Returning Individual Research Results to Participants Guidance for a New Research Paradigm (2018) / Chapter Skim
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6 Reshaping the Legal and Regulatory Landscape to Support Return of Individual Research Results
6 Reshaping the Legal and Regulatory Landscape to Support Return of Individual Research Results
Pages 241-278
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From page 241... ...
This chapter examines whether the regulatory environment is appropriately calibrated to the risks and benefits of participant access to research results and describes changes in the legal and regulatory landscape that are needed if the committee's recommendations are to be implemented and its vision for the return of results to participants as a more commonplace practice in research is to be achieved. LEGAL AND REGULATORY PROTECTIONS IN RELATION TO THE BENEFITS AND RISKS OF RETURNING INDIVIDUAL RESEARCH RESULTS1 The legal and regulatory landscape pertaining to the return of individual research results is governed by a complex assortment of federal and state laws (including statutes and regulations, see Box 6-1)
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HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA) PRIVACY RULE: The Office for Civil Rights (OCR)
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GENETIC INFORMATION NONDISCRIMINATION ACT OF 2008 (GINA) : Passed in 2008, GINA limits access to and the use of an individual's genetic information in health insurance and employment contexts.
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collectively form a strong argument for creating pathways to enable research participants access to their information. Indeed, the past few years have seen a significant shift in the regulatory environment toward allowing individuals greater access to their laboratory results.
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. Although the change was primarily aimed at ensuring patient access to clinical laboratory information, the revised HIPAA access rule, which preempts any state laws that restrict an individual's direct access to test results, has opened doors for participants to access their individual research results.
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. If laboratories report individual results that could be used for clinical decision making, even if this is not the intended purpose of returning results, CMS has interpreted the regulations to mean that those laboratories must be CLIA certified.
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acilit[ies] for the biological, microbiological, serological, chemical, immuno- Yes hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings." "CLIA-exempt" Laboratories licensed by states that have "enacted laws relating to laboratory No, but subject to CMS requirements that are equal to or more stringent than CLIA requirements" and CMS has approved, state regulations approved the licensure program.
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CONCLUSION: As many research laboratories are not CLIA certified, CLIA represents a formidable obstacle to the return of individual results to research participants even though the results may meet other quality standards and a right of access to laboratory results has been gaining credibility in other regulatory policies. Concerns Regarding an Access Right to Research Results Under HIPAA Since 2000, HIPAA has included a rule that individuals have a right of access to inspect and obtain a copy of their PHI maintained in a designated record set.
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Older guidance that does address obligations of research laboratories pre-dates the 2014 regulatory changes. This earlier guidance states that research participants shall have access to "any research records or results that are actually maintained by the covered entity as part of a designated record set" (OCR, 2013b)
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250 TABLE 6-2 Legal Obligations Related to Individual Access to Laboratory Test Results HIPA A-COVERED LABOR ATORY NON-HIPA A COVERED LABOR ATORY CLIA-certified Mandatory disclosure under HIPAA Permissive disclosure under CLIA laboratory Example: Clinical laboratory Example: Direct-to-consumer genetic testing laboratory that does not seek third-party reimbursement Non-CLIA-certified Mandatory disclosure under HIPAA (but act of disclosure then Mandatory, permissive, or prohibited disclosure under laboratory requires laboratory to become CLIA certified) state law Example: Academic research laboratory Example: Independent research laboratory
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, putting laboratories without the means to obtain and maintain CLIA certification in the difficult position of having to weigh the relative risks of violating CLIA or HIPAA. To avoid such conflicts, and in the absence of additional guidance from OCR, some research institutions are interpreting the definition of a designated record set to exclude research results and setting policies accordingly.
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, informed consent, and assurances of compliance.19 Under the Common Rule, IRBs are required to review and approve study protocols involving human participants to ensure that the risks are reasonable relative to the anticipated benefits and that participation is conditioned on the informed consent of research participants. The Common Rule neither explicitly encourages nor explicitly prohibits the return of results to study participants, but pending revisions to the regulation will require investigators to disclose their plans for returning individual research results (i.e., whether results will be returned to participants and, if so, under what conditions)
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(NHGRI, 2017) Second, the return of research results to research participants may affect the risk classification of a non-exempt investigational device study.
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FDA has not provided binding guidance on the role of the return of individual research results in the IDE process, including the determination of whether
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This ambiguity also contributes to confusion regarding research results that individuals can obtain under the HIPAA access rule, which allows individuals to access their protected health information that is contained within the DRS. The 2014 amendment to the HIPAA Privacy Rule states (in response to a comment)
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Discrimination Concerns for Research Participants The possibility that participants who receive individual research results may face discrimination if the results indicate a previously undiagnosed condition (or a genetic predisposition for a condition) is a concern among both proponents and opponents of the practice.
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30 prohibits discrimination in health insurance and employment contexts based on genetic information, which is defined as information about an individual's genetic tests, about the genetic tests of family members, or about the presence of a disease or disorder in family members. Congress's intent in passing GINA was to remove barriers to genetic testing for personal health and research purposes by providing legal protection against the misuse of genetic test results.
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CONCLUSION: Research participants who choose to receive results from the testing of their biospecimens (or who exercise their right of access under HIPAA) should be informed about the discrimination protections under GINA and the ADA and relevant state laws and what GINA/ADA/state laws do not protect against.
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Although research laboratories are not subject to the same quality requirements as clinical laboratories, they still must maximize the analytic and clinical validity of any results returned to participants. For example, if investigators return erroneous results generated by a research laboratory without indicating that the results need to be verified in a CLIA-certified laboratory before any clinical actions are undertaken, the researchers may be liable to a tort filing.
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. CONCLUSION: Perceived liability risks may dampen interest in returning individual results to research participants.
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CONCLUSION: Inconsistencies in terminology and discrepancies in requirements across different federal regulations relevant to the return of individual research results contribute to the confusion, but could be addressed through an effort to harmonize regulations. In developing its recommendations on changes to better align the regulatory environment for the return of individual research results with the risks and benefits to individuals, the research enterprise, and society, the committee carefully considered the pros and cons of different approaches as well as the potential downstream effects on the current regulatory framework.
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However, the burdens associated with CLIA certification (e.g., direct costs, human resource requirements) as well as the inconsistencies between some of the CLIA regulations and the functions of a research laboratory create an incentive for investigators to plan not to return results, which, given participants' interest in receiving results, may adversely affect public participation in biomedical research (Crawley, 2001; Hiratsuka et al., 2012; Northington Gamble, 2006)
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The committee also was concerned that this would create a perverse incentive to test human biospecimens for clinical decision making in research laboratories in order to avoid the burden associated with meeting and maintaining the CLIA certification requirements. Between these two extremes is a third option for CLIA regulatory changes which allows investigators and their institutions greater flexibility in determining the conditions under which returning results is appropriate when they have not been generated in a CLIA-certified laboratory.
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Considerations for Changes to the HIPAA Access Right The proposed changes to the CLIA regulations to allow the return of individual research results from laboratories operating under the NIH-defined externally accountable quality management system or following an IRB review and approval process (discussed above and in Chapter 3) would go a long way toward resolving the CLIA–HIPAA conflict.
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However, there is a crucial difference between laboratory results and these other types of protected health information -- an individual has no way to know or verify if the laboratory result is accurate or if it even belongs to the individual. By contrast, a patient or patient's caregiver may recognize by himself or herself (or in consultation with the provider)
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45 Research results that are also used in clinical decision making (e.g., results from a clinical trial conducted in a health care setting to evaluate the comparative effectiveness of medical treatments) would not be excluded from the designated record set and could be accessed by participants upon request under HIPAA.
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; B. CR should require all HIPAA-covered entities that conduct re O search on human biospecimens to develop a plan that is reviewed and approved by the IRB for the release of individual research re sults in the designated record set to participants in a responsive manner when requested under HIPAA; C. MS should revise CLIA regulations such that when there is a le C gal obligation under the HIPAA access right to return individual research results, a laboratory will not be considered in violation of CLIA and need not obtain CLIA certification before satisfying this legal obligation; D. MS should revise CLIA regulations to allow research results to be C returned from a non-CLIA-certified laboratory when they are not
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NOTE: CLIA = Clinical Laboratory Improvement Amendments of 1988; DRS = designated record set; HIPAA = Health Insurance Portability and Accountability Act of 1996; NIH = National Institutes of Health; QMS = quality management system.
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should ensure that all H regulations, policies, and guidance relevant to human research re fer to research "participants," rather than research "subjects," in accordance with the ethical principles of autonomy and respect for persons; and H. FDA should clarify and provide additional guidance that if a device is not exempt from investigational device exemption (IDE) regu lations, disclosure of results in many circumstances, including to healthy volunteers, will not necessarily entail significant risk, and FDA should clarify when it will consider the return of individual research results to entail significant risk.
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The committee is well aware that more frequent return of individual research results will create new demands on the research and clinical enterprise. Many institutions and researchers currently lack the experience and resources to return individual research results in a deliberate and effective manner.
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TABLE 6-3 Recommendations by Stakeholdera STAKEHOLDER RECOMMENDED ACTION HHS RECOMMENDATION 12G – Chapter 6 Refer to research volunteers as participants, not subjects in all regulations relevant to human research CMS RECOMMENDATIONS 12C and D – Chapter 6 Revise CLIA regulations to allow for the return of individual research results from non-CLIA-certified laboratories when results are requested under the HIPAA access right and when the quality of results has been established and they are not intended for use in clinical decision making RECOMMENDATION 12E – Chapter 6 Work with OCR to harmonize definitions of key terms relevant to the return of individual research results in the federal regulations FDA RECOMMENDATION 12H – Chapter 6 Clarify and provide additional guidance regarding how the return of individual research results affects IDE requirements for research studies NIH RECOMMENDATION 2 – Chapter 3 Lead an interagency effort with nongovernmental stakeholders to develop standards for a quality management system for research laboratories testing human biospecimens 271 continued
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TABLE 6-3, Continued 272 RECOMMENDATION 12F – Chapter 6 Work with OCR and OHRP to harmonize the definitions of key terms relevant to the return of individual research results in the federal regulations OCR RECOMMENDATION 12A – Chapter 6 Revise the definition of the designated record set (DRS) RECOMMENDATION 12B – Chapter 6 Require HIPAA-covered entities that conduct research on human biospecimens to develop a plan for the release of individual research results in the DRS when requested under HIPAA RECOMMENDATIONS 12E and F – Chapter 6 Work with CMS, OHRP, and NIH to harmonize definitions of key terms relevant to the return of individual research results in the federal regulations OHRP RECOMMENDATION 12F – Chapter 6 Work with OCR and NIH to harmonize definitions of key terms relevant to the return of individual research results in the federal regulations Research sponsors and RECOMMENDATION 4 – Chapter 3 funding agencies Ensure adequate resources and infrastructure to generate high-quality individual research results RECOMMENDATION 5 – Chapter 4 Engage community and participant representatives in the development of policy and guidance related to the return of individual research results
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RECOMMENDATION 7 – Chapter 4 Ensure planning for the return of individual research results in applications for funding RECOMMENDATION 11 – Chapter 5 Support research to expand the empirical evidence base relevant to the return of individual research results Research institutions RECOMMENDATION 1 – Chapter 2 Consider whether and how to return individual research results on a study-specific basis RECOMMENDATION 3 – Chapter 3 Ensure the high quality of individual research results that are returned to participants RECOMMENDATION 4 – Chapter 3 Ensure adequate resources and infrastructure to generate high-quality research results RECOMMENDATION 5 – Chapter 4 Enable and facilitate investigator access to relevant community and participant networks, resources, and training RECOMMENDATION 8 – Chapter 4 Develop policies and procedures that support the assessment of plans for the return of individual research results, and ensure that IRBs and research teams have or have access to the necessary expertise and resources to assess plans 273 continued
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TABLE 6-3, Continued 274 Research institutions RECOMMENDATION 10 – Chapter 5 Enable the understanding of individual research results by research participants IRBs RECOMMENDATION 3 – Chapter 3 Ensure the high quality of individual research results that are returned to participants RECOMMENDATION 7 – Chapter 4 Review the return-of-results plan and ensure the consent process aligns with it Investigators RECOMMENDATION 1 – Chapter 2 Consider whether and how to return individual research results on a study-specific basis RECOMMENDATION 5 – Chapter 4 Seek information on participant needs, preferences, and values related to return of individual research results RECOMMENDATION 6 – Chapter 4 Include plans for return of individual research results in research protocols RECOMMENDATION 9 – Chapter 5 Ensure transparency regarding return of individual research results in the consent process
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RECOMMENDATION 10 – Chapter 5 Enable the understanding of individual research results by research participants Participants RECOMMENDATION 5 – Chapter 4 Engage researchers to ensure that participant needs, preferences, and values are incorporated in decision making about the return of individual research results a An interactive version of this table can be found at http://resources.nationalacademies.org/ReturnofResults/index.html (accessed August 13, 2018)
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2018a. The Genetic Information Nondiscrimination Act at age 10: GINA's controversial assertion that data transparency protects privacy and civil rights.
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investigational device exemptions (IDEs) and genomics workshop: Meeting report: Summary, standing questions, and next steps.
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2015. Attachment C: Return of individual results and special considerations of issues arising from amendments of HIPAA and CLIA.
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