Population surveys collect information from participants by asking questions. Today, many surveys also collect biologic specimens that can be used to analyze a respondents DNA and other biomarkers. The National Health and Nutrition Examination Survey (NHANES) is a population survey that also administers a physical examination, collects biospecimens, and reports some test results (e.g., cholesterol levels) to the participant. While visiting communities large and small throughout the country, NHANES collects health and nutrition data from a representative sample of individuals through in-person interviews and health examinations that take place at special mobile examination centers. The examination component consists of medical, dental, and physiological examinations, as well as laboratory tests. On December 2, 7, and 8, 2022, a workshop was convened to focus on anticipated future collections of genomic data by NHANES. The 2022 workshop explored ethical considerations and current practices for returning genomic information from active research and population surveys. This Proceedings of a Workshop summarizes the presentations and discussions at the workshop.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• WORKSHOP PLANNING COMMITTEE ON CONSIDERATIONS FOR RETURNING INDIVIDUAL GENOMIC RESULTS FROM POPULATION-BASED SURVEYS WITH A FOCUS ON THE NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY
• COMMITTEE ON NATIONAL STATISTICS
• Reviewers
• Acknowledgments
• Acronyms and Abbreviations
• 1. Introduction
  • ROLE OF THE PLANNING COMMITTEE
  • ORGANIZATION OF THE PROCEEDINGS
  • OPENING REMARKS TO THE WORKSHOP
• 2. NHANES Current Structure and Opportunities for Adding Genomics (Session 1)
  • OVERVIEW OF THE NHANES RESOURCE
  • TYPES OF RESEARCH SUPPORTED BY THE CURRENT SURVEY DATA
  • GENETICS 101/201: UNDERSTANDING THE CURRENT GENETIC TESTING LANDSCAPE
  • QUESTIONS AND REFLECTIONS FOR SESSION 1
• 3. Return of Clinically Actionable Genetic Results (Session 2)
  • WHAT DATA IS BEING GENERATED?: IMPLICATIONS FOR RETURNING RESULTS
  • ETHICAL ARGUMENTS REGARDING THE RETURN OF RESEARCH RESULTS
  • CURRENT ACMG LIST, PROCESS, AND ALTERNATIVES
  • ATTITUDES AND OUTCOMES OF RETURNING RESULTS TO PARTICIPANTS
  • ISSUES REGARDING DATA REANALYSIS FOR ACTIONABLE VARIANTS
  • QUESTIONS AND RELFECTIONS FOR SESSION 2
• 4. Regulatory Issues in the Return of Genetic Results (Session 3)
  • CLINICAL LABORATORY IMPROVEMENT AMENDMENTS LAB CERTIFICATION AND TEST VALIDATION
  • POTENTIAL FDA OVERSIGHT AND APPROVAL
  • NAVIGATING FEDERAL AND STATE-SPECIFIC LAWS GOVERNING GENETIC TESTING AND THE RETURN OF RESULTS
  • QUESTIONS AND REFLECTIONS FOR SESSION 3
  • GENERAL END-OF-DAY DISCUSSIONS FOR SESSIONS 1, 2, AND 3
• 5. Process for the Return of Genetic Results (Session 4)
  • INFRASTRUCTURE, EXPERTISE, AND OTHER NECESSARY RESOURCES TO COMMUNICATE RESULTS IN A RESEARCH SETTING
  • COMMUNICATION STRATEGIES IN A CLINICAL RESEARCH SETTING
  • COMMUNICATION STRATEGIES IN A DIRECT-TO-CONSUMER CONTEXT^i,ii
  • SPECIAL ISSUES FOR RETURNS TO PARTICIPANTS IN LOW-RESOURCE COMMUNITIES: LESSONS FROM THE HEALTHY NEVADA PROJECT
  • SPECIAL ISSUES FOR RETURNS TO PARTICIPANTS IN LOW-RESOURCE COMMUNITIES: LESSONS FROM THE BIOME PROJECT
  • QUESTIONS AND REFLECTIONS FOR SESSION 4
• 6. Informed Consent When Considering Returning Genetic Results to Survey Participants (Session 5)
  • COMMUNITY ENGAGEMENT AND INFORMED CONSENT IN NHANES
  • INFORMED CONSENT: CONTENT FOR RETURN OF RESEARCH RESULTS AND BIOBANKING
  • THE INFORMED CONSENT PROCESS FOR RETURN OF RESULTS AND BIOBANKING
  • QUESTIONS AND REFLECTIONS FOR SESSION 5
  • GENERAL END-OF-DAY DISCUSSIONS FOR SESSIONS 4 AND 5
• 7. Considerations in the Return of Genetic Results: Lessons from Other Research Studies (Session 6)
  • GENOMICS ENGLAND
  • MILLION VETERAN PROGRAM
  • ALABAMA GENOMIC HEALTH INITIATIVE
  • ALL OF US
  • QUESTIONS AND REFLECTIONS FROM SESSION 6
• 8. Key Themes and Considerations for Future National Health and Nutrition Examination Survey (NHANES)
  • RECAP OF WORKSHOP DAYS 1 AND 2
  • PANEL DISCUSSION
• Appendix A. Public Meeting Agendas
• Appendix B. Committee and Speaker Biosketches
• Appendix C. Public-Facing Background Materials: Glossary of Terms and Acronyms
• Appendix D. Public-Facing Background Materials: Workshop Primer: Background and Context about the National Health and Nutrition Examination Survey (NHANES)
• COMMITTEE ON NATIONAL STATISTICS

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. (2023). Considerations for returning individual genomic results from population-based surveys: Focus on the National Health and Nutrition Examination Survey: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/27105.

Digital Object Identifier: https://doi.org/10.17226/27105

This publication is available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

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