Tfie Changing Landscape of Genomic Research Regulation

基因组研究监管格局的变化

• 批准号: 8126727
• 负责人: GEORGIA L WIESNER
• 金额: $ 4.31万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-05 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8126727
• 关键词: Belief; Benefits and Risks; Biomedical Research; Clinic; Code; Communities; Contracts; Data; Development; Equilibrium; Ethics; Focus Groups; Genetic; Genomics; Guidelines; Industry; Knowledge; Participant; Policies; Population; Process; Rare Diseases; Regulation; Research; Research Personnel; Sampling; Social Obligations; Societies; Speed; System; Technology; Translating; Triad Acrylic Resin; design; family genetics; improved; member; pressure; social; solidarity

Research Questions and Specific Aims: One important constellation of stakeholders Involved in the conduct of TGR is the triad composed of the researcher/investigator, the research participant, and members of the regulatory community. Large-scale genomic studies using banked population samples are changing the regulatory framework first developed for smaller family genetic studies of rare diseases. New federal regulations requiring the sharing of de-Identified coded genotypic information from these studies is but one challenge to the system, as new guidelines must be developed that balance the needs of research agenda with those of society. The rapid development of new genetic and genomic technologies has also increased the pressure to improve the speed and efficiency of entire research process, particularly when translating research findings into industry or the clinic. Understanding the views of each stakeholder in the biomedical TGR "triad" is paramount in order to harmonize and balance the needs of society with the needs of the research community. The major research agenda for this CGREAL research group focuses on a normative and empiric analysis of the changing regulatory landscape resulting from the advances In large-scale genetic and genomic studies. In particular, the obligation of the public to participate in genetic and genomic research, the evolving beliefs of researchers, regulators and participants about genomic research technologies and the access and use of genomic data that produces unique identifiers (known hereafter as GUIR for Genomic Unique Identifier Research) will be examined by the following specific aims: 1. Determine the knowledge and beliefs of researchers, regulators, and participants about; ¿ genomic technologies that produce unique identifiers (GUIR) ¿ the types of information that may be generated or result from GUIR ¿ how this information could be used in society 2. Determine the beliefs of researchers, regulators, and participants about; ¿ duties and social obligations to participate in genomic research ¿ correlating factors that may increase or decrease participation in genomic research ¿ implications for the design and regulation of genomic research ¿ potential risks and benefits from participation in genomic research, particularly GUIR 3. Conduct a normative, ethical and regulatory analysis of the social obligations and duties to participate in genomic research. These analyses will explore; ¿ whether all genomic research creates unique identifiers (GUIR). ¿ whether the current "social contract" for biomedical research pertains to genomic research and GUIR. ¿ the implications of the concept of solidarity on the perceived obligation for participation. ¿ implications of GUIR on regulatory guidelines and policy.

研究问题和具体目标： 参与TGR行为的一个重要的利益相关者群体是由研究者/调查者、研究参与者和监管团体成员组成的三元组。使用库存人群样本的大规模基因组研究正在改变最初为罕见疾病的较小家族遗传研究开发的监管框架。新的联邦法规要求共享来自这些研究的去识别编码基因型信息，这只是对该系统的一个挑战，因为必须制定新的指导方针，以平衡研究议程与社会需求。新的快速发展 遗传和基因组技术也增加了提高整个研究过程的速度和效率的压力，特别是在将研究成果转化为工业或临床时。 为了协调和平衡社会需求与研究界需求，了解生物医学TGR“三元组”中每个利益相关者的观点至关重要。该CGREAL研究小组的主要研究议程侧重于对大规模遗传和基因组研究进展所产生的不断变化的监管格局进行规范和经验分析。特别是，公众参与遗传和基因组研究的义务，研究人员、监管机构和参与者对基因组研究技术的不断发展的信念，以及获得和使用产生唯一标识符的基因组数据（以下称为基因组唯一标识符研究的GUIR），将由 具体目标如下： 1.确定研究人员，监管机构和参与者的知识和信念; 产生唯一标识符（GUIR）的基因组技术 GUIR可能生成或产生的信息类型 这些信息如何在社会中使用 2.确定研究人员，监管机构和参与者的信念; 参与基因组研究的责任和社会义务 可能增加或减少参与基因组研究的相关因素 对基因组研究的设计和监管的影响 参与基因组研究的潜在风险和益处，特别是GUIR 3.对参与基因组研究的社会义务和责任进行规范，伦理和监管分析。这些分析将探讨; 是否所有基因组研究都创建了唯一标识符（GUIR）。 目前生物医学研究的“社会契约”是否与基因组研究和GUIR有关。 * 团结概念对所认为的参与义务的影响。 GUIR对监管指南和政策的影响。