Thorogood Adrian, Joly Yann, Knoppers Bartha Maria, Nilsson Tommy, Metrakos Peter, Lazaris Anthoula, Salman Ayat
Centre of Genomics and Policy, McGill University, 740, avenue Dr. Penfield, suite 5200, Montreal, QC, H3A 0G1, Canada.
Faculty of Medicine, McGill University, Montreal, Canada.
BMC Med Ethics. 2014 Dec 23;15:88. doi: 10.1186/1472-6939-15-88.
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.
Procedural 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. Feedback 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.
本文概述了向参与者反馈个人研究数据的程序。该反馈框架是在加拿大一个个性化医疗研究项目的背景下制定的。该领域的研究人员有道德义务向参与者返还具有临床意义、有效且可采取行动的个人研究结果和/或偶然发现。个人研究数据的交流必须以符合道德且高效的方式进行。反馈包括三个程序步骤：评估发现的健康相关性、重新识别受影响的参与者以及传达发现。重新识别要求研究人员破解用于保护参与者身份的编码。编码系统用数字代码取代个人标识符。双重编码系统通过使用第三个“链接”数据库将研究数据与个人识别数据分开，提供了额外的隐私保护。一个可信赖且独立的中介机构“密钥保管者”控制对该链接数据库的访问。
缺乏返还个人研究结果和偶然发现的程序指南。本文概述了反馈三个步骤（评估、重新识别和传达）的程序框架。该框架明确了研究人员、研究伦理委员会和密钥保管者在此过程中的作用。该框架还解决了编码系统带来的挑战。破解编码涉及隐私风险，应仅在明确界定的情况下进行。在使用双重编码系统的情况下，密钥保管者在平衡个人反馈的益处与重新识别的隐私风险方面发挥着重要作用。反馈政策应明确概述发现评估、参与者重新识别和联系的程序。研究人员、研究伦理委员会和密钥保管者的职责必须明确界定。我们为参与反馈的密钥保管者提供了一般指南。我们还建议研究伦理委员会不应直接参与对个别发现的评估。医院应取而代之设立正式的跨学科临床咨询委员会，以帮助研究人员确定是否应返还不确定的发现。
