Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Medical Humanities, Julius Center, University Medical Center, Utrecht University, Utrecht, The Netherlands.
J Med Ethics. 2018 Dec;44(12):801-804. doi: 10.1136/medethics-2018-105088. Epub 2018 Oct 18.
Biomedical research funding bodies across Europe and North America increasingly encourage-and, in some cases, require-investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what 'good' or 'successful' public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement.
欧洲和北美的生物医学研究资助机构越来越多地鼓励——在某些情况下甚至要求——研究人员让公众参与资助的研究。然而，对于什么样的公众参与才算“好”或“成功”，仍然缺乏明确的认识。为了向研究人员和研究机构提供指导，英国的几个主要研究资助机构的代表最近聚集在一起，制定了《公众参与研究的国家标准》。这些标准对英国乃至其他国家的生物医学研究的未来具有重要影响，因为国外的研究人员和资助者正在将这些标准视为制定自己政策的典范。我们评估了这些标准，发现尽管它们为应对与公众参与相关的实际挑战提供了有用的建议，但这些标准未能解决关于何时、为何以及与谁首先进行公众参与的基本问题。我们表明，如果没有这种论证背景，这些标准中的许多建议充其量只是一些需要在自己的工作中应用这些标准的人进行大量阐述的片段，而在最坏的情况下，这些建议可能会被善意的研究人员错误地应用。随着资助机构越来越多地推动研究中的公众参与，我们分析得出的关键教训是，如果没有明确的公众参与的基本目标和理由，关于公众参与应该如何进行的未来建议就无法连贯地制定。
