IRB perspectives on the return of individual results from genomic research

Abstract

Purpose Return of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders—Institutional Review Board (IRB) reviewers—has been missing from this dialogue. This study explores the positions and experiences of IRB members and staff regarding this issue. Methods In depth interviews with 31 IRB professionals at six sites across the United States. Results IRB professionals agreed that research results should be returned to research participants when results are medically actionable but only if the participants wanted to know the result. Many respondents expected researchers to address the issue of return of results (ROR) in the IRB application and informed-consent document. Many respondents were not comfortable with their expertise in genomics research, and only a few described actual experiences in addressing ROR. Although participants agreed that guidelines would be helpful, most were reticent to develop them in isolation. Even where IRB guidance exists (e.g., CLIA lab certification required for return), in practice, the guidance has been overruled to allow return (e.g., no CLIA lab performs the assay). Conclusion An IRB-researcher partnership is needed to help inform responsible and feasible institutional approaches to returning research results.

When Patient Engagement and Research Ethics Collide: Lessons from a Dementia Forum

“…Currently, there exist very heterogeneous research ethics guidelines on the return of results to research participants, which vary between countries and even between institutions [37,38]. To some extent, the issue of return of results is addressed by ethical guidelines that recommend reporting incidental findings that are clinically relevant [39].…”

Stakeholders’ perspectives on biobank-based genomic research: systematic review of the literature

“…50 Also, REC professionals supported the return of incidental findings if the results were valid, clinically significant, treatable or preventable and if the participants wanted to receive them. 51 Regarding the reasons in favor of receiving incidental findings, patients and the public had similar perspectives, namely that the return of incidental findings would allow them to make decisions in family planning and take preventive actions to avoid certain diseases. 43,52 In addition, empowerment, respect for persons, a better public recognition of research and a feeling of control were expressed as arguments for the return of incidental findings.…”

“…33,50 Professionals shared the concerns about potential emotional and psychological harm to the patients in several quantitative and qualitative studies. 51,[53][54][55][56] Some felt that this could in turn lead to a loss of public trust in research institutions. 54 The most prominent concern of professionals was the complexity of the results, the uncertainty in their interpretation and concerns about the quality of information, including validity and clinical utility of genomic findings.…”

Engaging Hmong adults in genomic and pharmacogenomic research: Toward reducing health disparities in genomic knowledge using a community-based participatory research approach

“…In addition, individual results may be offered results if other conditions are met (National Heart Lung Blood Institute working group et al 2010). Since then, studies have identified support for disclosing personal genomic results from genomic study participants (Allen et al 2014;Bollinger et al 2012;Halverson and Ross 2012;Overby et al 2015;Trinidad et al 2015), researchers (Appelbaum et al 2015;Meacham et al 2010), IRB committee members (Beskow and O'Rourke 2015;Dressler et al 2012), ethicists and lawyers (Burke et al 2014;Evans 2014;Thorogood et al 2014;Wolf et al 2015), and two genomics research networks ). In addition, NHLBI (2010) recommended that Binvestigators conducting research with identifiable communities should engage the community on the return of aggregate and/or individual research results^, and other researchers concurred (Lemke et al 2012;Marsh et al 2013;Overby et al 2015;Trinidad et al 2015).…”