Standardizing return of participant results

As members of the National Academies of Sciences, Engineering, and Medicine committee that wrote the report on the return of individual research results ([ 1 ][1]), we reject the allegations in the Policy Forum “Return of results and data to study participants” (S. M. Wolf and B. J. Evans, 12 October, p. [159][2]) that the report is paternalistic, misunderstands the law, burdens Institutional Review Boards (IRBs), and creates barriers to the return of results. In the National Academies report, we advocate regulatory changes to expand the opportunities to give research participants access to their individual results. The Centers for Medicare and Medicaid Services (CMS) interprets the law governing laboratory standards as prohibiting any communication about research results to participants unless the laboratory is certified according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Wolf and Evans contend that CMS does not have the statutory authority for this restriction. However, there is no consensus regarding this position ([ 2 ][3], [ 3 ][4]) and CMS's interpretation has not been overruled by the courts. Given substantial penalties for noncompliance, many research institutions abide by CMS's interpretation. Our report recommends an explicit change to the regulations to bring clarity to the field that will not be achieved by assuming that CMS's position can be ignored, as Wolf and Evans suggest. We recommend that the Office of Civil Rights (OCR) clarify what research results participants have a right to under the Health Insurance Portability and Accountability Act (HIPAA) rule by clearly defining the Designated Record Set (DRS) to include all research results generated in laboratories that meet an accepted quality standard. Although the DRS includes information maintained by a covered entity that could be used for individual decision-making ([ 4 ][5]), there is no consensus about what research data should be included. In the absence of guidance from OCR, some institutions are excluding some research data from the DRS ([ 5 ][6]). Our recommendation supports broadening participant access to high-quality research results while adhering to the principle that results lacking demonstrated quality should not be used by participants or their health care providers for individual decision-making. We disagree with the notion that our recommendations are paternalistic. During our study, we consulted a diverse group of community members, study participants, and advocacy groups to fully understand how individuals might use results, as well as barriers to using and understanding results. The committee sought a balance that promotes broad access to results while addressing public expectations that results are accurate. Disclosing poor-quality results reflects bad science and does not respect participant autonomy or welfare. We maintain that quality standards for research laboratories will better ensure accurate results that meet the expectations of participants and will enhance the overall validity and reproducibility of the research enterprise. We believe that IRBs are up to the challenge of addressing the new responsibilities recommended by our report, although we acknowledge that these demands cannot be addressed overnight. The report recommends that investigators work with stakeholders to develop plans on whether and how to disclose results as protocols are developed. The informed consent process is key to fostering participant understanding of their options for return of results and to documenting expression of their preferences. IRBs must be involved in evaluating the return of results plan and consent process and, over time, will need to develop expertise and policies for this purpose. We are confident that our recommendations break down many of the existing barriers to the return of individual research results and, if followed, will enhance the collaboration among all stakeholders. Return of individual results is not a common practice ([ 6 ][7]) despite existing guidelines, and research participants rarely request results under their HIPAA access rights. Our report promotes the routine consideration of return of results by funders, researchers, and participants; the development of standards and policies to foster return, greater transparency, and engagement with participants; and an informed consent process that informs participants of their opportunities and rights. 1. [↵][8]The National Academies of Sciences, Engineering, and Medicine, “Returning individual research results to participants: Guidance for a new research paradigm” (Consensus Study Report, 2018); . 2. [↵][9]1. M. Barnes et al ., “The CLIA/HIPPA conundrum of returning test results to research participants,” Medical Research Law & Policy Report (2015); [www.ropesgray.com/~/media/Files/articles/2015/July/2015-07-15-Bloomberg-BNA.ashx][10]. 3. [↵][11]U.S. Department of Health and Human Services, Office for Human Research Protections, “Attachment C: Return of individual results and special consideration of issues arising from amendments of HIPAA and CLIA,” Office for Human Research Protections (2015); [www.hhs.gov/ohrp/sachrp-committee/recommendations/2015-september-28-attachment-c/index.html][12]. 4. [↵][13]U.S. Department of Health and Human Services, § 164.501 Definitions (2004); [www.gpo.gov/fdsys/pkg/CFR-2004-title45-vol1/pdf/CFR-2004-title45-vol1-sec164-501.pdf][14]. 5. [↵][15]Johns Hopkins Medicine, Office of Human Subjects Research—Institutional Review Board, HIPAA Questions and Answers Relating to Research, VI: Subject Requests for Access to Research Data or Test Results ([www.hopkinsmedicine.org/institutional\_review\_board/hipaa\_research/faq\_research.html#access][16]). 6. [↵][17]1. P. S. Appelbaum et al ., Gen. Med. 17, 644 (2015). 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