Ethical oversight of genomic citizen science

项目总结/摘要 近几十年来，公民科学倡议呈爆炸式增长，现在全世界已有数千人。 公民科学通常指的是一种科学探究的方法，其中公众成员 参与研究过程中的一个或多个步骤，而不是提供数据或 用于分析的生物样本。公民科学活动，研究生物医学问题， 控制，并执行最少或根本没有输入从机构为基础的科学家有时是 被称为生物黑客继最近发现廉价和相对容易使用的基因 编辑工具，特别是基因组实验，已经在生物医学公民中流行起来。 科学家虽然他们的许多活动可能被认为是相对安全的，但其他人，例如，自我， 实验与不受管制的基因治疗-与伤害的风险增加和独特的 伦理问题。然而，许多生物黑客活动都不在联邦道德审查的范围之内 道德操守要求，无法利用道德操守监督的体制机制， 这被称为公民科学中的“伦理鸿沟”。 对生物医学公民科学的伦理监督进行批判性审查的时机已经成熟，特别是 基因组生物黑客活动在公民科学环境中越来越普遍。一些 学者们提出了公民科学伦理审查的新机制。然而，迄今为止， 生物医学公民科学家的伦理态度和偏好尚未系统地 鉴定缺乏这些数据破坏了为解决人口问题而作出的任何努力。 “道德差距”，因为没有经验基础来了解拟议的机制是否会协调一致 与参与者的精神或经验，因此将是可接受的和有用的。 拟议的研究将收集这一关键的、缺失的证据，并将其用于评估 公民科学的伦理监督具体而言，目标1将确定伦理在基因组生物黑客中的作用 从参与者的角度，通过半结构化的定性访谈30个基因组 生物黑客代表了一系列的经验。下一步，Aim 2将评估基因组学的伦理审查 机构审查委员会和替代监督机制根据《生物黑客法》开展的生物黑客活动 它们与目标1中确定的生物黑客的道德态度和偏好的一致性。的 这项研究的贡献将是重大的，因为它将奠定必要的基础， 为基因组和其他生物医学公民科学家建立伦理工具和资源。

PROJECT SUMMARY/ABSTRACT Citizen science initiatives have exploded in recent decades and now number in the thousands worldwide. Citizen science generally refers to an approach to scientific inquiry in which members of the public participate in one or more steps of the research process other than, or in addition to, providing data or biospecimens for analysis. Citizen science activities that study biomedical questions and are designed, controlled, and executed with minimal to no input from institution-based scientists are sometimes described as biohacking. Following the recent discoveries of inexpensive and relatively easy-to-use gene editing tools, genomic experimentation in particular has become popular among biomedical citizen scientists. Although many of their activities might be considered relatively safe, others—for example, self- experimentation with unregulated gene therapies—are associated with elevated risk of harms and unique ethical concerns. Yet, many biohacking activities are outside the reach of federal ethics review requirements and do not have access to institutional mechanisms of ethics oversight, contributing to what has been described as an “ethics gap” in citizen science. The time is ripe for a critical examination of the ethical oversight of biomedical citizen science, especially genomic biohacking activities that are increasingly common across citizen science settings. Some scholars have proposed new mechanisms of ethics review for citizen science. To date, however, the ethical attitudes and preferences of biomedical citizen scientists have not yet been systematically identified. The absence of these data undermines any attempt to develop solutions to the problem of the “ethics gap” since there is no empirical basis for knowing whether the proposed mechanisms will align with the ethos or experience of participants and therefore will be acceptable and useful to them. The proposed research will collect this critical, missing evidence and use it to evaluate mechanisms of ethics oversight of citizen science. Specifically, Aim 1 will identify the role of ethics in genomic biohacking from the perspective of participants through semi-structured qualitative interviews of 30 genomic biohackers representing a spectrum of experiences. Next, Aim 2 will evaluate ethics review of genomic biohacking activities by institutional review boards and alternative oversight mechanisms on the basis of their consistency with the ethical attitudes and preferences of biohackers identified in Aim 1. The contribution of this research will be significant because it will lay the essential groundwork on which to build ethics tools and resources for genomic and other biomedical citizen scientists.