Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants

Abstract

Introduction: Many research programs are challenged to accommodate low-resource research participants' (LRRP) ancillary care needs when returning genomic research results. We define LRRP as those who are low income, uninsured, underinsured, or facing barriers to act upon the results returned. This study evaluates current policies and practices surrounding return of results (RoR) to LRRP, as well as the attitudes of investigators toward providing ancillary care to LRRP.

Methods: A semi-structured interview study was conducted with representatives of 35 genomic research programs nationwide. Eligible programs were returning, or planning to return, medically actionable genomic results to participants.

Results: Three content categories emerged from this study, including: (1) RoR structures, (2) barriers to RoR to LRRP, and (3) solutions to meet community and LRRP needs. Three major structures of RoR emerged: (1) RoR Embedded in Clinical Care, (2) RoR Independent of Clinical Care, and (3) Reliance on Clinical Partnerships to Facilitate RoR. Inadequacy of program resources to address the needs of LRRP was commonly considered a significant obstacle. The attitudes and views of informants regarding responsibility to provide ancillary care for LRRP receiving genomic results were highly varied. Some informants believed that genomic sequencing and testing was not a priority for LRRP because of other pressing issues in their lives, such as housing and food insecurity. Research programs differ regarding whether clinical and social support for LRRP is considered within the purview of the research team. Some programs instituted accommodations for LRRP, including social work referral and insurance enrollment assistance.

Conclusion: Support to access downstream treatment is not readily available for LRRP in many genomic research programs. Development of best practices and policies for managing RoR to LRRP is needed.

Trial registration: ClinicalTrials.gov NCT02156102.

Keywords: Genomics; Health equity; Research ethics; Return of results; Underserved communities.

Conflict of interest statement

Disclosure Statement

The authors have no conflicts of interest to declare.

© 2021 The Author(s) Published by S. Karger AG, Basel.

Figures

Figure 1.. Support Services Offered to Research Participants

(a): Assistance provided for participant to arrive at research appointments without a significant financial burden (b): Research appointments outside of working hours (9am to 5pm) to accommodate employed participants (c): Programs provided “mobile-friendly” resources for participants without access to computers (d): Programs provided enrollment assistance for research participants lacking health insurance (e): Programs with a connection to a social worker whether within their own research program or through an academic institution or hospital (f): To increase access to programs, research sites included Federally Qualified Health Centers and Community Health centers that commonly serve LRRP (g): Language interpretation and translation serves were offered to non-English speaking participants