An implementation framework for the feedback of individual research results and incidental findings in research

Abstract

Background: This article outlines procedures for the feedback of individual research data to participants. This feedback framework was developed in the context of a personalized medicine research project in Canada. Researchers in this domain have an ethical obligation to return individual research results and/or material incidental findings that are clinically significant, valid and actionable to participants. Communication of individual research data must proceed in an ethical and efficient manner. Feedback involves three procedural steps: assessing the health relevance of a finding, re-identifying the affected participant, and communicating the finding. Re-identification requires researchers to break the code in place to protect participant identities. Coding systems replace personal identifiers with a numerical code. Double coding systems provide added privacy protection by separating research data from personal identifying data with a third "linkage" database. A trusted and independent intermediary, the "keyholder", controls access to this linkage database.

Return of genetic testing results in the era of whole-genome sequencing

“…Participants have often provided consent for their data and samples to be stored in a biobank and to be used for future research: that is, as a resource for other researchers and irrespective of the type of genetic testing or technology. Moreover, as opposed to disease-specific biobanking 20 , longitudinal biobanks provide general results but usually do not communicate individual results 21 . This may have to change, however, as researchers accessing longitudinal studies will increasingly obtain findings that would meet the ACA criteria.…”

Stability of Attitudes to the Ethical Issues Raised by the Return of Incidental Genomic Research Findings in Children: A Follow-Up Study

“…There has been an explosion of literature in the last few years exploring the difficult ethical issues raised by advances in genomic technology and its impact on the research endeavour [1,2,3,4,5]. This narrative has consisted of both opinion and recommended guidelines to assist in deciding whether or not to return research results [3,6,7,8,9,10] as well as emerging empiric evidence examining participant views [11,12,13,14,15].…”

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).…”