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Suggested Citation:"Appendix A Study Approach and Methods." 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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Page 223
Suggested Citation:"Appendix A Study Approach and Methods." 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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Page 224
Suggested Citation:"Appendix A Study Approach and Methods." 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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Page 225
Suggested Citation:"Appendix A Study Approach and Methods." 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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Page 226
Suggested Citation:"Appendix A Study Approach and Methods." 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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Page 227
Suggested Citation:"Appendix A Study Approach and Methods." 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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Page 228
Suggested Citation:"Appendix A Study Approach and Methods." 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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Page 229
Suggested Citation:"Appendix A Study Approach and Methods." 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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Page 230

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.

A Study Approach and Methods In response to a request by the Centers for Medicare & Medicaid Services, the Food and Drug Administration, and the National Institutes of Health, the National Academies of Sciences, Engineering, and Medicine’s Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories was charged with reviewing and evaluating the ethical, social, regulatory, and operational issues regarding the return of individual-specific research generated in laboratories involved in research on human biospecimens. The committee’s final report will include a review and evaluation of available evidence, current practices, potential benefits and harms, the regulatory environment for returning individual research results to participants, and the ethical considerations involved in providing or denying access to individual research test results. COMMITTEE EXPERTISE The National Academies formed a committee of 15 experts to conduct a 14-month study to deliberate and respond to the statement of task. The committee was composed of individuals with expertise in bioethics, legal and regulatory practice, research and laboratory practice, health communication, healthy literacy, decision science, and patient and community advocacy. MEETINGS AND INFORMATION GATHERING ACTIVITIES The committee deliberated from July 2017 to May 2018, during the course of which it held five in-person meetings (July, September, October, December, and February). The July, September, October, and December meetings included portions open to the public, and there was a public webinar held in December 2017 as well. The open session agendas appear in Appendix B. The committee meeting in February 2018 was held in closed session. To inform its deliberations the committee gathered information through a variety of mechanisms: (1) one 2-day workshop with open public sessions; (2) one 90-minute webinar in December discussing laboratory standards for regulated and non-regulated biomedical laboratories; (3) two open public-comment session during its September and October meetings; (4) one 2-hour informal interview session with participant and community representatives at the PPREPUBLICATION COPY: UNCORRECTED PROOFS A-1

A-2 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS December meeting; (5) literature reviews of the scientific, ethical, and social issues and other pertinent background research; (6) solicitation and consideration of written statements from stakeholders and members of the public through the committee’s Current Projects System website and by coordinated e-mail outreach; and (7) personal communication between committee members and staff and individuals who have been directly involved in or have special knowledge of the issues under consideration. SOLICITATION FOR PUBLIC COMMENT The committee proactively solicited a call for public comments in order to capture the diverse perspectives on the current evidence base and on practices related to the return of individual research results generated in laboratories that perform tests on human biospecimens. The comments were solicited through internal listservs at the National Academies. There was also an external solicitation carried out by the National Academies communications office, which tweeted a call for public comments through the Health and Medicine Division (HMD) and National Academies Twitter accounts and emailed individuals who had signed up to receive updates on the following topics: aging; biomedical and health research; children and families; diseases; environmental health; global health; health care workforce; health services, coverage, and access; public health; select populations and health disparities; veterans’ health; and women’s health. This included the Board on Health Care Services and the Board on Health Sciences Policy as well as the HMD’s forums and roundtables which distributed the call for comments to the internal membership and external listservs. The forums and roundtables included Forum on Aging, Disability, and Independence Forum on Drug Discovery, Development, and Translation Forum on Microbial Threats Forum on Neuroscience and Nervous System Disorders Forum on Regenerative Medicine National Cancer Policy Forum Roundtable on Environmental Health Sciences, Research, and Medicine Roundtable on Genomics and Precision Health Roundtable on Health Literacy Roundtable on Population Health Improvement Roundtable on Quality Care for People with Serious Illness Roundtable on the Promotion of Health Equity Staff also sent the call for public comments to the principle investigators of the 60 universities affiliated with the Clinical and Translational Science Award (CTSA) consortium. These included 1. Albert Einstein College of Medicine (partnering with Montefiore Medical Center) 2. Boston University 3. Case Western Reserve University 4. Columbia University PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX A A-3 5. Children’s National Medical Center 6. Duke University 7. Emory University (partnering with Morehouse School of Medicine and Georgia Institute of Technology) 8. Georgetown University with Howard University 9. Harvard University 10. Indiana University School of Medicine (partnering with Purdue University and the University of Notre Dame) 11. Johns Hopkins University 12. Mayo Clinic 13. Medical College of Wisconsin 14. Medical University of South Carolina 15. Mount Sinai School of Medicine 16. New York University School of Medicine 17. Northwestern University 18. The Ohio State University 19. Oregon Health & Science University 20. Penn State Milton S. Hershey Medical Center 21. The Rockefeller University 22. Scripps Research Institute 23. Stanford University 24. Tufts University 25. University of Alabama at Birmingham 26. University of Arkansas for Medical Sciences 27. University of California, Davis 28. University of California, Irvine 29. University of California, Los Angeles 30. University of California, San Diego 31. University of California, San Francisco 32. The University of Chicago 33. University of Cincinnati 34. University of Colorado Denver 35. University of Florida 36. University of Illinois at Chicago 37. The University of Iowa 38. University of Kansas Medical Center 39. University of Kentucky Research Foundations 40. University of Massachusetts Worcester 41. University of Michigan 42. University of Minnesota 43. University of New Mexico Health Sciences 44. University of North Carolina at Chapel Hill 45. University of Pennsylvania 46. University of Pittsburgh 47. University of Rochester School of Medicine and Dentistry 48. University of Southern California PREPUBLICATION COPY: UNCORRECTED PROOFS

A-4 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS 49. The University of Texas Health Science Center at Houston 50. The University of Texas Health Science Center at San Antonio 51. The University of Texas Medical Branch 52. The University of Texas Southwestern Medical Center at Dallas 53. The University of Utah 54. University of Washington 55. University of Wisconsin–Madison 56. Vanderbilt University–CTSA Coordinating Center (partnering with Meharry Medical College) 57. Virginia Commonwealth University 58. Washington University 59. Weill Cornell Medical College (partnering with Hunter College) 60. Yale University In all, the solicitation of comments reached more than 25,000 individuals. We received 35 comments for committee consideration. SOLICITATION OF PARTICIPANT AND COMMUNITY REPRESENTATIVES To enhance its understanding of the diverse perspectives among research participants on issues relevant to the return of individual research results, the committee solicited nominations for interviewees from research participant networks (e.g., PCORNet), community advisory boards (e.g., the Yale community advisory board), patient advocacy groups, and researcher networks (e.g., CTSA advisory boards), which identified individuals who were well suited to participate in informal interviews with the committee. Committee members also sent targeted emails to contacts asking for recommendations about representatives from priority populations. The contacted organizations included AIDS Clinical Trials Group AIDS Research Consortium of Atlanta AIDS Vaccine Advocacy Coalition (New York City) All of Us institutional review board Black AIDS Institute (Louisiana) Centers of Excellence on Minority Health and Health Disparities, National Institutes of Health Community Advisory Board, Yale University Community–Campus Partnerships for Health (CCPH) Community Research Group (District of Columbia) CTSA (Clinical and Translational Science Awards) Collaboration and Engagement Domain Task Force Genetic Alliance Healthy African American Families HIV Prevention Trials Network HIV Vaccine Trials Network International Maternal Pediatric Adolescent AIDS Clinical Trials PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX A A-5 Jackson Heart Study National Minority AIDS Council (District of Columbia) NCATS (National Center for Advancing Translational Sciences) Council Subcommittee on Patient Engagement PACER—Partners for the Advancement of Community-Engaged Research PCORNet Rural and Underserved Health Research Center, University of Kentucky SisterLove (Atlanta) Treatment Action Group (New York City) The committee received 11 nominations and selected six for interviews based on the following criteria: (1) personal experience with topic, (2) experience with engaging population of interest or general knowledge of groups’ perspectives on the topic, and (3) represents population or group determined to be a priority for project. Those nominated individuals who were not selected for interviews were invited to provide written comments to the committee. The committee conducted five interview-style phone calls with research participants during the December committee meeting. This was done in a public session format, meaning that the calls were posted on the committee website 10 days before they occurred, and the full committee and public was able to listen in. The interviews were conducted by one committee member with one participant. Interviews lasted approximately 20 minutes. PUBLIC COMMENTS AND CONTRIBUTIONS Douglas A. Beigel, COLA Adam Berger, Food and Drug Administration Leslie Biesecker, National Human Genome Research Institute Angela Bradbury, University of Pennsylvania Christopher R. Cogle and Yulia Strekalova, University of Florida Carolyn Compton, Arizona State University The College of American Pathologists Nancy J. Cox, American Society of Human Genetics Stephanie Devaney, National Institutes of Health Rebecca Davies, University of Minnesota Karen Dyer, Centers for Medicare & Medicaid Services Barbara J. Evans, University of Houston Mary E. Freivogel, National Society of Genetic Counselors Gail Jarvik, Clinical Sequencing Evidence-Generating Research Consortium Joseph P. Kim, Eli Lilly and Company Memorial Sloan Kettering Federico A. Monzon, Association for Molecular Pathology Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Sally Okun, PatientsLikeMe Project Baseline PREPUBLICATION COPY: UNCORRECTED PROOFS

A-6 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS Randy Querry, American Association for Laboratory Accreditation Carlos Quijada, The University of Utah S.J. Quincy School of Law Mark E. Sobel, American Society of Investigative Pathologists Greta Lee Splansky, Framingham Heart Study Julie Anne Zawiska, Merck & Co., Inc. LITERATURE AND PRESS REVIEW The committee and staff conducted a series of literature searches that concentrated on journals found in the following databases: Embase, Medline, Cochrane Databases of Systematic Reviews, PubMed, Scopus, Web of Science, Lexis, Department of Energy, the Environmental Protection Agency, Greenfile, Proquest, and Science.gov. The articles obtained by use of the search terms were reviewed for their relevance to the committee’s charge. Search parameters for three of the committee’s literature searches are detailed below, This does not represent an exhaustive list of the research conducted. Other targeted literature reviews were conducted throughout the committee’s deliberations as novel issues arose and research gaps identified Return of Results in Practice Search Parameters: Date range: 2005 to present International, English only Databases: Embase Medline Cochrane Databases of Systematic Reviews PubMed Web of Science Scopus Search Strategy: Research participant Search terms: human experimentation, participant decision making, research participants, participant perspectives, study participants Return of research results Search terms: individual research results, methods of returning research results, research findings, individual research results, return of results Additional terms of interest Search terms: Native Americans, American Indians, attitudes, benefit, clinical care choices, decision making, end of life, harm, opinions, palliative care, privacy, PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX A A-7 risk, stigma, terminal care, therapeutics, treatment, trust, value, vulnerable populations, human rights, Helsinki Declaration Legal and Operational Considerations for Research Laboratories Search Parameters: Date range: 2005 to present International, English only Databases: Scopus Web of Science Lexis Law Reviews Search Strategy: TITLE (laboratories OR laboratory OR “biomedical laboratories” OR “clinical laboratory services” OR “research laboratories” OR “research laboratory” OR “CLIA-excepted laboratory” OR “CLIA-exempt laboratories”) AND TITLE-ABS-KEY (“CLIA accreditation” OR “cost of accreditation” OR accreditation OR “operational barriers” OR “confirmation of results” OR “confirmation of results” OR “confirmation of results in CLIA-certified laboratories” OR “clinical laboratory improvement amendments”) AND PUBYEAR AFT 2004 Return of Results in the Environmental Health Field Search Parameters: Date range: 2000 to present International, English only Databases: Department of Energy Environmental Protection Agency Greenfile Proquest Science.gov Scopus Web of Science Search Strategy: Research participant perspectives TITLE-ABS-KEY (“individual research results” OR “research findings” OR “research results” OR “return of individual research results” OR “return of results” OR “disclosure of research results”) AND TITLE-ABS-KEY (“research participants” OR “research participants perspectives” OR “study participants” OR subjects) AND PREPUBLICATION COPY: UNCORRECTED PROOFS

A-8 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS TITLE-ABS-KEY (“american indians” OR indians OR attitudes OR benefit OR “clinical care choices” OR “decision making” OR “end of life” OR harm OR “native americans” OR opinions OR “palliative care” OR privacy OR risk OR stigma OR “terminal care” OR therapeutics OR treatment OR trust OR value OR “vulnerable populations”) Return of research results ts=(“individual research results” OR “research findings” OR “research results” OR “return of individual research results” OR “return of results” OR “disclosure of research results”) AND ts=(“research participants” OR “research participants perspectives” OR “study participants” OR subjects) AND ts=(“american indians” OR indians OR attitudes OR benefit OR “clinical care choices” OR “decision making” OR “end of life” OR harm OR “native americans” OR opinions OR “palliative care” OR privacy OR risk OR stigma OR “terminal care” OR therapeutics OR treatment OR trust OR value OR “vulnerable populations”) Indexes=SCI-EXPANDED, SSCI, BKCI-S, BKCI-SSH Timespan=2000-2017 PREPUBLICATION COPY: UNCORRECTED PROOFS

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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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