Edwards Karen L, Korngiebel Diane M, Pfeifer Lesley, Goodman Deborah, Renz Anne, Wenzel Lari, Bowen Deborah J, Condit Celeste M
Epidemiology, University of California, Irvine, 224 Irvine Hall, Mail Code: 7550, Irvine, CA, 92697, USA.
Epidemiology, University of Washington, Seattle, WA, USA.
J Community Genet. 2016 Apr;7(2):133-43. doi: 10.1007/s12687-015-0259-8. Epub 2016 Jan 22.
The Precision Medicine Initiative (PMI) has created considerable discussions about research participant issues including re-consent and how and when to incorporate the patient experience into clinical trials. Within the changing landscape of genetic and genomic research, the preferences of participants are lacking yet are needed to inform policy. With the growing use of biobanks intended to support studies, including the national research cohort proposed under the PMI, understanding participant preferences, including re-consent, is a pressing concern. The Participant Issues Project (PIP) addresses this gap, and here we present data on participant attitudes regarding re-consent and broad consent in research studies. PIP study participants came from the Northwest Cancer Genetics Registry and included cancer patients, relatives, and controls. Thirty telephone interviews were conducted and analyzed using content and thematic analysis. Results indicate that in some scenarios, re-consent is needed. Most participants agreed that re-consent was necessary when the study direction changed significantly or a child participant became an adult, but not if the genetic variant changed. Most participants' willingness to participate in research would not be affected if the researcher or institution profited or if a broad consent form were used. Participants emphasized re-consent to provide information and control of the use of their data, now relevant for tailored treatment, while also prioritizing research as important. In the era of precision medicine, it is essential that policy makers consider participant preferences with regard to use of their materials and that participants understand genetic and genomic research and its harms and benefits as well as what broad consent entails, including privacy and re-identification risks.
精准医学计划（PMI）引发了关于研究参与者问题的大量讨论，包括重新获得同意以及如何、何时将患者体验纳入临床试验。在基因和基因组研究不断变化的格局中，参与者的偏好缺失，但政策制定需要这些偏好作为依据。随着旨在支持研究的生物样本库的使用日益增加，包括PMI提议的国家研究队列，了解参与者的偏好，包括重新获得同意，是一个紧迫的问题。参与者问题项目（PIP）填补了这一空白，在此我们展示关于研究中参与者对重新获得同意和广泛同意的态度的数据。PIP研究参与者来自西北癌症遗传学登记处，包括癌症患者、亲属和对照。进行了30次电话访谈，并使用内容和主题分析进行分析。结果表明，在某些情况下，需要重新获得同意。大多数参与者同意，当研究方向发生重大变化或儿童参与者成年时需要重新获得同意，但基因变异改变时则不需要。如果研究人员或机构获利或使用广泛同意书，大多数参与者参与研究的意愿不会受到影响。参与者强调重新获得同意以提供信息并控制其数据的使用，目前这与个性化治疗相关，同时也将研究视为重要事项。在精准医学时代，政策制定者必须考虑参与者对其材料使用的偏好，参与者也必须了解基因和基因组研究及其危害与益处，以及广泛同意所涉及的内容，包括隐私和重新识别风险。
