Foreign Involvement

"There is a heightened concern that certain foreign entities may be seeking to influence U.S. research at all levels including peer review, diversion of intellectual property, sharing of confidential information and the use of resources originating outside the U.S... Therefore, we must comply with existing and new policies and regulations, including those related to full disclosure of foreign engagements, conflicts of interest, and conflicts of commitment." (Elizabeth H. Simmons, Executive Vice Chancellor, Academics Affairs and Sandra A. Brown, Vice Chancellor, Research, UC San Diego, 1/25/2019)

"Applicants for federal grants must list all foreign affiliations [in their] biosketch and "other support" prior to award and are required to identify any changes in each annual progress report.

According to NIH policy foreign influence includes:

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."

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New Federal Requirements: Why You MUST Disclose ALL Foreign Engagements

Please read the important notice below from Elizabeth H. Simmons, Executive Vice Chancellor, Academics Affairs and Sandra A. Brown, Vice Chancellor, Research.

UC SAN DIEGO

CAMPUS NOTICE

University of California San Diego

OFFICE OF EXECUTIVE VICE CHANCELLOR - ACADEMIC AFFAIRS

OFFICE OF THE VICE CHANCELLOR - RESEARCH

January 25, 2019

ALL ACADEMICS AT UC SAN DIEGO

KEY ADMINISTRATORS/KEY SUPPORT STAFF

SUBJECT: New Federal Requirements: Why you MUST disclose all foreign engagements and what this means for you

UC San Diego is committed to sustaining an environment that attracts and retains the brightest scholars and most exciting scholarship - and likewise is committed to the University of California's principles of academic freedom. Our many talented foreign scholars and students are essential to the research and education enterprise on our campus and we value their contributions highly.

At the same time, like all other institutions of higher education, our university and its faculty must adhere to federal reporting and disclosure requirements. Not doing so could result in loss of federal funding, not only for the individual who failed to report, but for the institution as a whole.

Last year, the National Institutes of Health and Department of Defense issued guidance with respect to those agencies' growing concerns over the potential for foreign influence. Specifically, there is a heightened concern that certain foreign entities may be seeking to influence U.S. research at all levels including peer review, diversion of intellectual property, sharing of confidential information and the use of resources originating outside the U.S. While other federal agencies have not yet come forward with their own guidance, it is very likely they will follow suit.

Sustained federal research funding is critical to UC San Diego's success and impact; therefore, we must comply with existing and new policies and regulations, including those related to full disclosure of foreign engagements, conflicts of interest and conflicts of commitment.

ACTIONS:

*It is your professional responsibility to completely and accurately disclose all external financial interests and support, affiliations, activities and relationships with any foreign entities. The University of California requires all faculty to submit an annual Conflict of Commitment (COC) report indicating whether or not they have engaged in outside activities during the fiscal year. Outside professional activities are separated into three categories: Categories I and II include activities that must be reported and in the case of Category I, must receive prior approval before the faculty member engages in the activity. Examples of Category I activities include:

Faculty or research appointments at other institutions (even if uncompensated)
Directorships of labs, centers or programs at other institutions (even if uncompensated) Disclosure forms are required even if faculty members have nothing to disclose. Deans are responsible for ensuring that all faculty members submit an annual disclosure and that the disclosures are accurate. Read more about COC requirements on blink: https://academicaffairs.ucsd.edu/aps/reports/apm/index.html

*Conflict of Interest (COI) policies require all university employees who are conducting research or other related activities to disclose certain financial interests, whether domestic or foreign. Financial interests include anything of monetary value (whether that value can be easily determined or not) held by the employee, a spouse or registered domestic partner, and dependent children. Examples include:

income or payments for salaries
consulting or honorariums
holding a position such as founder, partner, employee or board member
having ownership interests such as stocks, bonds or stock options
travel funds or reimbursements

New financial interests should be disclosed within 30 days of their acquisition. Read more about required COI disclosures on blink: https://blink.ucsd.edu/sponsor/coi/quickreference.html

*Applicants for federal grants must list all foreign affiliations (biosketch) and "other support" prior to award and are required to identify any changes in each annual progress report. According to the NIH policy this includes:

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.

This covers research contracts and grants, cooperative agreements and organizational awards, including any from foreign governments or entities (e.g. affiliations; Collaborations; foreign patents; and exchange of information, materials or data): https://bit.ly/2CLVYVu

A KEY RULE OF THUMB

Any external support or engagement that you would acknowledge in public presentations or publications is something that you must also disclose in grant applications, annual reports and closeout summaries and in university-related COI and COC disclosure forms (as required).

FINAL THOUGHTS

It is essential for you to be transparent about any affiliations with foreign entities when applying for federal grants. Only by your full disclosure will UC San Diego be in compliance with University of California regulations and be able to advise, assist and protect you and your work.

This situation is fluid so there may be additional guidance in the future. If you have any questions or concerns, please contact your department chair or the Office of Research Affairs.

Elizabeth H. Simmons, Executive Vice Chancellor, Academic Affairs

Sandra A. Brown, Vice Chancellor - Research

UC San Diego International Research Town Halls & Research Compliance and Integrity Sessions

In May 2019, campus was encouraged by Chancellor Pradeep K. Khosla and Vice Chancellor, Research Sandra A. Brown to attend one of three town hall meetings to learn more and have questions and concerns addressed. For more information on foreign engagements at UC San Diego, please go here: https://blink.ucsd.edu/research/foreign-engagements.html. Additionally,

Research Compliance & Integrity (RCI) held an event in June 2019 on International Engagement Considerations, Existing and Evolving Federal, UC and Campus Requirements of Sponsored Research.

"UC San Diego is committed to an open engagement in our research and educational missions. Over the past year, the federal government has become increasingly concerned with the potential for foreign influence in federally funded research. These concerns can have a significant impact on the work of faculty and researchers on our campus. The Office of Research Affairs is working with the offices of the Executive Vice Chancellor, Vice Chancellor for Health Sciences and Vice Chancellor for Marine Sciences to host a series of town hall meetings focused on international research. The town halls will reinforce our commitment to international research, outline the rights and responsibilities of faculty, researchers and staff, and provide an opportunity for discussion regarding concerns."

The Handouts and PowerPoint for the Health Sciences Town Hall & RCI events can be found here:

Conflict of Commitment (COC) and Outside Activities of UC San Diego Faculty Members

Per the Conflict of Interest (COI) Office, "[a] conflict of commitment occurs when the commitment to external activities, whether professional or non-professional, compensated or uncompensated, interferes with the successful performance of the faculty member's University obligations. This form of conflict is easily defined and recognized since it involves a perceptible reduction of the individual's time and energy devoted to University activities." Moreover, "APM – 025 and APM – 671, "Conflict of Commitment and Outside Activities of Faculty Members," clarifies a faculty member's commitment to the University and outlines reporting guidelines for compensated and uncompensated outside professional and non-professional activities."

What is the difference between Conflict of Interest and Conflict of Commitment?

Conflict of Interest (COI)	Conflict of Commitment (COC)
A conflict of interest occurs when (1) an employee has a significant financial interest in a company that is providing funding for the employee's research or other University activity or (2) the research might directly and significantly affect the significant financial interest of an employee responsible for the conduct of the research project.	A conflict of commitment occurs when a University employee's commitment and time to an outside activity interferes with the employee's performance of University duties.

What are Category I & Category II Activities?

Category I Activities Include:

Category II Activities Include:

Teaching, research, or administering a grant at an educational institution, trust, organization, government agency, or foundation outside of the University; employment outside the University; assuming a founding/co-founding role of a company; assuming an executive or managerial position outside of the University. You must receive prior approval to engage in Category I activities, which always count toward the 21- 48-day limit and must be reported annually.

Additional University-compensated teaching, including teaching pursuant to APM – 662, Additional Compensation: Additional Teaching, for UNEX courses and programs, other continuing education programs run by the University, and self-supporting UC degree programs; consulting under the auspices of the University of California; consulting or testifying as an expert or professional witness; consulting for for-profit entities; consulting for non-profit entities; consulting for

non-profit health or education-related organizations; consulting for government agencies; serving on a

board of directors outside of the University whether compensated or uncompensated; providing or

presenting a workshop for industry; providing outside consulting or compensated professional activities

performed for entities such as the Los Alamos and Lawrence Livermore National Laboratories; other

income-generating activities specified in approved Implementing Procedures. Category II activities are

counted within the 21- 48-day limit and must be reported annually.

What do you do if you have a faculty member involved in a Category I activity?
You must make sure that the proper procedures are followed which are outlined in the UC San Diego School of Medicine Category I Pre-Approval Procedures. Paper forms are to be used till 9/2/2019, but as of 9/3/2019, the requests and approvals must be processed through UC Outside Activities Tracking System (UC OATS). (No more paper forms will be accepted after this date!)

Step 1: Prepare for the coming academic year a Request for Approval of Category I Activity form and submit it to their department chair(s) for review and approval.
Step 2: The department chair reviews Category I requests based on the established criteria, makes a recommendation for either approval or disapproval, and forwards the request to the Associate Dean for Academic Affairs.

The request includes both 1) the Prior Approval for Compensated Outside Professional Activities (Category I) form; and 2) an accompanying memo describing the activity and justification for allowing the faculty member to engage in the Category I activity.

Step 3: The Associate Dean for Academic Affairs reviews the Category I request based on the established criteria and the department chair’s recommendation and forwards the request to the Health Sciences Compliance Advisory Group (CAG).
Step 4: The Compliance Advisory Group (CAG) notifies the Associate Dean for Academic Affairs, the faculty member, and the department chair of its approval or disapproval of the request.
Step 5: After action by the Compliance Advisory Group (CAG), requests and related correspondence on Category I activities are maintained in the office of the Associate Dean for Academic Affairs and copies are filed in the faculty member’s official record.

Note: Faculty members are required to complete and submit an Annual Report of Category I and II Compensated Outside Professional Activities and Additional Teaching Activities each year during Fall Quarter.

For more information on COC, please see the following additional resources:

Public Health Service (PHS) Conflict of Interest (COI) Reporting Requirements

Federal regulations and the University of California policy require researchers who receive funding from the Public Health Services (PHS), inclusive of subawards or agencies who have adopted the PHS financial conflict of interest regulations, to disclose certain financial interests. Conflict of Interest (COI) policies require all university employees who are conducting research or other related activities to disclose certain financial interests, whether domestic or foreign.

Who Must Disclose PHS-funded research?
Principal Investigator (PI), Project Director, Senior/Key Personnel, and others who direct or can materially influence the research, or who are responsible for the design, conduct, and reporting of the research.

When to Disclose for PHS-funded research?
Initial submission, change in funding, addition of new personnel, change in financial interest, no cost extension and at least annually.

Submit an updated disclosure within 30 days of acquiring a new financial interest.

What to Disclose for PHS-funded research?
All outside financial interests that meet the threshold for disclosure regardless if related to the PHS-funded research, including interests with foreign Universities and foreign governments.

This includes interest by the researcher, their spouse or registered domestic partner, and dependent children.
The Institution determines which financial interests are related or have the appearance of being related to the PHS-funded research.

PHS Disclosure Thresholds

Income/Compensation: publicly traded or non‐publicly traded > $5,000
Equity:

Publicly traded > $5,000
Non‐publicly traded ≥ $0, including stock options that have yet to be exercised

Travel: Domestic and foreign travel paid for on the researcher's behalf or reimbursed to the researcher by one entity > $5,000 in the past 12 months.
Intellectual Property: Royalties from non-UC inventions > $5,000

PHS Training Requirement
Required prior to engaging in PHS-funded research and at least every four years.

The COI financial interest reporting requirements are available at: https://blink.ucsd.edu/sponsor/coi/quickreference.html. For more information about COI policies, see the COI Office website at: http://blink.ucsd.edu/sponsor/coi/policies.html

For additional information, please contact the Conflict of Interest Office at info@coi-ucsd.edu or (858) 534-6465.

NIH & Foreign Affiliations

UC San Diego is interpreting NIH's definition of foreign involvement as being work performed outside of the U.S. If the work is not done outside of U.S. soil, then it is not considered a foreign component. For NIH, all foreign affiliations that fit the above interpretation should be disclosed on proposals, progress reports, and final technical reports, be it financial or non-financial in nature.

For New, Renewal, Resubmission, and Supplement Applications in ASSIST, where do you identify foreign involvement?

R&R Other Project Information Form: Item 6: Does this project involve activities outside of the United States or partnerships with international collaborators? Indicate whether this project involves activities outside of the United States or partnerships with international collaborators. Check "Yes" or "No." If Yes, list the country(ies) as well as you are required to upload a Foreign Justification under Item 12: Other Attachments.

The Foreign Justification should "[d]escribe special resources or characteristics of the research project (e.g., human subjects, animals, disease, equipment, and techniques), including the reasons why the facilities or other aspects of the proposed project are more appropriate than a domestic setting. In the body of the text, begin the section with a heading indicating "Foreign Justification" and name the [PDF] file "Foreign Justification."
Foreign Justification Example Language to be used when foreign collaborations could result in co-authorship.

R&R Other Project Information Form: Item 10: Facilities & Other Resources. Describe any use of facilities or instrumentation at a foreign site.
Project/Performance Site Location(s) Form: Project/Performance Site Location 1 or Additional Location(s): enter all applicable non-U.S. performance sites that fit UC San Diego's interpretation of foreign involvement.

Note: if the foreign site does not have a DUNS #, then use 000000000 (nine zeros). For the Congressional District, use 00-000 (two zeros dash three zeros).

R&R Senior/Key Person Profile (Expanded) Form: Biosketch: B. Positions, Scientific Appointments, and Honors: list all foreign affiliations in this section of the Biosketch as well as include with research highlights in A. Personal Statement.
R&R Budget Form: Travel, Foreign: "Identify the total funds requested for foreign travel. Foreign travel includes any destination outside of the U.S., Canada, Mexico, or U.S. possessions. In Section L. Budget Justification, include the purpose, destination, dates of travel (if known), and the number of individuals for each trip. If the dates of travel are not known, specify the estimated length of trip (e.g., 3 days)."
For more information, please see the SF424 Guidelines.

For Just-in-Time in eRA Commons, where do you identify a foreign involvement?

Other Support: indicate all domestic and foreign support, awards, and applications under current support and pending support as well as any possible overlap issues with said foreign awards and/or applications all financial resources [domestic and foreign], 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 to ensure no scientific, budgetary or commitment overlap.
For more information, please see Just-in-Time as well as Other Support.

New Other Support Form Page * (use this form for all types of submissions)

For SNAP & Non-SNAP RPPR Progress Reports in eRA Commons, where do you identify a foreign involvement?

Section D – Participants: if the individual’s primary affiliation is with a foreign organization, provide the name of the organization and country.
Section E – Impact: E.4: indicate what dollar amount of the award’s budget is being spent in foreign country(ies), and if more than one foreign country, then identify the distribution between the foreign countries.
Section G. Special Reporting Requirements: G.9 Foreign Component: provide the organization name, country, and description of each foreign component.

Template language if you have a Paid Direct Foreign Student or Post Doc: "X were visiting graduate students from X Foreign University. They were financially supported by a scholarship from the foreign government, which covered their living expenses in San Diego, with no fund brought here to support their research work in the lab at UCSD. All the research work and experimental data reported in our most recent paper were done in Dr.’s X UCSD lab."
RPPR G.9 FOREIGN COMPONENT Example Language to be used if collaborations resulted in co-authorship.

Human Subjects System (HSS): Planned Inclusion Enrollment Report: indicate whether the IDR involves participants from a non-US site (i.e., foreign) or a US site (i.e., domestic).
For more information, please see the RPPR Instruction Guide.

NIH & Protecting U.S. Biomedical Intellectual Innovation

This website describes actions the NIH, institutions, and researchers can take to protect U.S. biomedical intellectual innovation, with regard to possible foreign influence as well as encouraged foreign collaboration. A helpful table is included on this page with examples of when and what recipients (awardees) need to disclose to NIH regarding Senior/Key Personnel on applications and/or awards (progress reports). If you have any questions or require further clarification, always consult with the appropriate SPO office.

NIH Grants Policy Statement (GPS): 8.1.2 Prior Approval Requirements

NIH Grants Policy Statement (GPS): 8.1.2 Prior Approval Requirements.

8.1.2.10 Foreign Component Added to a Grant to a Domestic or Foreign Organization

Adding a foreign component under a grant to a domestic or foreign organization requires NIH prior approval.

NIH Grants Policy Statement (GPS): 1.2 Definition of Terms

NIH Grants Policy Statement (GPS): 1.2 Definition of Terms.

Foreign Component	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. (See Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components chapter in IIB).
Foreign Organization	An entity that is: A public or private organization located in a country other than the United States and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance; A private nongovernmental organization located in a country other than the United States that solicits and receives cash contributions from the general public; A charitable organization located in a country other than the United States that is nonprofit and tax exempt under the laws of its country of domicile and operation, and is not a university, college, accredited degree granting institution of education, private foundation, hospital, organization engaged exclusively in research or scientific activities, church, synagogue, mosque or other similar entities organized primarily for religious purposes; or An organization located in a country other than the United States not recognized as a Foreign Public Entity.
Foreign Public Entity	(1) A foreign government or foreign governmental entity; (2) A public international organization, which is an organization entitled to enjoy privileges, exemptions, and immunities as an international organization under the International Organizations Immunities Act (22 U.S.C. 288 § 288f); (3) An entity owned (in whole or in part) or controlled by a foreign government; or (4) Any other entity consisting wholly or partially of one or more foreign governments or foreign governmental entities.

NIH Other Support

Other Support includes ALL FINANCIAL RESOURCES, whether Federal, non-Federal (not-for-profit, private, or foreign), commercial, institutional, or individual, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes, or gifts [at this time] do not need to be included.

More information can be found on NIH's GPS 2.5.1. Just-in-Time Procedures as well as our informational page on Other Support includes recent changes as of January 25, 2022.

NIH FAQs: Other Support and Foreign Components

Note on Foreign Affiliations, Appointments, and/or Support for New Form

Institutions are now required to submit copies of contracts specific to senior/key-personnel foreign appointments and/or employment with a foreign institution for all foreign activities and resources that are reported in Other Support. Personal service contracts for lab staff do not need to be provided.
Translations are required if they are not in English. Note, this does not include personal service contracts or employment contracts for fellows supported by foreign entities. NIH will accept machine-read translations. Your Central SPO will do the translations for you.
These contracts MUST be uploaded at time of JIT, following the Other Support documents.

Other Resources

AAMC	Research Security and Undue Foreign Influence at U.S. Academic Institutions
COGR	12/5/2019: COGR Other Support Guidance: Commentary on Disclosing Other Support and Other Resources in Research Funded by the National Institute of Health 6/10-12/2020: COGR Virtual Meeting Update: Foreign Influence on Research 2/24/2021: Disclosure of Outside Activities OSTP Slides on Disclosure Policies and Recommended Practices for the Research Enterprise 8/18/2021: COGR Federal Focus on Inappropriate Foreign Influence on Research: Practical Considerations in Developing an Institutional Response
FBI	4/10/2019: China's Risks To Academia 7/16/2020: PSA On Talent Plans Final
JASON	JSR-19-21: Fundamental Research Security (12/6/2019): JASON was asked by the National Science Foundation the following questions: What is the value and what are the risks of openness generally associated with fundamental research? How should the principles of scientific openness be affirmed or modified? Are there areas of fundamental research that should be more controlled rather than openly available? What are those areas? What controls, if any, could be placed on particular types of information, and how can this be managed in a way that maintains the maximum benefit of the open research environment for fundamental research? What good practices could be put into place by academic researchers to balance the open environment of fundamental research with the needs for national (and economic) security? What good practices could be put into place by funding agencies such as NSF to balance the open environment of fundamental research with the needs for national (and economic) security? Article on JASON Report: U.S. scientists who hide foreign ties should face research misconduct sanctions, panel says (AAAS Science Magazine, Jeffrey Mervis, 12/11/2019)
National Science & Technology Council (NSTC)	11/5/2019: 2019 White House Summit of the Joint Committee on the Research Environment (JCORE) 1/16/2021: Recommended Practices for Strengthening the Security and Integrity of America's Science and Technology Research Enterprise Fact sheet on the National Security Presidential Memorandum 33 (NSPM-33)
NIH	03/03/2018: NOT-OD-18-160: Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests 08/20/2018: Francis Collins, Director of the NIH,Foreign Influence Letter to Grantees 12/13/2018: NIH presentation on Foreign Influences on Research Integrity to NIH's Advisory Committee to the Director (ACD) 12/13/2018:ACD Report ACD Working Group for Foreign Influences on Research Integrity 08/13/2018: H.R. 5515 Sec. 1286: John S. McCain National Defense Authorization Act for Fiscal Year 2019 & the Initiative to support protection of national security academic researchers from undue influence and other security threats. 06/14/2019: ACD Working Group for Foreign Influences on Research Integrity Update. 07/10/2019: Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components 12/13/2019: ACD Working Group on Foreign Influences on Research Integrity Update 6/12/2020: ACD Working Group on Foreign Influences on Research Integrity Update 7/8/2020: Addressing Foreign Interference and Associated Risks to the Integrity of Biomedical Research, and How You Can Help, by Dr. Michael Lauer is NIH's Deputy Director for Extramural Research (Open Mike Blog Post)
Office of Inspector General (OIG)	03/2020: NIH Has Acted To Protect Confidential Information Handled by Peer Reviewers, But It Could Do More 06/2022: Opportunities Exist To Strengthen NIH Grantees’ Oversight of Investigators’ Foreign Significant Financial Interests and Other Support
The Pennsylvania State University	Penn State University has a great site on International Relationships and Activities. It describes the background (with source links) as well as the current situation, with regards to risk and best practices.
UC San Diego	Our Office or Research Affairs has created a site focused on international engagement as well as updates on foreign engagements.
UC Office of the President	The Office of Ethics, Compliance, and Audit Services has created an informative page on Foreign Influence with regards to research and awards. The area touches on the effects of foreign influences on research integrity, recent communications and policies of federal sponsors, the need for transparency of fostering relationships and collaborations as well as UC and Sponsor specific policies (COC, COI, Export Control), FAQs, other UC resources, and links to other institutions resources.
US Presidential Memorandum	1/14/2021: Trump Presidential Memorandum on United States Government-Supported Research and Development National Security Policy
US Senate	11/18/2019: Threats to the U.S. Research Enterprise: China’s Talent Recruitment Plans
Wall Street Journal	1/22/2021: Justice Department Weighs Amnesty for Academics to Disclose Foreign Funding
The White House Office of Science and Technology Policy (OSTP)	6/23/2020: Enhancing the Security and Integrity of America’s Research Enterprise, by Dr. Kelvin Drogemeier, Director of OSTP. 8/10/2021: Clear Rules for Research Security and Researcher Responsibility, by Dr. Eric Lander, President’s Science Advisor and Director of OSTP

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