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

Adrian Thorogood,Tommy Nilsson,Yann Joly,Peter Metrakos,Ayat Salman,Bartha Maria Knoppers,Anthoula Lazaris

doi:10.1186/1472-6939-15-88

Adrian Thorogood, Tommy Nilsson + Show 5 more

Open Access

https://doi.org/10.1186/1472-6939-15-88

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Abstract

BackgroundThis 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.DiscussionProcedural guidelines for the return of individual research results and incidental findings are lacking. This article outlines a procedural framework for the three steps of feedback: assessment, re-identification, and communication. This framework clarifies the roles of the researcher, Research Ethics Board, and keyholder in the process. The framework also addresses challenges posed by coding systems. Breaking the code involves privacy risks and should only be carried out in clearly defined circumstances. Where a double coding system is used, the keyholder plays an important role in balancing the benefits of individual feedback with the privacy risks of re-identification.SummaryFeedback policies should explicitly outline procedures for the assessment of findings, and the re-identification and contact of participants. The responsibilities of researchers, the Research Ethics Board, and the keyholder must be clearly defined. We provide general guidelines for keyholders involved in feedback. We also recommend that Research Ethics Boards should not be directly involved in the assessment of individual findings. Hospitals should instead establish formal, interdisciplinary clinical advisory committees to help researchers determine whether or not an uncertain finding should be returned.

Highlights

This article outlines procedures for the feedback of individual research data to participants
Researcher may disclose Incidental finding (IF) offering possible net benefit from participant’s perspective: (a) genetic information revealing significant risk of a condition likely to be grave or serious, when that risk cannot be modified but a research participant is likely to deem that information important; and (b) genetic information that is likely to be deemed important by a research participant and can be used in reproductive decision-making: (1) to avoid significant risk for offspring of a condition likely to be serious or (2) to ameliorate a condition likely to be serious
The role of the Research Ethics Board What role should the Research Ethics Board (REB) play in handling Individual research result (IRR) and IFs? We argue that the REB should not develop the feedback plan or assess whether or not an IRR or IF should be returned

Summary

Introduction

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. Double coding systems provide added privacy protection by separating research data from personal identifying data with a third “linkage” database. Incidental findings (“IFs”) concern an individual participant’s health, but are findings encountered outside the objectives of the research project. Pressure to disclose these two forms of individual research data has mounted with the advent of new genetic sequencing technologies, which reveal swaths of health information, and an increasing emphasis on translational research.

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