ELSI: Participating NIH ICs

(R01, R21, R03)

The NHGRI is interested in research that addresses:

• Genomics and Sociocultural Structures and Values: These projects may explore and elucidate the personal, social and cultural factors that shape the generation, interpretation, understanding and use of genetic and genomic information and associated technologies.
   
• Genomics at the Institutional and System Level: These projects may explore the interplay and influences between genetics and genomics and organizations, institutions, governments, systems or other organized stakeholders.
   
• Genomic Research Design and Implementation: These projects may investigate the ethical, legal, social and policy issues that arise in connection with the design and conduct of genetic and genomic research.
   
• Genomic Healthcare: These projects may examine issues that arise as genetic and genomic research are integrated into clinical medicine and healthcare in a variety of settings.
   

Research which focuses on the acceptability and accessibility of genetics or genomics to all communities is highly encouraged, particularly communities that have been understudied, underserved and/or marginalized (treated as insignificant or peripheral) by research institutions or healthcare systems. These communities could include, but are not limited to the health disparity populations defined by the NIH.

Further detail on topics of interest is included on the NHGRI ELSI Research Domains website. The examples provided here and online serve as a general guide to areas of importance and should not be viewed as a comprehensive list of research topics. Applicants are encouraged to propose topics and issues that are ripe for research, especially given rapid advances in genomic science and continued growth in the interpretation and use of genomic information.

Research projects may develop tools and findings that can be applied across many diseases and conditions. Projects focused on a single disease or disorder may be of lower priority for NHGRI unless generalizability or transferability of findings and resources is clearly demonstrated and described.

Dave Kaufman
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email: dave.kaufman@nih.gov

Nicole Lockhart
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email: lockhani@mail.nih.gov

Rene Sterling
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-1275
Email: rene.sterling@nih.gov

(R01, R21, R03)

The NCI is interested in research that focuses on the ethical, legal, and/or social implications of genetics and genomics in cancer-related research, care, and public health contexts; with additional emphasis on incorporating populations understudied in cancer research and addressing cancer disparities. In particular, the NCI is interested in the following:

• Studies on the ethical, regulatory, and policy challenges in cancer research involving genetic and genomic information (e.g., clinical oncology trials, population-based studies, observational studies, etc.); this includes innovative approaches to these challenges
   
• Studies on models of participant and community engagement or participatory research methods in cancer genomics research.
   
• Studies on the ethical, legal, and/or social implications of the use of genomic technologies and addressing cancer disparities; this includes studies on the challenges of improving genomic-based targeted therapies for a range of populations.
   
• Studies assessing the perspectives of populations from multiple racial, ethnic, and socioeconomic backgrounds, as well as children, older adults, and people with disabilities regarding the integration of genetics/genomics into cancer-related settings (including perspectives on genomic-based targeted therapies).
   
• Studies examining the uptake and outcomes of personalized genomic testing across populations.
   
• Studies on the ethical, legal, and/or social implications of the collection, storage, and future research uses of biological samples and of associated data obtained from cancer-related settings (e.g., participant preferences, informed consent, governance, privacy and security, and data sharing); this includes innovative approaches to these issues; additionally, multi-level studies examining patient, caregiver, provider, organizational, and health system perspectives on these issues.
   
• Studies on the ethical and social issues related to equitable patient access to precision oncology biomarker testing, as influenced by challenges such as tissue collection; provider, patient, and organizational knowledge and perception; reimbursement; and clinical trial access.
   
• Studies evaluating the ethical, legal, and/or social implications of communication strategies and tools used to share or disseminate genetic and genomic information with individuals, families, and communities/populations; this includes studies examining and aiming to improve the communication processes and disclosure of information about cancer genetics and genomics in a variety of contexts (clinical encounters, telemedicine, family communication, direct-to-consumer advertising).
   
• Studies evaluating the emerging ethical, legal, and/or social implications of having individuals’ genetic and genomic information made available digitally or online (through social media, electronic medical records, telemedicine, and participation in research on the Internet) 
   
• Studies on the anticipated and actual psycho-social and behavioral impact of genetic and genomic information on affected individuals, their families, and populations; including studies on the adoption of risk-reduction health behaviors (diet, physical activity, obesity/weight loss) after receiving genetic/genomic testing results.
   
• Studies on understanding and improving well-being among individuals at elevated genetic risk for cancer.
   
• Studies on how context affects use of genomic technologies and related patient outcomes of cancer care delivery (examples of context include community setting vs. academic setting, availability of relevant clinical expertise, extent of clinical team collaboration, patterns and channels of communication, and use of various IT systems).

The ultimate goal of this research will be to understand how people make sense of and act upon genetic and genomic information related to cancer; to inform the ethical conduct of cancer research involving genetic and genomic information and data; and overall to improve outcomes related to cancer.

Contact

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

(R01 and R21)

The National Eye Institute (NEI) is interested in supporting projects that address ethical, legal and social issues arising from genomic research relevant to our mission of eliminating vision loss and improving quality of life through vision research, especially those that are relevant to NEI’s Strategic Plan (i.e., to understand the eye and visual system, prevent and treat vision diseases, and expand opportunities for people who are blind or require vision rehabilitation).

Contact:

Cheri Wiggs
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: wiggsc@nei.nih.gov

NIAID is NOT interested in supporting clinical trials under this announcement but would consider non-IND trials, e.g., social/behavioral-relevant trials.

NIAID is interested in supporting projects that focus on ethical, legal, and social implications of genomic research that derive from domestic or international research on HIV/AIDS, other infectious diseases including those transmitted by vectors; immunologic and allergic diseases, or organ transplantation; and other ELSI issues arising from genomics that are relevant to NIAID's scientific mission. Applications should consider the following:

• Supporting the integration of bioethics work with genomic research in immunology, allergies, infectious diseases, transplantation, and other topics within NIAID’s mission.
• Enhanced engagement of key populations in genomic research on HIV and other infectious disease prevention, treatment, cure; HIV-related comorbidities and co-infections including those transmitted via sexual contact; to improve dissemination and communication of results and mitigate barriers to research participation.
• Representation of key populations in genomic research on immune-mediated diseases and transplantation for disease prevention, treatment, and/or cure; improving dissemination, communication of results, and mitigating barriers.
• Research on genome editing for correcting heritable traits and genetic disorders that impact diseases relevant to NIAID’s mission (e.g., inborn errors of immunity, primary immunodeficiencies).
• Investigate perceptions, beliefs, and attitudes towards genomic research among diverse stakeholders including researchers, clinicians, patients, community members, IRB/Ethics committee members, and regulators; analyze ethical implications of these views in planning and conducting NIAID research.
• Research to avoid or mitigate negative consequences of genetic findings on human phenotypes or identity, as well as genetic findings that reveal directionality of disease transmission of pathogens.
• Research to improve the implementation of Artificial Intelligence (AI) and Machine Learning methods to minimize bias in algorithms, coding, and analyses of genomic data.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is interested in supporting ELSI research on topics relevant to NICHD's populations of interest, including children; adolescents; pregnant and/or lactating individuals; and persons with intellectual, developmental, and/or physical disabilities across the lifespan.  NICHD is particularly interested in research that relates to the Institute’s high-priority research areas: see the current research priorities and strategic plan regarding research themes for the Institute. Please note that applications assigned to NICHD that address the mission and priorities of other Institutes that are not participating in this NOFO will not be prioritized for funding by NICHD.

Specific topics of interest to the NICHD include, but are not limited to, ELSI research on the following, subdivided by the NHGRI ELSI research areas:

Genomics and sociocultural structures and values

• The influence of ableism in genomic research on intellectual, developmental, and/or physical disabilities, and the societal implications of developing genomic therapies that aim to treat or “cure” disabilities.
• The societal impact of the development or use of cognition-altering genetic therapies for intellectual or developmental disabilities.
• Changes in national or regional policies and societal trends that impact the willingness to participate in genetic research and/or undergo genetic testing.

Genomics at the institutional and system level

• Equitable distribution of downstream benefits of genomic research with marginalized communities, such as benefit-sharing or equitable access to gene therapies.
• Genomic sequencing and newborn screening:
  • Real and perceived benefits and harms of genomic sequencing of newborns.
  • Impact of newborn sequencing on families/caregivers, healthcare providers, and state public health newborn screening programs.
  • Lifelong implications of being sequenced as a newborn, such as the inability to have an open future, genetic privacy, and insurance or job discrimination.
  • Use of residual newborn screening dried blood spots for purposes beyond public health, like medical research, forensic investigations, or initiation of cascade screening of biological relatives.
  • Facilitators and barriers for implementing population-wide newborn sequencing, such as whether parental/caregiver consent is needed.
• Considerations around population-wide genomic sequencing, such as ethical and societal concerns, like population-wide acceptance of genomic sequencing; legal, regulatory, and policy needs, like gaps in genetic anti-discrimination legislation or unintended secondary uses of these data; and public health resource constraints, like costs and personnel.
• Impact of germline gene editing technologies on the consent and autonomy of future generations.
• Use of genomic technology to identify genetic causes of disease and disability that currently lack effective treatments or other evidence of clinical utility, thereby ending the “diagnostic odyssey” but perhaps providing personal utility to patients/families.

Genomic research design and implementation

• Attitudes toward use and modification of patient-derived or genetically modified organoids to study NICHD populations of special interest (e.g., children, IDDs) and/or NICHD research priorities.
• Returning secondary findings to participants in genomic research, such as carrier status, environmental exposures, or pharmacogenomics; assent considerations when returning genetic risks for adult-onset conditions to infants, children, and adolescents; and cascade screening and the impact on family members, especially from prenatal, newborn, or pediatric sequencing.
• Informed consent and/or assent considerations toward genomic research, especially among vulnerable populations (e.g., pregnant women, fetuses and newborns, children and adolescents, individuals with intellectual and developmental disabilities, youth affected by or at high risk of HIV and/or other infectious diseases).
• Research on human genetic determinants of HIV and/or infectious disease transmission, acquisition, and associated co-morbidities among vulnerable populations of mothers, infants, children, adolescents, and young adults, in the US or in international settings.
• Returning genetic research results about HIV and/or other infectious diseases to participants from vulnerable populations and/or resource-limited settings, especially among marginalized groups of youth.
• How differential access to clinical genetic testing impacts the equitable application of genotype-driven recruitment approaches.

Genomic healthcare

• Use of genomic and other omics technologies for screening and/or diagnostic purposes and the implications of these results on patients, families, and caregivers; this includes carrier status, preimplantation selection of embryos, and prenatal and/or newborn risk assessment.
• Considerations for the use of genomic technologies to diagnose and treat benign gynecologic disorders and fertility-related disorders.
• Use of polygenic risk scores in preimplantation embryo screening.
• Clinical and personal utility of the "portable genome" across the lifespan.

Facilitators and barriers to accessing clinical genetic testing, such as biases around which types of tests are offered and to whom; access to follow-up specialty care; coverage and reimbursement considerations; initiation of cascade testing; and trust in healthcare providers and researchers, especially around the handling and protection of genomic data.

The NIDCD is interested in addressing ethical, legal and social issues, related to normal and disordered process, that evolve from genomic research in our mission areas of hearing, balance, taste, smell, voice, speech, and language.

The National Institute on Drug Abuse (NIDA) is interested in research that focuses on the ethical, legal, social, and policy issues related to genetic, epigenetic, and genomic research on addiction and addictive substances, especially those that align with NIDA’s Strategic Plan.

NIDA encourages applicants to consider developing novel collaborations between the ELSI and Addiction research communities. ELSI research topics of particular interest to NIDA include, but are not limited to, the following:

• What policies should/should not be adopted to protect individuals legally, e.g. If one is genetically predisposed to addiction, knows about this prediction, and decides to use addictive substances? What factors are important for these policies?
• Does genetics predict risk for problem use of opioids better than what is currently achieved? Will such a test improve clinical outcomes?
• What specificity and selectivity are needed to predict a substance use disorder (SUD) in a clinical setting? What are the consequences of misclassification?
• What is the best experimental design to validate risk prediction for substance use disorder (SUD)?
• If we validate genetics and other biomarkers to risk for OUD how do we use it clinically for acute pain and/or chronic pain?
• What are the potential misuses by clinicians of genetic test and other biomarkers of problem misuse of different drugs with addictive potential?
• Does current genetic data and or methods reinforce bias against any ethnic group?
• Will a device that predicts a substance use disorder (SUD) be accepted by patients?
• What impact does genetic liability for substance use disorders (SUDs) have on the stigma associated with substance use disorders?
• How would genetic tests for addiction impact treatment decisions?
• What implications does it have for insurance?
• Will genetic and other biomarker tests for substance use disorders (SUDs) be cost effective?

(R01, R21, R03)

The NIEHS is interested in addressing social, ethical, and legal concerns in research related to gene-environment (G x E) interactions, genetic susceptibility to environmental exposures, and ELSI issues related to research involving children, aged populations, tribal communities, and other vulnerable populations impacted by specific environmental exposures. NIEHS is interested in environmental justice and health disparities issues associated with the identification of vulnerable populations in G x E studies and the incorporation of social determinants of health into the G x E research framework. The potential evolving ELSI issues associated with developing improved health risk assessments that leverage emerging findings from combined epigenomics, exposomics, and genomics research is particularly welcome. Identifying, developing, and testing strategies for responsibly reporting back health results from research on G x E interactions to study participants is relevant. Exploring best practices to identify and share actionable environmental exposures (e.g., giving participants and communities access to resources to mitigate environmental exposures) and exploring how people and communities respond and modify their behavior with report-back is also of interest.

NIEHS is additionally interested in research on potential stigmas, discriminations, and privacy concerns associated with either identification of subpopulations at disease/disorder risk due to genetic susceptibility of environmental exposures or potential identification of individuals living in geographic areas linked to high exposures of environmental pollutants. Exploration of best practices to protect the privacy and use of G x E research data at the community level is of particular interest as well. ELSI issues surrounding community engagement approaches and best practices to establish sustainable infrastructures to conduct community-based/community-led research in G x E is also needed.

Contact:

Kimberly A. McAllister
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3287
Email: mcallis2@niehs.nih.gov

(R01, R21, R03)

The NIMH is interested in research to address a range of ethical, legal and social 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.

Areas of emphasis include but are not limited to:

• Implementation of psychiatric genomic medicine that takes into account cultural practices and values to promote inclusion and equity in mental health outcomes
  • Studies on outreach and community engagement in neuropsychiatric genetics research study design and execution, especially the inclusion of diverse cultural values and perspectives from populations currently underrepresented in the scientific community and/or the research subject population whose populations may be the focus of increased recruitment efforts for neuropsychiatric research.
  • Advance understanding on how to avoid or mitigate against stigmatization, group harms, and unintended negative social implications/exacerbations of structural inequalities when conducting research addressing the genomic underpinnings of cognitive and behavioral traits across the spectrum of human phenotypic variation (e.g. intelligence, sexual orientation, gender identity, socio-economic activities) when examined in the context of their contribution to risk and resilience in mental health outcomes.
  • Research related to implications of investigating genetic risk for mental health disorders in communities that experience sustained systemic community stressors that may influence risk for poor mental health outcomes, such as the experience of marginalization, discrimination, and/or racism.
  • Investigations into how to appropriately contextualize genetic information with environmental, cultural, intervention combinations and response, mental and physical health comorbidities, and societal (e.g. systemic racism) factors when assessing diagnosis, disorder trajectory, treatment recommendations, and drug-drug interactions in diverse patients.
  • Research related to the implementation of Artificial Intelligence that integrates genetic information with environmental and other health information in the diagnosis and/or stratification of clinical populations for treatment. The goal should be developing efficient computational strategies to reduce model bias, improve data coverage, equity, fairness towards underserved racial and ethnic minorities (e.g., through Generative Adversarial Networks & Digital-Twin technology).
     
• Research on the use of genetic screening and genetic testing for neuropsychiatric disorders in medical practice, especially among vulnerable and/or underserved populations, including the implications for:
  • Ethical and cultural issues surrounding informed consent, data sharing, and privacy for data collected in a health care setting (i.e. EHR or health-care system biobanks).
  • Return of results and communication of primary findings and secondary findings in a health care setting (e.g. how would the communication of the absence/presence of genetic findings influence patient behavior or encourage/discourage individuals from seeking treatment).
  • The ethical issues related to early intervention therapies (e.g. somatic gene editing, drugs, behavioral) for neuropsychiatric developmental conditions identified by genomic technologies, especially in 1) disorders with late childhood, adolescent or adult onset; or 2) early childhood onset disorders that present with a broad spectrum of severity in outcomes. These studies should consider differences in cultural practices and values across different communities.
  • Use of genomics in Precision Medicine, both for clinical and personal decision making, including indications favoring specific interventions (e.g. genetic testing that suggests favoring biological rather than psychosocial interventions; pharmacogenomic testing favoring higher-risk treatments as potentially more effective than those with lower risk; absence/presence of genetic finding discouraging providers from considering all available treatment options).
  • Effects on the legal and regulatory landscape and existing structural inequalities. (e.g. avoiding discrimination in employment, housing, military service, etc. based on genetic risk of mental disorder and/or use of preventive interventions or services).
     
• Studies on ethical, legal, and social implications raised by the collection, storage, and future research uses of biological samples and genetic data collected for neuropsychiatric research (e.g. participant preferences, informed consent, governance, privacy and security, and data sharing)
  • Risk assessment is needed for how changes in the science of a neuropsychiatric disease would impact the research subject community (i.e. those living with the disorder and their families who have contributed data or samples to prior research) with respect to informed consent. An example is the increased understanding of the genetic interrelatedness of neuropsychiatric disorders, pleiotropy and locus heterogeneity as it applies to consent for use in related disorder research. Assessment is needed to determine how such a change can most easily be appreciated by the study population and research subject community at large, and how these changes impact subjects understanding of informed consent and the ability to share data and samples.
  • Investigations relating to ethical and cultural issues raised by collections of data and samples from vulnerable and underserved populations in US, including Tribal communities, and populations in different cultural contexts in LMICs, whose populations may be the focus of increased recruitment efforts for neuropsychiatric research.
     

NIMH encourages projects that will partner with/embed within existing large-scale psychiatric genetics research efforts and others global research network to facilitate answering questions relevant to the execution of that research and implementation of the findings. Such networks include, but are not limited to, PsychENCODE, PsycheMERGE, Psychiatric Genomics Consortium, the Autism Sequencing Consortium, the Convergent Neuroscience Research Network, the Genes 2 Mental Health Network, and the Global Mental Health Genetics Network, Collaborative Hubs for International Research in Mental Health and Collaborative Hubs to Reduce the Burden of Suicide among American Indian and Alaska Native Youth. NIMH also strongly encourages groups to leverage existing ELSI resources developed by NHGRI under prior ELSI funding calls.

NIMH will only award non-trials or mechanistic clinical trials under this announcement. Groups wishing to Address the Safety, Efficacy, and Effectiveness of Preventive, Therapeutic, and Services Interventions should apply through the NIMH Clinical Trial Pipeline.

Contacts:

Tara Dutka
National Institute of Mental Health (NIMH)
Telephone: 301-451-3074
Email: tara.dutka@nih.gov  

Geetha Senthil
National Institute of Mental Health (NIMH)
Telephone: 301-402-0754
Email: geetha.senthil2@nih.gov

(R01 only)

Racial and ethnic minority populations are understudied in genomic research, particularly those who do not identify as White.Historical misuse of race and ethnicity data as population descriptors in genomics research has resulted in miscommunication of complex relationships between social identity, ancestry, socioeconomic status and health, perpetuating misguided ideas and mistrust. NIMHD is interested in supporting research that promotes scientifically and socially meaningful uses of genomic research and genomic health care for racial/ethnic minority populations. NIMHD is also interested in supporting research that will advance creation of guidelines and adoption of consensus practices for the use of social determinants of health and ancestry data in study design, interpretation of results, publications, and medical care for genomic studies.

Projects should focus on the ethical, legal, and social implications of research participation and/or health care for racial/ethnic minority and persons of less privileged socioeconomic status (SES) and at the intersection of race/ethnicity and lower SES for sexual and gender minorities and underserved rural residents. Research may use available secondary data, health system data and/or collection of primary data.

Contact:

Nancy L. Jones
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email. nancy.jones@nih.gov

(R01 and R21)

The NINDS is interested in research that addresses ethical, legal, and social issues for individuals and communities that emerge from human genome research in the domain of NINDS’s core mission and the topics and disorders for which NINDS serves as a primary lead at the NIH. Learn more about NINDS.

Areas of interest specific to NINDS include but are not limited to the ethical, legal, and social implications of: aspects of neurogenetic research with human participants, such as differing stakeholder views on return of research results to participants or patient consent-related issues (including, but not limited to, waivers of informed consent or exceptions from informed consent), or therapeutic misconception, including for rare genetic diseases; neurogenetic research with human nervous system tissue; development and/or application of gene therapy and gene editing technologies for neurogenetic disorders; issues collecting and sharing human neurogenetic data, such as de-identification, privacy, and re-use practices; predictive/diagnostic neurogenetic research related to nervous system disorders; management and understanding of uncertain individual neurogenetic research results and secondary findings; and issues pertaining to neurogenetic research with children, patients with rare diseases, and other vulnerable populations who may have a limited ability to consent for themselves.

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 and provides additional guidance to the scientific community.

While this funding opportunity also accepts clinical trials, only applications proposing “mechanistic clinical trials or studies” (studying pathophysiology or mechanism of action of an intervention, but not safety or efficacy) or basic experimental studies with humans (BESH) will be supported by NINDS.

Applications for clinical trials studying efficacy or safety will not be supported, and may be better suited for PAR-22-142, PAR-21-237, or other relevant clinical trials funding opportunities supported by NINDS. In addition, applications addressing ethical issues associated with and resulting from research on emerging technologies and advancements supported by the BRAIN Initiative will not be supported and may be better suited for RFA-MH-21-205.

Contact:

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

(R03 only)

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

Contact

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

The Office of Research on Women’s Health (ORWH) is part of the NIH Office of the Director and works in partnership with the NIH Institutes, Centers, and Offices (ICOs) to ensure that women's health research is part of the NIH scientific framework and supported throughout the biomedical enterprise. ORWH uses a multidimensional framework to represent the intersection of factors that underlie patterns of disease and determinants of health outcomes in populations.

For this NOFO, ORWH is interested in supporting research that addresses health equity in genomic research that will eliminate health inequities among women, including those who are understudied, underrepresented, and underreported (U3). The evolving conceptualization of factors relevant to the understanding and promotion of minority health and to the understanding and reduction of health disparities is illustrated in the NIMHD Minority Health and Health Disparities Research Framework. Applying such a framework to genomic research will help to advance the community engagement, access to genomic technology, acceptability of genomic approaches, and interventions to the public needed to advance the equitable use of genomics to improve health in US populations.

There is also a crucial need to address sex and/or gender influences in genomic research relevant to women's health, and, where appropriate, include both sexes to better understand the influence of sex as a biological variable (SABV) on health and disease. Integrating the purposeful accounting for SABV in biomedical research, from the most basic to the clinical and applied efforts, will fill gaps in our knowledge, and will inform more effective and personalized approaches for women and men. For additional guidance, please review the 2019-2023 Trans-NIH Strategic Plan for the Health of Women.

The Office of Data Science Strategy (ODSS) leads implementation of the NIH Strategic Plan for Data Science through scientific, technical, and operational collaboration with the institutes, centers, and offices that comprise NIH. ODSS is committed to growing a stronger and broader community in data science and ensuring that data science advances in biomedical and health research can benefit all populations. ODSS is interested in supporting Ethical, Legal, and Social Implications (ELSI) research that proposes normative or conceptual analyses, including focused legal, economic, philosophical, anthropological, or historical analyses of new or emerging issues related to data science. Examples of such projects include, but are not limited to:

• Advanced data management analytics, visualization tools and artificial intelligence (AI), machine learning (ML), and deep learning related areas.
• Individual, groups, or population risks associated with AI/ML, and data access and sharing

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 NIDCR Strategic Plan). Within the goals of this notice, and as related to its mission, NIDCR is interested in ELSI research in the following areas:

• Management of incidental findings about overall health from genetic and genomic studies that focus on DOC phenotypes using research, health, and clinical data. 
• Approaches to mitigate privacy and confidentiality issues related to the public dissemination of research, clinical, and health data, including but not limited to facial images, audio and video data, multi-omics data, and associated metadata. 
• Assessment and management of risks associated with the reuse of genomic and genetic data in combination with other sensitive or potentially identifiable DOC-relevant data types, including but not limited to, facial imaging, vocal recordings and other biometrics, clinical diagnoses, and dental or health records.
• Considerations of biases in data analyses and modeling, including best practices for bias mitigation. Causal factors for such biases to investigate include, but are not limited to, underrepresentation of certain populations in collected research, health, and clinical data, intrinsic limitations in the data analytics and models used, and/or varied interpretations of data outputs by different data analysts.
• Approaches to address topics such as privacy preservation and data ownership that may arise in the course of application of generative AI in the analysis, modeling, and sharing of human data (including but not limited to facial images/scans, audio/video samples, multi-omics data, and other types of individual human data) relevant for DOC-specific applications.