The NIH Director Dr. Francis Collins sent a letter to institutions in August of 2018 warning of "threats to the integrity of U.S. biomedical research" and citing three areas of major concern: not disclosing foreign "substantial resources", diverting intellectual property, and sharing confidential information by peer reviewers. Since that letter, the NIH has investigated more than 180 researchers and 65 institutions for violating the policy on reporting foreign ties. Consequences can range from warnings, notification of the home institution, potentially leading to job termination and referral to the Office of the Inspector General for prosection. Multiple scientists have lost their jobs and a small number have been arrested.
Understanding Correct Disclosure of Foreign Ties
Disclosure of foreign ties takes place through a variety of mechanisms, and depending on the precise relationship, it may need to be disclosed through multiple avenues. In addition to the information below, it may be helpful to reference the NIH's website on Protecting US Biomedical Intellectual Innovation, which includes a helpful table on where different items should be disclosed.
1. Disclosure of all "Other Support" as required by NIH applicants
The NIH expects any support in research or salary from an institution (Federal, non-Federal, commercial, or academic) other than the faculty's primary employer to be listed on the "Other Support" document included in NIH proposals and progress reports. This includes:
- salary support to the faculty member
- postdoctoral fellows, graduate students, technicians, etc. in the faculty member's lab who are being paid/supported from a different institution (especially a foreign institution/government).
- lab supplies paid for by an outside institution
- honorariums and travel expenses
- anything that facilitates the conduct of research similar to the NIH-funded research at a non-US institution for the US faculty member
- appointments at another institution, especially a foreign institution
For further information, please refer to NIH notice NOT-OD-19-114 or the NIH's guidance on Other Support or contact the grants management specialist assigned to the opportunity (contact information can be found in Section IV of the RFA).
2. Disclosure of Foreign Components
If a significant portion of the project will be conducted outside of the US then there may be a foreign component. This may include collaborations with investigators at a foreign site that are 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 Components must be disclosed as part of the NIH application process, but if a foreign component needs to be added during the middle of the grant, PIs must obtain NIH Prior approval. Note that if all of the research is being conducted within the United States but there is a non-US source providing support for the research, then that would be reported under Other Support, as described above.
3. Disclosure of Financial Conflict of Interests (FCOI)
A Financial Conflict of Interest exists when the institution determines that an investigator's financial interest could affect the design, conduct, or reporting of PHS-sponsored research. Potential FCOIs must be disclosed to the institution regardless of whether they are also reported on an Other Support page. UMB investigators must take FCOI training every 4 years and disclose potential FCOIs every year. If a new FCOI develops in between annual disclosures, it must be disclosed to UMB's COI officer within 30 days. See here for how to access UMB FCOI training, disclosure forms, and further FCOI instructions and policies.
Please note that all investigators must disclose ALL financial interests from a foreign institution or foreign government, including local, provincial, or equivalent governments of another country. Further detail can be found in NIH NOT-OD-18-160.
Foreign Influence FAQs
I am a Principal Investigator on an NIH award to a domestic university and have an unpaid appointment at a foreign university. At the foreign site I have access to lab space, research materials, and staff. Should I report this as Other Support?
Yes. While the researcher is not receiving monetary compensation, the lab space, materials, and staff are resources made available to them in support of their research efforts. Other payments, such as travel or living expenses must also be reported. As outlined in NOT-OD-19-114 this appointment must be reported as Other Support.
I am key personnel on an NIH grant in the United States. I am collaborating with another scientist in the US, whose experiments have directly benefitted my research. Their experiments were conducted with funds awarded to their institution. Should this be reported as Other Support?
Yes. Other Support includes domestic research collaborations that directly benefit the researcher’s research endeavors.
What is an example of an activity that is not a foreign component, but would meet the definition of Other Support? What is the difference?
If a PI on an NIH grant has an appointment and a lab at a foreign university, the research being done at the foreign lab is not related to the PI’s NIH project. This would not qualify as a foreign component of the NIH research, as the foreign work is not part of the NIH-funded project. However, any other resources in support of an investigator’s research, it must be reported as Other Support.
Do I need to make disclosures related to the work of my graduate students if they are foreign nationals? Does this affect postdoctoral scholars?
It depends on the support resources for international students and postdoctoral scholars. If they are supported by the PI’s domestic funding, there is no need to disclose; if they are supported by foreign government/institutions, the disclosure to NIH as other support is needed.
I am the PI on an NIH grant to a domestic university. I have a visiting post-doctoral fellow in my lab, who works on my NIH grant and does all of his/her work in the United States. The fellow’s salary is paid by a foreign government/university. Is this a foreign component?
No. In this case, all the work is being conducted in the US, so there is no foreign component. But it is a resource made available to the PI in support of their research. Therefore, it must be reported as Other Support. Since specific circumstances may vary, it would be best to discuss with your Grants Management Officer.
When to disclose FCOI to UMB by the Investigator?
- At or before (previous 12 month period) the time of submission of an application for PHS-Funded Research
- Within 30 days of discovering or acquiring a new FCOI
- At least annually, in accordance with the specific time period prescribed by the Institution, during the period of award.
What to disclose the occurrence of sponsored travel by a foreign entity?
- The purpose of the trip
- The identity of the sponsor/organizer
- The destination, and
- The duration
- Monetary value (maybe required by the Institution FCOI policy)
I still have questions. Who should I contact?
FCOI questions? Please contact UMB's Conflict of Interest Officer, Allison Watkins
Specific questions relating to your issue, please contact Associate Vice President for Sponsored Programs, Dennis Paffrath
General questions, please contact Office of Research Affairs staff, Grace Zhang
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