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

BMC Medical Ethics 15 (1):88 (2014)

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
Keywords Genetics  Genomics  Research ethics  Incidental findings  Individual research results  Participant feedback  Double coding
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DOI 10.1186/1472-6939-15-88
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Empirical Analysis of Current Approaches to Incidental Findings.Frances Lawrenz & Suzanne Sobotka - 2008 - Journal of Law, Medicine and Ethics 36 (2):249-255.

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