Guidance on Responsibilities Reporting & Disclosure Requirements
1. 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
- 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.
2. 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.
3. 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.
4. Protection of Intellectual Property (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 email@example.com.
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.