McGuire Amy L, Achenbaum Laura S, Whitney Simon N, Slashinski Melody J, Versalovic James, Keitel Wendy A, McCurdy Sheryl A
Baylor College of Medicine, Houston, TX, USA.
J Empir Res Hum Res Ethics. 2012 Jul;7(3):1-14. doi: 10.1525/jer.2012.7.3.1.
Study of ethical, legal, and social implications (ELSI) of human microbiome research has been integral to the Human Microbiome Project (HMP). This study explores core ELSI issues that arose during the first phase of the HMP from the perspective of individuals involved in the research. We conducted semi-structured in-depth interviews with investigators and NIH employees ("investigators") involved in the HMP, and with individuals recruited to participate in the HMP Healthy Cohort Study at Baylor College of Medicine ("recruits"). We report findings related to three major ELSI issues: informed consent, data sharing, and return of results. Our findings demonstrate that investigators and recruits were similarly sensitive to these issues yet generally comfortable with study design in light of current knowledge about the microbiome.
人类微生物组研究的伦理、法律和社会影响（ELSI）研究一直是人类微生物组计划（HMP）不可或缺的一部分。本研究从参与研究的个人角度探讨了HMP第一阶段出现的核心ELSI问题。我们对参与HMP的研究人员和美国国立卫生研究院员工（“研究人员”）以及被招募参加贝勒医学院HMP健康队列研究的个人（“招募对象”）进行了半结构化深度访谈。我们报告了与三个主要ELSI问题相关的研究结果：知情同意、数据共享和结果反馈。我们的研究结果表明，研究人员和招募对象对这些问题同样敏感，但鉴于目前关于微生物组的知识，他们总体上对研究设计感到满意。
