued to work on the project, show that person as a graduate student, preferably explaining the change in involvement.

Project Roles:

PD/PI

Co PD/PI

Faculty

Community College Faculty Technical School Faculty

K-12 Teacher

Postdoctoral (scholar, fellow or other postdoctoral position) Other Professional

Technician

iii. ​​​​​​​Identify the person’s state, U.S. territory, and/or country of residence

State whether this person collaborated internationally.

If the participant was U.S.-based, state whether this person collaborated internationally with an individual located in a foreign country and specify whether the person traveled to the foreign country as part of the collaboration, and, if so, what the duration of stay was. The foreign country(ies) should be identified.

If the participant was not U.S.-based, state whether this person traveled to the U.S. or another country as part of a collaboration, and, if so, what the duration of stay was. The destination country should be identified.

Example:

Name: Mary Smith

Total Number of Months: 5.5

Project Role: Graduate Student

Researcher Identifier: 1234567

Contribution to Project: Ms. Smith has performed work in the area of combined error-control and constrained coding.

State, U.S. territory, and/or country of residence: Michigan, U.S.A.

Collaborated with individual in foreign country: Yes

Country(ies) of foreign collaborator: China

Travelled to foreign country: Yes

If traveled to foreign country(ies), duration of stay: 5 months

  1. ​​​​​​​What other organizations have been involved as partners?

Describe partner organizations- academic institutions, other nonprofits, industrial or commercial firms, state or local governments, schools or school systems, or other organizations (foreign or domestic) – that have been involved with the project. Partner organizations may provide financial or in-kind support, supply facilities or equipment, collaborate in the research, exchange personnel, or otherwise contribute.

  1. ​​​​​​​Have other collaborators or contacts been involved?

Some significant collaborators or contacts within the recipient’s organization may not be covered by “What people have worked on the project?”. Likewise, some significant collaborators or contacts outside the recipients’ organization may not-be-covered under “What other organizations-have been involved as partners?

For example, describe any significant:

  • collaborations with others within the recipient’s organization, especially interdepartmental or interdisciplinary collaborations;
  • collaborations or contact with others outside the organization; and
  • collaborations or contacts with others outside the United States or with an international organization.”
Compliance with Regulatory Requirements

(As of February 22, 2021)

  1. Export Controls:

Items, information, and technologies used for University research, including some readily available in the U.S., may be subject to U.S. export control regulations intended to prevent the proliferation of chemical or biological weapons, support national security policies, or protect U.S. developed intellectual property. The entire research team will need to consider these regulations when shipping, hand-carrying or transferring certain items, technology, or information to foreign nationals within the U.S. as well as outside the U.S.

  1. Sanctions:

Additionally, U.S. government sanctions restrict travel to, financial transactions with, and the provision of services to, certain countries, individuals, and organizations, including certain foreign universities. It is important to understand and comply with country-specific sanctions when travelling abroad and to comply with financial sanctions on individuals and organizations when entering into research collaborations with foreign individuals and entities.

  1. Why it is important:

Export controls apply to all activities, not just sponsored research activities. University researchers are individually subject to U.S. export control regulations and trade sanctions. The consequences for violating these regulations and sanctions are substantial, including criminal and steep financial penalties.

  1. How to Comply:

Make sure your research qualifies as fundamental research: Be alert to restrictions on the publication of your research results and on who can participate in your research. Provide your sponsored office with a complete description of the research you propose, including any non-disclosure agreements or other agreements that may outline restrictions on your research activities or that contemplate the possible acceptance or use of items or technology subject to U.S. export controls.

Consult your School or Institute’s Export Control Administrator before shipping, hand-carrying or sharing technology, information or tangible research materials internationally. Research equipment, as well as the tangible results of research, such as prototypes, materials, and biological samples may require a license to ship or hand-carry outside the U.S. Consult your School or Institute’s Export Control Administrator prior to shipping or travelling with research items or technology (including research equipment) internationally.

When collaborating with foreign individuals and organizations, confirm that they are not subject to U.S. embargoes or sanctions. Contact your School or Institute’s Export Control Administrator to screen foreign nationals and organizations. Additionally, contact your School or Institute’s Export Control Administrator before travelling to, or conducting research in, or otherwise providing services to Cuba, Iran, North Korea, Syria, or the Crimea Region of the Ukraine.

Protection of Intellectual Property (IP)

Harvard University researchers generate new data and information that contribute to the advancement of knowledge and serve as the basis for new products and services that benefit the public. The data generated, and developments created by researchers are defined in this discussion as Intellectual Property. Nationally, there are well documented instances of researcher’s data being compromised and published by others with significant negative impact on the owner of the research data, such as of loss of valuable time and money used to create the data and potentially patentable inventions.Federal policy and legislation relating to intellectual property (including patents and copyrights), as well as funders’ requirements, have resulted in Harvard University developing policies and procedures to protect the intellectual property generated by its researchers. Below is an overview of key requirements:

  1. “Statement of Policy in Regard to Intellectual Property” (IP Policy)

Harvard University’s IP Policy governs the ownership and disposition of intellectual property which includes, but is not limited to, inventions, copyrights (including computer software) and unpatented research property, such as biological or other tangible materials.

 

You should report inventions promptly (prior to publication) to the University’s Office of Technology Development:  http://www.otd.harvard.edu.

 

  1. The Participation Agreement (“PA”) and Visitor Participation Agreement (“VPA”) forms

To facilitate compliance with the IP Policy and all other Harvard policies and agreements relevant to research, and so mitigate the reputational and financial risks associated with non-compliance, Harvard utilizes its Participation Agreement (“PA”) and Visitor Participation Agreement (“VPA”) forms. By signing the PA or VPA, the terms of which are non-negotiable, individuals agree that they will abide with the terms of all Harvard policies and agreements that may apply to their work and, with respect to IP developed through their Harvard activities:

  1. agree to cooperate with the University’s representatives to protect the IP; and
  2. assign (or ‘deed’) to Harvard their rights in IP that Harvard is entitled to own.

Each person who conducts research at (or administered by) Harvard and/or who participates in any externally-supported studies or programs, including: faculty members, staff members; postdoctoral or other research fellows, and students are required to sign the PA.  The PA should be signed before an individual begins any research or engages in any externally-supported activity at Harvard.

To access the Harvard University Participation Agreement for signature, please follow this link: LINK TBD

Harvard’s research policies cover all individuals who perform work under the University’s auspices, including visitors.  Thus, in addition to the PA, there is the VPA. Because visitors may be differently situated with respect to pre-existing obligations that may relate to their research, alternative forms of the VPA, as described and made available for download here, have been designed to accommodate their various situations, depending on the type of organization, if any, from which they are visiting Harvard.  Except as described below, each visitor who conducts research at (or administered by) Harvard and/or who participates in any externally-supported studies or programs, must sign a VPA.

Exceptions: The following, do not, by themselves, trigger the PA/VPA signature requirement:

  1. Engagement as a consultant, for which all issues of research compliance and IP ownership shouldbe addressed in the consulting agreement.
  2. Use of, or receipt of services from, a Harvard core facility under the terms of its user or vendor agreement, as applicable, even by personnel of other organizations.

iii. ​​​​​​​Collaborators who are not paid by Harvard research funds, or who do not visit Harvard as part of the research collaboration.

  1. ​​​​​​​Visitors from the Dana Farber Cancer Institute or MIT (unless they are undergraduates) need not sign the VPA.

The VPA should be signed before an individual begins any research or engages in any externally-supported activity at Harvard.  Foreign visitors should be asked to sign and return the VPA before leaving their home country, so that if a visitor is unable or unwilling to sign the VPA, the issue can be addressed before he or she travels to the U.S.

Timing of signature for the PA and VPA forms is critical, since a delay can cause Harvard to lose its IP rights to any third party that might stake an earlier claim.

Detailed information on the PA and VPA forms can be found here.

  1. Protection of IP while Travelling:

The loss of intellectual property (e.g. research data) is not an unusual occurrence, whether due to loss or theft of laptops or other devices or intentional attacks on such devices with malicious software to collect information. The procedures outlined in this following are designed to provide guidance on security measures and protocols that should be followed when traveling abroad.  The measures and protocols are designed to minimize the ability for technology and paper documents to be compromised.

The following measures should be considered as best practices when traveling anywhere outside of the United States:

  1. ​​​​​​​Register your international trip and sign up for travel alerts at globalsupport.harvard.edu.
  2. ​​​​​Contact your school’s IT Security Officer to get a secure thumb drive if you’ll be carrying, or collecting, sensitive data.

iii. ​​​​​​​Make your devices “healthy” for travel. For Harvard devices, work with HUIT Support (ithelp@harvard.edu).

  1. ​​​​​​​It is strongly recommended that you do not take any personal technology or devices with you. Contact your school’s IT department to see if they provide loaner equipment with additional security measures enabled.
  2. ​​​​​​​Keep your phone with you. Computers and sensitive paper records should be stored in a hotel safe. Computers should be powered down to activate encryption, not just placed in sleep mode.
  3. ​​​​​​​Use VPN and be wary of free Wi-Fi hotspots that do not require a password or are unsecured open-access. Expect connectivity outages and blocked services such as Google or Yahoo webmail in some countries. If you have a personal hotspot, use that for access to the internet viayour computer or tablet.

vii. ​​​​​​​Disable Bluetooth and Wi-Fi on your phone when you aren’t using it.

viii. ​​​​​​​Communicate with contacts using a secure messaging program but be judicious in your content. Some governments may break encryption for regulatory monitoring, e.g., “illegal” content.

  1. ​​​​​​​When you return: Contact IT support and change your password if you notice your computer acting strangely.
  2. ​​​​​​​Never plug in a USB drive that is not yours or that someone gives you. Use the secure USB drives provided to you that you can use if you need to transfer files that way.
  3. ​​​​​​​Never plug in a USB drive that was previously plugged into a device not provided to you by Harvard for this trip.

xii. ​​​​​​Do not load files or data that are not required during your trip on your devices. Consider using a password for protection of any sensitive or unpublished files you need during your travel.

 

Contact your School’s IT Security Officer for additional information or any questions you may have.

  1. Protecting Research Data

Protection of research data is important for a variety of reasons such as:

  1. Preventing the loss of data, especially unpublished data.
  2. ​​​​​​​Protecting intellectual property of Harvard researchers (e.g., potentially copyrightable or patentable material)

iii. ​​​​​​​Regulatory requirements for the protection of sensitive or personal data (e.g., from human subject research) obtained during your research.

  1. ​​​​​​​Maintaining confidential or proprietary information obtained from others (e.g., those from collaborators under a Data Use Agreements-DUA).

 

Available Resources: Harvard University has developed extensive enterprise and research data protection and security policies that could help with the specific requirements of various categories of data. You should become familiar with these requirements. Below are links to the relevant policies and procedures. Your School’s Data Security Officers are available to assist with your specific needs.

 

The Information Security Policy: Defines Data Classification for different data types and the and the suggested requirements for each data security level.

https://policy.security.harvard.edu/

 

Harvard Research Data Security Policy (HRDSP): Provides information on research data security requirement, including those for protection of human subject data.

https://vpr.harvard.edu/2020/06/26/research-data-management/

 

Research Data Management @ Harvard: is a joint effort by Office of Vice Provost for Research, the Harvard Library, Harvard University Information Technology, and School Data Management Offices to provide a central hub to coordinate all the research data management efforts across Harvard.

https://researchdatamanagement.harvard.edu/

 

General Research Data Security Rules

The flowing are some general rules that you should consider as you develop your data protection plan:

  1. Ensure that all data collection and storage devices are password protected with a strong password.  A strong password requires a level of complexity.
  2. Use encryption to protect all sensitive research information on portable devices.

iii. Store the data on Harvard University’s secure servers and limit access to data to members of the study team. Consider creating different folders for different projects and limiting access to each to those involved in the corresponding element of the research.

  1. Develop a process for removing access to the data when a team member is no longer involved with the research or has left your research group.
  2. For human subject data:  identifiers, data, and keys should be placed in separate, password-protected/encrypted files and each file should be stored in a different secure location.
  3. If it is necessary to use portable devices for initial collection of identifiers:
  4. ​​​​​​​the data files should be encrypted, and the identifiers moved to a secure system as soon as possible; and
  5. ​​​​​​​the portable device(s) should be locked up in a secure location when it is not in use.

vii. When transmitting data, use secure data transmission channels to protect against data interception.

viii. If using file sharing sites (e.g. Dropbox, cloud service) consult your School’s Data Security Officers to determine if the site meets data security requirements for the type of data involved.

  1. Avoid transmitting sensitive, or unpublished, data as e-mail attachments and always use your Harvard email.
  2. Notify your School’s Data Security Officer immediately if there has been, or you suspect there may have been, a breach of data security.

Disclosure Letter 

August 21, 2019 letter from Vice Provost of Research in response to NIH Notice (NOT-OD-19-114) and NSF Federal Register Notice (Vol. 84, No 103). 

Faculty Disclosure Letter

Click here to view the Faculty Disclosure Letter.

FAQs – Guidance on Reporting and Disclosure Requirements

Integrity of Peer Review Process

The following Q&A are extracted from NIH’s “Top NIH Peer Review Q&As for Reviewers”

Q1.1: The rules say that I can’t share applications with someone who has not been officially designated to participate in the peer review meeting. How do I know who has been officially designated? 

Applications, proposals, and confidential meeting materials cannot be shared with anyone who is not a member of the study section where those documents and information are being reviewed. Officially-designated members include appointed members, temporary ad hoc members, the Scientific Review Officer, and NIH staff with a need to know.

Q1.2: Which relationships constitute a conflict of interest in initial peer review? 

Generally speaking, conflicts of interest in initial peer review or technical evaluation result from one or more of the following scenarios:

    • The potential for financial benefit
    • Employment
    • Major Professional Roles in the work proposed
    • Professional associations with individuals listed with Major Professional Roles in the work proposed

Q1.3: What would NIH do to me if they thought I had broken confidentiality in peer review? 

If NIH determines that you committed a bona fide breach of confidentiality in the peer review process, we could contact you and your institution, and ask you to step down from an appointed term of service on a study section. Depending on the severity of the breach, the NIH may refer the matter to the NIH Office of Management Assessment and possibly to the Office of the Inspector General in the Department of Health and Human Services, which could result in further administrative actions such as debarment or even criminal penalties. If the matter is referred to these authorities, the NIH would be unlikely to contact you or your institution first, as it now involves possible criminal violations.

Q1.4: How would NIH know about breaches of confidentiality in peer review? 

Information about possible breaches of confidentiality come to the NIH in numerous ways. Often, an applicant will report that data, figures or text from his or her grant application appears in a publication authored by a reviewer on the panel where the application was reviewed. In addition to being a breach of confidentiality, this may also constitute research misconduct in the form of plagiarism.

NIH sometimes learn about breaches of confidentiality from other reviewers, colleagues and students of reviewers, or even members of the media. NIH also has internal controls to monitor access to NIH computer systems.

Transparency & Disclosure of Information

Q2.1: What do I have to disclose as part of my “Outside Activity or Other Professional Activity” reporting?

You should follow your School’s specific requirements. However, at a minimum, you must disclose all your domestic and foreign professional activities including but not limited to consulting and related outside professional activities, advisory board memberships, activities such as research projects, conferences, teaching programs, consulting agreements, etc., that you as a faculty undertake on an individual basis.

Q2.2 Do I have to disclose travel reimbursements in my Financial Conflict of Interest disclosures?

Yes, if you are a Public Health Service- PHS (e.g. NIH, CDC, FDA, AHRQ) funded investigator. The PHS regulation requires investigators to disclose any reimbursed travel exceeding a threshold amount of $5,000 in total payments from a single sponsor in a single year, as well as sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available) related to the Investigator’s institutional responsibilities. The disclosure requirement also applies to the Investigator’s spouse and dependent children. However, the disclosure requirement does not apply to travel that is reimbursed or sponsored by Harvard or the following entities:

    • a federal, state, or local government agency,
    • an Institution of higher education as defined at 20 U.S.C. 1001 (a),
    • an academic teaching hospital,
    • a medical center, or
    • a research institute that is affiliated with an Institution of higher education

Note: The exemption does NOT apply to any reimbursement from a foreign entity, university, or government.

For additional information sees NIH FAQ E.8, E.9 and E.4

Q2.3: Is there a threshold for travel reimbursement disclosures?

Yes, there is a $5,000 de minimis threshold to reimbursed or sponsored travel disclosure from any given entity in 12-month period. This includes all expenses such as transportation, accommodation, and food during a one-year period.

Q2.4: When should I disclose my travel reimbursements?

Within 30 days of the date when the reimbursed amount exceeds the $5,000 threshold, or within 30 days of your return from sponsored travel.

Q2.5: What is meant by remuneration?

Remuneration includes salary and any payment for services not otherwise identified as university salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

Q2.6: A pharmaceutical company that sponsors my research reimburses me for a trip to Scotland valued at $4,000. My spouse accompanies me on this trip, and the sponsor also reimburses me $2,000 for my spouse’s airfare and meals, making the total amount of reimbursed travel $6,000. What, if anything, do I need to disclose about this trip?

The reimbursement is from a company that is directly related to your research and the total amount exceeds the $5,000 threshold, so you must disclose the full reimbursement relating to your and your spouse’s travel expenses.

Q2.7: My spouse consults for a pharmaceutical company and they reimburse travel for my spouse to attend a seminar valued at more than $5,000.   The seminar has nothing to do with my institutional responsibilities.  I do not have any interactions with this company.  What, if anything, do I need to disclose about my spouse’s trip? 

This reimbursement for trip does not need to be disclosed as it is not related to your research or institutional responsibilities.

Q2.8: I am taking a trip to California in March 2020 to give an invited talk at a conference. My travel expenses, which will be around $3,000, will be reimbursed to me by a professional society. The same society also reimbursed me for a trip to a conference in Seattle in July 2019, for about $2500. What, if anything, do I need to disclose about these trips?

The California trip will put your total reimbursement amount from that single entity over the $5,000 threshold within a 12-month period, so reimbursement for both trips needs to be disclosed. The exemption for reporting only applies to the following entities:

    • a federal, state, or local government agency,
    • an Institution of higher education as defined at 20 U.S.C. 1001(a),
    • an academic teaching hospital,
    • a medical center, or
    • a research institute that is affliliated with an Institution of higher education

Professional socities do not meet these exceptions.

Q2.9: I have an NSF award; do I have to disclose? 

Yes, NSF requires each grantee organization employing more than fifty persons to maintain an appropriate written and enforced policy on conflict of interest and that all conflicts of interest for each award be managed, reduced or eliminated prior to the expenditure of the award funds. Harvard University Policy on Individual Financial Conflicts of Interest for Persons Holding Faculty and Teaching Appointment applies to NSF awardees.

Q2.10: What should be included in the “Current and Pending” or “Other Support” pages of a grant application?

You should follow the specific instructions issued by the agency to which you are applying for funding. Agencies require that the page include:

    • All current financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual’s research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. This includes all sources of funding from foreign sources.
    • All pending applications (i.e., submitted but not funded yet) for funding to any Federal, non- Federal, commercial or institutional, or foreign entity.

Note: The requirements are currently under review by NIH and NSF and revision are expected within the next six months. The sections below will be update to reflect any announced changes.  

Q2.11: The “Other Support” pages of the grant application ask for OVERLAP (summarized for each individual). What does this require?

The NIH “other support” form provides the following description:

“Overlap: After listing all support, you must summarize for each individual any potential overlap with the active or pending projects and the application in terms of the science, budget, or an individual’s committed effort”.

The NIH Grants Policy Statement, 2.5.1 Just-in-Time Procedures, Other Support provides that “IC scientific program and grants management staff will review this information before award to ensure that there is no scientific, budgetary, or commitment overlap.

    • Scientific overlap occurs when (1) substantially the same research is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific research objective and the research design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source.
    • Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.
    • Commitment overlap occurs when an individual’s time commitment exceeds 100 percent (i.e., 12-person months), whether or not salary support is requested in the application.

Overlap, whether scientific, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the IC with the applicant and the PD/PI at the time of award.”

Q2.12: The NSF Current and Pending support page does not specifically ask for information about” overlap.” Is this information required on NSF grant applications as well?

While NSF does not use the term “overlap,” the Proposal & Award Policies & Procedures Guide (PAPPG), Chapter II.C.2.h, on Current and Pending Support, provides the following description (underline added for emphasis):

This section of the proposal calls for required information on all current and pending support for ongoing projects and proposals, including this project, and any subsequent funding in the case of continuing grants. All current project support from whatever source (e.g., Federal, State, local or foreign government agencies, public or private foundations, industrial or other commercial organizations, or internal funds allocated toward specific projects) must be listed. The proposed project and all other projects or activities requiring a portion of time of the PI and any other senior personnel must be included, even if they receive no salary support from the project(s). The total award amount for the entire award period covered (including indirect costs) must be shown as well as the number of person-months per year to be devoted to the project, regardless of source of support. Similar information must be provided for all proposals already submitted or submitted concurrently to other possible sponsors, including NSF. Concurrent submission of a proposal to other organizations will not prejudice its review by NSF. The Biological Sciences Directorate exception to this policy is delineated in Chapter I.G.2.

If the project now being submitted has been funded previously by a source other than NSF, the information requested in the paragraph above must be furnished for the last period of funding.

Q2.13: I received an honorary visiting professorship at a foreign institution. Do I have to disclose it?

Yes. In addition to your School specific requirements, you must disclose all such affiliations in your biosketch submitted as part of a grant application.

Q2.14: I received an honorary Membership at a foreign Academy of Sciences. Do I have to disclose it?

Yes. In addition to your School specific requirements, you must disclose all such affiliations in your biosketch submitted as part of a grant application.

Q2.15: As part of a collaboration effort with a colleague at a foreign institution, we are submitting a joint application for funding to a foreign entity. What disclosures do I need to make?

You must consult with your School’s Office of Research Administration (ORA) or Office of Sponsored Programs (OSP) regarding the internal approval process. In addition, you must disclose all such applications in your “Current and Pending” or “Other Support” page. If the award is made, ORA or OSP will assist with the necessary modifications.

Q2.16: What is a “Foreign Component?”

NIH defines a “Foreign Component” as:

“The performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would 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. Examples of other grant-related activities that may be significant are:

    • collaborations with investigators at a foreign site anticipated to result in co-authorship;
    • use of facilities or instrumentation at a foreign site; or
    • receipt of financial support or resources from a foreign entity
    • Foreign travel for consultation is not considered a foreign component.

U.S. institutions: If your proposed research relies on resources that exist outside the U.S., whether they are research subjects, facilities and equipment, or collaborators, then your research has a foreign component.”

Foreign Components should be disclosed or clearly stated in grant applications and if they occur after award should be approved in accordance with sponsored guidelines.

Q2.17: I have a collaborator from another country who will work in my NIH-funded laboratory on my NIH project but receive no salary from my NIH grant. Is this considered a “Foreign Component?”

NIH takes the position that a foreign component exists if:

    • Your project receives funding support from a non-U.S. source in addition to NIH funding. Note that if your collaborator, who does not draw salary from NIH or any other US source, is paid by his or her home institution, NIH may consider that to constitute “funding support from a non-US [source]” and therefore a foreign component.
    • You travel abroad for data collection, surveying, or sampling.
    • You carry out research at your institution’s branch site in another country.
    • A foreign investigator provides advice on your application’s research design. (A general rule of thumb is that consultation from a foreign investigator becomes a foreign component if there is an expectation of publication co-authorship.)
    • Collaborations with investigators at a foreign site anticipated to result in co-authorship

Conversely, the following examples are not foreign components:

    • You analyze existing data originally gathered abroad.
    • You travel abroad exclusively for consultation.
Compliance with Regulatory Requirements

Q3.1: I have been invited to present at an international conference in a country that is on the U.S. sanctions list. Can I do this?

Presenting at an international conference in a U.S. sanctioned country may be viewed as providing a prohibited “service” under U.S. sanctions regulations.  You should consult with your School or Institute’s Export Control Adminstrator prior to presenting to determine if a license is required.

Generally, any presentation to an international audience should be limited to the following:

    • information that is already published;
    • information already in the public domain; and/or
    • information consistent with that conveyed by instruction in catalog courses and associated teaching laboratories at U.S. institutions of higher education.

Q3.3: I am collaborating with a colleague abroad and would like to send some data to my collaborator. What should I do?

Depending on the nature of the data and the related technology, exchange of data with foreign collaborators may require a license. Please contact your School or Institute’s Export Control Adminstrator who can review the data and the country of the collaborator to determine whether there are any restrictions, or if a license is required.

A Data Use Agreement may also be needed to facilitate the transfer of data to a collaborator. Please reach out to your School’s Office of Research Administration (ORA) or Office of Sponsored Programs (OSP) for additional assistance with Data Use Agreements. Alternatively, you can route a request at DUA.harvard.edu

Q3.4: Can I collaborate with an individual or entity (e.g. university or company) included on the Specially Designated National (SDN) list?

No, unless you receive specific authorization in the form of a license from the U.S. government. It may be possible to secure a license to allow for such a collaboration in certain limited circumstances (e.g. when the reason for the individual or entity’s inclusion on the list is unrelated to the proposed collaboration). However, the license must be secured before any such collaboration is initiated and any restrictions outlined in the license must be strictly followed.

Q3.5: I am planning to use equipment supplied by my collaborator, who is requesting the implementation of a Technology Control Plan. Can I use such equipment in my laboratory?

Yes, but only subject to the access and dissemination controls outlined in the Technology Control Plan (TCP). A TCP outlines how controlled technology or equipment will be handled/secured to prevent access by unapproved foreign nationals.  A TCP may impose restrictions on foreign nationals in the laboratory (e.g. restricted access to the lab, an area of the lab and/or certain equipment and data stored in the lab; and limitation on discussion of the work during regular laboratory meetings, etc.).

Your School or Institute’s Export Control Administrator can review the reasons for control of the equipment and help you develop a TCP with acceptable access and dissemination controls. All TCPs also require review and final approval by Office of the Vice Provost for Research.

Q3.6: What is Foreign National?

A foreign national is defined as any natural person who is NOT a:

    • U.S. citizen,
    • lawful permanent resident of the U.S. (i.e., does not have a green card), or
    • person granted refugee or asylum status.

Q3.7: What is a Foreign Entity?

A foreign entity is any corporation, business, or other entity (e.g. university, medical center) that is not incorporated to do business in the U.S. This includes international organizations, foreign governments, or any agency of a foreign government.

Q3.8: Can I engage in activities that are prohibited under OFAC?

Not without an OFAC license. OFAC is the federal agency that administers and enforces economic sanctions programs against countries and groups of individuals. You should consult with your School or Institute’s Export Control Administrator  to determine if an OFAC license is required prior to engaging in activities in U.S. sanctioned countries, with individuals or entities located in U.S. sanctioned countries or prior to entering into international research collaborations.

Q3.9: I plan to host a webinar/web conference on my research to be shared internationally. What do I need to know?

Information released at an open conference, meeting or webinar is considered published and excluded from certain controls. “Open” means that all technically qualified members of the public are eligible to attend, and attendees are permitted to take notes or otherwise make a personal record (not necessarily a recording) of the proceedings and presentations. An “open” conference can charge a registration fee reasonably related to cost, and can limit actual attendance, as long as attendees either are the first who have applied or are selected on the basis of relevant scientific or technical competence, experience, or responsibility. However, certain sensitive information cannot be shared via open conference or webinar.  Evaluation is case-specific.  Thus, it is recommended that you contact your School or Institute’s Export Control Administrator to review your circumstance.

Q3.10: How do I transfer equipment out of the United States?

An export license may be required to ship or hand-carry items or equipment out of the U.S.  The need for a license is dependent upon the nature of the equipment, as well as the end-use, recipient, and destination of the equipment.  Due to complexities of the requirements you should consult your School or Institute’s Export Control Administrator for assistance regarding shipping or traveling with equipment internationally.

Protection of Intellectual Property (IP)

Q4.1: Who can help me with questions about my IP?

Harvard’s Office of Technology Development (OTD) can provide you with information and guidance regarding IP.

Q4.2: A new post-doc will be joining my laboratory shortly. Does this individual have to sign the Participation Agreement (PA)

Yes. Individuals who perform research at Harvard and/or who may create intellectual property through the use of Harvard resources are subject to University IP policies and, in some cases, to the terms of agreements between Harvard and third parties (e.g., other institutions, organizations or companies). Such policies cover, for example, the ethical conduct of research, publication of research results, retention of research records and handling of intellectual property.

Among these policies is the University’s “Statement of Policy in Regard to Intellectual Property” (or “IP Policy”), which governs patentable inventions, copyrightable works and tangible materials made through the use of funds, facilities or other resources provided by or through Harvard.

Q4.3: A colleague is taking his sabbatical next year and would like to join my group as a collaborator. Does he need to sign the PA?

Short term visitors are subject to the Harvard University Visitor Participation Agreement, rather than the PA.

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 more information on who should sign which form, see the PA and VPA Guidance.

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

Foreign visitors should be asked to sign and return the VPA before leaving their home country, so that if a visitor is unable or unwilling to sign the VPA, the issue can be addressed before he or she travels to the U.S.

For copies of the forms visit: https://vpr.harvard.edu/visitor-participation-agreements

Q4.4: I am collaborating with a number of international colleagues on a multi-national project. The collaborators are not visiting or working in my laboratory or at Harvard, but we collaborate via video-conferencing. Do they need to sign a VPA?

No. Collaborations that do not include visits to conduct research at Harvard do not require signing the VPA.

Note: If your project is funded by NIH, you should consult your research administrator to determine if the collaboration may trigger a foreign component (e.g. collaboration resulting in a joint publication).

Q4.5: I have a collaborator who is refusing to sign the VPA. What should I do?

In general, the terms of the VPA are non-negotiable. Refusals to sign the form ‘as is’ should be referred to the OVPR, where a decision will be made as to whether or not to waive the VPA signature requirement based on a case-by-case risk assessment, with a single exception.

VPAs that cover visitors from for-profit organizations may be modified by the terms of research agreements (e.g., industry-sponsored research agreements or collaboration agreements) signed by OTD. Any refusals to sign or requests to negotiate corporate VPAs should be referred to OTD at otd@harvard.edu.

Q4.6: How do I determine who is a “visitor?”

For purposes of deciding who should sign a VPA form, as opposed to the ‘regular’ Harvard PA, a researcher should be considered a visitor if he/she is:

    • employed by or primarily affiliated with another organization (including the HMS affiliated medical centers);
    • a student enrolled at another institution;
    • a researcher who will not be employed/enrolled elsewhere while at Harvard, but:
      • already has agreed to take up or resume employment with another organization upon leaving Harvard;
      • plants to participate in Harvard-administered research without a formal Harvard appointment; or
      • will have a Harvard appointment with a title designed as “Visiting” or “Visitor.”

Q4.7: I have a visiting scientist in my group who signed a VPA and who is taking a post-doc position. Are there any additional requirements?

Yes, he or she should then sign the ‘regular’ Harvard PA.

Q4.8: I am hiring a consultant to participate in my research project. Do they need to sign a VPA?

No. Consultant engagements do not require a VPA, but all issues of research compliance and IP ownership should be addressed in the consulting agreement. Consulting Agreements should be negotiated with your School Finance office or the Office of the General Counsel.

 

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