Expired NOT-OD-21-020: Notice of Special Interest: Administrative Supplement for Research and Capacity Building Efforts Related to Bioethical Issues (Admin Supp Clinical Trial Optional)

Notice of Special Interest: Administrative Supplement for Research and Capacity Building Efforts Related to Bioethical Issues (Admin Supp Clinical Trial Optional)

Notice Number:

NOT-OD-21-020

Key Dates

Release Date:

November 17, 2020

First Available Due Date:

December 16, 2020

Expiration Date:

March 06, 2021

Related Announcements

NOT-OD-22-026 - Notice of Special Interest: Administrative Supplement for Research and Capacity Building Efforts Related to Bioethical Issues (Admin Supp Clinical Trial Optional)

NOT-OD-21-042 - Notice of Correction to NOT-OD-21-020 Application and Submission Information

NOT-OD-20-038 - Notice of Special Interest: Administrative Supplement for Research on Bioethical Issues (Admin Supp Clinical Trial Optional)

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

Office of The Director, National Institutes of Health (OD)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

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 Institute on Minority Health and Health Disparities (NIMHD)

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)

Food and Drug Administration (FDA)

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.

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Tribal Health Research Office (THRO)

Purpose

The NIH Office of Science Policy (OSP) within the Office of the Director (OD) announces the availability of administrative supplements to support 1) research on bioethical issues to develop or support the development of an evidence base that may inform future policy directions, and/or 2) certain efforts to develop or augment bioethics research capacity. Applicants may propose to supplement parent awards focused on bioethics or to add a component related to bioethics to a parent award in which bioethics was not the focus. Note that applications must be within the general scope of the parent award.

Background

Ethical considerations are intrinsic to the responsible conduct of biomedical research and the translation of scientific and technological advances into practice. Research into bioethical issues can provide an evidentiary basis to guide conduct, content, and/or application of the biomedical and behavioral sciences and their associated policies, which becomes of increasing importance as science and societal views continue to evolve. Ethical questions and challenges are interlinked with many of NIH’s general areas of scientific priority, such as responding to public health needs (e.g., the opioid crisis, desire for precision medicine interventions) and emerging scientific opportunities (e.g., new data sharing infrastructure, innovative technologies). The investment in and the integration of bioethics-related research and policy demonstrate NIH’s commitment to safeguarding the integrity of the research that it conducts and supports, which, in turn, facilitates public participation and trust in the research enterprise.

This administrative supplement funding opportunity announcement will provide an opportunity for NIH-supported grantees to 1) conduct research on bioethical issues to develop or support the development of an evidence base that may inform future policy directions, and/or 2) develop projects that support certain types of capacity building efforts in bioethics.

Specific Areas of Interest

The NIH seeks to fund research on ethical considerations related to biomedical research and projects that support capacity building in bioethics. Applications should propose 1) research on topics that can provide or support the development of an evidence base that may inform future policy directions, and/or 2) certain efforts to develop or augment bioethics research capacity.

Research on topics that can provide or support the development of an evidence base that may inform future policy directions

Policies of interest include current NIH-issued policies or potential future policy directions, other federal policies, laws, and regulations, as well as policies governing the practice of research, medicine, or public health. Issues of interest fall within the scope of research supported by the NIH but may be beyond the focus of any one Institute or Center. Overarching areas of interest may include but are not limited to:

New and emerging technology development and use, such as: gene editing; organoids; artificial intelligence; machine learning; neural implants and invasive or non-invasive modulation; digital health; consumer-generated data; synthetic biology
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 data types; biases in datasets and algorithms
Precision and personalized medicine
Personal, institutional, and research privacy and security
Learning Healthcare System; interface of clinical research and clinical care; pragmatic trials; real-world data
Crowdsourcing, citizen science, and DIY biomedical research
Participant driven, directed, or sponsored clinical research
Patient/participant representation in research oversight and study design
Appropriate return of research results and incidental findings, including the process for return and usefulness of information returned
Special and vulnerable population research, including pediatric and palliative care
Issues related to public health research, including 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, including issues related to inclusion of and research with sexual and gender minorities
Current and emerging regulatory and policy environments, including NIH policy
Innovative study design, conduct, management, and oversight, including methods for obtaining and documenting informed consent; virtual clinical trials and other remote or passive sensing, monitoring or assessment
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 developing, enhancing, and measuring effectiveness of, bioethics infrastructure and training
New means for enhancing and assessing the scientific workforce, including policies to promote scientific workforce diversity and inclusion and promote a safe and inclusive research environment.

Projects that support certain types of capacity building efforts

Capacity building efforts of particular interest may include the development of educational content (e.g., curricula, practicum experiences for trainees, publicly accessible web-based modules) and new or innovative resources, tools, and/or strategies addressing bioethical challenges. Other types of projects (e.g., IRB management, funding for employees to meet human subjects research competency requirements, training slots) will not be supported by this funding mechanism.

Additional specific areas of interest

In addition to overarching areas of interest, individual NIH Institutes, Centers, and Offices as well as the FDA have indicated the following specific areas of research interest:

FIC

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

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.

Note concerning the Award Project Period: Supplement project and budget periods are limited to the remaining active budget period that started in FY21 for the existing parent award. To be eligible, the parent award must be active (i.e. not be in an extension period), and the activities proposed in the supplement must be accomplished within the remaining active budget period that started in FY21 for the existing parent award. The earliest anticipated start date is July 1, 2021

NCCIH

The National Center for Complementary and Integrative Health (NCCIH) 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://nccih.nih.gov/about/plans

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, cohort studies, 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; issues raised by the use of ancestry markers vs. ethnicity/race in research and treatment; innovative methods for recruitment and retention of participants who are underserved, hard to reach, or otherwise underrepresented in research; participant, community, or patient engagement; return of research results; participant and patient perception and comprehension; effective communication (including patient-provider and to/within families); increasing access to care for populations with cancer disparities. Additional issues may be found here: https://epi.grants.cancer.gov/bioethics-cancer-research.html. NCI encourages investigators to contact the parent grant program officer to address any budgetary issues prior to submitting a supplement application.

NEI

The National Eye Institute (NEI) is interested in bioethics applications that address topics relevant to research on blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems of individuals who are visually impaired or blind.

For information, please see https://www.nei.nih.gov/grants-and-training/funding-opportunities/programs-and-research-priorities

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. Examples could include, but are not limited to: research on the implications of new and emerging genomic technologies and novel uses of existing technologies across cultures and communities, the use of polygenic risk scores in diverse ancestral populations, synthetic biology and the application of artificial intelligence and/or machine learning to genomic data.

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:

Addressing bias and health equity in heart, lung, blood, and sleep research
The return of research results (e.g., genomic, omic, environmental) with context 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
Bioethical questions raised by the COVID-19 pandemic, such as ethical rationing of/equitable access to mechanical ventilators
Issues related to clinical trials, including adaptive clinical trial designs, usual care arms, or other novel designs
Bioethical questions related to implementation science research
Waivers of informed consent, exceptions from informed consent, or obtaining consent from surrogates
Ethics of cardiopulmonary support, including end-of-life care and support/device withdrawal
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 or creating culturally-appropriate messaging, especially with regards to American Indian/Alaska Native populations and tribal sovereignty

Investigators are encouraged to contact NHLBI staff to discuss their ideas

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

NIAAA

The mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is to generate and disseminate fundamental knowledge about the effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems, including alcohol use disorder, across the lifespan. NIAAA is interested in bioethics applications that address topics relevant to its mission, research objectives, and cross-cutting research areas as outlined in its strategic plan at https://www.niaaa.nih.gov/strategic-plan. Investigators are strongly encouraged to contact NIAAA staff to discuss their ideas.

NIAID

NIAID is 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), other infectious diseases including those transmitted by vectors, immune-mediated diseases including allergy/asthma, autoimmune disease, and cell, tissue, or organ transplantation; 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:

Research involving adolescents and young adults, including autonomy and informed consent
Policy issues at the intersections of public health surveillance, care delivery, and research
Research involving child-bearing age and pregnant women
Enhanced engagement of key populations in research on HIV prevention, treatment cure, and comorbidities; improving dissemination, communication of results
Representation of key susceptible populations in research on immune-mediated diseases and transplantation for disease prevention, treatment, cures; improving dissemination, communication of results
Community engagement and attitudes concerning novel vector control measures, vaccines for infectious diseases, organ transplantation (including xenotransplants)
Informing study designs for safety and efficacy evaluations, best practices for development and uptake of future therapeutics, prevention strategies
Best methods for securing highly sensitive data including genetic data; risks from data breaches and reidentification; effective tools for anonymizing such data
Research on genome editing for correcting heritable traits and genetic disorders

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. 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 bioethics research relevant to its mission to support the development of innovative technologies in bioimaging and bioengineering. Areas of particular interest to NIBIB include, but are not limited to, ethical issues related to: artificial intelligence and machine learning; digital health and wearable/implantable technologies; connected health/mHealth and Point-of-Care (POC) technologies; clinical decision support systems (for healthcare professionals, caregivers, and/or patients); data sharing, privacy, and security; synthetic biological systems; neuromodulation technologies; health disparities and inclusion in biomedical research. Investigators are strongly encouraged to contact NIBIB staff to discuss their ideas. For more information on areas of interest to the NIBIB, please visit: https://www.nibib.nih.gov/research-funding

NICHD

The Eunice Kennedy Shriver National 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 https://www.nichd.nih.gov/grants-contracts/research-areas/priorities for the current research priorities for the institute and in https://www.nichd.nih.gov/about/org/strategicplan regarding future themes for the Institute.

NIDA

The National Institute on Drug Abuse (NIDA) is interested in bioethics applications that address topics relevant to its mission and research priorities as provided in its strategic plan, including research involving pregnant women using substances. For more information, please see: https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan

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. In addition to the overarching priority areas of this notice as related to dental, oral, and craniofacial health, the NIDCR is also interested in:

Return of incidental findings about overall health from clinical and non-clinical data (e.g., genome-wide omics data) produced in studies that focus on dental, oral and craniofacial phenotypes
Privacy, confidentiality, and bias issues related to the collection, analysis, and dissemination of research and clinical data, as well as re-use of data for different research questions, particularly with regards to facial image, genetic, and omics data
Ethical and societal implication of applying regenerative medicine technologies to treating non-life-threatening dental, oral and craniofacial diseases and conditions

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

NIEHS

The National Institute of Environmental Health Sciences (NIEHS) 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.niehs.nih.gov/about/strategicplan/index.cfm

NIGMS

The National Institute of General Medical Sciences (NIGMS) 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.nigms.nih.gov/about/overview/

NIMH

The National Institute of Mental Health (NIMH) is interested in bioethics applications that address a range of issues for individuals and communities relevant to its core mission, and the subjects and disorders which it serves as a primary lead at the NIH. Such areas include, but are not limited to:

How can researchers address changes in consent capacity among vulnerable research populations (e.g. children, cognitively impaired elders, actively psychotic patients)?
Developing and implementing personalized medicine in psychiatry (i.e. development of predictive algorithms for guiding intervention and treatment).
Advancing the understanding on how to avoid or mitigate against stigmatization, group harms, and unintended negative social implications/exacerbations of structural inequalities when conducting psychiatric research.
Developing best practices and guidelines for sharing with patients clinically valuable and or medically actionable genetic results from psychiatric research, and implementation of the best practices in real world clinical settings (e.g. genetic counselling, stratifying patients, genetic diagnosis).
What/how are the issues/protections against bias that need to be considered when using novel data analytic approaches such as artificial intelligence, machine learning, or complex algorithms to inform clinical decision making?
Studies examining the bioethical issues related to suicide research that consider (including but not limited to):
- Suicide research in younger children (<10 years), including developmentally appropriate measures of suicidal intent, safe approaches to assessing suicide risk in young children, and developmentally appropriate interventions that mitigate risk for children endorsing suicidal thoughts or behaviors.
- Applications of various technologies for identifying suicide risk (e.g. risk algorithms; passive monitoring via worn sensors or web search behaviors, virtual reality paradigms), and approaches for monitoring and addressing states (real time; asynchronous; periodic review).
- These and additional suicide research bioethical issues are identified in this document: https://www.nimh.nih.gov/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers.shtml

For further information about Institute priorities, please see:https://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml

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.

NINDS

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in research on 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. Consistent with the description of capacity-building efforts above, NINDS also is interested in capacity-building efforts including the development of educational content and new or innovative resources, tools, and/or strategies addressing neuroethical challenges relevant to the NINDS mission. Additional information about the NINDS mission may be found here: http://www.ninds.nih.gov/about_ninds/mission.htm. Note that applications must consider neuroethical questions and be within the general scope of the parent award. Also, NINDS will not consider supplement applications that include basic research activities or research with vertebrate animals.

NINR

NINR is interested in studies examining the bioethical issues related to nursing research that consider (including but not limited to):

The needs/challenges of families, caregivers, and proxy decision makers of individuals with serious, advanced illness.
Prioritization of patient preferences, beliefs, and values with respect to treatment and/or end of life decision making.
The end-of-life and palliative (EOLPC) needs of individuals with serious, advanced illness, particularly in vulnerable populations such as: children, frail elderly, and individuals with limited decision-making capacity.
Disparities in access to EOLPC for individuals across settings (urban, rural, remote), including differences among socioeconomic, racial/ethnic and geographic sub-populations.
The impact of emerging and artificial intelligence-based technologies on individual autonomy
Protecting privacy and confidentiality in research involving large datasets

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

NLM
The National Library of Medicine (NLM) is interested in bioethics applications that address topics relevant to its mission and research priorities as provided in its strategic plan (https://www.nlm.nih.gov/pubs/plan/lrp17/NLM_StrategicReport2017_2027.html). Such topics include research into methods for reducing bias in health data sets and the tools used for mining them, enhancing public health information resources to meet the needs of underrepresented groups, and novel approaches for enhancing and assessing the informatics/data science workforce, including policies to promote scientific workforce diversity and inclusion and promote a safe and inclusive research environment.

FDA

FDA is interested in evaluating and promoting understanding of the ethical considerations related to the use of real-world data (RWD) to produce real-world evidence (RWE). Specifically, FDA is interested in research on how current ethical and human subject protection frameworks can be applied to the use of RWD. Examples of areas of interest include, but are not limited to:

Utilizing broad consent, dynamic consent, and implied consent for studies using RWD
Data protection and privacy safeguards to be employed while utilizing RWD, including (but not limited to) compliance with the Health Insurance Portability and Accountability Act (HIPAA)
Methods and tools to ensure transparency when using RWD
Use of digital health technology to capture data for research, including (but not limited to) the use of consumer electronics such as fitness trackers and health-related sensors
Other related topics

FDA welcomes applications with innovative approaches to evaluate, understand, and expand knowledge regarding the ethical considerations of using RWD in clinical research. For background information on FDA’s RWE program, please see the following link: https://www.fda.gov/media/120060/download.

Scope of Support

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The Office of the Director intends to commit at least $2,000,000 in FY 2021 to fund approximately 10 awards. The FDA intends to commit up to $500,000 in FY 2021.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

Application Due Date(s) March 5,2021, by 5:00 PM local time of applicant organization.
For funding consideration, applicants must include NOT-OD-21-020 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
Application budget cannot exceed a maximum direct cost of $100,000. In addition to the direct cost, applicable F&A (indirect) costs can also be requested.
Requests may be for one year of support only.
The Research Strategy section of the application is limited to 6 pages. The Specific Aims page is not included in this page limit.
Applications should specify in the Project Summary/Abstract whether the project is specific to bioethics research, capacity building in bioethics, or both.
All criteria for review in Section V. Application Review Criteria in PA-20-272will be followed, except that the following criteria will be used instead of the criteria provided for Overall Impact:
NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award as appropriate:
- Will the administrative supplement increase or preserve the likelihood for the project to exert an influence on the bioethics-related policy of or capacity building in the research field(s) involved?
- Will the administrative supplement provide an evidence base that may inform or support the development of future policy directions?
- Does the administrative supplement address a bioethical issue that is pressing, recurring, and/or emerging in biomedical research or capacity building for bioethics?
- Are the overall strategy, methodology, and analyses proposed in the supplement application well-reasoned and appropriate to accomplish the proposed effort in a one-year period?

All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package.

Inquiries

Please direct all inquiries to:

Scientific/Research Contact(s)

Shari Feirman, PhD
Office of the Director (OSP/OD)
Telephone: 301-435-6350
Email: [email protected]

Barbara Sina, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-402-9467
Email: [email protected]

Juanita Marner
FDA CDER Office of Medical Policy
Email: [email protected]

Elaine Collier, M.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0794
Email: [email protected]

Charlisse Caga-anan, J.D.
National Cancer Institute (NCI)
Telephone: 240-276-6738
Email: [email protected]

Cheri Wiggs, Ph.D.
National Eye Institute (NEI)
Telephone: (301) 451-2020
Email: [email protected]

Nicole Lockhart, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2493
Email: [email protected]

Kathleen N. Fenton, MD, MS
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-6523
Email:[email protected]

Kristina McLinden, PhD
National Institute on Aging (NIA)
Telephone: 301-827-2563
Email: [email protected]

Pamela Wernett, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-827-5391
Email: [email protected]

Joana Roe
National Institute of Allergies and Infectious Disease (NIAID)
Telephone: 240-627-3213
Email: [email protected]

Marisol Espinoza-Pintucci, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-827-6959
Email: [email protected]

Todd Merchak
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8592
Email: [email protected]

Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email:[email protected]ov

Tammara Jenkins, MSN, RN, PCNS-BC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6837
Email: [email protected]

Ruben Baler, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-2733
Email: [email protected]

Trinh Ly, M.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-4085
Email: [email protected]

Leslie Frieden, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-4263
Email: [email protected]

Aynur Unalp-Arida, MD, MSc, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8879
Email: [email protected]

Lindsey Martin, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984.287.4036
Email:[email protected]

Veerasamy Ravichandran
National Institute Of General Medical Sciences (NIGMS)
E-mail: [email protected]

James Churchill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3621
Email: [email protected]

Nancy Jones, Ph.D., M.A.
National Institute on Minority and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email: [email protected]

Khara Ramos, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-594-2614
Email: [email protected]

Lynn Adams, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-8911
Email: [email protected]

Hua-Chuan Sim, MD
National Library of Medicine (NLM)
301-594-4882
[email protected]

Jamie Marshell White
Office Of Research On Women's Health (ORWH)
Phone: 301-496-9200
E-mail: [email protected]

Toccara Chamberlain
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984.287.4482
E-mail: [email protected]

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-2075
Email: [email protected]

Mark Lauda
FDA CDER Office of Medical Policy
Email: [email protected]

Zulema Eldridge
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-3066
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Karen Robinson Smith
National Eye Institute (NEI)
Telephone: (301) 451-2020
Email: [email protected]

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: [email protected]

Tawana McKeither
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-9238
Email:[email protected]v

Jeff Ball
National Institute on Aging (NIA)
Telephone: 301-403-7736
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: [email protected]

Leslie Littlejohn
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5055
Email: [email protected]

Monique Day, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4797
Email: [email protected]

Shelley Carow
National Center For Complementary & Integrative Health (NCCIH)
Phone: 301.594.3788
E-mail: [email protected]

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Pamela G. Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: [email protected]

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: [email protected]

Diana Rutberg, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Thuthuy Nguyen
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
301-594-8825
[email protected]v

Grace Olascoaga
National Institute Of General Medical Sciences (NIGMS)
E-mail: [email protected]

Theresa Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Ronald Wertz
National Institute of Nursing Research (NINR)
Telephone: (301) 594-2807
Email: [email protected]

Samantha Tempchin
National Library of Medicine (NLM)
301-496-4221
[email protected]

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
E-mail: [email protected]