Returning Individual Research Results to Participants

Guidance for a New Research Paradigm

Recommended Actions for Stakeholders

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 12

Refer to research volunteers as participants, not subjects in all regulations relevant to human research

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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

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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

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Chapter 6

Recommendation 12H

Clarify and provide additional guidance regarding how the return of individual research results affects IDE requirements for research studies

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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

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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

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Chapter 6

Recommendation 12A

Revise the definition of the designated record set (DRS)

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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

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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

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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

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Chapter 3

Recommendation 4

Ensure adequate resources and infrastructure to generate high-quality individual research results

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Chapter 4

Recommendation 5

Engage community and participant representatives in the development of policy and guidance related to the return of individual research results

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Chapter 4

Recommendation 7

Ensure planning for the return of individual research results in applications for funding

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Chapter 5

Recommendation 11

Support research to expand the empirical evidence base relevant to the return of individual research results

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Chapter 2

Recommendation 1

Consider whether and how to return individual research results on a study-specific basis

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Chapter 3

Recommendation 3

Ensure the high quality of individual research results that are returned to participants

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Chapter 3

Recommendation 4

Ensure adequate resources and infrastructure to generate high-quality research results

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Chapter 4

Recommendation 5

Enable and facilitate investigator access to relevant community and participant networks, resources, and training

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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

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Chapter 5

Recommendation 10

Enable the understanding of individual research results by research participants

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Chapter 3

Recommendation 3

Ensure the high quality of individual research results that are returned to participants

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Chapter 4

Recommendation 7

Review the return-of-results plan and ensure the consent process aligns with it

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Chapter 2

Recommendation 1

Consider whether and how to return individual research results on a study-specific basis

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Chapter 4

Recommendation 5

Seek information on participant needs, preferences, and values related to return of individual research results

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Chapter 4

Recommendation 6

Include plans for return of individual research results in research protocols

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Chapter 5

Recommendation 9

Ensure transparency regarding return of individual research results in the consent process

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Chapter 5

Recommendation 10

Enable understanding of individual research results by research participants

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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

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