Dear Faculty and Staff,

Pursuant to the email communications that the GCO sent on 4/4/19 entitled “NIH - Foreign Influences on Research Integrity,” we are following up and providing more specific information on disclosing foreign affiliations and best practices. 

Before we go into those details, we thought we’d share with you a timely article from Science Magazine on the NIH and foreign influences on research integrity.

Why are the NIH and the FBI so concerned?

During a hearing of a Senate panel that oversees the NIH budget, Senator Roy Blunt (R–MO), asked NIH Director Frances Collins “..about NIH’s ongoing efforts to ensure that grantees are complying with agency rules on disclosing foreign ties, protecting the confidentiality of peer review, and handling intellectual property. ‘Something that the research community needs to take more seriously,’ Blunt said in his opening remarks, is ‘that foreign governments are initiating systematic ways to influence our research and frankly to take advantage of our research by stealing it.’ Blunt mentioned China in particular, which he said has a ‘government program to recruit NIH-funded researchers’ to set up shadow labs in China and steal U.S. intellectual property and confidential grant information. ‘I think NIH has to be sure that the research community is fully aware of the threats and more importantly, how to combat those threats,’ Blunt said.”  Click here for the full Science Magazine article.

This communications focuses on the NIH definition of foreign involvement and how to report foreign involvement on your NIH grant application and after your grant is underway  It does not replace the NIH application instructions so be sure to read those when completing.

“If I don’t pay for it, does it actually happen?” What is Foreign Involvement?

A common misconception is that foreign involvement only occurs when there is a subaward to a foreign institution. The actual definition (in section 1.2) from the NIH Grants Policy Statement (NIHGPS)  is much broader:

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.

How do I report foreign involvement to the NIH? 
There are 3 ways to do.

1. Reporting in Competitive Grant Application
2. Reporting in Annual Research Performance Progress Report (RPPR)
3. Prior Approval Request

1. Reporting in Competitive Grant Application

• Other Project Information Page

Whenever there is Foreign Involvement as defined above, question 6 in the Other Project Information Page must be answered “yes.”

Depending on the type of foreign involvement, there are numerous other places where this information may also be disclosed. 

• Performance Sites Tab
  The Project/Performance Site Location(s) Form is used for all grant applications. It is used to report the primary location and any other locations at which the project will be performed. Include foreign site/s if appropriate.

• Senior/Key Personnel Form
  Unless otherwise specified in a FOA, senior/key personnel are defined as all individuals who contribute in a substantive, meaningful way to the scientific development or execution of the project, whether or not salaries are requested. Consultants should be included in this “Senior/Key Person Profile (Expanded)” Form if they meet this definition. List individuals that meet the definition of senior/key regardless of what organization they work for.

• Budget tab
  Subaward form, if appropriate. 

• Budget Justification
  List all personnel whether paid or not salaries are requested.
  For non modular grants, explain foreign travel.  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)

• Research Plan > Consortium / Contractual (i.e, subawards) if appropriate
  Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee.

• Biosketches for Senior/Key Personnel¸if appropriate
  We will review this section in detail in a future Helpful Hints on the topic. The NIH instructions are here.
   
• Progress Report Publication List, if appropriate
  A “Progress Report Publication List” attachment is required only if the type of application is renewal.   List the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively.  The NIH instructions are here.

        2. Reporting in Annual Research Performance Progress Report (RPPR)

       Please see the sections below.  The NIH RPPR instructions are here.

• Special Reporting Requirements – Section G

G.9 Foreign component. Provide the organization name, country, and description of each foreign component.

Depending on the type of foreign involvement there are numerous other places where this information may also be disclosed. 

• Products section – Section C
  This section allows agencies to assess and report both publications and other products to Congress, communities of interest, and the public.

C.1 – Publications
Are there publications or manuscripts accepted for publication in a journal or other publication (e.g., book, one-time publication, monograph, preprint) during the reporting period resulting directly from the award?

• Participants – Section D
  This section allows the agency to know who has worked on the project to gauge and report performance in promoting partnerships and collaborations.
  D.1 What individuals have worked on the project?
  Provide or update the information for: (1) program director(s)/principal investigator(s) (PDs/PIs); and (2) each person who has worked at least one person month per year on the project during the reporting period, regardless of the source of compensation

Is the individual’s primary affiliation with a foreign organization? Y/N

• Impact – Section E
  This section will be used to describe ways in which the work, findings, and specific products of the project have had an impact during this reporting period.

E. 4 - What dollar amount of the award’s budget is being spent in foreign country(ies)?  If more than one foreign country identify the distribution between the foreign countries.

• Special Reporting Requirements – Section G

G.8  Project/Performance Sites.
If there are changes to the project/performance site(s) displayed, edit as appropriate.

      3. Prior Approval Request - What if foreign involvement was not included in the competitive NIH application or a subsequent RPPR and I’m adding later on?

This prior approval request follows the standard process as explained in this GCO prior approval guidance document.  The PI sends the request to the GCO and the GCO reviews and endorses it.

We plan on posting this communication series on foreign influence and disclosure to the NIH on the GCO webpage. In the meantime, if you need any former communications, please do contact me.

Sincerely, Allison Gottlieb

Allison Gottlieb, M.S. | Director, Sponsored Programs Education | Grants and Contracts Office
150 East 42nd, 10th Floor | New York, New York 10017-5629
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Website: http://www.icahn.mssm.edu/research/resources/grants-and-contracts-office

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