The National Academies Press

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1 Introduction
Pages 39-58

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From page 39... ... This push is the product not only of transformation in the research enterprise but also of the changing expectations of the research participants themselves. There is a growing demand by research participants to gain access to their individual results -- a demand that is driven not just by the potential benefit that individuals could gain by learning about clinically actionable information, but also by participants' desire to learn about themselves from information that they would not otherwise obtain (Facio et al., 2013; Sanderson et al., 2016) Read the entire page →
From page 40... ... Over the last several decades, consensus has been growing in certain research domains that some types of research results or secondary findings2 -- specifically, those that are clinically actionable and valid -- can be and, when certain conditions apply (e.g., immediate clinical action is warranted) , should be returned to participants (see the section "Past Expert Group Recommendations on the Return of Individual Research Results") Read the entire page →
From page 41... ... requested that the National Academies of Sciences, Engineering, and Medicine (the National Academies) convene a committee to consider whether and under what circumstances individual research results generated in research laboratories ought to be returned to study participants, considering participant preferences and investigator obligations, current practices, and the available evidence on potential benefits and harms as well as the regulatory environment for returning individual research results to participants. Read the entire page →
From page 42... ... • Review the current regulatory environment, including CLIA and any other applicable laws, for conducting tests and returning individual specific research results, including the potential regulatory considerations associated with returning such results. In doing so, the committee will assess how the current regulations ensure or fail to ensure minimization of risks (e.g., erroneous or unreliable results) Read the entire page →
From page 43... ... º Whether there are any operational or other requirements, including regulatory requirements, for research laboratories that may be developed or modified and implemented under CLIA or any other applicable laws to more adequately address the return of individual-specific research results. Additionally, whether there are or may be specific considerations for research laboratories (including any obligations or desires on the part of researchers to fulfill requests for access to research test results and whether they have the appropriate personnel or resources to explain the research results) Read the entire page →
From page 44... ... .3 This is an important issue in the broader context of returning information generated in the course of research to individual participants, but the sponsors clarified that it was not intended to be a central focus of this committee's report. Instead, in this report the committee uses the term "individual research results" to refer to results that are generated in the course of a study to help answer the research question or otherwise support the study objectives (e.g., to determine clinical trial inclusion/exclusion) Read the entire page →
From page 45... ... Frequently, the considerations that stakeholders will need to take into account when deciding on the return of individual-specific research results to research participants will be the same for all of the three scenarios described above. Therefore, throughout the report, the committee uses the shorthand phrase "return of results" to refer to the practice of returning individual research results in any of the three scenarios described above when it is not important to make a distinction among them. Read the entire page →
From page 46... ... In discussions with the sponsors, the committee also clarified the scope as it applies to CLIA. The sponsors indicated to the committee that it would be appro priate to include in its description of the current regulatory environment for the return of individual research results CMS's current interpretation of the scope and applicability of CLIA, which is that "only those facilities performing research testing on human biospecimens that do not report patient-specific results may qualify to be excepted from CLIA certification" (CMS, 2014) Read the entire page →
From page 47... ... The increased focus by the research enterprise on engagement has been in part motivated by the recognition that health is socially determined and that addressing the health needs of diverse communities requires the involvement of those most affected, enabling them to be the beneficiaries of the research. In 21st-century research, patient groups have catalyzed a growing array of sophisticated, innovative initiatives, including launching patient registries and conducting natural history studies, funding translational and early phase clinical research programs, designing trials, developing novel trial infrastructure, sing venture philanthropy to drive therapy development, and conducting u olicy advocacy aimed at the evolving regulatory environment (CTTI, 2015) Read the entire page →
From page 48... ... , a perception that may contribute to public distrust in the research enterprise and to the challenges that many investigators face in the recruitment and retention of research participants. High-profile historical examples of research participants and their families pushing back on this dynamic and demanding a more active role in research involving their biospecimens include the Henrietta Lacks story and the gene patent legal suit (Skloot, 2010) Read the entire page →
From page 49... ... , the committee refers to human research volunteers as "research participants" rather than "research subjects," in accordance with the ethical principles of autonomy and respect for persons and to reflect their changing role in the research enterprise. a Greenberg v. Read the entire page →
From page 50... ... . Past Expert Group Recommendations on the Return of Individual Research Results The question of whether and when to return individual-specific research results has been considered by several expert groups, and a number of recommendations and position statements have been released supporting the return of results and secondary findings under specific conditions (Bookman et al., 2006; Fabsitz et al., 2010; Green et al., 2013; Jarvik et al., 2014; MRCT Center, 2017; N ational Bioethics Advisory Commission, 1999; PCSBI, 2013; SACHRP, 2016; Wolf et al., 2008) Read the entire page →
From page 51... ... Collins, director of NIH, emphasized the important role of participants in the research endeavor and how implementing this project will require a shift in the traditional perceptions concerning research participants. "Equally important, the Precision Medicine Initiative Cohort Program will change the way we do research," he wrote. Read the entire page →
From page 52... ... . Moreover, HIPAA regulations give patients full right of access to their medical information in the designated record set maintained by any HIPAA-covered entity.5 The designated record set is defined as the group of records maintained by 5 HIPAA-covered entities include health plans, health care clearinghouses, and health care roviders p who transmit health information in electronic form in connection with covered financial or administrative transactions (e.g., billing transactions) Read the entire page →
From page 53... ... , and the first four meetings included i nformation-gathering sessions that were open to the public. A 2-day workshop was conducted in conjunction with the September 2017 meeting and covered participant and community perspectives on the return of individual research results, the perspectives of investigators and institutions, applicable laws and regulations, the institutional infrastructure and oversight needed to enable the appropriate r eturn of results, and communication practices used in returning results. Read the entire page →
From page 54... ... One paper described the legal and regulatory landscape relevant to the return of individual research results, and the second provided a critical analysis of the ethical principles commonly used to justify disclosure or non-disclosure as well as of the philosophic literature on the relationship between the research participant and the investigator or research institution and the implications of that analysis for the return of results. Additional detailed information on the committee's methodology, including its literature search strategies and processes for the solicitation of public comments, is provided in Appendix A Read the entire page →
From page 55... ... 2015. The CLIA/HIPAA conundrum of returning test results to research participants. Read the entire page →
From page 56... ... 2016. Clinical trials registration and results information submission. Read the entire page →
From page 57... ... 2016. Recommendations for reporting of secondary findings in clinical exome and genome sequencing, 2016 update: A policy statement of the American College of Medical Genetics and Genomics. Read the entire page →
From page 58... ... 2016. Motivations, concerns and preferences of personal genome sequencing research participants: Baseline findings from the HealthSeq project. Read the entire page →

From page 39...

... This push is the product not only of transformation in the research enterprise but also of the changing expectations of the research participants themselves. There is a growing demand by research participants to gain access to their individual results -- a demand that is driven not just by the potential benefit that individuals could gain by learning about clinically actionable information, but also by participants' desire to learn about themselves from information that they would not otherwise obtain (Facio et al., 2013; Sanderson et al., 2016)

1 Introduction Pages 39-58

1 Introduction
Pages 39-58