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Suggested Citation:"Front Matter." 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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Returning Individual
Research Results to
Participants

GUIDANCE FOR A NEW RESEARCH PARADIGM

Jeffrey R. Botkin, Michelle Mancher, Emily R. Busta,
and Autumn S. Downey, Editors

Committee on the Return of Individual-Specific Research Results
Generated in Research Laboratories

Board on Health Sciences Policy

Health and Medicine Division

A Consensus Study Report of

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THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." 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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This activity was supported by contracts between the National Academy of Sciences and the Centers for Medicare & Medicaid Services, the Food and Drug Administration, and the National Institutes of Health (HHSN26300117). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

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Suggested citation: 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: https://doi.org/10.17226/25094.

Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

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Suggested Citation:"Front Matter." 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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COMMITTEE ON THE RETURN OF INDIVIDUAL-SPECIFIC RESEARCH RESULTS GENERATED IN RESEARCH LABORATORIES

JEFFREY R. BOTKIN (Chair), Associate Vice President for Research and Professor of Pediatrics, The University of Utah School of Medicine

PAUL S. APPELBAUM, Elizabeth K. Dollard Professor of Psychiatry, Medicine, and Law, Columbia University

SUZANNE BAKKEN, Professor of Biomedical Informatics, Columbia University

CHESTER BROWN, Professor and the St. Jude Chair of Excellence in Genetics for the Department of Pediatrics, University of Tennessee Health Science Center

WYLIE BURKE, Professor Emeritus, University of Washington

RICHARD FABSITZ, Adjunct Faculty, George Mason University

VANESSA NORTHINGTON GAMBLE, University Professor of Medical Humanities, The George Washington University

GREGG GONSALVES, Assistant Professor, Yale School of Public Health

RHONDA KOST, Director, Clinical Research Support Office, Co-Director Community Engaged Research Core, Associate Professor of Clinical Investigation, The Rockefeller University Center for Clinical and Translational Science

DEBRA G. B. LEONARD, Professor and Chair of Pathology and Laboratory Medicine, Robert Larner, M.D. College of Medicine, University of Vermont, University of Vermont Health Network

AMY McGUIRE, Leon Jaworski Professor of Biomedical Ethics, Baylor College of Medicine

JAMES H. NICHOLS, Professor of Pathology, Microbiology, and Immunology, Vanderbilt University School of Medicine

BRAY PATRICK-LAKE, Director of Stakeholder Engagement, Duke Clinical Research Institute

CONSUELO H. WILKINS, Associate Professor of Medicine, Vanderbilt University Medical Center and Meharry Medical College

BRIAN J. ZIKMUND-FISHER, Associate Professor, University of Michigan

Study Staff

MICHELLE MANCHER, Study Director

AUTUMN S. DOWNEY, Interim Study Director

EMILY R. BUSTA, Associate Program Officer

OLIVIA C. YOST, Research Associate

CAROLINE M. CILIO, Senior Program Assistant

DANIEL BEARSS, Senior Research Librarian

ANDREW M. POPE, Director, Board on Health Sciences Policy

Suggested Citation:"Front Matter." 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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Consultants

REBECCA L. DAVIES, Associate Professor, University of Minnesota

CHRISTI GUERRINI, Assistant Professor, Baylor College of Medicine

E. HAAVI MORREIM, Professor, University of Tennessee Health Science Center

Suggested Citation:"Front Matter." 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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Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report:

BARBARA E. BIERER, Harvard Medical School and Brigham and Women’s Hospital

JULIA GREEN BRODY, Silent Spring Institute

ELLEN WRIGHT CLAYTON, Vanderbilt University Medical Center

BARRY S. COLLER, The Rockefeller University

CRISPIN GOYTIA-VASQUEZ, Mount Sinai Health System

ALBERTO GUTIERREZ, NDA Partners LLC

KATHY L. HUDSON, People-Centered Research Foundation

DEVEN McGRAW, Ciitizen

J. STEPHEN MIKITA, Spinal Muscular Atrophy Foundation

ELLEN PETERS, The Ohio State University

HEIDI REHM, Massachusetts General Hospital

MARK E. SOBEL, American Society for Investigative Pathology

SUSAN M. WOLF, University of Minnesota

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Suggested Citation:"Front Matter." 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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BARBARA A. ZEHNBAUER, Emory University School of Medicine

MARK L. ZEIDEL, Harvard Medical School and Beth Israel Deaconess Medical Center

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by LYNN R. GOLDMAN, The George Washington University, and JOSHUA M. SHARFSTEIN, Johns Hopkins Bloomberg School of Public Health. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

Suggested Citation:"Front Matter." 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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Preface

There is a long-standing tension in biomedical research arising from a conflict in core values—the desire to respect the interests and desires of research participants by communicating results contrasted with the responsibility to protect participants from uncertain, perhaps poorly validated information. Traditionally, the balance has been tipped toward the latter resulting in what has been termed “helicopter research.” The notion here is that investigators drop into communities or people’s lives, engage with them in often very personal ways, and then take off, never to be heard from again.

Yet, people are curious about themselves, particularly about their health and their family’s health, leaving a sense of frustration and loss when investigators take but do not share. Studies show that many participants want and expect their personal results. They often have these expectations regardless of what the consent discussion promised. Experimental results are often uncertain and disclosure of unvalidated results can, in some circumstances, lead to harmful medical or life decisions. But, of course, investigators are confident enough in experimental results to publish their work, suggesting that individual data points are sufficiently meaningful to contribute to generalizable knowledge. A participant might ask, “If the findings are good enough to publish, why can’t my results be shared with me?” This conflict in values is central to this report. In struggling with the complex and competing considerations, we have attempted to achieve a new balance, one that leans toward communication of results while seeking to enhance the quality of results emerging from research laboratories. Our push toward more disclosure, we believe, is part and parcel of the larger cultural transition toward more engagement, collaboration, and transparency between investigators and research participants.

Suggested Citation:"Front Matter." 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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Our committee has had the opportunity to work together for 1 year to produce this report, with strong support from the extraordinary staff at the National Academies of Sciences, Engineering, and Medicine. We have achieved consensus on a number of core issues. We are recommending a transition away from firm rules, such as those embodied in current interpretations of the Clinical Laboratory Improvement Amendments and the Health Insurance Portability and Accountability Act regulations, that stipulate when results must or cannot be disclosed toward a process-based approach. In many circumstances, and on a study-by-study basis, we recommend a peer-review process to assess the risks and benefits of results disclosure with careful attention to laboratory quality. Establishing supporting processes will require motivation, resources, and time.

This report is the product of a wonderful collaboration between a diverse set of committee members who came to the task with divergent viewpoints about core issues. Through extended discussions, mutual respect, and multiple iterations of the language, we achieved a remarkable degree of consensus. This is a testament to the integrity, scholarship, and humility of the dedicated people who agreed to serve on the committee. We were also privileged to work with the outstanding staff of the National Academies who were unfailingly creative and supportive. We are deeply grateful to Michelle Mancher, Autumn Downey, Emily Busta, Caroline Cilio, Olivia Yost, and Andrew Pope for their expertise, hard work, and insights. We also benefited greatly from consultants to the project including Christi Guerrini, E. Haavi Morreim, and Rebecca Davies and to those who testified to the committee and submitted comments to enrich our understanding and deliberations.

Our hopes and expectations are that this report will provide a roadmap toward better and more collaborative and transparent research practices that will benefit participants, investigators and society more broadly.

Jeffrey R. Botkin, Chair
Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories

Suggested Citation:"Front Matter." 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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Acknowledgments

This Consensus Study Report reflects contributions from a number of individuals and groups. The committee takes this opportunity to recognize those who so generously gave their time and expertise to inform its deliberations. To begin the committee would like to thank the individuals who attended and presented at their open-session meetings and webinars and the many individuals and organizations who submitted written comments to the committee (see Appendix A). The committee greatly benefited from the opportunity for discussion with these individuals and is appreciative for their many contributions. The committee also thanks the participants who graciously gave their time, knowledge, and perspectives through interviews with the committee. Their thoughtful remarks enriched the committee’s understanding of the complex issues and informed their deliberations (see Appendix B).

Many others provided support to this project in various ways. We thank Paul Bachner, University of Kentucky College of Medicine; Karen Dyer, Centers for Medicare & Medicaid Services; Michael P. Ryan, New York State Department of Health; and David E. Sterry, Clinical and Laboratory Standards Institute, for their technical review. Finally, our gratitude to Casey Weeks for his creative efforts in our graphic design process and Robert Pool for his editorial assistance in preparing this report.

Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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4-4 Challenges in Reporting Back Personal Exposure Results

4-5 Individual Research Results That Should and Should Not Be Returned to Participants

4-6 Memorial Sloan Kettering Cancer Center’s Genomic Advisory Panel

5-1 Select Engagement and Communication Practices for the Return of Research Results in Environmental Health

5-2 Best Practices for Health-Literate Informed Consent Related to the Return of Individual Research Results

5-3 Presenting Laboratory Results to Consumers—Experiences of the Food and Drug Administration

5-4 Types of Reference Information

5-5 Examples of Visualizations Relevant to Results Reporting

5-6 Standards That Support Integration of External Resources with Electronic Health Records and Patient Portals and Are of Relevance to Return of Research Results

6-1 Overview of Federal Laws and Regulations Relevant to the Return of Individual Research Results

FIGURES

S-1 Determining whether laboratory quality is sufficient for investigators to return individual research results

S-2 A conceptual framework for decisions on returning individual research results

S-3 Determining whether participants have the right to access their individual research results under HIPAA

3-1 Diagram of pre-analytic to post-analytic phases of research

3-2 Determining whether laboratory quality is sufficient for investigators to return individual research results

3-3 Costs, infrastructure, and resources needed to implement a quality management system

3-4 Opposing forces encountered by investigators when considering implementing a quality management system

3-5 Systematic benefits of standards

4-1 A conceptual framework for decisions on returning individual research results

6-1 Investigational device exemption process for research studies

Suggested Citation:"Front Matter." 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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Acronyms and Abbreviations

ACA Patient Protection and Affordable Care Act of 2010
ACMG American College of Medical Genetics and Genomics
AIDS acquired immunodeficiency syndrome
AV analytic validity
BRISQ Biospecimen Reporting for Improved Study Quality
CBPR community-based participatory research
CDC Centers for Disease Control and Prevention
CDS clinical decision support
CIOMS Council for International Organizations of Medical Sciences
CLIA Clinical Laboratory Improvement Amendments of 1988
CLIAC Clinical Laboratory Improvement Advisory Committee
CLSI Clinical and Laboratory Standards Institute
CMS Centers for Medicare & Medicaid Services
CSER Clinical Sequencing Evidence-Generating Research consortium
CTSA Clinical and Translational Science Awards Program
CU clinical utility
CV clinical validity
DNA deoxyribonucleic acid
DRS designated record set
DTC direct-to-consumer
EHR electronic health record
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Suggested Citation:"Front Matter." 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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eMERGE Electronic Medical Records and Genomics Network
EPA Environmental Protection Agency
FDA Food and Drug Administration
FHS Framingham Heart Study
GAP Genomic Advisory Panel
GINA Genetic Information Nondiscrimination Act of 2008
HHS Department of Health and Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996
HIV human immunodeficiency virus
IDE investigational device exemption
IDIOM Scripps Idiopathic Diseases of Man Study
IF incidental finding
IND investigational new drug
IRB institutional review board
ISO International Organization for Standardization
KKI Kennedy Krieger Institute
LDT laboratory developed test
MRCT Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
NBAC National Bioethics Advisory Commission
NCI National Cancer Institute
NDA new drug application
NGS next-generation sequencing
NHGRI National Human Genome Research Institute
NIEHS National Institute of Environmental Health Sciences
NIH National Institutes of Health
OCR Office for Civil Rights
OHRP Office for Human Research Protections
PCB polychlorinated biphenyl
PCORI Patient-Centered Outcomes Research Institute
PGT personal genetic test
PHI protected health information
PI principal investigator
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Suggested Citation:"Front Matter." 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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PU personal utility
QA quality assurance
QC quality control
QMS quality management system
RCT randomized controlled trial
REVEAL Risk Evaluation and Education for Alzheimer’s Disease
RoR return of individual research results
SOP standard operating procedure
VUS variant of unknown significance
WHO World Health Organization
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Suggested Citation:"Front Matter." 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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Abstract

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. A committee of the National Academies of Sciences, Engineering, and Medicine reviewed 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. The committee’s report includes 12 recommendations directed to various stakeholders—investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participants—that 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.

SUPPORT DECISION MAKING REGARDING THE RETURN OF RESULTS ON A STUDY-BY-STUDY BASIS

Decisions on whether to return individual research results will vary depending on the characteristics of the research, the nature of the results, and the interests of participants. The justification for returning results becomes stronger as both the potential value of the result to participants and the feasibility of return increase. Investigators should not make assumptions about the kinds of results

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Suggested Citation:"Front Matter." 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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that participants may value and should incorporate participant needs, preferences, and values into their decision-making process.

The responsible return of individual research results requires careful forethought and preparation. Thus, the committee recommends that investigators include plans in study protocols that describe whether results will be returned and, if so, when and how and that research sponsors and funding agencies require that applications for funding consistently address the issue. Additionally, institutions and IRBs should develop policies to support the review of plans to return individual research results.

PROMOTE HIGH-QUALITY INDIVIDUAL RESEARCH RESULTS

Confidence in the validity of individual research results is critical to decisions about whether to return results to participants. Requirements established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were designed to ensure the quality of results from clinical laboratories and are not appropriate or feasible for all research laboratories. However, no alternative exists that defines basic quality standards for research laboratories in the United States. To promote the quality of results returned and to improve the reproducibility of science, the committee recommends that the National Institutes of Health lead an effort to develop a quality management system (QMS) for research laboratories testing human biospecimens.

When individual research results are intended for clinical decision making in the study protocol, investigators must continue to perform tests only in laboratories that are CLIA certified. However, when results are not intended for clinical decision making in the study protocol, IRBs should permit the return of results under the recommended QMS—once developed—or after determining that the laboratory analysis is sufficient to provide confidence in the result, the value to participants outweighs the risks, and appropriate disclaimer information on the limitations of the validity and interpretation of the individual’s result is provided.

FOSTER PARTICIPANT UNDERSTANDING OF INDIVIDUAL RESEARCH RESULTS

Once the decision is made to return individual research results to participants, investigators and institutions should communicate those results in a manner that conveys the key takeaway messages and fosters participants’ understanding. Doing so requires providing contextualizing information and explanations that convey what is known and unknown about the meaning and potential clinical implications of the results, including the level of uncertainty in the results’ validity. Communications should be appropriate for participants with different needs, capabilities, resources, and backgrounds. The development of evidence-based best practices, which will require the systematic evaluation of the effectiveness of

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Suggested Citation:"Front Matter." 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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various approaches, will improve the quality of the process of returning individual research results.

REVISE AND HARMONIZE CURRENT REGULATIONS

As currently written and implemented, the regulations governing access to research laboratory test results are not harmonized: they afford inconsistent and inequitable access for participants, and regulatory conflicts create dilemmas for laboratories, investigators, and institutions. For example, the Centers for Medicare & Medicaid Services (CMS) prohibits the return of results from laboratories that are not CLIA certified, but in some circumstances the Health Insurance Portability and Accountability Act of 1996 (HIPAA) may require the return of results requested by a participant, regardless of whether they were generated in a CLIA-certified laboratory. Accordingly, the committee recommends that regulators revise and harmonize the relevant regulations in a way that respects the interests of research participants in obtaining individual research results and appropriately balances the competing considerations of safety, quality, and burdens on the research enterprise. For example, CMS should revise CLIA regulations to allow for the return of results from non-CLIA-certified laboratories when results are requested under the HIPAA access right and also when an IRB process determines it is permissible. However, the Office for Civil Rights of the Department of Health and Human Services should limit access to individual research results under HIPAA to those generated in a CLIA-certified laboratory or in a research laboratory compliant with the recommended externally accountable QMS for research laboratories.

Taken together, the recommendations in this report promote a process-oriented approach to returning individual research results that considers the value to the participant, the risks and feasibility of return, and the quality of the research laboratory. The committee expects that adoption of its recommendations will lead to an increase in the return of individual research results over time, but it also acknowledges that this will create new demands on the research enterprise that cannot be addressed overnight. The recommendations in this report are intended to help stakeholders discuss and prepare for these responsibilities and to develop the necessary expertise, infrastructure, policies, and resources. The initial investments will likely be significant, but ultimately the return on those investments in terms of increased participant trust and engagement with the research enterprise and higher-quality standards for research laboratories will be worthwhile.

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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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Suggested Citation:"Front Matter." 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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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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