United States: NIH Issues New Guidance On "Other Support" And "Foreign Components" In Funded Research

In the wake of ongoing concerns expressed about “foreign influence” in U.S.-funded research activities, the National Institutes of Health (NIH) last week released a series of documents addressing disclosures of “foreign components,” “other support” and affiliations in grant applications and reports. Collectively, these documents include an overview blog from the NIH Deputy Director for Extramural Research, a Guide Notice entitled “Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components” and a number of Frequently Asked Questions (FAQs).

Presented as “clarifications” of long-standing policies, they are important and valuable tools for applicants and awardees to understand better the NIH’s thinking on these issues. However, some of the information contained will sound new and may raise concerns or operational challenges. Universities, academic medical centers and other entities that receive any NIH research funding should review these documents carefully. Recipients of research funding from other agencies, e.g., from the National Science Foundation, may want to examine these documents also, as they likely are predictive of how other federal agencies may interpret their own related regulations.

Following are highlights and some examples of the questions that arise from the guidances.

Other Support

The NIH’s Grants Policy Statement (GPS) at section 2.5.1 defines the “other support” that must be disclosed to NIH as part of initial grant reporting (i.e., Just–in-Time) or ongoing grant reporting. The new Guide Notice emphasizes that “other support” “includes 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.” In detailing this further, among other clarifications, the NIH explains in the Guide Notice that disclosure must include:

  • All positions and appointments held by senior/key personnel relevant to an application, including domestic or foreign, full or part time, paid or unpaid, adjunct, visiting, or honorary.
  • All resources for senior/key personnel, regardless of “whether such support is provided through the applicant organization, through another domestic or foreign organization, or is provided directly to an individual that supports the senior/key personnel’s research efforts.”
  • All current projects and activities for senior/key personnel, including “in-kind (e.g. office/laboratory space, equipment, supplies, employees)” and “foreign financial support, research or laboratory personnel, lab space, scientific materials, selection to a foreign ‘talents’ or similar-type program….”

NIH’s FAQs add that other support disclosures must include, for example, all: (1) lab space, materials, staff, travel and living expenses for appointments, paid or unpaid, at foreign universities (FAQ3); (2) outside consulting and teaching activities, whether paid or unpaid, that relate to research activities or expertise (FAQ6); and (3) start-up packages for investigators and research grants (FAQ5).

In applying NIH’s thinking to real-world settings, a number of question arise regarding the vast scope of “other support” that must be reported under a literal reading of the guidance. For example, the guidance indicates that all foreign relationships, appointments and even compensation arrangements in support of the senior/key personnel’s research represent “other support” that must be reported. How to distinguish this other support from, for example, personal consulting income may be less than clear under this new guidance. Similarly, start-up packages can include direct funding, space, general funding, salary, compensation and more. Disclosing all of these sources of support is not necessarily relevant to the question of whether there are one or more foreign sources of support, which appears to be the agency’s primary goal. Nonetheless, it appears to be required for all senior/key personnel, regardless of whether they are employed by the prime awardee. Furthermore, while this information would not be distributed to peer reviewers, as it would need to be provided only for funded or likely-to–be-funded projects at Just-in-Time, compiling and disclosing extensive details on specific financial plans may create an undue burden on awardees and may threaten the personal privacy interests of senior/key personnel. We understand from NIH sources that actual dollar amounts of start up packages are not expected to be reported, but this may require additional clarification from NIH.

Foreign Components

International collaboration is a mainstay of scientific progress, and federal funders like NIH support it, subject to certain limitations and disclosure. If individual funding opportunity announcements permit foreign components, and if applicants disclose their foreign component plans in the application, then NIH may approve a “foreign component” of the project. A foreign component can also be added during the performance of the award by obtaining NIH’s prior approval.

NIH defines a foreign component in the GPS at section 1.2 as: “[T]he 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.”

Last week’s guidance documents emphasize how geography is a critical element to distinguishing foreign components from other support. The agency offers a formula for assessment: first, determine if any activities will be performed outside of the U.S., and, second, determine if those activities are significant. If so, prior authorization is required to add them as foreign components.

By contrast, if all research activities for a project occur in the U.S., but an investigator or researcher receives support from outside the U.S., either for that project or others, then it must be disclosed as “other support.” This means that NIH would not typically regard a visiting researcher with a salary paid by her foreign institution to be a “foreign component” requiring prior approval if she works in a laboratory in the U.S. on an NIH-supported project. However, her service would likely be considered “other support” for the senior/key personnel and would be reportable to NIH as such.

Financial Conflict of Interest

The agency’s new guidance documents do not elaborate on its financial conflict of interest regulation, found at 42 CFR Part 50, Subpart F, except to emphasize that investigators must report all sources of income to their institutions and that these duties to disclose income related to one’s primary appointment are distinct from, and in addition to, the other support and foreign component disclosures that must be made to the NIH.

Implications

It remains to be seen how much this new guidance will allay concerns about how the government is examining and accounting for possible undue foreign influence in federally-funded research. 

It is important at this time in history that attention continue to be paid to the many valuable contributions of foreign and non-native scientists working in the United States and foreign collaborators working to advance U.S.-funded research activities around the globe. NIH has continued to emphasize this, noting again in the Open Mike blog describing this new guidance that the “overwhelming majority of researchers participating in NIH grants, whether U.S. or foreign-born, are honest contributors to the advancement of knowledge that benefits us all.” This bears repeating, especially as methods for accurate and proper reporting of foreign ties are implemented and refined.

Additionally last week, the White House’s Office of Science and Technology Policy hosted a high-level, intergovernmental leadership meeting focused, among other issues, on “undue foreign influence” in research and developing further guidance, including possibly standardizing conflict of interest and commitment disclosure requirements and enforcement. Engaging the academic and research communities is expected to be a key element of this process over time.

The new documents for review are:

Information on the White House Office of Science and Technology Policy activities may be found here

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions