A report from the National Academies of Sciences, Engineering, and Medicine offers a process-oriented approach to returning individual research results to participants that considers the value of the results to the participant, the risks and feasibility of return, and the quality of the research laboratory. The report’s 12 recommendations aim to support decision making on a study-by-study basis, promote high-quality individual research results, foster participant understanding of the results, and revise and harmonize current regulations.
Read below to learn more about what different stakeholders can do.
To download a free copy of the report, please visit nationalacademies.org/ReturnofResults.
Recommendations by Stakeholder
Department of Health and Human Services
Chapter 6
Recommendation 12G
Refer to research volunteers as participants, not subjects in all regulations relevant to human research
Centers for Medicare & Medicaid Services
Chapter 6
Recommendation 12C and D
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
Chapter 6
Recommendation 12E
Work with OCR to harmonize definitions of key terms relevant to the return of individual research results in the federal regulations
Food and Drug Administration
Chapter 6
Recommendation 12H
Clarify and provide additional guidance regarding how the return of individual research results affects IDE requirements for research studies
National Institutes of Health
Chapter 3
Recommendation 2
Lead an interagency effort with nongovernmental stakeholders to develop standards for a quality management system for research laboratories testing human biospecimens
Chapter 6
Recommendation 12F
Work with OCR and OHRP to harmonize the definitions of key terms relevant to the return of individual research results in the federal regulations
Office for Civil Rights
Chapter 6
Recommendation 12A
Revise the definition of the designated record set (DRS)
Chapter 6
Recommendation 12B
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
Chapter 6
Recommendation 12E and F
Work with CMS, OHRP, and NIH to harmonize definitions of key terms relevant to the return of individual research results in the federal regulations
Office for Human Research Protections
Chapter 6
Recommendation 12F
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 funding agencies
Chapter 3
Recommendation 4
Ensure adequate resources and infrastructure to generate high-quality individual research results
Chapter 4
Recommendation 5
Engage community and participant representatives in the development of policy and guidance related to the return of individual research results
Chapter 4
Recommendation 7
Ensure planning for the return of individual research results in applications for funding
Chapter 5
Recommendation 11
Support research to expand the empirical evidence base relevant to the return of individual research results
Research Institutions
Chapter 2
Recommendation 1
Consider whether and how to return individual research results on a study-specific basis
Chapter 3
Recommendation 3
Ensure the high quality of individual research results that are returned to participants
Chapter 3
Recommendation 4
Ensure adequate resources and infrastructure to generate high-quality research results
Chapter 4
Recommendation 5
Enable and facilitate investigator access to relevant community and participant networks, resources, and training
Chapter 4
Recommendation 8
Develop policies and procedures that support the assessment of plans for the return of individual research results, and ensure that IRBs and research team have or have access to the necessary expertise and resources to assess plans
Chapter 5
Recommendation 10
Enable the understanding of individual research results by research participants
Institutional Review Board
Investigators
Chapter 2
Recommendation 1
Consider whether and how to return individual research results on a study-specific basis
Chapter 4
Recommendation 5
Seek information on participant needs, preferences, and values related to return of individual research results
Chapter 4
Recommendation 6
Include plans for return of individual research results in research protocols
Chapter 5
Recommendation 9
Ensure transparency regarding return of individual research results in the consent process
Chapter 5
Recommendation 10
Enable understanding of individual research results by research participants
Participants
Chapter 4
Recommendation 5
Engage researchers to ensure that participant needs, preferences, and values are incorporated in decision making about the return of individual research results
© 2018 National Academy of Sciences