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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.
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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
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.
×

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 Group

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)
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.
×

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

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

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.
×

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

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
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.
×

Third Committee Meeting
Public Workshop

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

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

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.
×

Fourth Committee Meeting

Community and Participant Perspectives—Public Webinar

December 11, 2017
Arnold and Mabel Beckman Center
100 Academy Drive, Irvine, CA

3:30–6:30 p.m. Community and Participant Perspectives—Public Webinar

John Molina, Native Health, Phoenix

Sonja Fuqua, Jackson Heart Study Participant and Community Health Advisor

Crispin Goytia-Vaquez, Mount Sinai Centers for Community and Academic Research Partnerships

Matthew Rose, National Minority AIDS Council

Lisa Schlager, Facing Our Risk of Cancer Empowered

Stephen Mikita, Aspirin in Reducing Events in the Elderly

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 289
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 290
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 291
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 292
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 293
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 294
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
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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.

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