Web notes  

January 2022

Updated Guidance from NIH on COVID-19 Flexibilities for Applicants and Recipients

This notice is in follow-up to the research administration guidance regarding COVID-19 agency flexibilities extended to applicants and grantees. The NIH has again updated their guidance on COVID-19 flexibilities. In light of the recent update, the University Research Administration offices (JHURA, SOM ORA, and BARA) are offering the following revised guidance to JHU faculty:

1. Salaries charged to sponsored awards. Researchers are encouraged to continue to work on their projects to the extent possible, using telework and other methods consistent with the current restrictions. Under existing OMB guidelines, which are in effect until June 15, 2020, personnel who are budgeted to a grant, but cannot perform work on the grant because of COVID 19 restrictions, may continue to be charged consistent with this current JHU statement on the JHU COVID Hub site (https://hub.jhu.edu/novel-coronavirus-information/research-preparedness/covid-19-faqs/). In these cases where researchers are not able to carry out any work on their sponsored projects, faculty must notify their applicable Research Administration office (JHURA/SOM ORA/BARA). The Research Administration offices will facilitate notifications to the applicable funding agency program officers and the University Financial Research Compliance office.

In addition, NIH has indicated that researchers must report adverse effects resulting from the COVID 19 pandemic on the conduct of NIH funded research in the RPPR's that are due within the next 90 days. Understanding that there may have been delays in the progress of the project, when preparing the RPPR, investigators should outline details related to the disruptions to the research efforts. NIH has stated that they remain committed to working with recipients and will consider the effects that are reported by the recipient when reviewing and approving the RPPR, including any delays in the submissions of RPPRs and other reports. See NOT-OD-20-086 for details on late submission. Please work with your applicable research administration office when submitting your RPPR.

    2. Salaries charged to new sponsored awards. The NIH has stated that recipients may not initiate charges for salaries and benefits on new awards where the work has not yet started because of COVID restrictions, unless the performance can commence immediately (i.e. COVID research taking place on campus) or if the project can begin progressing via telework.

    3. Foreign Component. For post-docs that returned to, or were unable to return from a foreign country due to COVID-19 travel restrictions, but are working remotely from that site, where no grant funds are going to a foreign entity, NIH has determined that this scenario does not constitute the performance of a significant scientific element or segment of the project outside the US, as outlined in the NIH Grants Policy Statement definition of a foreign component. You do not need to seek approval for a foreign component in such cases.

    As a general reminder, researchers should be monitoring activity on research projects, and ensuring that personnel are accurately recording in the E210 when they are not able to work. For purposes of progress reports, applications for administrative supplements, and extensions, principal investigators should be tracking and documenting additional costs resulting from COVID-19 disruption and the impact it has had on the project.

We will continue to update you on any COVID-related guidance as we receive it. Please contact your Research Administration office for any additional questions you may have.

COVID-19 and Research Updates

The Office of the Vice Provost for Research (VPR) is regularly updating the JHU Response website with information specific to COVID-19. See the most recent updates listed below and please contact us if you have any questions.

Nine research response teams with diverse expertise have been assembled to find solutions amidst the COVID-19 pandemic. Want to get involved? Read about the aims of the COVID-19 Research Response Program Areas and fill out an interest form here.

Point of Contact for NIH Loan Repayment Program

The Institutional Business Official (IBO) for the School of Medicine is different than the IBO contact for JHURA.

School of Medicine Point of Contact:
Institutional Business Official (IBO): Karen Falter
(email address): kjustice@jhmi.edu

ERA Commons ID: KFalter1

Karen Falter is the Institutional Business Official for the School of Medicine and the email (kjustice@jhmi.edu) should be used.

Extramural Loan Repayment Program for Clinical Researchers

This notice provides program specific information on the NIH Loan Repayment Programs (LRPs) established by Congress and designed to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers.

An IBO represents the LRP applicant's employing institution in an official capacity and will be asked to certify that an applicant:

  • is a U.S. citizen, U.S. national, or permanent resident of the U.S.;
  • is not a federal or for-profit employee;
  • is employed to conduct research for an average of at least 20 hours a week per quarter (13 weeks) by a domestic, non-profit organization;
  • has protected research time for the length of the award and the research is not prohibited by Federal law.
For more information, read the full NIH Notice: NOT-OD-19-116

JHU SOM Update on NIH Policy on Foreign Involvement

NIH has 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.

Institutional Letter of Support Required for Institutional Training Grant Applications

All 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 website.

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.
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.

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/

January 2022 articles:
Essential Information for Human Subjects Research Teams Related to COVID-19
Fundamentals of Research Coordination: A Course for Research Staff
Coronavirus Research Billing Notices and FAQ
Managing Investigational Product Returns from Research Participants
Update to Organization Policy on Registration of Clinical Trials
Changes in HSR Recertification
Update on Insurance and Research Participant Financial Responsibility Information Sheet: Signature No Longer Required
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
Changes to NIH-funded Human Subjects Research
Free Resources for Longitudinal Clinical Research Studies
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
New Year! New Inspection Items!
BioRAFT Chemical Registry
Johns Hopkins 2021-22 Flu Campaign
Johns Hopkins Occupational Health Services
Dual Use Research of Concern (DURC) policies
COVID-19 Funding Opportunities
The Packard Fellowship for Science and Engineering
Michael J. Fox Foundation (MJFF) Challenge
Updated Guidance from NIH on COVID-19 Flexibilities for Applicants and Recipients
COVID-19 and Research Updates
Point of Contact for NIH Loan Repayment Program
JHU SOM Update on NIH Policy on Foreign Involvement
Disclosure of Payments from Foreign Educational Institutions and Government Agencies
Institutional Letter of Support Required for Institutional Training Grant Applications
NIH Policy on Foreign Component Involvement
NIH Policy: Foreign Components Added to a Grant to a Domestic or Foreign Organization

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