FIGURE 6-2. Determining whether participants have the right to access their individual research results under HIPAA.

FIGURE 6-2Determining whether participants have the right to access their individual research results under HIPAA

a CLIA-certified includes tests run in a CLIA-certified, -accredited, or -waived laboratory.

b See Recommendation 2.

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.

From: 6, Reshaping the Legal and Regulatory Landscape to Support Return of Individual Research Results

Cover of Returning Individual Research Results to Participants
Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories; Downey AS, Busta ER, Mancher M, et al., editors.
Washington (DC): National Academies Press (US); 2018 Jul 10.
Copyright 2018 by the National Academy of Sciences. All rights reserved.

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