THE NATIONAL ACADEMIES PRESS This PDF is available at http://nap.edu/25094 SHARE Returning Individual Research Results to Participants: Guidance for a New Research Paradigm DETAILS 398 pages | 6 x 9 | PAPERBACK ISBN 978-0-309-47517-4 | DOI 10.17226/25094 CONTRIBUTORS GET THIS BOOK 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 FIND RELATED TITLES Medicine Division; National Academies of Sciences, Engineering, and Medicine Visit the National Academies Press at NAP.edu and login or register to get: – Access to free PDF downloads of thousands of scientific reports – 10% off the price of print titles – Email or social media notifications of new titles related to your interests – Special offers and discounts Distribution, posting, or copying of this PDF is strictly prohibited without written permission of the National Academies Press. (Request Permission) Unless otherwise indicated, all materials in this PDF are copyrighted by the National Academy of Sciences. Copyright © National Academy of Sciences. All rights reserved. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm Summary1 Biospecimens from research participants are an essential resource for a broad range of studies, from exploratory, basic science inquiries to clinical trials using well-validated tests. These types of research have been enormously valuable in advancing knowledge about almost every aspect of human health and disease. The conduct of research with human volunteers is dependent on a collaborative, productive relationship between participants who give their time and samples and the investigators and research teams that conduct the research. This complex relationship has many elements, but in the past the communication of individual research results to participants has generally not been one of them. In the last several decades, questions have been raised about the practice of not returning test results generated in a research study to the study’s participants; early on, much of the discussion was focused on returning results from imag- ing studies, while more recently the focus has moved more to the disciplines of genetics and environmental research. At the same time, the push for increased community and participant engagement across the research study life cycle and the rise of technology-enabled open science and data-sharing movements have added further momentum to the issue. Recent significant changes to federal regulations have promoted transparency and allowed individuals greater access to their clinical and research test results. These changes include the elimination of the laboratory exclusion from the Health Insurance Portability and Account- ability Act (HIPAA) privacy rule and revisions to the Common Rule that require prospective participants to be told during the consent process whether clinically 1 This Summary does not include references. Citations for the discussion presented in this Summary appear in subsequent report chapters. 1 Copyright National Academy of Sciences. All rights reserved. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm 2 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS relevant individual research results will be returned. On the other hand, the Clini- cal Laboratory Improvement Amendments of 1988 (CLIA) bars laboratories that are not CLIA certified from reporting individual research results. This creates a dilemma when research results that are clinically relevant or otherwise valuable to participants, particularly those that might not otherwise be discovered, are generated in research laboratories that are not CLIA certified. See Box S-1 for a brief description of these federal regulations. (Box 6-1 in Chapter 6, from which Box S-1 is adapted, includes additional laws and regulations relevant to the return of individual research results.) Over the last couple of decades expert groups have written position state- ments supporting the return of individual research results and secondary find- ings2 under certain conditions, such as when the results are clinically actionable, valid, and reliable. However, participant demand for individual research results is driven not just by the potential benefits that individuals could gain by learning about clinically actionable information, but also by their desire to learn about themselves from information that they would not otherwise obtain. More spe- cific guidance is needed on how stakeholders should consider the benefits, risks, and costs associated with the return of individual research results, including the broad spectrum of results which may not be accurate, medically actionable, or have clear meaning. Seeking guidance on these issues from a consensus body of experts represent- ing diverse perspectives, the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) asked the National Academies of Sciences, Engineering, and Medicine to conduct a study and generate a report that reviews and evaluates the ethical, soci- etal, regulatory, and operational issues related to the return of individual-specific research results generated from research on human biospecimens. The full State- ment of Task for the committee is presented in Box S-2. SCOPE AND KEY TERMINOLOGY The topic of the return of research results is exceptionally broad in scope and encompasses all fields of human research (e.g., biomedical, psychological, behav- ioral). During its first meeting on July 19, 2017, the committee had an opportunity to clarify the scope of the study with representatives of the three sponsoring fed- eral agencies. In the course of that discussion, the study sponsors clarified that the committee was intended to focus on research results that are generated from the analysis of human biospecimens (samples of material collected from the human 2 Secondary findings are results that are not the primary objective of the research. Such findings are referred to in the literature by a variety of terms, such as “additional,” “secondary,” “incidental,” “ancillary,” “supplemental,” etc., and these terms can be combined with additional clarifiers such as “unanticipated” and “anticipated.” Copyright National Academy of Sciences. All rights reserved. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm SUMMARY 3 BOX S-1 HIPAA, CLIA, and the Common Rule Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: The Office for Civil Rights (OCR) is the authority responsible for implementing and enforcing the HIPAA privacy rule. The privacy rule standards are directed toward protecting individuals’ health information “while allowing the flow of health information needed to provide and promote high-quality health care and to protect the public’s health and well-being.” Since 2000, the HIPAA regulations have recognized the right of individuals to inspect and obtain a copy of their protected health information (PHI)a contained within a designated record set (DRS).b This right of access is binding on all HIPAA-covered entities,c except that before 2014 this right did not apply to HIPAA- covered laboratories. Clinical Laboratory Improvement Amendments of 1988 (CLIA): Laboratories in the United States that perform tests on human specimens for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or for the assessment of the health of an individual are regulated by CLIA and are required by the Centers for Medicare & Medicaid Services (CMS) to be CLIA certified through a process that ensures that certain quality-control assurances and requirements are in place. CLIA requirements for clinical laboratories ensure the quality and integrity of data, accurate reconstruction of test validation and test performance, and the comparability of test results regardless of performance location. Federal Policy for the Protection of Human Subjects (the “Common Rule”): A policy adopted by 15 federal agencies that addresses the protection of human participants in research and includes requirements for informed consent and institutional review board (IRB) review of research protocols. The Office for Human Research Protections (OHRP) leads the Department of Health and Human Services’ (HHS’s) efforts to protect human subjects in biomedical and behavioral research and to provide leadership for all federal agencies that conduct or support human subjects research under the Common Rule. In January 2017, HHS announced its adoption of revisions to the Common Rule, which for the first time require continued Copyright National Academy of Sciences. All rights reserved. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm 4 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS BOX S-1, CONTINUED that investigators disclose their plans on whether and under what circumstances “clinically relevant research results, including individual research results,” will be returned to participants. The changes are expected to go into effect on January 21, 2019. a PHI is defined as individually identifiable health information, which is any information (including genetic information) that (a) is created or received by a covered entity or employer; (b) “relates to the past, present, or future