National Academies Press: OpenBook
« Previous: Appendix A Study Approach and Methods
Suggested Citation:"Appendix B Public Agendas." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
×
Page 231
Suggested Citation:"Appendix B Public Agendas." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
×
Page 232
Suggested Citation:"Appendix B Public Agendas." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
×
Page 233
Suggested Citation:"Appendix B Public Agendas." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
×
Page 234
Suggested Citation:"Appendix B Public Agendas." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
×
Page 235
Suggested Citation:"Appendix B Public Agendas." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
×
Page 236

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

B Public Agendas Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories First Committee Meeting July 19, 2017 National Academies Keck Building 500 Fifth Street NW, Washington, DC 20001 AGENDA OPEN SESSION 1:00–1:15 p.m. Opening Remarks to Public Audience Jeffrey Botkin, Committee Chair 1:15–2:00 p.m. Presentation by Sponsors: Stephanie Devaney, National Institutes of Health Adam Berger, Food and Drug Administration Karen Dyer, Centers for Medicare & Medicaid Services 2:00–2:45 p.m. Sponsor Q&A with Committee Moderator: Jeffrey Botkin, Committee Chair 2:45 p.m. ADJOURN Open Session PREPUBLICATION COPY: UNCORRECTED PROOFS B-1

B-2 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Second Committee Meeting September 6–7, 2017 National Academy of Sciences Building 2101 Constitution Avenue NW, Washington, DC 20148 AGENDA OPEN SESSION Day 1: September 6, 2017 8:30–8:45 a.m. Welcome and Opening Remarks Jeffrey Botkin, Committee Chair 8:45–10:15 a.m. Session 1: Participant and Community Perspectives Moderator: Gregg Gonsalves, Committee Member Fran Visco, President, National Breast Cancer Coalition Ellen Wagner, Board of Directors, Parent Project Muscular Dystrophy Chioma Nnaji, Program Director, Multicultural AIDS Coalition 10:15–10:30 a.m. BREAK 10:30 a.m.–12:00 p.m.Session 2a: Perspectives of Researchers and Laboratorians Moderator: Debra Leonard, Committee Member Wendy Chung, Professor of Pediatrics and Medicine, Columbia University Carolyn Compton, Professor of Life Sciences, Arizona State University Jessica B. Langbaum, Principal Scientist, Banner Alzheimer’s Institute Lea C. Harty, BioBank Biological Materials Custodian, Pfizer Inc., Representative of The Industry Pharmacogenomics Working Gro 12:00–12:30 p.m. LUNCH 12:30–1:15 p.m. Session 2b: Successes and Challenges—CSER and eMERGE Moderator: Steven Joffe, Committee Member (resigned from the committee on September 26, 2017) Rex Chisholm, Vice Dean for Scientific Affairs and Graduate Education, Adam and Richard T. Lind Professor of Medical Genetics, Feinberg School of Medicine, Northwestern University, eMERGE Gail Jarvik, Head, Division of Medical Genetics, University of Washington, CSER/eMERGE PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX B B-3 1:15–2:45 p.m. Session 2c: Experiences to Date of Returning Results from Different Health Care Institutions Moderator: Chester Brown, Committee Member Febe Wallace, Director of Primary Care, Cherokee Health Systems Ronald Przygodzki, Director, Genomic Medicine Implementation, Department of Veterans Affairs, Office of Research & Development Joanne Murabito, Research Center Director, Framingham Heart Study Adam Buchanan, Clinical Investigator I, Geisinger Health System 2:45–3:00 p.m. BREAK 3:00–4:30 p.m. Session 3: Laws and Regulations Governing the Return of Results Moderator: Jeffrey Botkin, Committee Chair Susan M. Wolf, McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine; University of Minnesota Law School, Medical School, and Consortium on Law and Values in Health, Environment & the Life Sciences David J. Peloquin, Associate, Ropes & Gray LLP Sally Howard, Head of Regulatory Affairs and Policy and Chief Privacy Officer, Human Longevity, Inc. 4:30–6:00 p.m. Session 4: Institutional Management and Oversight Moderator: Rhonda Kost, Committee Member Leslie G. Biesecker, Chief, Medical Genomics and Metabolic Genetics Branch, National Institutes of Health, National Human Genome Research Institute Alexis Carter, Physician Informaticist, Children’s Healthcare of Atlanta, Representative from College of American Pathologists Mark Sobel, Executive Officer, American Society for Investigative Pathology Heather Pierce, Senior Director, Science Policy and Regulatory Counsel Association of American Medical Colleges 6:00 p.m. ADJOURN DAY 2: September 7, 2017 8:00–8:15 a.m. Welcome and Opening Remarks Jeffrey Botkin, Committee Chair 8:15–9:45 a.m. Session 5: Communicating Results to Meet User Needs Moderator: Consuelo Wilkins, Committee Member Sally Okun, Vice President for Policy and Ethics, PatientsLikeMe Julia Wynn, Senior Genetic Counselor and Clinical Research Manager, Columbia University Medical Center PREPUBLICATION COPY: UNCORRECTED PROOFS

B-4 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS Sara Czaja, Leonard M. Miller Professor in the Departments of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine (participating via WebEx) John Wilbanks, Chief Commons Officer, Sage Bionetworks 9:45–10:00 a.m. BREAK 10:00–11:00 a.m. Session 6: A Discussion with Workshop Panelists Moderator: Jeffrey Botkin, Committee Chair Gail Javitt, Member of the Firm in the Health Care and Life Sciences Practice, Office of Epstein Becker Green (participating via WebEx) Leslie G. Biesecker, Chief, Medical Genomics and Metabolic Genetics Branch, National Institutes of Health, National Human Genome Research Institute Ellen Wagner, Board of Directors, Parent Project Muscular Dystrophy 11:00–11:30 a.m. Public Comment Moderator: Jeffrey Botkin, Committee Chair 11:30 a.m. ADJOURN Public Workshop Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Third Committee Meeting October 24, 2017 National Academies Keck Building 500 Fifth Street NW, Washington, DC 20001 AGENDA OPEN SESSION 1:00–2:30 p.m. Basic and Translational Researcher Panel (non-genetic genomics) Moderator: Suzanne Bakken, Committee Member Nicholas Newman, Department of Pediatrics, Cincinnati Children’s Hospital Medical Center Theresa Powell, University of Colorado Anschutz Medical Campus 4:30–5:30 p.m. Public Comment Session 5:30 p.m. ADJOURN Open Session PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX B B-5 Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Public Webinar December 7, 2017 90-Minute Webinar 2:00–3:30 p.m. Quality Standard for Regulated and Non-Regulated Biomedical Research Laboratories Moderator: Debra Leonard, Committee Member Rebecca Davies, University of Minnesota Randy Querry, American Association for Laboratory Accreditation Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Fourth Committee Meeting Community and Participant Perspectives—Public Webinar December 11, 2017 Arnold and Mabel Beckman Center 100 Academy Drive, Irvine, California 3:30–6:30 p.m. Community and Participant Perspectives—Public Webinar John Molina, Native Health, Phoenix Sonja Fuqua, JHS Participant and Community Health Advisor Crispin Goytia-Vaquez, Mount Sinai Matthew Rose, NMAC (National Minority AIDS Council) Lisa Schlager, FORCE (Facing Our Risk of Cancer Empowered) Stephen Mikita, ASPREE (ASPirin in Reducing Events in the Elderly) PREPUBLICATION COPY: UNCORRECTED PROOFS

Next: Appendix C Analysis of Legal and Regulatory Landscape Relevant to Return of Individual Results Generated from Biospecimens in Research »
Returning Individual Research Results to Participants: Guidance for a New Research Paradigm Get This Book
×
Buy Prepub | $94.00 Buy Paperback | $85.00
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research results—such as results with unknown validity—and the associated burdens on the research enterprise are competing considerations.

Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholders—investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participants—and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  6. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  7. ×

    View our suggested citation for this chapter.

    « Back Next »
  8. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!