Return of results: Ethical and legal distinctions between research and clinical care

Abstract

The return of individual results to research participants has been vigorously debated. Consensus statements indicate that researchers and bioethicists consider the return of research results most appropriate when the findings are clinically relevant. Even when clinical utility is the motivator, however, the return of individual research results is not equivalent to clinical care. There are important differences in the domains of research and medical care, both from a legal standpoint and in terms of the ethical responsibilities of clinicians and researchers. As a corollary, researchers risk promoting a therapeutic misconception if they create quasi-clinical settings for return of clinically relevant research results. Rather, efforts should be focused on clarity in the provision of research results, appropriate caveats and, most important, appropriate referrals when the results may be helpful to consider in medical care.

The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms?

“…Among the 13 consent forms, there is great variation in how they treat the possible beneficial return of research results from the investigations and whether or how results might be incorporated into the medical record. The return of individual results to research participants, a particularly contentious issue in genomic research, 37,38 raises critical questions about the boundary between research and clinical care, and whether surrogate or clinical endpoints mentioned in the consent forms might be misconstrued to represent possible medical benefits. At the least, consent forms should be clear about the significance of such endpoints and the difference between clinically relevant results that may be returned and those that will not.…”

Amnestic MCI Patients’ Perspectives on Volunteer Participation in a Research Context

“…For example, most research subjects may be unaware that the main goal of research is to produce new general knowledge in a particular field of inquiry, not to produce and return individual bits of knowledge to a research participant [13,14]. This blurring of the boundary between clinical practice and research in the minds of research participants is often mentioned in the literature as an argument against the disclosure of these results [11][12][13][14][15]. Yet, there are also counter-arguments, such as the return of the IRRs would make research more transparent for society, who ultimately benefits and often funds the research [16].…”

“…Yet, there are also counter-arguments, such as the return of the IRRs would make research more transparent for society, who ultimately benefits and often funds the research [16]. Transparency may enhance public understanding and increase participants' willingness to contribute to future research studies [11,[15][16][17]. However, it is understandable that participants perceive the disclosure of the IRR as common sense and that there is a blurring of the boundary between clinical care and the research setting.…”

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).…”