A Cultural Understanding of Research Ethics Governance

By Brunger, Fern; Burgess, Michael C. | Health Law Review, Spring-Fall 2005 | Go to article overview

A Cultural Understanding of Research Ethics Governance


Brunger, Fern, Burgess, Michael C., Health Law Review


Introduction

Analyses of research ethics tend to characterize ethical review and its components as a linear process of submission, review, revision, research conduct and reporting. Recommendations to improve research ethics usually seek to provide a way to better support this linear process through improved guidance, training, regulation, institutional power or legal authority. We refer to this as a linear model of research ethics governance. Recommendations on this model implicitly recognize that research is influenced by a complex web of relations. Recent discussion about conflicts of interest and research ethics also recognizes that research review and standards are subject to a web of influences. We suggest a cultural model of research ethics governance or stewardship that explicitly acknowledges that research and research ethics are subject to complex social influences that are simultaneously antagonistic and supportive of the goals of research ethics. These influences inevitably shape even the standards, practices and structures of research ethics. Recognizing this embeddedness is more than a clever social analysis--it locates research ethics as one of many activities in an arena of social action and makes it possible to identify and evaluate the presumptions that have shaped the goals of research ethics as well as a wider range of means for achieving them.

The Linear Model of Research Ethics

Discussions of research ethics are rooted in the linear characterization of a process that begins with a research proposal and passes step-wise through stages of review and revision to be approved, implemented and reported. Research ethics scholarship has generally utilized the linear model in an attempt to directly influence research activities to promote high quality and ethical research. Recommendations to improve research ethics usually seek to provide a way to better support this linear process through improved guidance, training, regulation, institutional power or legal authority. As a result, the field of research ethics has been dominated by discussions of ethics review, ethical regulations and guidelines, and forms such as informed consent.

In The Governance of Health Research Involving Human Subjects, (1) Michael McDonald characterizes the practice of human subject ethics review in Canada as the funnel-like reduction of complexity into an inappropriately narrow review process:

     In short, ethics is funnelled into a bureaucratic process, and the
     process itself is reduced to a bare minimum. That bare minimum
     consists of the tangible parts--consent forms and other items, like
     adverse incident reports.... An important general result of this
     funnelling and narrowing down of ethical concerns is that important
     issues are missed at all levels and at all stages.... More
     generally in terms of governance processes and structures designed
     to promote ethical RIHS, the REB is seen as the focal institutional
     tool and in turn its role is defined in terms of front-end research
     protocol approval. This ignores other possible tools or structures
     for promoting ethical research. It also ties too much of ethics in
     research to a particular stage--a very preliminary one at that--
     taken in isolation from the rest of the research process. The big
     picture is missed--concerning the larger cultural environment of
     research.

The funnel example demonstrates the bureaucratization of research ethics--how a broad range of research ethics issues, when channelled through the administrative mechanisms of review and consent, end up neglecting the original complexity.

Discussions of conflicts of interest in relation to research ethics also make explicit concerns about how diverse influences on research shape the research agenda. (2) Some of the most oft-cited influences on research and the ethics of research in practice include: industry influence;; directed calls for research proposals by funding agencies; private funding of research; matched funding requirements; influence of disease-based and community-based groups; and patterns of health care funding. …

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