Ethical, Legal and Social Implications Research Program

The ELSI Research Program funds and manages studies, and supports workshops, research consortia and policy conferences related to these topics. For a more in depth exploration of the program, read The Ethical, Legal and Social Implications Program of the National Human Genome Research Institute: Reflections on an Ongoing Experiment.

The NHGRI Division of Genomics and Society has identified the following three research domains to be considered for support by the Ethical, Legal and Social Implications (ELSI) Research Program. The domains are overlapping, and it is anticipated that many research projects will address issues that cut across domains. A more detailed discussion of these domains and a list of examples of possible research topics is available at ELSI Research Domains. 

Genetic and Genomic Research.  These projects may investigate and address the ethical, legal, social, and policy issues that arise in connection with the design and conduct of genetic and genomic research. 

Genetic and Genomic Health Care.  These projects may investigate and address the ethical, legal, social, and policy issues that arise in connection with the translation of genetic and genomic research into clinical medicine and health care in a variety of healthcare settings.

Broader Legal, Policy and Societal Issues.  These projects may investigate and address a range of broader ethical, legal, policy and societal issues raised by the use of genetic and genomic technologies and information in research, clinical or non-medical settings.

News

• NIH funds new studies on ethical, legal and social impact of genomic information
  May 17, 2016

Meetings

• ELSI Strategic Planning Webinar: Genomic Decision-Making: Power and Identity
  July 9, 2019
   
• ELSI Strategic Planning Webinar: Appropriate Use and Implementation of Genomics in Diverse Communities
  June 28, 2019
   
• ELSI Webinars March 13 and March 26, 2018
   
• The 4th ELSI Congress: Genomics and Society: Expanding the ELSI Universe
  June 5-7, 2017
   
• Trans-NIH Workshop to Explore the Ethical, Legal and Social Implications (ELSI) of Citizen Science
  January 13-14, 2015

Genetic Testing

• Follow-up Workshop to the Consensus Development Conference on Genetic Testing for CF (10/97)
• Promoting Safe and Effective Genetic Testing in the United States: Final Report of the Task Force on Genetic Testing (09/97)
• Genetic Testing for Cystic Fibrosis Consensus Development Conference Statement (04/97)
• NIH Workshop Statement - Reproductive Genetic Testing: Impact on Women (11/91)
• NIH Workshop Statement - Population Screening for the CF Gene (07/90)

Genetic Discrimination and Health Insurance

• Genetic Information and the Workplace (01/98)
• NIH-DOE ELSI Working Group and National Action Plan on Breast Cancer Workshop on Genetic Discrimination and the Workplace(10/96)
• NIH-DOE ELSI Working Group and National Action Plan on Breast Cancer Workshop on Genetic Discrimination and Health Insurance (07/95)
• Insurance Task Force Report--Executive Summary (05/93)
• Genetic Information and Health Insurance - Report of the Task Force on Genetic Information and Insurance (05/93)

Issues Related to the Conduct of Genetic Research

• Report of the First Community Consultation on the Responsible Collection and Use of Samples for Genetic Research (09/00)
• NCHGR/CDC Workshop on Informed Consent for Genetics Research Using Stored Tissue Samples (07/94)
• Protecting Human Research Subjects: 1993 OPRR IRB Guidebook Chapter on Human Genetic Research (1993)
• Report of the Working Group on Ethical, Legal, and Social Issues Related to Mapping and Sequencing the Human Genome (04/90)

Underrepresented Minorities

• Summary of Grantees' Workshop on Strategies for Increasing the Number of Underrepresented Minorities Participating in Genomics and ELSI Research (11/01)
• Plan for Increasing the Number of Underrepresented Minorities Trained in Genomics and ELSI Research (2001)

Specific Research Topics

• Studying interactions Among Social, Behavioral & Genetic Factors in Health (10/01)
• Cancer Genetic Studies Consortium (1998)
• Hereditary Hemochromatosis: Gene Discovery and Policy Meeting (03/97)

Program Reviews

• Report to the National Advisory Council for Human Genome Research (02/05)
• The Role of ELSI Research & Policy Activities in the NHGRI Plan (10/02)
• A Review and Analysis of the ELSI Research Programs at NIH and DOE (ERPEG Final Report) (02/00)
• Report of the Joint NIH/DOE Committee to Evaluate the Ethical, Legal and Social Implications Program of the Human Genome Project (12/96)
• Review of the ELSI Program: 1990-1995 (03/96)

NIH is instituting a number of changes to how it categorizes clinical trial research. Many ELSI studies that previously were not considered clinical trials will now be categorized as such and will be subject to new application, review and reporting requirements.  Please visit the Clinical Trials definition website for guidance in determining how your study will be categorized. If you have any questions or concerns, please contact our ELSI program directors

ELSI applications that do not involve a clinical trial can still be submitted under the ELSI R01, R21 and R03 program announcements listed below. 

ELSI applications that are determined to involve a clinical trial cannot be submitted under these announcements and must now be submitted under either the NIH Parent R01--Clinical Trial Required (PA-18-345) or the NIH Parent R21--Clinical Trial Required (PA-18-344) program announcements.  When submitting these applications, researchers should use the PHS Assignment Request Form to request that NHGRI (and any other relevant Institutes or Centers) be assigned the grant, and to request study section review assignment to the Continuous Special Emphasis Panel on Societal and Ethical Issues in Research Study Section (ZRG1 SEIR).

ELSI Research Program Announcements (PA)

The NHGRI, along with several other National Institutes of Health (NIH) institutes, has released revised general program announcements to solicit research projects that anticipate, analyze, and address the ethical, legal, and social implications of the discovery of new genetic technologies and the availability and use of genetic information resulting from human genetics and genomic research.

• Ethical, Legal, and Social Implications (ELSI) of Genomic Research Regular Research Program (R01) 
  PA-17-444 
  Application Receipt Date(s): Standard dates apply
  Expiration Date: September 8, 2020
   
• Ethical, Legal, and Social Implications (ELSI) of Genomic Research Small Research 
  Grant Program (R03)
  PA-17-445
  Application Receipt Date(s): Standard dates apply
  Expiration Date: September 8, 2020
   
• Ethical, Legal, and Social Implications (ELSI) of Genomic Research Exploratory/Developmental Research Program (R21) 
  PA-17-446 
  Application Receipt Date(s): Standard dates apply
  Expiration Date: September 8, 2020

NIH-wide Bioethical Research Funding Notice

• Notice of Interest in High Priority Research in Bioethical, Legal, and Societal Implications of Biomedical Research 
  NOT-LM-17-001

ELSI Conference Grants

The NHGRI ELSI Program accepts Conference Grant (R13) applications. For specific instructions for preparing a conference grant application, see:

• PA-16-294: NIH Support for Conferences and Scientific Meetings (Parent R13)
  Application Receipt Dates: Standard Dates Apply 

ELSI Training and Career Development Funding Opportunities

The ELSI program participates in a number of training and career development funding opportunities.

International Bioethics Training

The Fogarty International Center's international bioethics training programs [fic.nih.gov] support education and research training to develop ethics expertise in low- and middle-income countries (LMICs). The programs complement other global health research and research training programs in the mission areas of NIH Institutes and Centers.

• PAR-16-081: International Research Ethics Education and Curriculum Development Award (R25)
  This award, which NIH established in fiscal year 2000, supports curriculum development for master's level courses; courses for skill development, including practicum experiences; and mentoring activities.
   
• PAR-16-082: International Bioethics Research Training Program (D43)
  This new program support LMIC-U.S. collaborative institutional bioethics doctoral and postdoctoral research training programs that incorporate didactic, mentored research and career development components to prepare trainees for positions of scholarship and leadership at health research institutions in LMICs.

Pre- and Post-Doctoral Training Opportunities

• PA-16-308:  Ruth L. Kirschstein National Research Service Award Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research 
• Expiration Date: May 8, 2019
   
• PA-16-309: Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31) 
  Expiration Date: May 8, 2019
   
• PA-16-307:  Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32) 
  Expiration Date: May 8, 2019
   
• PA-16-310:  Ruth L. Kirschstein National Research Service Award (NRSA) Individual Senior Fellowship (Parent F33) 
  Expiration Date: May 8, 2019
   
• PA-18-403: Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Program (Parent T32) 
  Expiration Date: January 8, 2021
   
• NOT-HG-15-004: Notice of NHGRI Participation in PA-14-015 "Ruth L. Kirschstein NRSA Institutional Research Training Grants (Parent T32)" and Establishment of New Training Program in the Ethical, Legal and Social Implications of Genetic and Genomic Research

Career Development Opportunities 

• PA-18-363: Mentored Research Scientist Development Award (Parent K01-Independent Clinical Trial Required) 
  Expiration Date: January 8, 2021
   
• PA-18-369: Mentored Clinical Scientist Research Career Development Award (Parent K01-Independent Clinical Trial Not Allowed) 
  Expiration Date: January 8, 2021 
   
• PA-18-372: Mentored Research Scientist Development Award (Parent K01-Independent Clinical Trial Required) 
  Expiration Date: January 8, 2021
   
• PA-18-373: Mentored Clinical Scientist Research Career Development Award (Parent K01-Independent Clinical Trial Not Allowed) 
  Expiration Date: January 8, 2021 
   
• PA-18-397: NIH Pathway to Independence Award (Parent K99/R00-Independent Clinical Trial Required) 
  Expiration Date: January 8, 2021 
   
• PA-18-398: NIH Pathway to Independence Award (Parent K99/R00-Independent Clinical Trial Not Required ) 
  Expiration Date: January 8, 2021 

• PA-16-288: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)
  Expiration Date: September 30, 2019

• PA-16-289: Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp)
  Expiration Date: September 30, 2019