Ownership Interests in Research Outputs of Genomic Citizen Science Initiatives

项目摘要/摘要 克里斯蒂·格雷尼女士是贝勒大学医疗伦理和卫生政策中心的研究人员 医学院(BCM)。BCM是一家以卓越著称的顶级学术健康科学中心 在教育、研究和病人护理方面。BCM主校区位于德克萨斯医疗中心 该中心是世界上最大的医疗中心。医学伦理与健康中心 BCM的政策建立于1982年，并创建了由和定义的学术文化 支持合作研究和教学。由NIH、PCORI、NEH、Greenwall支持 基金会、米尔班克纪念基金、福特基金会和其他私人基金会， 该中心的教职员工参与了合作研究，已有550多人 同行评议文献中的出版物，医学和科学教科书中的150章，100 学术专著中的章节，以及35本编辑或撰写的书籍。 Guerrini女士毕业于哈佛法学院(JD 2001)和弗吉尼亚大学(BA 1998)， 她目前是德克萨斯大学公共卫生学院的研究生(预计公共卫生硕士 2016)。在过渡到学术界之前，她是一名执业知识产权律师，并 曾在纽约和芝加哥的法学院担任全职讲师。格雷尼女士最近 在芝加哥-肯特法学院获得知识产权奖学金。她的著作发表在 学术法律期刊和今年春天将有更多的文章发表在同行评议上 文学。格雷尼女士曾担任多个法律会议的特邀主持人或主持人。 和讨论会，包括最高法院知识产权审查，PatCon，法律和 协会年会、芝加哥知识产权研讨会和许可 高管协会(美国和加拿大)年会。 尽管格雷尼到目前为止的学术和专业经验为她提供了坚实的 在规范分析和实证方法方面的基础，她将受益于额外的培训 实现她的长期职业目标。这些目标包括：(1)成为一名独立调查员 在与新兴生物医学研究模式相关的ELSI问题研究方面处于领先地位；(2)和 在进行定性和实验研究以收集有助于健康的数据方面的专家 政策。为实现这些目标，格雷尼女士提议在以下领域开展重点培训： 理论和应用伦理学；定性研究设计和数据分析；以及联合分析 设计和数据分析。拟议的计划还包括基因组学方面的高级教学。这个 培训将包括贝勒医学院伦理学和基因组学的正式课程 德克萨斯大学公共学院定性方法和统计学的正式课程 健康，除了在约翰霍普金斯大学彭博社接受联合分析方法学的强化培训外 公共卫生学院。本课程工作和拟议的研究将在 BCM的主要导师艾米·L·麦奎尔博士和共同导师谢丽尔·A·麦柯迪博士的指导 德克萨斯大学公共卫生学院和约翰霍普金斯大学彭博社的约翰·F·P·布里奇斯博士 公共卫生学院。此外，BCM的理查德·吉布斯博士和Genetic的Sharon Terry女士 联盟将根据需要就该项目提供建议。 拟议的研究涉及以下产出的所有权主张和利益问题 在合作的“公民科学”背景下进行的基因组研究。互联网提供了 为公民科学家提供参与设计和进行研究的机会，这些 在基因组学领域，倡议越来越普遍，基于网络的门户网站正在收集 基因测序数据和将个体连接到要求不同水平的基因组研究 参与其中。然而，目前尚不清楚基因组公民科学家是否拥有合法的 该研究的成果--即研究成果、书面产品和发现 他们支持的研究。这项研究将找出实践、政策、原则和 与基因组公民科学产出中的所有权利益相关的偏好，以提供标准化的 和经验基础，以此为基础制定最佳做法和政策，以促进公众 对生物医学研究的信任和参与。

PROJECT SUMMARY/ABSTRACT Ms. Christi Guerrini is research faculty in the Center for Medical Ethics and Health Policy at Baylor College of Medicine (BCM). BCM is a premier academic health science center known for excellence in education, research, and patient care. The BCM main campus is located in the Texas Medical Center, which is the largest medical center in the world. The Center for Medical Ethics and Health Policy at BCM was established in 1982 and has created an academic culture defined by and supportive of collaborative research and teaching. Supported by NIH, PCORI, NEH, the Greenwall Foundation, the Milbank Memorial Fund, the Ford Foundation, and other private foundations, the Center's faculty have engaged in collaborative research that has resulted in more than 550 publications in the peer-reviewed literature, 150 chapters in medical and scientific textbooks, 100 chapters in scholarly monographs, and 35 edited or authored books. Ms. Guerrini is a graduate of Harvard Law School (JD 2001) and the University of Virginia (BA 1998), and she is currently a graduate student at University of Texas School of Public Health (MPH expected 2016). She was a practicing intellectual property attorney before transitioning to academia and has served as a full-time instructor in law schools in New York and Chicago. Ms. Guerrini recently completed an intellectual property fellowship at Chicago-Kent College of Law. She has published in academic law journals and this spring will have additional articles published in the peer-reviewed literature. Ms. Guerrini has served as an invited presenter or moderator at multiple legal conferences and colloquia, including the Supreme Court Intellectual Property Review, PatCon, the Law and Society Association Annual Meeting, the Chicago Intellectual Property Colloquium, and the Licensing Executives Society (US & Canada) Annual Meeting. Although Ms. Guerrini's academic and professional experiences to date have provided her a solid foundation in normative analysis and empirical methods, she will benefit from additional training to achieve her long-term career goals. These goals include becoming (1) an independent investigator and leader in the study of ELSI issues related to emerging models of biomedical research and (2) an expert in the conduct of qualitative and experimental studies to collect data that will inform health policies. To achieve these goals, Ms. Guerrini has proposed focused training in the following areas: theoretical and applied ethics; qualitative research design and data analysis; and conjoint analysis design and data analysis. The proposed plan also includes advanced instruction in genomics. The training will consist of formal coursework in ethics and genomics at Baylor College of Medicine and formal coursework in qualitative methodology and statistics at University of Texas School of Public Health, in addition to intensive training in conjoint analysis methodology at Johns Hopkins Bloomberg School of Public Health. This coursework and the proposed research will be conducted under the guidance of primary mentor Dr. Amy L. McGuire of BCM and co-mentors Dr. Sheryl A. McCurdy of University of Texas School of Public Health and Dr. John F.P. Bridges of Johns Hopkins Bloomberg School of Public Health. In addition, Dr. Richard Gibbs of BCM and Ms. Sharon Terry of Genetic Alliance will advise on the project as needed. The proposed research concerns the question of ownership claims and interests in the outputs of genomic research conducted in a collaborative “citizen science” context. The internet is providing opportunities for citizen scientists to participate in the design and conduct of studies, and these initiatives are increasingly prevalent in the field of genomics, where web-based portals are collecting genetic sequencing data and connecting individuals to genomic studies requesting varying levels of involvement. It is unclear, however, whether genomic citizen scientists have legitimate claims to the outputs of that research—i.e., the findings, written products, and discoveries that are the results of the studies that they support. This research will identify gaps in practice, policy, principles, and preferences relevant to ownership interests in genomic citizen science outputs to provide a normative and empirical foundation from which to develop best practices and policies that will promote public trust and engagement in biomedical research.