The ethics of consent for the public release of potentially identifiable DNA data

描述(由申请人提供)：基因组学研究面临的一个重大伦理和政策挑战来自于现有的快速公开发布所有测序DNA数据的任务。现在很明显，一个人可以通过获得该人的少量SNPs来唯一识别。全基因组关联研究经常使用超过10万个SNP来对个体进行基因分型，这造成了隐私风险，随着技术进步和电子数据库的激增，这种风险只会增加。DNA数据发布目前不需要知情同意，因为未识别的数据被错误地认为是无法识别的。我们一直主张进行政策改革，要求对数据共享征得知情同意。这项提案的目标是通过开发一种同意程序来带头开展这项工作，该程序将鼓励数据共享，同时建立公众信任并促进对基因研究的参与。这个项目建立在参与者对DNA数据发布态度的初步研究的基础上，有三个具体的目标：(1)对DNA数据共享的三种可选同意类型(传统、二进制和分级)进行随机试验，以比较它们对登记和同意数据共享的影响；(2)评估受试者对数据共享的判断和对传统、二进制和分级同意的评估，重点是计算风险和收益、信息需求和期望的决策控制水平，以及(3)制定与临床相关的DNA数据发布的政策建议。BCM正在进行的癌症和癫痫基因组研究的参与者将被邀请参加。答复将按同意类型(传统、二元、分级)、受试者群体(患者、受影响未成年人的父母、对照)和疾病类型(癫痫、癌症、健康志愿者)进行比较。我们的假设是，分级同意将最能满足参与者的判断范围，将产生对数据共享的最高同意，并且不会对基因研究的注册产生负面影响。该项目将最终形成一种实用的数据共享模式同意程序和形式，可供研究人员改编并作为IRBs的指南，其结果将有助于形成人类受试者研究同意类型的伦理差异的更广泛的概念模型。此外，它还将增加我们对参与者对数据共享的判断和态度的理解，这将改善生物医学研究的整体进行，建立公众信任，并促进研究参与。

DESCRIPTION (provided by applicant): A major ethical and policy challenge facing genomics research stems from the existing mandate for rapid public release of all sequenced DNA data. It is now clear that an individual can be uniquely identified with access to a small number of SNPs from that person. Genome-wide association studies routinely use more than 100,000 SNPs to genotype individuals, creating privacy risks that are only going to increase as technology advances and electronic databases proliferate. Informed consent is not currently required for DNA data release because de-identified data are incorrectly assumed to be unidentifiable. We have argued for policy reform that mandates informed consent for data sharing. The goal of this proposal is to spearhead this effort by developing a consent process that will encourage data sharing while building public trust and fostering participation in genetic research. This project builds on a preliminary study of participants' attitudes toward DNA data release and has three specific aims: (1) conduct a randomized trial of three alternative types of consent for DNA data sharing (traditional, binary, and tiered) to compare their impact on enrollment and consent to data sharing, (2) evaluate subjects' judgments about data sharing and assessments of traditional, binary and tiered consent, focusing on calculations of risks and benefits, informational needs, and desired levels of control over decision making, and (3) develop clinically relevant policy recommendations for DNA data release. Participants in ongoing genomic studies of cancer and epilepsy at BCM will be invited to participate. Responses will be compared by type of consent (traditional, binary, tiered), subject population (patient, parent of affected minor, control), and disease type (epilepsy, cancer, healthy volunteer). It is our hypothesis that tiered consent will be best able to satisfy the range of participants' judgments, will yield the highest consent to data sharing, and will not negatively impact enrollment into genetic research. This project will culminate in a practical model consent process and form for data sharing that can be adapted by investigators and used as a guide by IRBs, and the results will help shape a broader conceptual model for ethical variation in types of consent for human subjects research. Moreover, it will increase our understanding of participants' judgments and attitudes toward data sharing, which will improve the overall conduct of biomedical research, build public trust, and foster research participation.