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| August 2021 |
| GRANT AND CONTRACT PROCEDURES-
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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.
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Research
Resources (reagents, BSL-3 labs, ICTR Clinical Research
Coordinating Committee, etc.)
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Reminder on NIH
guidance for charging salaries and stipends to grants
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FAQs
on grants administration guidance
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
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:
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is a U.S. citizen, U.S. national, or permanent
resident of the U.S.;
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is not a federal or for-profit employee;
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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;
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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:
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Applications that do not include this letter
will be withdrawn.
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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.
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This letter is required in addition to the
commitment letter that describes institutional support for the training
program.
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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:
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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.
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If you are proposing a new foreign component,
mid-project, propose the new foreign involvement in your RPPR.
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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:
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The involvement of human subjects
or vertebrate animals at a foreign site.
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Extensive foreign travel by grantee project
staff for the purpose of data collection, surveying, sampling, and
similar activities.
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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:
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/
nihgps_ch16.htm#_Toc27126527
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