Returning genetic research results to individuals: Points-to-consider
Returning genetic research results to individuals: Points-to-consider
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DOI：
10.1111/j.1467-8519.2006.00473.x
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发表时间：
2006-02-01
期刊：
影响因子：
2.2
通讯作者：
Brazell, C
中科院分区：
文献类型：
--
作者：
Renegar, G;Webster, CJ;Brazell, C
本文旨在激发国际研究界利益相关者就将个人遗传研究结果返还给研究参与者这一主题进行辩论。药物遗传学和疾病遗传学研究正变得越来越普遍，导致越来越多的关于药物反应性和疾病易感性的遗传关联的信息，这些信息具有改善医疗保健的潜力。目前，这些数据中的大部分都是探索性的（未经验证或产生假设）。然而，有一种趋势是，如果研究参与者愿意，他们可以被允许查阅自己的个人资料。因此，研究人员、赞助商、患者倡导团体、伦理委员会和监管机构都面临着研究参与者是否以及如何获得个人结果的问题。注意到国际伦理法律准则和公共政策立场在欧洲和美国的背景进行审查。作者根据他们的知识和经验，提供了关于在药物开发试验背景下返回研究结果的“考虑要点”。这些考虑因素包括：数据的临床相关性、实验室资格、知情同意程序、医疗信息的保密性以及向参与者提供结果的人员的能力。讨论的框架是风险获益评估，以平衡对参与者的潜在积极和消极影响，同时保持进行遗传研究的完整性和可行性。
This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non-validated or hypothesis-generating). There is, however, a trend for research participants to be permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico-legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer 'Points-to-Consider' regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit-to-risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies.