Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box.
Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box.
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实现研究法规现代化还不够：是时候跳出监管框框思考了。
DOI：
10.1080/15265161.2017.1328899
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
Goldenberg,AaronJ
中科院分区：
文献类型：
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作者：
Rivera,SuzanneM;Brothers,KyleB;Cadigan,RJean;Harrell,HeatherL;Rothstein,MarkA;Sharp,RichardR;Goldenberg,AaronJ
我们是一个由生物伦理学家、社会科学家、临床医生和律师组成的多学科合作组织，他们的工作重点是生物储存库的网络化方法所带来的伦理挑战。和许多人一样，我们一直担心我们的人体研究法规已经严重过时。虽然1991年共同规则所设想的干预性、假设驱动的研究仍然很重要，但当代研究越来越依赖于收集样本和数据，以进行未指明的未来研究。在过去的十年中，用于研究的大量生物材料的收集在复杂性和范围上都有了增长，创造了机构间、国家和国际的网络。这些生物储存库网络也嵌入到利用学习卫生系统、大数据分析和复杂卫生信息学方法的研究途径中。虽然近几十年来科学不断发展，但它必须在一个最适合个人、假设驱动的研究的监管框架内进行。这种方法不太适合研究系统、合作和多站点基础设施，而这些正在推动精准医学和转化科学的未来。我们感兴趣的是，尽管监管框架不合适，但网络生物储存库如何为研究数据和样本提供多站点基础设施，解决了人类受试者保护方面的挑战。出于这个原因，我们怀着极大的兴趣关注着更新共同规则的努力。在这6年的漫长旅程中，我们和我们专业团体的其他成员把我们对人类研究监督的希望寄托在这样一种信念上：让共同规则“正确”，将有助于弥合科学与监管之间的鸿沟，这种鸿沟在过去20年里已经变成了一条鸿沟。这一希望不仅没有实现，而且我们可能被误导，认为让共同规则“正确”是可能的，因为它需要解决极其复杂的政治、社会和科学因素。也许我们天真地以为联邦监管程序可以跟上不断发展的科学模式。然而，回顾过去，我们认为对修订《共同规则》的关注可能使我们失去了促进更有活力的治理结构、生物银行最佳实践和促进患者和捐赠者利益的非监管策略的机会。根据《联邦公报》的公告，修订《共同规则》（Common Rule）的努力始于2011年，当时对拟议的规则制定进行了预先通知，修订的重点应该是更新法规，以考虑到新兴科学类型，包括大规模研究基础设施。虽然共同规则的最终版本确实在解决这些趋势方面取得了渐进式进展，但它并没有为监督跨越机构和国际边界的开放式研究基础设施和生物存储网络提供一个强有力的框架。这真的不应该让我们感到惊讶。监管充其量是一种钝器，它们不能解决所有问题。
We are a multidisciplinary collaborative made up of bioethicists, social scientists, clinicians, and lawyers whose work focuses on the ethical challenges posed by a networked approach to biorepositories. Like many, we have been concerned that our human research regulations had become woefully out of date. While the interventional, hypothesis-driven research envisioned by the 1991 Common Rule remains important, contemporary research increasingly depends on the collection of samples and data for unspecified future research. Over the past decade, large collections of biological materials for research have grown in complexity and scope, creating interinstitutional, national, and international networks. These networks of biorepositories also are embedded in research pathways that leverage learning health systems, big data analytics, and sophisticated health informatics approaches. While science has evolved in recent decades, it has had to do so within a regulatory framework best suited to individual, hypothesis-driven research studies. This approach is a poor fit for the research systems, collaborations, and multisite infrastructures that now are driving the future of precision medicine and translational science. We are interested in how networked biorepositories, which provide multisite infrastructure for research data and samples, have addressed human subjects protections challenges despite an ill-fitting regulatory framework. For this reason, we followed with great interest the effort to update the Common Rule. During this 6-year odyssey, we and other members of our professional communities pinned our hopes for human research oversight on the belief that getting the Common Rule “right” would help bridge a gap between science and regulation that had grown into a chasm over the last two decades. Not only was this hope not realized, we probably were misguided to think that getting the Common Rule “right” was even possible, given the extremely complex political, social, and scientific factors that it needed to address. Perhaps we were naive to imagine that the federal regulatory process could keep pace with evolving models of science. In retrospect, however, we think the focus on revising the Common Rule may have diverted us from an opportunity to promote more dynamic governance structures, best practices for biobanking, and nonregulatory strategies for advancing patient and donor interests. According to the Federal Register announcement, the effort to revise the Common Rule, which started in 2011 with an advance notice of proposed rulemaking, was supposed to focus on updating the regulations to account for emerging types of science, including large-scale research infrastructure. While the final version of the Common Rule does make incremental progress in addressing these trends, it does not provide a robust framework for the oversight of open-ended research infrastructure and biorepository networks that span institutional and international borders. This really should not have surprised any of us. Regulations are at best a blunt instrument, and they cannot solve every problem.