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主要的伦理和政策挑战源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，可以通过访问该人的少量SNP来唯一识别该人。全基因组关联研究通常使用超过10万个SNP对个体进行基因分型，随着技术进步和电子数据库的激增，这种隐私风险只会增加。目前DNA数据发布不需要知情同意，因为去识别数据被错误地认为是不可识别的。我们主张进行政策改革，要求对数据共享进行知情同意。该提案的目标是通过制定一个同意程序来推动这一努力，该程序将鼓励数据共享，同时建立公众信任并促进对遗传研究的参与。该项目建立在对参与者对DNA数据发布态度的初步研究的基础上，有三个具体目标：（1）对DNA数据共享的三种不同类型的同意进行随机试验（传统、二元和分层）比较其对入组和同意数据共享的影响，（2）评价受试者对数据共享的判断以及对传统、二元和分层同意的评估，重点是风险和收益的计算，信息需求，以及对决策的期望控制水平，以及（3）为DNA数据发布制定临床相关的政策建议。将邀请正在进行的癌症和癫痫基因组研究的参与者参加。将按知情同意类型（传统、二元、分层）、受试者人群（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）比较缓解。我们的假设是，分层同意将能够最好地满足参与者的判断范围，将产生对数据共享的最高同意，并且不会对遗传研究的招募产生负面影响。该项目将最终形成一个实用的同意过程模型和数据共享形式，可供研究者调整并用作IRB的指南，其结果将有助于为人类受试者研究的同意类型的伦理变化塑造一个更广泛的概念模型。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了解，这将改善生物医学研究的整体行为，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.