Center for Bioethics & Health Law, University of Pittsburgh, 519 Barco Law Building, 3900 Forbes Ave, Pittsburgh, Pennsylvania, 15260, USA.
Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, Pennsylvania, 19104, USA.
Genet Med. 2019 Feb;21(2):505-509. doi: 10.1038/s41436-018-0065-x. Epub 2018 Jul 4.
The Ethical, Legal, and Social Implications (ELSI) Research Program of the National Human Genome Research Institute sponsors research examining ethical, legal, and social issues arising in the context of genetics/genomics. The ELSI Program endorses an understanding of research not as the sole province of empirical study, but instead as systematic study or inquiry, of which there are many types and methods. ELSI research employs both empirical and nonempirical methods. Because the latter remain relatively unfamiliar to biomedical and translational scientists, this paper seeks to elucidate the relationship between empirical and nonempirical methods in ELSI research. It pays particular attention to the research questions and methods of normative and conceptual research, which examine questions of value and meaning, respectively. To illustrate the distinct but interrelated roles of empirical and nonempirical methods in ELSI research, including normative and conceptual research, the paper demonstrates how a range of methods may be employed both to examine the evolution of the concept of incidental findings (including the recent step toward terming them 'secondary findings'), and to address the normative question of how genomic researchers and clinicians should manage incidental such findings.
国家人类基因组研究所的伦理、法律和社会影响（ELSI）研究计划赞助研究，以探讨遗传学/基因组学背景下出现的伦理、法律和社会问题。ELSI 计划认可这样一种理解，即将研究不仅仅视为经验研究的唯一领域，而是将其视为包括多种类型和方法的系统研究或探究。ELSI 研究既采用经验方法，也采用非经验方法。由于后者对于生物医学和转化科学家来说相对陌生，因此本文旨在阐明 ELSI 研究中经验方法和非经验方法之间的关系。本文特别关注规范研究和概念研究的研究问题和方法，分别探讨价值和意义问题。为了说明 ELSI 研究中包括规范研究和概念研究在内的经验和非经验方法的不同但相互关联的作用，本文展示了如何采用一系列方法来研究偶然发现概念的演变（包括最近朝着将其称为“次要发现”的步骤），并解决基因组研究人员和临床医生应如何管理偶然发现的规范性问题。
