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

NOT-OD-23-018

Key Dates

Related Announcements

NOT-OD-22-026 - Notice of Special Interest (NOSI): Administrative Supplement for Research and Capacity Building Efforts Related to 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 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)

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 Research on Women's Health (ORWH)

Office of Data Science Strategy (ODSS)

Sexual and Gender Minority Research Office (SGMRO)

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 address a component related to bioethics in a biomedical and/or health-related behavioral research study. Note that applications must be within the general scope of the parent award.

Background

Ethical considerations are intrinsic to the conduct of biomedical and health-related behavioral 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 health-related 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., COVID-19, 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 advancing the most ethical research possible, which, in turn, can facilitate public participation and trust in the research enterprise.

Specific Areas of Interest

OD is particularly interested in applications that identify, analyze, and/or address bioethical issues related to digital health and/or real-world data; participant engagement; return of research results for individuals, families, communities, and/or society; and data sharing. Examples of such projects include, but are not limited to:

Digital Health and/or Real-World Data

• Designing and evaluating tools or approaches to aid individual, family, and community decision-making about use of digital health technologies and/or real-world data

• Studies that examine understanding of ethical issues related to digital health and/or real-world data among researchers and/or examine issues related to disclosure of information about the use of digital health and/or real-world data for biomedical and/or health-related behavioral research

• Evaluations of practices related to using digital health technologies in research, including issues related to data privacy and data security, consent, transparency, access, and equity

• Analyzing ethical, legal, and policy issues raised by use of digital health technologies in research

• Considerations for using digital health data and/or real-world data to generate knowledge for biomedical and/or health-related behavioral research

Participant Engagement

• Studies on participant and community engagement or participatory research methods, including participant voices in clinical trial design and outcomes and longer-term engagement with the scientific enterprise

• Participant attitudes on the collection and use of longitudinal, multidimensional data from disparate sources, including data privacy and data security considerations

Return of Research Results

• Assessments of participant preferences regarding the return of individual research results and methods for returning various types of research results to participants across various clinical fields, including results from clinical tests, environmental health measurements, and non-genomic data

• Research to help understand how people make sense of and act upon individual research results

Data Sharing

• Empirical assessments of the value of data sharing

• Implications for participant consent and privacy when conducting data linkage, including linking genomic with non-genomic data or controlled-access data with publicly available data

• Research to develop or refine existing methods, tools, or technologies (e.g., de-identification) to facilitate appropriate data sharing while protecting research participant privacy, including for datasets that contain indirect identifiers and sensitive data

• Research to elucidate ethical issues (e.g., potential re-identifiability) raised by the sharing of multi-omics data, including proteomics, metabolomics, and microbiomics, as well as possible risk mitigation options

• Best practices, tools, technologies, and/or perspectives on obtaining informed consent for data sharing in settings that may not typically involve research consent (e.g., social media, clinical or public health settings where data is de-identified)

• Best practices, tools, and technologies for communicating the status of consent as well as data use limitations to downstream users of data

• Research on processes that institutions undertake to assess risks of sharing data, evaluation of those processes, and how to optimize those processes for improved data sharing and participant protection

OD also seeks to fund research on additional bioethics topics. Applications should propose 1) research on topics that can develop or support the development of an evidence base that may inform future policy directions, and/or 2) projects that support certain efforts to develop or augment bioethics research capacity.

Research on topics that can develop 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 should 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 (e.g., gene editing, organoids, artificial intelligence, machine learning, neural implants and invasive or non-invasive modulation, consumer-generated data, synthetic biology)

• Big data and data science analytics, integration of data for research (e.g., clinical, research, environment, social media, participant/patient provided, other data types), biases in datasets and algorithms, research using electronic health record data, and ethical implications for the use of non-traditional data (e.g., social media information, consumer data) for research purposes

• Precision and personalized medicine

• Personal, institutional, and research privacy and security

• Learning Healthcare System, interface of clinical research and clinical care, and pragmatic trials

• Crowdsourcing, citizen science, and DIY biomedical and/or health-related behavioral research

• Participant driven, directed, or sponsored clinical research

• 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; patient access to drugs and medical services

• Issues related to the inclusion of populations underrepresented in biomedical and/or health-related behavioral research, including sexual and gender minorities, people from racial and ethnic minority groups, people living with disabilities, non-U.S. born persons, people experiencing poverty, older adults, formerly or currently incarcerated individuals, and other marginalized communities

• Issues related to the inclusion of Tribal members and American Indian/Alaska Native populations in biomedical and/or health-related behavioral research

• Research involving individuals who are pregnant/lactating

• Research involving individuals potentially at higher risk for undue influence, including for pediatric and palliative care research

• Issues related to aging research

• Issues related to health disparities and health inequities, including effects of structural racism on the biomedical and health-related behavioral research enterprise

• Current and emerging regulatory and policy environments, including NIH environments

• 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 methods

• 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 assessing and enhancing the scientific workforce, including policies promoting scientific workforce diversity and inclusion and promoting a safe and inclusive research environment

• Issues related to collecting, analyzing, and applying data related to social determinants of health

Projects that support certain efforts to develop or augment bioethics research capacity

OD is interested in supporting capacity building projects that directly strengthen and/or sustain the field of bioethics. 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.

This announcement is intended to support projects that have a strong focus on bioethics. Investigators proposing capacity building projects should ensure that bioethics is the primary focus of the content/resource/tool/strategy being developed. The contribution of the proposed project to the field of bioethics should be made clear in the application.

IC areas of interest

In addition to overarching areas of interest, individual NIH Institutes, Centers, and Offices 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 FY23 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 FY23 for the existing parent award. The earliest anticipated start date is July 1, 2023.

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 healthcare delivery, such as issues raised in cancer clinical trials, cohort studies, cancer prevention studies, cancer centers, cancer surveillance, prospective biobanking, studies using previously collected samples/tissues, or studies re-using previously collected data. Bioethical issues of interest include, but are not limited to:

• Issues raised by novel cancer therapies or diagnostic technologies

• Issues raised by use of genetic testing for cancer screening or prevention studies

• Issues raised by use of ancestry markers vs. ethnicity/race in cancer research, care, or prevention

• Issues raised by use of artificial intelligence or machine learning in cancer research or care

• Issues raised by use of digital health technology (e.g., telehealth, wearables, implantable sensors, mobile apps in cancer research), including disparities in access to technology, inclusivity and usability of technology, and data ownership; see also the issues highlighted above on the impact of digital health and/or real-world data issues

• Issues raised by use of social media as data sources or cancer control intervention platforms, including consent, privacy, data access, and algorithmic issues related to social media data

• Privacy, confidentiality, and governance of data and ethical re-use of data, including data originally collected in a broad range of settings

• Innovative models for data governance

• Community, patient, or participant engagement

• Return of research results

• Participant or patient perception and comprehension

• Effective communication and cancer prevention

• Patient-centered communication, including patient-provider and to/within families

• Prognosis and goals of care communication

• Innovative methods and technologies for recruitment, retention, and ongoing engagement of participants who are underserved and/or vulnerable, hard to reach, or otherwise underrepresented in research

• Access to care for populations with cancer disparities

• Effective approaches to increase transparency in research

• Issues related to cancer research on individuals whose age, illness, or cognitive impairment do not allow them to provide informed consent or independently complete self-report measures

• Issues raised by advance care planning

• Addressing challenges of conducting cancer-related trials on cannabinoids due to variations in state laws and access

NCI encourages investigators to contact the parent grant program officer to address any budgetary issues prior to submitting a supplement application.

NIAID

The National Institute of Allery and Infectious Diseases (NIAID) is interested in supporting supplemental projects that focus on ethical, legal, and social implications relevant to domestic and international collaborative research on HIV/AIDS or its co-morbidities (e.g., TB, malaria, hepatitis, sexually transmitted infections); other infectious diseases including those transmitted by vectors, immunologic and allergic diseases, and/or organ transplantation; ethics of clinical trials and implementation science; and other ELSI 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 to the respective divisions of NIAID 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

• Issues within NIAID’s mission that are unique to child-bearing age and pregnant people

• Enhanced engagement of key populations in research on HIV prevention, treatment, cure; HIV-related comorbidities and co-infections including those transmitted via sexual contact; improving dissemination, communication of results, mitigating barriers to research participation

• Representation of key populations in research on immune-mediated diseases and transplantation for disease prevention, treatment, and/or cure; improving dissemination, communication of results, and mitigating barriers

• Community engagement and attitudes concerning novel vector control measures, vaccines, other mitigation strategies for infectious diseases, and organ transplantation, including xenotransplants

• Informing study designs for safety and efficacy evaluations of interventions, best practices for development and uptake of future therapeutics and/or prevention strategies

• Best methods for securing highly sensitive data, including genetic data; risks from data breaches and reidentification; effective tools for anonymizing sensitive data; stakeholders attitudes toward data sharing methods and policies

• Research on genome editing for correcting heritable traits and genetic disorders

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 NIBIB, please visit: https://www.nibib.nih.gov/research-funding.

NIDA

The mission of the National Institute on Drug Abuse (NIDA) is to advance the science of drug use and addiction and to apply that knowledge to improve individual and public health through:

• Strategically supporting and conducting basic, clinical, and epidemiological research on drug use, its consequences, and the underlying neurobiological, behavioral, and social mechanisms involved

• Ensuring the effective translation, implementation, and dissemination of scientific research findings to improve the prevention and treatment of substance use disorders (SUDs), reduce the harms associated with drug use, guide policies, enhance public awareness of addiction as a chronic but treatable medical illness, and reduce stigma

NIDA’s research advances fundamental knowledge and provides scientific evidence to inform individual and public health, including the policies and practices of other federal agencies; state and local health, education, and human services; and the legal system.

NIDA is interested in bioethical issues relevant to research involving all individuals, with particular attention to individuals who have, or are at risk of developing, SUDs with particular emphasis on vulnerable populations, including children, adolescents, pregnant women, and those with other mental illnesses. Areas of particular interest in the context of this Bioethics NOSI include:

• Identifying and developing approaches to reduce stigma

• Understanding sex, sexual orientation, and gender differences

• Identifying and developing approaches to reduce health disparities

• Understanding interactions between substance use, HIV, and other comorbidities

• Leveraging data science and analytics to understand real-world complexity

• Developing personalized interventions informed by people with lived experience

NIDCR

The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to advance fundamental knowledge about dental, oral, and craniofacial (DOC) health and disease and translate these findings into prevention, early detection, and treatment strategies that improve overall health for all individuals and communities across the lifespan (see: https://www.nidcr.nih.gov/about-us/strategic-plan). In addition to the overarching priority areas of this notice as related to its mission, NIDCR is also interested in:

• Management of incidental findings about overall health from studies that focus on DOC phenotypes using research, health, and clinical data collected under the same studies or elsewhere and crowd-sourced data

• Privacy, confidentiality, inclusion, and bias related to the collection, analysis, and dissemination of research and clinical data, as well as re-use of data for different research questions, including facial images, audio and video samples, genetic variants, multi-omics, other deep phenotyping data, and associated metadata collected prenatally, postnatally, and through adulthood

• Ethical and societal implications of screening or treatment approaches where risk calculations are especially relevant (e.g., applying regenerative medicine technologies to treating non-life-threatening DOC diseases and conditions, routine screening for health conditions in the dental setting)

• Ethical and societal implications of applying precision medicine approaches to diagnosis, treatment, or management of DOC 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: https://www.niddk.nih.gov/about-niddk/research-areas.

NIEHS

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people in order to promote healthier lives. NIEHS is interested in applications that advance the bioethics evidence base and/or support bioethics research capacity building and are within the scope of its 2018-2023 Strategic Plan (https://www.niehs.nih.gov/about/strategicplan/index.cfm). Specific areas of interest to NIEHS include, but are not limited to:

Bioethics Evidence Base:

• Bioethical issues related to precision environmental health

• Bioethical issues related to community engaged/citizen science environmental health research

• Return of environmental health research results to participants/communities and/or building capacity to support the return of environmental health research results

• Bioethical issues related to the inclusion of populations underrepresented in environmental health research

• Bioethics of conducting environmental health disparities and environmental justice research in U.S. and low- and middle-income country settings

• Research on the bioethical issues associated with environmental health prevention and intervention strategies

• Bioethical issues focused on the impacts of climate change and climate change related disasters on health

Bioethics Research Capacity Building:

• Bioethics capacity building projects that support/enhance scientific workforce diversity in the environmental health sciences

• Capacity building projects to develop curricula/educational content for researchers and community members focused on environmental health bioethical issues

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 informed consent-related issues, or therapeutic misconception, including for rare diseases

• Issues related to human donors of biological materials, including, but not limited to, 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

• 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.

NINDS, as part of NIH, strives for rigor and transparency in all research it funds. For this reason, NINDS explicitly emphasizes the NIH application instructions related to rigor and transparency (https://grants.nih.gov/policy/reproducibility/guidance.htm) and provides additional guidance to the scientific community (https://www.ninds.nih.gov/Funding/grant_policy).

Additional information about the NINDS mission may be found here: https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Mission. 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 propose new basic research activities or research with vertebrate animals.

NEI

The National Eye Institute (NEI) is interested in bioethics applications that address topics relevant to research on mechanisms of visual function, prevention and treatment of vision diseases, and improving quality of life through expanding opportunities for people who are blind or have low vision.

NHGRI

The National Human Genome Research Institute (NHGRI) is interested in research related to the ethical, legal, regulatory, policy, economic, cultural and societal issues raised by the advancement and use of genomics, including, in combination with other omic data. These issues may relate to:

• The design and conduct of research in genetics and genomics

• The translation of genetic and genomic research into clinical medicine and health care

• The interplay among a broad array of stakeholders in the field of genomics

• The value and meaning of genomics for the broader public

Examples of possible topics of interest are available on the ELSI Research Areas and Sample Topics website: https://www.genome.gov/Funded-Programs-Projects/ELSI-Research-Program/research-areas.

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 related to gene editing, such as examining the ethical issues of generating chimeric animals for human organ transplantation, discerning the difference between genetic therapy and genetic enhancement, consideration of the effect of patenting gene editing technologies, and consideration of the high cost of gene therapy and its effect on accessibility

• 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 (AUD), 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.

Examples of bioethical issues of interest include but are not limited to:

• Impact of stigma on recruitment and retention of clinical trial participants with alcohol misuse, AUD, and co-occurring disorders, including individuals from underserved, high-risk and hard to reach populations

• Pharmacotherapy research involving pregnant people and adolescents

• Issues related to the inclusion of females, sexual and gender minorities, and other populations underrepresented in alcohol research

• Health provider attitudes towards patients with AUD in need of liver transplantation

Investigators are strongly encouraged to contact NIAAA staff to discuss their ideas

NIAMS

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in bioethics applications that address topics of relevance to the NIAMS mission and research priorities as provided in its Strategic Plan: https://www.niams.nih.gov/sites/default/files/pdf/NIAMS-StrategicPlan-2020-2024-v1.pdf.

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 people, and people with disabilities. Areas of particular interest include:

• 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

• 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 https://www.nichd.nih.gov/about/org/strategicplan regarding future themes for the Institute.

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: https://www.nidcd.nih.gov/about/strategic-plans.

NLM

The National Library of Medicine (NLM) supports research that incorporates innovative biomedical informatics and data science approaches that harness the digital healthcare ecosystem and have the potential to reduce bias while improving personal health, access to care, continuity of care, and/or health outcomes. NLM’s vision is to unleash the potential of data and information to accelerate and transform discovery and improve health and health care. This important task understands that the use of data science and informatics methods, especially in health disparity populations, ethical principles of justice, benevolence, and respect must be maintained using health-related data. For more information about NLM, please see the Strategic Plan: https://www.nlm.nih.gov/pubs/plan/lrp17/NLM_StrategicReport2017_2027.pdf.

NLM’s interests include, but are not limited to, areas of science that address:

• Research in algorithmic fairness in healthcare
• Issues related to ethical approaches to public health data
• Identification of data science and informatics approaches to translational science, including genomic approaches to health-related issues in health disparity populations
• Artificial intelligence approaches to clinical and non-clinical data and analytics

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 for which it serves as a primary lead at the NIH. Such areas include, but are not limited to:

• Developing strategies to better engage participants, families, and other relevant groups in the research process as partners, not just subjects

• How researchers can address changes in consent capacity among vulnerable research populations (e.g., children, cognitively impaired elders, actively psychotic patients)

• Considering unique concerns and strategies to be applied in the thoughtful engagement of marginalized populations in biomedical research, while advancing 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 are the issues/protections against bias, especially as related to racial, ethnic, or other underserved populations, 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

• As data sharing in mental health research becomes more ubiquitous, what steps are necessary to protect participant privacy, data security, the appropriate use of data, and guard against the inappropriate use of data and unintended consequences of data sharing

• Studies examining the bioethical issues related to suicide research that consider, but need not be 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)

  • With input from research participants and families, developing best practices in suicide research for ethical consent of children and adolescents and parents/guardians, considering the research contexts where assent, consent, and combined consent/assent might be used, taking into account the study population, research questions and research design, participant burden, and ethical principles

  • These and additional suicide research bioethical issues 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)
• Mitigating stigmatization, group harms, and unintended social implications of research

NINR

The National Institute of Nursing Research (NINR) supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest.

SGMRO

The Sexual & Gender Minority Research Office (SGMRO) is interested in bioethics applications that address topics relevant to NIH’s mission and research priorities provided in the NIH Strategic Plan to Advance Research on the Health and Well-being of Sexual and Gender Minorities FY 2021 2025.

For more information, please see: https://dpcpsi.nih.gov/sites/default/files/SGMStrategicPlan_2021_2025.pdf.

ORWH

The Office of Research on Women’s Health (ORWH) focuses on research that is relevant to the health of women, the inclusion of women in clinical studies, and the advancement of women in biomedical careers. ORWH is interested in research on bioethics issues that intersect with the goals, objectives, and guiding principles of the 2019-2023 Trans-NIH Strategic Plan for Women’s Health Research (https://orwh.od.nih.gov/about/trans-nih-strategic-plan-womens-health-research). Specific examples include, but are not limited to:

• Ethical, legal, and social implications of sex and/or gender differences research across the lifespan; and the ethics of the consideration of sex, gender, and intersectionality in basic, translational, clinical, and implementation science research
• Inclusion of an intersectional perspective in research involving women who are underrepresented, understudied, and underreported (U3) in biomedical research (e.g., women of underrepresented racial and ethnic communities, women in economically disadvantaged groups, women with physical, mental/intellectual, or sensory disabilities, women residing in both underserved rural and urban areas, pregnant and lactating women, women of sexual and gender minority groups); and the implications of implicit bias (e.g., racial, ethnic, sex, and/or gender) on the inclusion or exclusion of women from U3 populations in research
• Ethical issues governing the retainment and advancement of women in biomedical careers (e.g., power dynamics and/or differentials, gender harassment, hiring, promotion, and tenure) and issues related to women participating in team science and conducting interdisciplinary and/or trans-disciplinary research
• Bioethical issues derived from data generated in research and development (R&D) of drugs, medical devices, diagnostics, and emerging technologies, along with health screenings (e.g., mammograms, Pap-smears, newborn screening, EKG) with particular interest in COVID-19 implications on the health of women
• Societal implications, such as stigma based on gender dimensions, related to sex and/or gender bias or considerations in the development and use of novel and emerging technologies (e.g., artificial intelligence, machine learning, multi-accuracy auditing, digital/mobile health, social media tools)
• Neuroethics and ethics related to sex, gender, and intersectional (i.e., age, race/ethnicity) considerations in genomic research and precision health

• Ethical and social issues around provider-patient interactions/relationships and family caregiving related to its impact on women’s health and well-being. This could include evaluation of sex and/or gender concordance or discordance between health care providers and patients. Intersectional approaches are encouraged

THRO

The Tribal Health Research Office (THRO) is interested in bioethics applications that address topics relevant to the goals and priorities outlined in the NIH Strategic Plan for Tribal Health Research FY 2019 - 2023.

For more information, please see: https://dpcpsi.nih.gov/sites/default/files/2019_THRO_StrategicPlan_508.pdf.

ODSS

The Office of Data Science Strategy (ODSS) is interested in stimulating research to identify, analyze, and understand relevant ethical issues and their implications in data science related to the F.A.I.R. (Findable, Accessible, Interoperable, and Reusable) and C.A.R.E. (Collective Benefit, Authority to Control, Responsibility, and Ethics) principles, data ecosystems, and data access and sharing, or policy development and implementation. For example, supporting projects that address 1) understanding ethical issues in broad knowledge domains to ensure ethical, meaningful, interpretable, and scalable utility of data from individuals and communities in individual, community, and population-level health and/or biomedical discovery and 2) enabling the expansion of diversity, equity, inclusion, and accessibility to enhance the scientific workforce for responsible data utility, access, and sharing.

Scope of Support

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

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) Feb 17, 2023 by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-OD-23-018 (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 $200,000. 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-20-272 will 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 bioethics-related policy 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 and/or health-related behavioral 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.
• Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center. Only one application per parent award may be submitted.
• Applicants are strongly encouraged to notify the program contact at the NIH Institute or Center supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Scientific/Research Contact(s)

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

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

Elaine Collier, MD
National Center for Advancing Translational Science (NCATS)
Telephone: 301-435-0794
Email: [email protected]

Wendy Weber, ND, PhD, MPH
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: [email protected]ov

Charlisse Caga-anan, JD
National Cancer Institute (NCI)
Telephone: 240-376-6738
Email:[email protected]

Cheri Wiggs, PhD
National Eye Institute (NEI)
Telephone: 301 402-0276
Email: [email protected]

Nicole Lockhart, PhD
National Human Genome Research Institute (NHGRI)
Telephone: 301-385-1622
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, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-827-5391
Email: [email protected]

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

Emily Carifi, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-496-0665
Email:[email protected]

Tuba Fehr, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-7958
Email: [email protected]

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, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-2733
Email:[email protected]

Merav Sabri, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-827-0908
Email:[email protected]

Alicia Chou, MS
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4874
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]v

Matthew Rudorfer, MD
National Institute of Mental Health (NIMH)
Telephone: 301-443-1111
Email: [email protected]

Lindsey Martin, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-4036
Email: [email protected]

Nancy Jones, PhD, MA
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email: [email protected]

Adam L. Hartman, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: [email protected]

Karen Kehl, PhD, RN, FPCN
National Institute of Nursing Research (NINR)
Telephone: 301-594-8010
Email: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email:[email protected]

Meryl Sufian, PhD
National Library of Medicine (NLM)
Telephone: 301-761-6249
Email: [email protected]

Jamie Marshell White, MS
Office of Research on Women's Health (ORWH)
Telephone: 301-496-9200
Email: [email protected]

Juliana M. Blome, PhD, MPH
Tribal Health Research Office (THRO)
Telephone: 240-338-8464
Email: [email protected]

Shu Hui Chen, PhD
Office of Data Science Strategy (ODSS)
Telephone: 301-402-5392
Email: [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]

Matt Zeback
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-8309
Email: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]

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

Karen Robinson Smith
National Eye Institute (NEI)
Telephone: 301-435-8178
Email: [email protected]

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

Alyse Burton
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8019
Email: [email protected]

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 Binger, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4797
Email: [email protected]

Margaret Young
Eunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
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, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email:[email protected]

Gabriel Hidalgo
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone 301-827-4630
Email:[email protected]

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

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
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 J Tempchin
National Library of Medicine (NLM)
Telephone: 301-496-4222
Email: [email protected]