| 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 |
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 funding agencies | RECOMMENDATION 4 –
Chapter 3
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 |
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 |
| 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 |
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 |
