FOA-Notice of Special
Interest (NOSI): Emergency Competitive Revisions for Social, Ethical, and
Behavioral Implications (SEBI) Research on COVID-19 Testing among Underserved
and/or Vulnerable Populations; September 9, 2020
Notice
Number:
NOT-OD-20-119
Release
Date:
June
12, 2020
First
Available Due Date:
July
08, 2020
Expiration
Date:
September
09, 2020
PA-20-135 -
Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement -
Clinical Trial Optional)
NOT-OD-20-121 -
Notice of Special Interest (NOSI): Limited Competition for Emergency Competitive
Revisions for Community-Engaged Research on COVID-19 Testing among Underserved
and/or Vulnerable Populations
NOT-OD-20-120 -
Notice of Special Interest (NOSI): Emergency Competitive Revisions for
Community-Engaged Research on COVID-19 Testing among Underserved and/or
Vulnerable Populations
RFA-OD-20-013-
Emergency Awards: RADx-UP Coordination and Data
Collection Center (CDCC) (U24 Clinical Trial
Optional)
Office
of The Director, National Institutes of Health
(OD)
National
Institute on Minority Health and Health Disparities (NIMHD)
National
Institute on Aging (NIA)
National
Eye Institute (NEI)
National
Heart, Lung, and Blood Institute (NHLBI)
National
Human Genome Research Institute (NHGRI)
National
Institute on Alcohol Abuse and Alcoholism (NIAAA)
National
Institute of Allergy and Infectious Diseases (NIAID)
National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National
Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice
Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
National
Institute on Deafness and Other Communication Disorders (NIDCD)
National
Institute of Dental and Craniofacial Research (NIDCR)
National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National
Institute on Drug Abuse (NIDA)
National
Institute of Environmental Health Sciences (NIEHS)
National
Institute of General Medical Sciences (NIGMS)
National
Institute of Mental Health (NIMH)
National
Institute of Neurological Disorders and Stroke (NINDS)
National
Institute of Nursing Research (NINR)
National
Library of Medicine (NLM)
Fogarty
International Center (FIC)
National
Center for Complementary and Integrative Health (NCCIH)
National
Center for Advancing Translational Sciences (NCATS)
National
Cancer Institute (NCI)
All
applications to this funding opportunity announcement should fall within the
mission of the Institutes/Centers. The following NIH Offices may co-fund
applications assigned to those Institutes/Centers.
Sexual
and Gender Minority Research Office (SGMRO)
Tribal
Health Research Office (THRO)
Office
of The Director, National Institutes of Health
(OD)
Division
of Program Coordination, Planning and Strategic Initiatives, Office of Disease
Prevention (ODP)
Office
of Behavioral and Social Sciences Research (OBSSR)
Office
of Research on Women's Health (ORWH)
This
Notice of Special Interest (NOSI) highlights the urgent need to understand the
social, ethical, and behavioral implications (SEBI) of COVID-19 testing among
underserved and/or vulnerable populations across the United States through the
Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP)
initiative. The overarching goal is to understand factors that have led to
disproportionate burden of the pandemic on these underserved populations so that
interventions can be implemented to decrease these disparities. The funding for
this supplement is provided from the Paycheck Protection Program and Health Care
Enhancement Act, 2020.
The
Office of the Director is therefore offering Emergency Competitive Revisions to
active eligible grants and cooperative agreements addressing the objectives
described below. This NOSI is one of four related RADx-UP opportunities. The purpose of this SEBI NOSI is to
identify, analyze, and address the social, ethical, and behavioral factors
likely to influence access and uptake of COVID-19 testing in underserved and/or
vulnerable populations. Single or mixed methods approaches involving community
partners will inform the development and evaluation of such testing programs.
These studies will assess the ethical, historical, healthcare, social and
contextual factors surrounding COVID-19 testing, as well as how cultural beliefs
and attitudes, perceived expectations, and preferences influence the ability and
willingness to get tested and participate in follow-up evaluations. Findings
will be used to develop interventions to mitigate barriers to access and
increase uptake of testing. Studies focused on unintended consequences of
COVID-19 testing in these groups are also of interest when related to social and
ethical issues.
The
related program initiatives include:
Collectively,
projects funded under these three NOSIs will serve as one consortium of
interlinked community-engaged research projects across the United States to
understand COVID-19 health disparities, and to deploy implementation strategies
to improve the reach, acceptance, uptake, and sustainability of COVID-19
testing.
NIH
expects that all supplements funded under this NOSI and the related NOSIs will
actively coordinate and share data (where allowed) with other grantees, the
CDCC, and other research supported by the RADx-UP
program.
Research
that specifically develops or implements novel COVID-19 testing programs for
the UP populations as defined below under Key Definitions should be submitted
under either NOT-OD-20-120 or NOT-OD-20-120instead
of this NOSI. Applicants to this SEBI NOSI are allowed, but not required, to
apply to the other RADx-UP opportunities.
Researchers applying to this NOSI are strongly encouraged to read all four of
these interrelated funding opportunities.
Researchers
applying to this NOSI are strongly encouraged to read all four of these
interrelated funding opportunities.
Key
Definitions
This
NOSI is applicable to those populations that are underserved as well as
populations that are COVID-19 vulnerable due to medical, geographic, and social
factors, as defined below (referred to as “underserved and/or vulnerable”
elsewhere in this NOSI):
Underserved:
NIH-designated health disparity populations and/or other groups known to
experience barriers to needed health care services, or to have inadequate health
care coverage. A full description can be found at https://www.nimhd.nih.gov/about/overview/.
COVID-19
medically and/or socially vulnerable populations: Residents
of nursing homes and assisted living facilities; community-dwelling older
adults; individuals with intellectual, developmental, sensory, or physical
disabilities, cognitive impairment or dementia, or communication disorders;
homeless populations; individuals involved with the criminal or juvenile justice
systems (incarcerated or under community supervision); individuals with medical
comorbidities known to increase risk of severe COVID-19, including heart failure
and related cardiovascular conditions, diabetes mellitus, chronic lung disease,
obesity, HIV/AIDS; pregnant and post-partum women; children and adolescents;
individuals living in congregate housing such as shelters or residential
treatment facilities; individuals in overcrowded or public
housing; individuals with substance use disorders or serious mental illness;
detainees in immigration detention centers; migrant and immigrant communities;
residents of tribal lands or reservations; communities exposed to high rates of
air pollution or other toxic exposures; and rural and remote
communities.
Background
SARS-CoV-2
is a novel coronavirus that has recently been identified as the causative agent
of COVID-19, a respiratory disease that exhibits a wide range of clinical
outcomes from asymptomatic and mild disease to severe viral pneumonia, Acute
Respiratory Distress Syndrome (ARDS), Multisystem Inflammatory Syndrome in
Children (MIS-C), acute kidney injury, thrombotic disorders and serious
cardiac, cerebrovascular and vascular complications. United States Food and
Drug Administration (FDA)-authorized COVID-19 diagnostic testing is critical
for slowing the spread of the virus and preventing future outbreaks. Growing
evidence suggests that underserved and/or vulnerable populations are more
susceptible to COVID-19 infection, severe COVID-19 complications, and
associated death, as well as the social, behavioral and economic impacts of the
pandemic.
Over
the next six months, advances in testing technology and vaccine development are
anticipated. Strategies to accelerate the dissemination of these improved tests
and vaccine trials in underserved and/or vulnerable populations also must be
developed. However, these populations experience multilevel barriers to testing
arising at individual, interpersonal, institutional (e.g., health care system),
community, and policy levels – that reduce access to and acceptance of COVID-19
testing. Similar concerns have the potential to limit the uptake and public
health impact of future vaccination trials and implementation programs, and
dissemination of effective therapeutics in ambulatory care
settings.
Against
that backdrop, COVID-19 testing programs in underserved and/or vulnerable
populations must design communication strategies, consent materials, data
governance plans, processes to return results, and informational and referral
resources that are responsive to the communities they will serve. To inform the
development and evaluation of such testing programs, the studies solicited here
will focus on assessing how ethical, historical, healthcare, social, economic,
and contextual factors surrounding COVID-19 testing, as well as cultural
beliefs and attitudes, expectations, and preferences for testing and test
results influence these groups’ ability and willingness to get tested. These
factors may include but are not limited to individual and proximal
environmental factors such as normative beliefs, peer influence, and
incentive/disincentive structures in the social and community environment that
may influence testing uptake. The SEBI studies also will focus on factors at the
interpersonal, institutional (e.g., health system), community, and policy levels
that affect access to COVID-19 testing among underserved and/or vulnerable
populations. Findings will be used to inform development of intervention
strategies and tools to increase access to and acceptability of testing in
specified populations. These findings may help guide the design of
implementation strategies in other domains of the consortium (see,
NOSI NOT-OD-20-121 and
NOSI NOT-OD-20-120,
respectively]) or in Phase II of the RADx-UP
initiative (to be announced at a later date), which will address developments
in diagnostics and vaccination.
Studies
supported under this NOSI should work closely with communities to support in
depth examination of social, ethical and behavioral factors related to COVID-19
testing and vaccination research. Projects are also expected to specify
strategies to address social determinants of health (SDOH) that present
barriers to participation in testing and follow-up. RADx-UP projects are expected to demonstrate their ability
to leverage existing partnerships (such as with Tribal governments and
organizations, academic and community medical centers or health systems,
safety-net health or social service systems, grassroots organizations, public
health departments, community and faith-based organizations, and schools or
child care settings) to complete the study aims. Applicants should provide
evidence of collaboration with community organizations with whom they will work
and must describe the roles of all partners. Study budgets should include funds
for the community partners to be fully engaged and successfully participate in
research design and implementation.
To
address the expected impacts of COVID-19 on the scientific workforce, projects
are also strongly encouraged to support early stage investigators, specifically
targeting the ability to enhance diversity in their research
workforce.
Applicants
are strongly encouraged to contact SEBI program officials prior to developing
an application to determine programmatic responsiveness to the
NOSI.
Areas
of Research Interest
Supported
studies should address key questions at more than one level of analysis (e.g.,
individual, interpersonal, institutional [e.g., health system], community, and
policy). Scientific questions of interest include, but are not limited
to:
Applicants
are encouraged to consider and investigate:
Where
possible, applications should work towards outcomes or products that could be
used to improve access to and acceptability of COVID-19
diagnostics. Examples of possible study outcomes are included below.
However, researchers should address outcomes identified as high priority by the
communities being studied.
These
studies will focus on specific communities, yet they should also consider the
extent to which findings can be generalized or adapted and implemented across
other underserved and/or vulnerable populations. Applications should briefly
describe the generalizability, where possible, of study approaches and findings
to broader populations and include plans for the development of materials or
toolkits to facilitate adaptation, dissemination, and
implementation.
Applications
should detail community-engaged methods to assess barriers to COVID-19 test
access, uptake and follow-up, and develop and evaluate strategies or
interventions to address those barriers. Applications should include
dissemination activities that maintain bi-directional feedback loops with
community experts about RADx-UP study findings.
Development and pre-testing of potential interventions to increase testing
access, acceptability, feasibility, and uptake would be of interest. However,
they should not be the primary aim of the application. Potential applicants
considering applications focused on interventions to increase access and uptake
of COVID-19 diagnostics should consult as additional
opportunities.
Applications
may propose studies using either single or mixed methods. Proposed approaches
may include, but are not limited to hypothesis-generating qualitative and
quantitative approaches, observational research, randomized efficacy studies,
policy, economic and normative analyses, and other types of analytical and
conceptual research methodologies, such as those involving the direct
engagement of stakeholders.
Sample
Research Topics and Products
Broad
research topic areas are listed below, followed by examples of specific issues
within that area. The list of research topics and issues are not exhaustive,
and the order listed does not indicate relative priority. Also listed are
possible outcomes, products and tools that could be used to improve access and
uptake of COVID-19 testing. Applicants should develop aims and products
appropriate to the goals of this NOSI, in close collaboration with community
partners.
Decision-Making
about COVID-19 Diagnostics
Products
Return
of COVID-19 Test Results
Products
Data
Stewardship, Data Sharing and Privacy
Product
Health
Communication, Literacy, and Language Increasing
understanding about COVID-19 testing and vaccination are precursors to uptake.
Approaches should make use of multiple formats and channels and address
linguistic and cultural barriers.
Products
Vaccine
Preparedness in Underserved and/or Vulnerable
Populations
Products:
Applications
nonresponsive to terms of this NOSI will not be considered. The following
types of projects would generally not be appropriate and may be deemed
non-responsive:
To
maximize comparisons across datasets or studies, and facilitate data integration
and collaboration where appropriate to study aims, researchers funded through
this NOSI are strongly encouraged to use the following
resources:
Additionally,
researchers with funding through this NOSI will be required to share their
survey items, data collection instruments and methods for other researchers to
consider by submitting these resources to
Review
Process
Applications
will be evaluated for scientific and technical merit by an appropriate internal
NIH staff review panel, in accordance with the review criteria specified
in PA-20-135 as
well as these additional review criteria:
Pre-award
costs
Reporting
Application
and Submission Information
Applications
in response to this NOSI must be submitted using the Emergency Competitive
Revision to Existing NIH Awards (Emergency Supplement – Clinical Trial
Optional) mechanism (PA-20-135 https://grants.nih.gov/grants/guide/pa-files/PA-20-135.html),
or its subsequent reissued equivalents.
Eligibility
Eligible
existing grants that can be revised in response to this NOSI are limited to
eligible non-fellowship active research or resource grants and cooperative
agreements. Currently funded grantees may apply for work that is related to
their funded project, whether within the scope or outside of the scope of the
current project, regardless of the time remaining on the current project.
Grants currently in a no-cost extension are eligible to
apply.
All
instructions in the SF424
(R&R) Application Guide and
in the target funding opportunity announcement (PA-20-135)
must
be followed, with the following additions:
Specific
to applications that target PA-20-135 (Emergency
Supplements):
·
o
Competitive
revision applications to PA-20-135 must use the application form package with
the Competition ID that contains
"FORMS-F-COMP-REV".
Investigators
planning to submit an application in response to this NOSI are strongly
encouraged to contact and discuss their proposed research/aims with Program
staff listed on this NOSI well in advance of the application receipt date to
better determine appropriateness and interest of the
relevant Institute. Applicants are also strongly encouraged to notify
the Program staff listed on this NOSI that a request has been submitted in
response to this FOA in order to facilitate efficient processing of the
request.
The
Office of Behavioral and Social Sciences (OBSSR) does not accept assignment of
applications or manage awards that are funded. Please contact one of the ICs
listed below for inquiries regarding the suitability of the proposed project
for the FOA and the IC's research portfolio.
Applications
nonresponsive to terms of this NOSI will be withdrawn from consideration for
this initiative.
Please
direct all inquiries to the contacts in Section VII of the listed funding
opportunity announcements with the following
additions/substitutions:
National
Institute on Minority Health and Health Disparities
(NIMHD):
Scientific
Program Contact: Nancy Jones, PhD, 301.594.8945, nancy.jones@nih.gov
Grants
Management Contact: Priscilla Grant, JD, 301-594-8412, grantp@mail.nih.gov
National
Institute on Aging (NIA):
Scientific
Program Contact: Jonathan W. King, PhD., 301-496-3136, kingjo@nia.nih.gov
Grants
Management Contact: E. C. Melvin, 301-480-8991, e.melvin@nih.gov
Eunice
Kennedy Shriver National Institute of Child Health and Human Development
(NICHD):
Scientific
Program Contact: Sonia Lee, PhD, 301-594-4783, leesonia@mail.nih.gov
Grants
Management Contact: Bonnie Jackson, 301-496-5482, jacksonbo@mail.nih.gov
Fogarty
International Center (FIC):
Program
Contact: Marya Levintova, PhD, 301-496-1653, levintovam@mail.nih.gov
Grants
management Contact: Mollie Shea, 301-451-6830, Mollie.Shea@nih.gov
National
Cancer Institute (NCI):
Scientific
Program Contact: LeeAnn Bailey, PhD, MS,
240-276-5337, leeann.bailey@nih.gov
Grants
Management Contact: Crystal Wolfrey,
240-276-6277, wolfreyc@mail.nih.gov
National
Center for Advancing Translational Sciences (NCATS):
Scientific
Program Contact: Xinzhi Zhang, MD, PhD,
301-827-9205, xinzhi.zhang@nih.gov
Grants
Management Contact: Esther Young, 301-402-7138, esther.young@nih.gov
National
Center for Complementary and Integrative Health (NCCIH):
Scientific
Program Contact: Dave Clark, DrPH,
301-827-1916, Dave.Clark@nih.gov
Grants
Management Contact: Shelley Carow,
301-594-3788, carows@mail.nih.gov
National
Eye Institute (NEI):
Scientific
Program Contact: Cheri Wiggs, PhD, 301-451-2020, cheri.wiggs@nih.gov
Grants
Management Contact: Karen Robinson Smith, 301-451-2020, Karen.Robinson.Smith@nei.nih.gov
National
Heart, Lung, and Blood Institute (NHLBI):
Scientific
Program Contact: Catherine M Stoney, PhD, 301-435-6670, catherine.stoney@nih.gov
Grants
Management Contact: Tracee Forster, 301-827-8030, tracee.foster@nih.gov
National
Human Genome Research Institute (NHGRI):
Scientific
Program Contact: Dave Kaufman, PhD, 301-594-6907, dave.kaufman@nih.gov
Grants
Management Contact: Deanna Ingersoll, 301-435-7858, Deanna.Ingersoll@nih.gov
National
Institute of Allergy and Infectious Diseases (NIAID):
Scientific
Program Contact: Ann Namkung, MPH, 240-627-3099, anamkung@niaid.nih.gov
Grants
Management Contact: Ann Devine, 240-669-2988, Ann.Devine@niaid.nih.gov
National
Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS):
Scientific
Program Contact: Stephanie George, PhD, MPH, MA, (301) 594-4974, stephanie.george@nih.gov
Grants
Management Contact: Erik Edgerton, (301) 594-7760, edgertont@mail.nih.gov
National
Institute of Biomedical Imaging and Bioengineering
(NIBIB):
Scientific
Program Contact: Qi Duan, PhD, 301-827-4674, qi.duan@nih.gov
National
Institute of Dental and Craniofacial Research (NIDCR):
Scientific
Program Contact: Elise Rice, PhD, 301-594-4814, elise.rice@nih.gov
Grants
Management Contact: Diana Rutberg, 301-594-4798, rutbergd@mail.nih.gov
National
Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK):
Scientific
Program Contact: Paul L. Kimmel, MD, MACP, 301-594-1409, paul.kimmel@nih.gov
Grants
Management Contact: Natasha Loveless, 301-594-8853, natasha.loveless@nih.gov
National
Institute of Environmental Health Sciences (NIEHS):
Scientific
Program Contact: Gwen W. Collman, PhD,
984-287-3249, collman@niehs.nih.gov
Grants
Management Contact: Jenny Greer, 984-287-3332, jenny.greer@nih.gov
National
Institute of General Medical Sciences (NIGMS):
Scientific
Program Contact: Dorit Zuk, PhD, 301-827-7616, dorit.zuk@nih.gov
Grants
Management Contact:Christy Leake, 301-594-7706, Christy.leake@nih.gov
National
Institute of Mental Health (NIMH):
Scientific
Program Contact:Crystal
L. Barksdale, PhD, MPH, 301-443-7034, crystal.barksdale@nih.gov
Grants
Management Contact:Rita
Sisco, 301-443-2805, siscor@mail.nih.gov
National
Institute of Neurological Disorders and Stroke (NINDS):
Scientific
Program Contact:Richard
T. Benson, MD, PhD, 301-827-9071, Richard.benson@nih.gov
Grants
Management Contact:Chief
Grants Management Officer, ChiefGrantsManagementOfficer@ninds.nih.gov
National
Institute of Nursing Research (NINR):
Scientific
Program Contact:Jeri L.
Miller, PhD, 301-594-6152, jmiller@mail.nih.gov
Grants
Management Contact: Brian Albertini, 301-594-6869, albertib@mail.nih.gov
National Institute on Alcohol Abuse and Alcoholism
(NIAAA):
Scientific
Program Contact:Judith
A. Arroyo, PhD, 301-402-0717, jarroyo@mail.nih.gov
Grants
Management Contact: Judy Fox, 301-443-4704, jfox@mail.nih.gov
National
Institute on Deafness and Other Communication Disorders
(NIDCD):
Scientific
Program Contact:Judith
Cooper, PhD, 301-496-5061, cooperj@nidcd.nih.gov
Grants
Management Contact: Chris Myers, 301-435-0713, myersc@mail.nih.gov
National
Institute on Drug Abuse (NIDA):
Scientific
Program Contact:Richard
A. Jenkins, PhD, 301.443.1923, jenkinsri@nida.nih.gov
Grants
Management Contact:Pam
Fleming, 301.480.1159, pfleming@nida.nih.gov
National
Library of Medicine (NLM):
Scientific
Program Contact: Valerie Florance, PhD,
301-496-4621. florancev@mail.nih.gov
Grants
Management Contact:Samantha Tempchin,
301-496-4221, Tempchins@mail.nih.gov
Office
of the Director, Environmental Influences on Child Health Outcomes
(ECHO):
Scientific
Program Contact: Carol Blaisdell, MD, MEd,
301-435-5606, carol.blaisdell@nih.gov
Grants
Management Contact (ECHO Cohorts): Donna Sullivan, 240-669-2979, dsullivan@niaid.nih.gov
Grants
Management (ECHO ISPCTN) Contact: Bryan S. Clark, MBA
Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD),
301-435-6975, clarkb1@mail.nih.gov
Office
of Behavioral and Social Science Research (OBSSR):
Scientific
Program Contact: Deborah Young-Hyman, PhD, 301-451-0721; deborah.young-hyman@nih.gov
The
Office of Disease Prevention (ODP/DPCPSI/OD):
Scientific
Program Contact:Jacqueline Lloyd, PhD, MSW, 301.827.5559, lloydj2@nih.gov
Office
of Research on Women’s Health (ORWH):
Scientific
Program Contact: Damiya S. Whitaker, PsyD,
MA, 301-451-8206, damiya.whitaker@nih.gov
Sexual
and Gender Minority Research Office (SGMRO):
Scientific
Program Contact:Christopher Barnhart, PhD, 301-594-8983, Christopher.barnhart@nih.gov
Tribal
Health Research Office (THRO):
Scientific
Program Contact:Maria
Jamela Revilleza, PhD,
301-451-0724, MariaJamela.Revilleza@nih.gov
Link to Full
Announcement
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-119.html