Lawrence C. For more than two decades, the National Human Genome Research Institute has NHGRI has been committed to driving the responsible use of genomics in society in order to advance knowledge and ensure that genomics benefits the health of all populations. NHGRI considers the Ethical, Legal and Social Implications ELSI of genomics research, including the following key issues: genetic discrimination, health disparities, human subjects research, informed consent, intellectual property, privacy and confidentiality and regulation and coverage of genetic tests.
His research interests include neural tube defects, vitamin B12 metabolism, personalized genetic information, and BRCA -related cancers. Eligibility Information Section IV. Application and Submission Information Section V. Other Information. Continuing advances in genomic technology coupled with lowered sequencing costs have rapidly increased the numbers of people being sequenced, and are transforming biomedical research. As knowledge of relationships between genetic variation and human diseases and traits proliferates, the distinctions between basic and clinical genomic research blur, and new findings are altering the practice of medicine.
Taken together these developments may have profound effects on many long-standing societal beliefs and norms. The purpose of this FOA is to solicit research applications that identify, analyze, and address the ethical, legal and social implications ELSI of these genetic and genomic advances for individuals, families, communities and society more broadly. To address the broad scope and reach of genomic advances in society, applications are invited from investigators representing a wide range of disciplines, including but not limited to ethics, genetics and genomics, clinical medicine, law, health services research, public health, bioinformatics and health information sciences, behavioral and social sciences e.
Applications may propose multi-disciplinary studies using either single or mixed methods. Proposed methods may include but are not limited to data-generating qualitative and quantitative approaches, legal, economic and normative analyses, and other types of analytical and conceptual research methodologies, such as those involving the direct engagement of stakeholders.
Applicants are strongly encouraged to contact ELSI program officials prior to developing an application. The specific areas of research interest targeted through this FOA fall roughly into the following broad domains. Genomic Research. These projects may examine and address the ethical, legal, and social issues that arise in connection with the design and conduct of genetic and genomic research.
Research areas of particular interest include:. Genomic Health Care. These projects may examine and address the ethical, legal, and social issues that arise in connection with the translation of genetic and genomic research into clinical medicine and health care. Broader Legal, Policy and Societal Issues. These projects may examine and address a range of broader legal, policy and bioethical and societal issues raised by the use of genomic technologies and information in research, clinical or non-medical settings.
The research areas and possible research questions described at this website are provided as a general guide to areas of interest and should not be viewed as a comprehensive list of all possible research topics. As genomic research advances and as the interpretation and use of genomic information continues to evolve, applicants are encouraged to identify additional topics and issues ripe for research.
Many of the specific topics listed on the ELSI Research Domains website are relevant to the design and implementation of genomic research or genomic medicine studies and may be appropriately examined in conjunction with a variety of planned or ongoing genomic research projects.
Potential applicants are encouraged to explore possible collaborations with genomics or other researchers conducting such studies. This includes basic normative and conceptual research and the generation of data and development of tools that can be applied across many different diseases and conditions. Projects focused on a single disease or disorder may be of lower priority for NHGRI unless generalizability is clearly shown. The National Institute on Aging NIA is interested in research that focuses on the ethical, legal and social issues related to aging and genomics.
Examples of topics of particular interest include: research on the anticipated and actual impact of genetic and genomic information; studies on ethical, regulatory and policy challenges in aging research such as clinical trials, population-based studies incorporating genetic and genomic technologies; issues raised by the collection, storage and use of biological samples and associated data; studies that incorporate and investigate the perspectives of diverse communities; and studies on models of participant and community engagement or participatory research in aging research.
The ultimate goal of this research will be to understand how people make sense of and act upon genetic and genomic information related to aging and diseases of aging; to inform the ethical conduct of aging research involving genetic and genomic information and data; and overall to improve outcomes related to aging and diseases of aging. The NIEHS is interested in addressing social, ethical, and legal concerns of the public in research endeavors related to gene-environment interactions, environmental health hazards, 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.
In particular, NIEHS has an interest in supporting collaborations between scientists and the public for the development of culturally appropriate translations of the scientific findings of research on complex, environmentally-relevant diseases, as well as assessment of the comprehensibility and effectiveness of educational interventions used i. NIEHS is additionally interested in research on the bioethical issues related to ownership of biosamples collected in environmental health studies, data sharing requirements when it involves data derived from tribal-based environmental health studies, or stigma associated with identification of genetic conditions that put individuals at greater risk from environmental exposures.
Other Information for award authorities and regulations. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 5 years, but given how quickly the field is evolving, it is expected that many projects will be no more than 3 years in duration. Longer project periods should be well justified.
Additional consideration for longer projects may be given to new or early stage investigators. Non-domestic non-U. Entities Foreign Institutions are eligible to apply. Organizations are eligible to apply. All registrations must be completed prior to the application being submitted.
Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Obtaining an eRA Commons account can take up to 2 weeks. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. Do not use the Appendix to circumvent page limits. Foreign non-U. See Part 1. Section III. Part I. Overview Information contains information about Key Dates and times.
Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. As NIH begins to fund more studies of GxE interactions and genetic susceptibility to environmental exposures, there is a need to develop a framework to ensure that NIH and its GxE researchers understand and address unique issues that arise from this work. For questions about meeting content please contact Kimberly McAllister , For logistical questions please contact Justin P.
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