Concerns from Federal Agencies
Reporting Requirements and Best Practices
Guidance for Department Review of Outside Professional Activities with a Foreign Entity (School of Medicine)
Who to Contact
FAQ
As conveyed by Chancellor Martin, in his June 24, 2019 blog posting: Reaffirming the intrinsic value of our international community, Washington University deeply values its international collaborations through our research endeavors and our students and scholars from around the world. These global partnerships enrich our culture and are critical components to providing the highest quality education, research, and patient care.
Issues surrounding foreign influence and international activities in federally funded research has been an evolving topic, in which the U.S. Government has shown increasing concern. These concerns include:
- Diversion of intellectual property to foreign entities
- Disclosure of confidential grant application information by NIH peer reviewers to third parties
- Failure of researchers to disclose research resources and support provided by other organizations, including foreign entities
With the heightened sensitivity on these issues nationally, we want to remind you of your obligations to report on international research and scholarly activities. This site provides additional information around the government’s concerns and best practices pending further clarifications from Federal Agencies.
Concerns from Federal Agencies
- The National Institutes of Health (NIH) Director Dr. Francis S. Collins issued a “Foreign Influence Letter to Grantees” on Aug. 20, 2018 that indicates concerns about systematic programs of foreign influence in U.S. research. Dr. Collins reminds the research community to “disclose all forms of other support and financial interests, including support coming from foreign governments or other foreign entities…in accordance with the NIH Grants Policy Statement, [on] all applications and progress reports.”
- The FY 19 National Defense Authorization Act, signed in August 2018, included Sec. 1286, which states that “The Secretary of Defense shall, in consultation with other appropriate government organizations, establish an initiative to work with academic institutions who perform defense research and engineering activities . . . to limit undue influence, including through foreign talent programs, by countries to exploit United States Technology … “
- The National Science Foundation issued a statement on “Security and Science” dated October 23, 2018, stating that U.S. universities must “embrace transparency and rigorously adhere to conflict of interest and conflict of commitment policies.”
- The Department of Energy (DOE) issued a directive dated June 7, 2019, mandating that “federal and contractor personnel fully disclose and, as necessary, terminate affiliations with foreign government-supported talent recruitment programs” on new DOE contracts and subcontracts.
- The National Aeronautics and Space Administration (NASA) has grant/contract restrictions on using NASA funds to enter into agreements “to participate, collaborate, or coordinate bilaterally in any way with China or any Chinese-owned company, at the prime recipient level or at any subrecipient level, whether the bilateral involvement is funded or performed under a no-exchange of funds arrangement.”
Reporting Requirements and Best Practices
Disclosing Foreign Components
Other Support
Proposal Certification Form Assurances for Foreign Influence
International Affiliations
Disclosing Personal Financial Interests
Personal Agreements
International Travel
Hosting International Visitors
International Graduate Students Conducting Research Outside the U.S.
Most international collaborations are not problematic and are encouraged, but researchers must disclose and be transparent regarding their involvement in activities of this nature. A general assurance is required for grant applications to all sponsors. The disclosures should include (whether foreign or domestic): current & pending support, resources and all academic, professional, scientific, or institutional appointments, employment, research oversight, teaching courses or student advisory activities.
Additional assurance certifications may be required by federal funding sources (such as NASA and DOE). See Proposal Certification Form Assurances for Foreign Influence for a current list of additional certification forms.
It is ultimately the responsibility of the individual researcher to ensure reporting requirements are complete and accurate to the best of his or her knowledge. Principal Investigators (PIs) should review all pending federal proposals and active awards to ensure that all proper disclosures have been made.
Disclosing Foreign Components
Foreign components should be disclosed on proposals, progress reports, and final technical reports. Under NIH’s Grants Policy Statement, a foreign component is defined as “any significant scientific element or segment of a project outside of the United States” whether or not NIH grant funds are expended, either by “a researcher or recipient in a foreign location or by a researcher in a foreign location employed or paid by a foreign organization.” Refer to NIH issued guidance: NOT-OD-19-114 for additional details. Other sponsors may have similar requirements to disclose foreign components.
For NIH funded research, when a segment of the research is performed outside of the U.S., the following activities would constitute a foreign collaboration that must be disclosed as a foreign component:
- Research involving human subjects or animals;
- Extensive travel for the purpose of data collection, surveying, sampling, and similar activities (excluding foreign travel for consulting);
- Collaborations with investigators anticipated to result in co-authorship;
- Use of facilities or instrumentation;
- Receipt of financial support or resources from a foreign entity.
Examples of ways to disclose a foreign component in a funding application:
- Identifying a foreign component in an NIH grant application on the R&R Other Project Information Form (G.220):
- Check “Yes” to Question 6, “Does this project involve activities outside of the United States or partnerships with international collaborators?”
- Upload a “foreign justification” document in Field 12, Other Attachments. This attachment should describe the resources or characteristics of the foreign research component (e.g., human subjects, equipment, research techniques, etc.) including reasons why the use of foreign facilities or other aspects of the project are appropriate for an international setting.
- Listing a “non-U.S. performance site”
Reporting an Annual Research Performance Progress Report (RPPR)
- Special Reporting Requirements – Section G
- G.9 Foreign component. Provide the name, country, and description of each foreign component.
For questions, contact the Office of Sponsored Research Services at researchgrants@wusm.wustl.edu or 314-747-4134.
Other Support
Other Support reporting should include all your ongoing or proposed research activities. This includes any foreign sources of funding/in kind support, including equipment, supplies, lab resources and visitors to your lab supported by a foreign entity. Such support should be disclosed on an “Other Support” or “Current & Pending” form. Most federal sponsors have guidance, for example:
- NIH issued guidance: NOT-OD-19-114 clarifying “Just-In-Time” reporting for Other Support requires information about an investigator’s overall funding/resources prior to issuing an award. Reporting for senior/key personnel must include “all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes resource and/or financial support from all foreign and domestic entities, including but not limited to, financial support for laboratory personnel, and provision of high value materials that are not freely available (e.g., biologics, chemical, model systems, technology, etc.).” Examples include:
- Federal contracts, non-federal research grants, cooperative agreements, institutional awards, talent program payments, in-kind support, etc.
- Non-U.S. resource that supports the research of an investigator and/or researcher, but does not meet the definition of a foreign component because the work is being performed in the U.S.
- NIH has also issued guidance that addresses different examples and the reporting requirements.
- The Department of Defense (DOD) issued a memo (PDF) on March 20, 2019 outlining disclosure requirements for all key personnel for new DOD Notices of Funding Opportunities, requiring reporting of “all current projects the individual is working on, in addition to any future support the individual has applied to receive, regardless of source.”
- The National Science Foundation (NSF) issued the Proposal and Award Policies and Procedures Guide effective June 1, 2020. Reporting required for all senior personnel must include “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…irrespective of whether such support is provided through the proposing organization or is provided directly to the individual.” It includes “in-kind contributions (such as office/laboratory space, equipment, supplies, employees, students)”, even those “not intended for use on the project/proposal being proposed.” Additional information from NSF: Current and Pending Support Frequently Asked Questions (FAQs) and NSF-approved format for current and pending support.
For questions, contact the Office of Sponsored Research Services at researchgrants@wusm.wustl.edu or 314-747-4134.
International Affiliations
Biographical Sketches should include international affiliations, such as paid/unpaid appointments, positions, or honors with non U.S. academic institutions. This could include teaching courses or regular student advisory activities.
- NIH requires listing “all positions and scientific appointments both domestic and foreign held by senior/key personnel that are relevant to an application including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).” NIH has also issued guidance that addresses different examples and the reporting requirements.
- NSF requires, effective June 1, 2020, listing “all the individual’s academic, professional, or institutional appointments, beginning with the current appointment. Appointments include any titled academic, professional, or institutional position whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).”
For questions, contact the Office of Sponsored Research Services at researchgrants@wusm.wustl.edu or 314-747-4134.
Disclosing Personal Financial Interests
Personal financial interests received from any international entity (government, non-profit, for-profit, university/academic) must be disclosed to the University, per the Washington University COI Research Policy via the financial disclosure statement. This includes all personal remunerations/financial interests that appear to be related to your institutional responsibilities within 30 days of acquiring the interest based on disclosure requirements. Examples include, living allowances; “consulting” to be a PI on a grant; honorariums; personal activities during summer months for 9-month appointments. NIH has also issued guidance that addresses different examples and the reporting requirements.
If you are unsure whether a particular interest or activity should be disclosed, contact the askCOI team at COI@wustl.edu or 314-747-4181; M-F, 8:30-5:00.
Personal Agreements
The University does not formally review and approve your personal agreements/contracts; however, there are aspects of an agreement you may need to be more mindful about when partnering with a foreign entity that you may not experience with a domestic entity. Refer to Guidance for Personal Agreements for a list of examples and best practices; some areas of concern include:
- Be careful of any contractual obligations that could put you at risk for abrogating your ability to comply with University policies, such as strict confidentiality requirements, intellectual property assignments, or over-commitment of effort.
- Some entities may be considered a restricted party, which could prohibit or limit certain activities with an entity (or country or person). There is a consolidated screening list search engine available online. However the University can provide a more comprehensive screening of these and additional lists. Please contact the export control manager at ovcrexportcompliance@wustl.edu for assistance.
WashU’s Faculty Consulting Privileges Policies for the Danforth and Medical Campuses outline the time permitted for external activities and department chair oversight responsibilities. An area under significant scrutiny by the federal government is participation in foreign talent programs, such as China’s Thousand Talents Program. Participation in those types of programs should also be discussed with your department chair, even if participation was previously disclosed to other university officials.
International Travel
International Travel should be disclosed in the following circumstances:
- If your travel is paid for or reimbursed by an outside entity and you are involved in the design, conduct, and reporting of Public Health Service (PHS)/NIH funded research submit a travel disclosure form. Disclosure applies to registration fees, accommodations, meals, and transportation. For foreign entities, this includes any companies, universities/institutions of higher learning, non-profit organization/association, or any level of government. Refer to the disclosure requirements for more details.
- For WashU sponsored or supported travel, the International Travel Policy likely applies and your trip should be entered into the Travel Registry. This policy outlines different requirements for faculty, staff, and students.
Hosting International Visitors
If hosting international visitors, even for a short period of time, notify your business office in advance of their arrival. Individuals and institutions may be on government restricted lists, limiting allowable interactions or prohibiting access to controlled equipment. Depending on the length of the visit, a visitor appointment may be appropriate. In some circumstances, an agreement may need to be established depending on what information is being shared and/or accessed.
For visiting faculty, staff, and students where WashU is supporting their visa application, the Office of International Students and Scholars works with the Export Controls Office to appropriately screen individuals and institutions for government restriction lists. This also initiates export control assessments around allowable interactions, access to controlled equipment, and additional requirements for H-1B visas.
International Graduate Students Conducting Research Outside the U.S.
In some circumstances, a School may determine an international WashU graduate student can pursue their academic training program while located outside of the U.S. If the student needs to conduct research as part of their training, certain details must be addressed to ensure compliance with regulatory requirements. Schools should follow the Guidance for International WashU Graduate Students Conducting Research Outside the U.S. when considering the student’s engagement in research, and work with the applicable offices as appropriate based on the activities.
Guidance for Department Review of Outside Professional Activities with a Foreign Entity (School of Medicine)
Guidance and an example disclosure form (Word doc) have been developed, at the request of the Executive Faculty, for departments to collect and review outside professional activities involving foreign entities that are considered the highest risk until a more systematic solution can be implemented.
Who to Contact
If you have any further questions regarding the disclosure and reporting of international activities, please contact:
Jeneane Braden
Associate Vice Chancellor for Research Ethics and Compliance
314-747-4152