Foreign Influences
Background
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.
The NIH released a Notice of Upcoming Changes to the Biographical Sketch and Other Support Format Page for grants with due dates on or after May 25, 2021. This notice aligns NIH guidance with that of other federal agencies with many of the updates and announces some changes relating to the required disclosure of foreign relationships. A follow-up notice delayed this requirement until submissions on or after January 25, 2022. As part of this effort, the NIH set up a new inbox specifically for questions regarding the changes to the Biographical Sketch and Other Support Format page at nihosbiosketch@nih.gov.
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 or this NIH Disclosures Table on where and when different items should be disclosed.
1. Disclosure of ALL current positions and appointments in Biosketch regardless of whether or not monetary value involved, this includes:
- All current positions and affiliations both domestic and foreign in full time, part-time, or volunteer (including adjunct, visiting, or honorary)
- Ongoing and completed research projects from the past three years that you want to draw attention to (previously known as research support)
A full copy of the updated Biosketch instructions can be found here.
2. Disclosure of all "Other Support" as required by NIH applicants
The NIH expects any active and pending resources or salary made available to a researcher in support of and/or related to any of their research endeavors to be listed on the "Other Support" document included in NIH proposals and progress reports. These active and pending resources are required to be disclosed during Just in Time submission (JIT) and/or Research Performance Progress Report (RPPR). This includes:
- All current research projects and other resources made availale to senior/key personnel (e.g. other research projects funded by NIH, other federal, or foundation sponsors, internal awards like MPower, etc.).
- Extramural research relevant consulting agreements. We define research relevant as any consulting relationship that might result in a peer-reviewed published paper. Consulting reporting should be estimates of the amount of compensation received rather than time and effort reflected in calendar months.
- In-kind contributions, e.g., office/laboratory space, equipment, supplies, employees, or students supported by foreign entities, high-value materials such as biologics, chemicals, model systems, or technology that are not broadly available to everyone. Materials provided within the past 3 years, that are still in use, must be included.
- Supporting documents, including copies of contracts, grants, or any other agreements specific to senior/key personnel active appointments and/or employment with a foreign institution (all translated into English). The NIH does accept machine-read translations, e.g., Google Translate.
- PIs and key personnel must electronically sign their other support forms prior to submission to certify the accuracy of the information.
For further information, please refer to NIH notice NOT-OD-19-114, NOT-OD-21-073, the NIH's guidance on Other Support, the NIH's FAQs for Foreign Influences, or contact the new NIH Inbox (nihosbiosketch@nih.gov) specifically designed for questions regarding these changes to the NIH biosketches and Other Support pages.
3. 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.
4. 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
If a new source of support is received after submitting an Other Support document correctly at a time of submission, does an updated other support document need to be submitted at that time?
No. Changes in other support that occur during the project period need to be reported at the time of RPPR submission. If an element of the other support submissions was omitted at the previous time of reporting, it's required to be reported to the NIH immediately (e.g., within 30 days). Otherwise, changes to active other support should be reported at time of RPPR.
The NIH requires immediate notification when a recipient organization discovers that Senior/Key Personnel on an active NIH grant failed to disclose Other Support information outside of Just-in-Time or the RPPR. What does NIH consider "immediate notification" to mean?
The NIH policy requires notification as soon as it becomes known. Institutions are expected to report failures to dsiclose no later than 30 days after it becomes known.
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, any appointments at foreign entities should be disclosed on the Biosketch whether or not there is compensation involved. While the researcher is not receiving monetary compensation, the lab space, equipment, supplies, and employees or students supported by an outside source are in-kind contributions made available to them in support of their research efforts. As outlined in NOT-OD-19-114 and NOT-OD-21-073, this appointment and in-kind contribution must be reported in Biosketch and Other Support as appropriate.
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.
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 them with your Grants Management Officer.
How do I know if my consulting activity is research-related?
If your consulting has the potential for you to be included as an author on a peer-reviewed publication, this is considered a research consulting activity and the consulting must be disclosed in your Other Support document. If you are serving in a capacity where you will not end up as an author on a peer-reviewed publication, you do not need to list this in your other support. However, any current, science-related consulting activity should be listed as a current appointment in your biosketch. As an example, serving as a consultant on a Clinical Trial Steering Committee would generally need to be included in Other Support, as you could well be listed as an author on future publications. However, serving as an advisor or on a scientific advisory board would not need to be listed on your Other Support, but should be listed in your biosketch list of current appointments. Consulting for educatioal purposes or reviewing grants for a foundation, even when a small honorarium is received, would not need to be disclosed in Other Support.
For in-kind resources that do not have any associated effort, do they need to be disclosed in Other Support, if yes, can researchers enter zero effort when they reported?
Yes, ALL in-kind contributions, e.g. space, equipment, supplies, or employees or students supported by an outside source need to be disclosed in Other Support, for in-kind resources with no associated time commitment, researchers can list zero effort, but must provide an estimated dollar value of the in-kind resource. The effort and dollar value cannot be both zero.
Do in-kind contributions that will be used for the project being proposed need to be included in Other Support?
If an in-kind contribution, such as technology, chemicals, etc. is intended for use on the project being proposed to NIH in the application, the information must be included as part of the Facilities and Other Resources or Equipment section of the application and does not need to be replicated on Other Support.
If an in-kind contribution is listed in Facilities and Other Resources or Equipment, does it also need to be included in Other Support?
If an in-kind contribution is not intended for use on the project being proposed, then the information must be included as part of Other Support. If the in-kind contribution is intended for use on the project being proposed, then the information must be included as part of the Facilities and Other Resources or Equipment section and does not need to be replicated on Other Support.
Do applicants need to disclose materials provided 20 years ago if they are still in use?
Materials provided within the past 3 years, that are still in use, must be included in Other Support.
How should researchers list materials (e.g., data, samples, etc.) received from external collaborators on Other Support?
Information on materials received from collaborators must be included in the in-kind contribution section of Other Support, including the source, a summary of the in-kind contribution, and the estimated value. Only resources uniquely available to the researcher must be reported.
If my foreign contracts, grants, or any other agreements are not in English, how do I deal with that?
For foreign contracts, grants, or any other agreements not in English, NIH will accept machine-read translations, e.g., google translate.
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)
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 at 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 must be reported as Other Support.
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 the award.
I still have questions. Who should I contact?
FCOI questions? Please contact UMB's Conflict of Interest Officer, Allison Watkins
For specific questions relating to your foreign influence question, please contact Associate Vice President for Sponsored Programs, Dennis Paffrath
General questions, please contact Office of Research Affairs staff, Grace Zhang
Other Resources
UMB Resources
Financial Conflicts of Interest
UMB Policy and Procedure on FCOI to Promote Objectivity in PHS-Funded Research
UMB Procedure on Implementing Board of Regents Policy on COI in Research or Development
Extramural Resources
NOT-OD-18-160: FCOI: Investigator Disclosures of Foreign Financial Interests
NIH FAQs on Other Support and Foreign Components
HHS Office of the Inspector General Report
AAMC Memo on Undue Foreign Influence at US Research Institutions
Department of Defense (DOD) Memorandum
NSF Current and Pending Support
Recent Articles on Foreign Influences in US Biomedical Science Research
The New York Times, January 6, 2019
NIH Report on Findings: 2016 to 2021