Web notes  

June 2019

JHU SOM Update on NIH Policy on Foreign Involvement

NIH has recently (January 17, 2019) provided clarification of their foreign collaboration policies as follows:

I. Foreign Other Support must be disclosed to NIH in advance, by including it in the Just-in-Time Other Support submission on a new or renewal award, or updated in the annual RPPR, or submitted by letter to the awarding office and thereafter included in the RPPR. For example, "Visiting scientist, name, degree, role on project, supported by institution, country, for the period of __/__/____ to __/__/____. "

II. Foreign Involvement, requiring NIH Prior Approval, only applies to NIH work scope performed in a foreign location, either funded by the NIH grant or by other sources, domestic or foreign. Continued collaboration (e.g., research data generation, data analysis, etc.) by a foreign supported scientist or student, who had previously been visiting the grantee institution and reported as Other Support, upon their return to their foreign home institution, would require NIH prior approval for foreign involvement.

III. Foreign personal payments received by a funded investigator, including stipends and honorariums, must be disclosed to JHU via eDisclose and evaluated by the institution for COI under the PHS regulations and JHU policies. Additionally, sponsored or reimbursed travel must be disclosed when the value received from a single foreign entity reaches or exceeds $5,000 during a twelve month period.

Disclosure of Payments from Foreign Educational Institutions and Government Agencies

Please remember that existing Public Health Service (including NIH) conflict of interest regulations are applicable to payments you may receive from foreign universities, research organizations, and government agencies.

While it is normal as part of our international collaborations that faculty may from time to time be invited to speak at or participate in activities with a foreign institution, relevant Public Health Service regulations and our policy require that you disclose financial interests, payments, or support that you receive directly from foreign universities and government agencies. Although the policy does not require disclosure of payments from institutions of higher education that are located within the U.S., or U.S. federal, state or local government agencies, you must disclose all financial interests in and payments from foreign institutions of higher education (e.g., universities, academic medical centers, research institutes) or governments of another country (including local, provincial, or equivalent governments).

Section C of the School of Medicine's Policy on Disclosure and Professional Commitment outlines the details of these requirements. Disclosures should be made in JHU eDisclose. Please direct any questions to policy@jhmi.edu.

As a final reminder, financial interests in and payments from all commercial entities, as outlined in the policy, regardless of where they are incorporated, must also be disclosed. Your attention to this reminder is appreciated.

New Institutional Letter of Support Required for Institutional Training Grant Applications

Effective January 25, 2019, NIH institutional training grants (T15, T32, T34, T35, T36, T37, T90/R90, TL1, TL4) must include an letter outlining the institutional policies and procedures JHU has in place to prevent discriminatory harassment and practices. The letter is available for download on the SOM Research Administration web site.

As you develop your applications, please be mindful of the following:

  • Applications that do not include this letter will be withdrawn.
  • This letter must be uploaded to the Letters of Support Section located on the PHS Research Training Program form/tab. Do not upload it to the Appendix or the Other Attachment fields.
  • This letter is required in addition to the commitment letter that describes institutional support for the training program.
  • The letter must be included in all institutional training grant applications submitted for deadlines on or after January 25, 2019.
Read the full NIH policy notice here: NOT-OD-19-029. Please do not hesitate to contact your assigned Grants team representative if you have questions.

Notice to the Johns Hopkins Community Regarding the National Science Foundation Grant Reporting Requirement for Harassment Findings and Actions

The National Science Foundation ("NSF") released a final grant term and condition on September 21, 2018, requiring institutions that receive NSF funds to report to the NSF findings about any NSF funded principal investigator or co-principal investigator ("PI/co-PI") of sexual harassment, sexual assault, or other harassment based on a protected category (such as race, religion, sexual orientation or national origin). The new reporting requirement applies to NSF grants awarded on or after October 21, 2018, and to any funding amendments to existing NSF awards issued on or after October 21, 2018. The NSF grant term also requires reporting of any administrative action that Johns Hopkins may take during the pendency of any investigation (including suspensions, bans from campus or restrictions on the PI/co-PI's ability to interact with lab members) which may affect the NSF funded work. The Office of Institutional Equity will work closely with the responsible research offices at Johns Hopkins to ensure that, should a report to NSF be required by this new grant term, the appropriate report is made to the NSF Office of Diversity and Inclusion within ten business days. Should the NSF require any changes in an award as the result of a report, the responsible research office will work with the NSF to implement such changes.

Johns Hopkins is committed to ensuring that its work, research and teaching environment is free of all forms of harassment and discrimination based upon a protected class, including sexual misconduct. More information about the NSF grant term and condition is available here: https://www.nsf.gov/od/odi/term_and_condition.jsp. More information about Johns Hopkins policies and procedures related to investigating and responding to allegations of sexual harassment, sexual assault, or discrimination are available here: http://oie.jhu.edu/.

Prohibited Mention of Prior Review for New Replacement Applications

If you are submitting a revised application that does not qualify as an A1 resubmission, you are prohibited from referring to the prior review and must present the application as a new application. Recently a limited RFA application, submitted because the revised application was also unfunded, was rejected because the PI included reference to the prior review and priority score of the prior resubmitted application. Get more information on this policy or view Frequently Asked Questions about resubmissions.

NIH Policy on Foreign Component Involvement

Foreign collaborations involving NIH funding have always required prior approval. Recent congressional concern over the U.S. losing IP to foreign countries has led to a reminder announcement in May, recent close review of RPPR cited publications to confirm compliance and a special announcement by NIH Director Collins. While most PIs understand that the policy applies to sub-awards of federal $s for foreign performance of part of the work scope, the latest announcement has clarified that the policy also applies to foreign conduct of any of the work scope regardless of the source of funding. Based on program officer reviews recently received, such involvement also includes unfunded collaborations with a foreign entity or a foreign person, including visiting scholars, graduate students, and fellows funded by their home country, exchanging material and/or data, or other use of foreign resources. The announcement in May appears below.

Please note:

  • If you have such a foreign involvement with a current NIH or other federal award, prepare a letter explaining the relationship, you recent awareness of the clarified policy, and request approval from your program officer for the foreign involvement. Your ORA Grants Associate must countersign the letter before it is submitted.
  • If you are proposing a new foreign component, mid-project, propose the new foreign involvement in your RPPR.
  • If you are applying for a new or competitive renewal with foreign involvement, the applicable application instructions are located in part 6, posted at: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/research-forms-e.pdf.

NIH Policy: Foreign Components Added to a Grant to a Domestic or Foreign Organization

Adding a foreign component under a grant to a domestic or foreign organization requires NIH prior approval. For purposes of this policy, a foreign component is defined as performance of any significant element or segment of the project outside the United States either by the grantee or by a researcher employed by a foreign institution, whether or not grant funds are expended. Activities that would meet this definition include the following:

  • The involvement of human subjects or vertebrate animals at a foreign site.
  • Extensive foreign travel by grantee project staff for the purpose of data collection, surveying, sampling, and similar activities.
  • Any activity of the grantee that may involve the population, environment, resources, or affairs 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.
A change in the performance site within a foreign country or the addition of a performance site in a country other than that specified in the approved application requires NIH awarding IC prior approval. The transfer of work by a domestic grantee to a foreign component also requires awarding IC prior approval. For more information on this policy, visit: http://grants.nih.gov/grants/policy/nihgps_2013/

Why Project Outcomes Matter in your Interim and Final Research Performance Progress Report (RPPR)

The next time you are completing your interim or final Research Performance Progress Report (RPPR) for your NIH grant, pay special attention to writing the project Outcomes section (Section I). Any project outcomes submitted on or after October 1, 2017 will be made available to the general public via NIH's Research Portfolio Online Reporting Tool (RePORTER).

Please see the blog post from Dr. Michael Lauer, NIH's Deputy Director for Extramural Research for more information and tips on how to write the Outcomes section of your RPPR.

NIH Matchmaker, A Tool For Finding Similar NIH Projects

Matchmaker is a new extension of the NIH RePORTER website system that makes it easy to find similar projects already funded by the NIH. Matchmaker takes user-submitted scientific text, and analyzes it for relevant terms and concepts and compare those terms and concepts to other funded research projects from the NIH. Matchmaker then returns up to 100 similar projects, including a graphical overview highlighting the study sections that reviewed similar projects, the NIH institutes and centers that funded the projects, and the activity codes of those similar projects. More information about Matchmaker and NIH RePORTER page can be found at http://projectreporter.nih.gov. You may also view this short informational video about Matchmaker.

NIH Video Tutorials on How to Apply for Grants

The NIH Office of Extramural Research (OER) has developed several video tutorials to walk researchers through the process of applying for grants. The 4-part series covers the basics of preparing, writing, and submitting an application. Review these video tutorials on the NIH OER website.

June 2019 articles:
Research Billing Buzz eNewsletter - May 2019
Third Thursdays with the ICTR Lecture Series
Clinical Research Annual Reports
Change in JHM IRB Review Fees for Commercially-Funded Studies
Data and Safety Monitoring Board Training Manual Now Available
Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Change in Federalwide Assurance [FWA] Numbers
Changes to NIH-funded Human Subjects Research
Free Resources for Longitudinal Clinical Research Studies
NIH Requirement for Single IRB (sIRB)
JHM IRB Reliance Requests
Sharing Partnership for Innovative Research in Translation
Johns Hopkins Institute for Clinical and Translational Research
Johns Hopkins Clinical Research Network
Visit Animal Care and Use Committee Website
Current Classes
"Interinstitutional Assurance" Agreement
Health, Safety, and Environment (HSE) presents: Safety in Research Updates
Funding for Prostate Cancer Research
Michael J. Fox Foundation (MJFF) Challenge
JHU SOM Update on NIH Policy on Foreign Involvement
Disclosure of Payments from Foreign Educational Institutions and Government Agencies
New Institutional Letter of Support Required for Institutional Training Grant Applications
Notice to the Johns Hopkins Community Regarding the National Science Foundation Grant Reporting Requirement for Harassment Findings and Actions
Prohibited Mention of Prior Review for New Replacement Applications
NIH Policy on Foreign Component Involvement
Why Project Outcomes Matter in your Interim and Final Research Performance Progress Report (RPPR)
NIH Matchmaker, A Tool For Finding Similar NIH Projects
NIH Video Tutorials on How to Apply for Grants

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