Notice of NIAID’s Participation in PA-19-217 “Administrative Supplement for Research on Bioethical Issues (Admin Supp Clinical Trial Optional)"

Notice Number: NOT-AI-19-054

Key Dates
Release Date: April 05, 2019

Related Announcements
PA-19-217
NOT-OD-19-101

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice is to inform potential applicants that the National Institute of Allergy and Infectious Diseases (NIAID) is participating, effective immediately, in PA-19-217 “Administrative Supplement for Research on Bioethical Issues (Admin Supp Clinical Trial Optional)".

The following information (shown initalics) has been added:

Part 1. Overview Information

Components of Participating Organizations

National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute of Neurological Disorders and Stroke (NINDS)
Fogarty International Center (FIC)
National Center for Advancing Translational Sciences (NCATS)
National Heart, Lung, and Blood Institute (NHLBI)
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 of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Nursing Research (NINR)
Office of Strategic Coordination (Common Fund)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.121, 93.172, 93.173, 93.233, 93.242, 93.273, 93.286, 93.307, 93.310, 93.350, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.865, 93.866, 93.989

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Areas of Research Interest for the Administrative Supplement

The NIH seeks to fund research on ethical considerations related to biomedical research. The issues fall within the scope of research and policy activities of the NIH but may be beyond the focus of any one Institute or Center. Overarching areas of research interest may include but are not limited to:

  • New and emerging technology development and use, such as: gene editing; organoids; artificial intelligence; machine learning; brain implants and modulation; digital health; consumer-generated data
  • Clinical and non-clinical data sharing; big data and data science analytics; integration of data for research, including clinical, research, environment, social media, participant/patient provided, and other
  • Precision and personalized medicine
  • Personal, institutional, and research privacy and security
  • Learning Healthcare System; interface of clinical research and clinical care; pragmatic trials
  • Crowdsourcing, citizen science, and DIY biomedical research
  • Participant driven, directed, or sponsored clinical research
  • Patient/participant representation in research oversight, including appropriate return of research results and incidental findings
  • Special and vulnerable population research, including pediatric, palliative care, emergency, disaster, and pandemic research
  • Individual or community health, treatment, and/or research disparities; accessing and sharing benefits of research; post-study obligations
  • Issues related to the inclusion of Tribal and American Indian/Alaska Native populations
  • Issues related to the inclusion of populations underrepresented in research
  • Current and emerging regulatory environments
  • Innovative study design, conduct, management, and oversight, including methods for obtaining and documenting informed consent; virtual clinical trials
  • International research including research in resource-constrained settings, transnational research, and research in low and middle income countries
  • Research on stigmatized conditions
  • Historical analyses of bioethics issues
  • Novel approaches for enhancing bioethics infrastructure and training

In addition to overarching areas of interest, individual Institutes and Centers have indicated the following specific areas of research interest:

NCI

The National Cancer Institute (NCI) is interested in bioethics issues relevant to cancer research and care, such as issues raised in cancer clinical trials, cancer cohorts, cancer prevention studies, cancer centers, prospective biobanking, or projects using existing samples/tissues. Bioethical issues of interest include but are not limited to issues raised by new therapies/technologies; patient and participant perception and comprehension; patient, participant, and community engagement; return of results; and new methods for recruitment/retention of “hard to reach” participants. Additional issues may be found here:https://epi.grants.cancer.gov/bioethics-cancer-research.html.

NHGRI

The National Human Genome Research Institute (NHGRI) is interested in applications which investigate and address bioethical issues related to the use of genetics and genomics in research, clinical medicine and healthcare, and society. NHGRI supports studies into specific conditions or diseases only if the proposed work will produce knowledge that is generalizable or transferable to other genetic conditions.

NIA

The National Institute on Aging (NIA) is interested in applications that address topics relevant to its core mission. For more information, please see:https://www.nia.nih.gov/about/mission

FIC

The Fogarty International Center (FIC) is interested in research on ethical issues relevant to low- and middle-income countries, in particular, studies conducted by investigators in these countries.

NINDS

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in research on bioethical and neuroethical questions relevant to its mission to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. In addition to the general areas of interest listed above, areas of interest specific to NINDS include but are not limited to the ethical implications of: aspects of neuroscience research with human participants, such as differing stakeholder views on trial design, return of research results to participants, patient consent-related issues, or therapeutic misconception (including for rare diseases); research with brain organoids or ex vivo human brain tissue; collecting and sharing human brain data, such as de-identification, privacy, and re-use practices; the development and use of neuromodulation and neuroimaging technologies, such as device maintenance, data security, and intended and unintended uses of these technologies; predictive/diagnostic research related to brain disorders; and advances in neural recording and/or neuromodulation specifically for use in children. Additional information about the NINDS mission may be found here:http://www.ninds.nih.gov/about_ninds/mission.htm. Note that applications must consider bioethical and/or neuroethical questions and be within the general scope of the parent award. Also, NINDS will not consider applications that include basic research activities or research with vertebrate animals.

NCATS

The National Center for Advancing Translational Sciences (NCATS) is interested in research on ethical issues that cross disease domains and span the translational research spectrum. NCATS encourages collaboration between translational researchers and bioethics researchers on projects addressing ethical challenges in moving discoveries from laboratory, clinic, and community into interventions that improve health.

NIMHD

The National Institute on Minority Health and Health Disparities (NIMHD) is interested in supporting research projects on the ethical, legal, and social implications of research participation and/or health care for racial/ethnic minority or other health disparity populations. Areas of interest to NIMHD include but are not limited to studies that seek to understand or address cultural preferences; values and norms to ensure ethical and equitable conduct of research and delivery of health care; ethical integration of social and biomedical sciences (e.g., social epigenomics and incorporation of social determinants into the health care system); and mitigating stigmatization, group harms, and unintended social implications of research.

NICHD

TheEunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD) is interested in bioethical issues relevant to research involving children, pregnant women, and people with disabilities. Research in the fields of developmental biology, reproductive health, pediatrics, population health, and medical rehabilitation, research that addresses health disparities and improves prevention efforts among the populations served by NICHD, as well as areas identified as high-priority research areas to the institute are of particular interest. See andhttps://www.nichd.nih.gov/grants-contracts/research-areas/prioritiesfor the current research priorities for the institute and inhttps://www.nichd.nih.gov/about/org/strategicplanregarding future themes for the Institute.

NHLBI

The National Heart, Lung, and Blood Institute (NHLBI) is interested in research on bioethics issues relevant to its Strategic Vision (https://www.nhlbi.nih.gov/about/strategic-vision), and its focus on heart, lung, blood, and sleep conditions. Specific examples include, but are not limited to:

  • The return of research results (e.g., genomic, omic, environmental) to participants and communities, such as environmental toxins that may impact community health, the handoff between research and clinical care, and providing genetic counseling at large scales
  • Waivers of informed consent or obtaining consent from surrogates
  • Ethics of cardiopulmonary support
  • Novel and emerging technologies, such as machine learning bias or algorithm overreach and physician autonomy
  • Privacy and confidentiality (especially in large datasets), such as artificial intelligence applied to imaging data or concerns that may arise from multi-omics profiles
  • The impact of NIH policy changes, such as updates to the management of genomic summary results
  • Issues related to working with understudied or vulnerable populations (e.g., pregnant women, pediatric or perinatal patients, Indigenous groups), such as community engagement or ensuring equal access to research advances

Investigators are encouraged to contact NHLBI staff to discuss their ideas.

Investigators interested in developing applications for this funding opportunity announcement are strongly encouraged to discuss their ideas with specific IC contacts listed below prior to submission as ICs have varying levels of interest in high priority areas.

NIAAA

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in bioethics applications that address topics relevant to its mission and research priorities as provided in its strategic plan. For information, please see:https://www.niaaa.nih.gov/strategic-plan

NIAID

NIAID is particularly interested in supporting supplemental projects that focus on ethical issues relevant to domestic and international collaborative research on HIV/AIDS or its co-morbidities (TB, malaria, hepatitis, sexually transmitted infections), and other infectious diseases; ethics of clinical trials and implementation science; other ethical issues relevant to NIAID's scientific mission. Applications may include conceptual work in bioethics, or empirical work gathering and analyzing data relevant to ethical issues in research, or a combination of the two. For empirical projects, data collection may include quantitative or qualitative methods, or both. Although not intended to be an exhaustive list, of particular interest are projects on:

  • Ethical issues in research involving adolescents and young adults
  • Ethical issues in research on curing HIV
  • Ethical, legal and policy issues in research with big data
  • Ethics of research involving child-bearing age and pregnant women

Applications addressing empirical research on informed consent are not of interest.

NIAMS

The mission of The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. NIAMS also conducts and supports basic research on the normal structure and function of bones, joints, muscles, and skin. Basic research involves a wide variety of scientific disciplines, including immunology, genetics, molecular biology, structural biology, biochemistry, physiology, virology, and pharmacology. Clinical research areas include rheumatology, orthopedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. NIAMS is interested in bioethics topics relevant to its core mission.

NIBIB

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in applications that address topics relevant to its core mission. For more information, please see:https://www.nibib.nih.gov/research-funding.

NIDCD

The National Institute on Deafness and Other Communications Disorders (NIDCD) is interested in applications that address topics in the areas of hearing, balance, taste, smell, voice, speech, and language. For more information, please see:NIDCD Strategic Plan.

NIDCR

The National Institute of Dental and Craniofacial Research (NIDCR) is interested in applications that propose bioethics research relevant to dental, oral, and craniofacial health. For more information, please see:https://www.nidcr.nih.gov/about-us/mission.

NIDDK

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in applications that address topics relevant to its core mission. For more information, please see:NIDDK Research Areas.

NIMH

Priority areas for research include but are not limited to bioethical considerations around privacy issues; consent capacity, agency, and autonomy; use of predictive analytics; safety monitoring; participant, provider, and community perceptions and comprehension of research; issues related to the engagement and recruitment of understudied groups; and additional safety and ethical considerations necessary for conducting research in populations at risk for suicide (https://www.nimh.nih.gov/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers.shtml). In addition, the bioethics of new interventions and technologies, biobanking approaches, and use of biospecimens and biopreparations are of interest.

NINR

NINR is interested in studies examining the bioethical issues related to end of life and palliative care (EOLPC) research that consider (including but not limited to):

  • The EOLPC needs of individuals with serious, advanced illness, particularly in vulnerable populations such as: children, frail elderly, and individuals with limited decision-making capacity.
  • Prioritization of patient preferences, beliefs, and values with respect to treatment and/or end of life decision making.
  • The needs/challenges of families, caregivers, and proxy decision makers of individuals with serious, advanced illness.
  • Disparities in access to EOLPC for individuals across settings (urban, rural, remote), including differences among socioeconomic, racial/ethnic and geographic sub-populations.

Because of the complex, multi-factorial nature of this issue, multi-disciplinary teams are highly encouraged.

Common Fund

Office of Strategic Coordination (Common Fund) -supported projects that propose to include relevant investigations of Research on Bioethical Issues are eligible to apply.

Section VII. Agency Contacts

Scientific/Research Contact(s)

Jennifer Plank-Bazinet, Ph.D.
Office of Science Policy/Office of the Director (OSP/OD)
Telephone: 301-435-8342
Email:jennifer.bazinet@nih.gov

Nicole Lockhart
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2493
Email:lockhani@mail.nih.gov

Tammara Jenkins, MSN, RN, PCNS-BC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6837
Email:tjenkins@mail.nih.gov

Mollie Minear, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0448
Email:mollie.minear@nih.gov

Aynur Unalp-Arida, MD, MSc, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8879
Email:aynur.unalp-arida@nih.gov

Khara Ramos, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-594-2614
Email:khara.ramos@nih.gov

Barbara Sina, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-402-9467
Email:sinab@mail.nih.gov

Elaine Collier, M.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0794
Email:colliere@mail.nih.gov

Emilie Caga-Anan, J.D.
National Cancer Institute (NCI)
Telephone: 240-276-6738
Email:charlisse.caga-anan@nih.gov

Kristina McLinden, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-827-2563
Email:kristina.mclinden@nih.gov

Pamela Wernett, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-827-5391
Email:wernettpj@mail.nih.gov

Joana Roe
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3213
Email: Joana.Roe@nih.gov

Robyn Bent, M.S.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-827-2272
Email:robyn.bent@nih.gov

Todd Merchak
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8592
Email:merchakt@mail.nih.gov

Trinh Ly, M.D.
National Institute of Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email:trinh.ly@nih.gov

Leslie Frieden, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-4263
Email:leslie.frieden@nih.gov

Andrea Beckel-Mitchener, Ph.D
National Institute of Mental Health (NIMH)
Telephone: 301-443-2847
Email:amitchen@mail.nih.gov

Nancy Jones, Ph.D., M.A.
National Institute on Minority and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email:jonesna@nimhd.nih.gov

Lynn Adams, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-8911
Email:adamsls@mail.nih.gov

Leslie K. Derr, Ph.D.
Office of Strategic Coordination (Common Fund)
Telephone: 301-594-8174
Email:derrl@mail.nih.gov

Financial/Grants Management Contact(s)


Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email:clarkb1@mail.nih.gov

Eunica Haynes

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Telephone: 301-827-4018

Email:Haynese@niddk.nih.gov

Tawana McKeither
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-9238
Email:tawana.mckeither@nih.gov

Tijuana Decoster, Ph.D.
National Institute Neurological Disorders Stroke (NINDS)
Telephone 301-496-9531
Email:decostert@mail.nih.gov

Monique Day, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4797
Email:Monique.day@nih.gov

Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-2075
Email:butrumb@mail.nih.gov

Harvey Kincaid
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0850
Email:harvey.kincaid@nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email:wolfreyc@gab.nci.nih.gov

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email:Deanna.Ingersoll@nih.gov

Traci Lafferty
National Institute on Aging (NIA)
Phone: 301-496-8987
Email:laffertt@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email:jfox@mail.nih.gov

Dhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
Email: Vandhana.Khurana@nih.gov

Leslie Littlejohn
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5055
Email:Leslie.Littlejohn@nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email:myersc@mail.nih.gov

Diana Rutberg, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email:rutbergd@mail.nih.gov

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email:theresa.jarosik@nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email:pg38h@nih.gov

Ronald Wertz
National Institute of Nursing Research (NINR)
Telephone: (301) 594-2807
Email:wertzr@mail.nih.gov

Chris Darby
Office of Strategic Coordination (Common Fund)
Telephone: 301-480-1059
Email:DarbyCh@mail.nih.gov

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Joana Roe
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3213
Email: Joana.Roe@nih.gov