Abstract
A growing body of literature critical of ethics review boards has drawn attention to the processes used to determine the ethical merit of research. Citing criticism on the bureaucratic nature of ethics review processes, this literature provides a useful provocation for (re)considering how the ethics review might be enacted. Much of this criticism focuses on how ethics review boards deliberate, with particular attention given to the lack of transparency and opportunities for researcher recourse that characterise ethics review processes. Centered specifically on the conduct of ethics review boards convened within university settings, this paper draws on these inherent criticisms to consider the ways that ethics review boards might enact more communicative and deliberative practices. Outlining a set of principles against which ethics review boards might establish strategies for engaging with researchers and research communities, this paper draws attention to how Deliberative communication, Engagement with researchers and the Distribution of responsibility for the ethics review might be enacted in the day-to-day practice of the university human ethics review board. This paper develops these themes via a conceptual lens derived from Habermas’ (The theory of communicative action. Volume 1: Reason and the rationalization of society, 1984) articulation of ‘communicative action’ and Fraser’s (Social Text, 25(26), 56–80, 1990) consideration of ‘strong publics’ to cast consideration of the role that human ethics review boards might play in supporting university research cultures. Deliberative communication, Engagement with researchers and the Distribution of responsibility provide useful conceptual prompts for considering how ethics review boards might undertake their work.
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An exception is found in Allen’s (2008) accounts. We draw on this example in the later sections of this paper and extend Allen’s considerations of the participatory model he proposes.
These documents have led to the development of further codes and guidelines, including the United States National Commission for the Protection of Human Subjects’ (1989) Belmont Report: Principles of Ethical Research with Human Subjects. The historical context that defines current ethical review processes is summarised in the following:
There has…been increased attention to ethical reflection about human research since the Second World War. The judgment of the Nuremberg military tribunal included ten principles about permissible medical experiments, since referred to as the Nuremberg Code. Discussion of these principles led the World Medical Assembly in 1964 to adopt what came to be known as the Helsinki Declaration, revised several times since then. The various international human rights instruments that have also emerged since the Second World War emphasise the importance of protecting human beings in many spheres of community life. During this period, written ethical guidelines have also been generated in many areas of research practice as an expression of professional responsibility. (Australian Government, 2007/2018, p. 3).
As a summary of the guiding principles that frame the considerations of ethical conduct contained in these (and similar) documents, we offer the following typology as a summary of the key tenets common to contemporary guidelines. In general terms, most guidelines give attention to the following:
- Research Design: how is the research defined? What merit does this research maintain and what value does it hold? How will the methodological fidelity of stated procedures be ensured?
- Benefits and Risks: how are the inherent risks associated with the research weighed in terms of an intent toward nonmaleficence?
- Participant Recruitment: how will participants be informed of the research and recruited into its conduct?
- Research Conduct: how will the treatment of participants proceed as part of the research? How will participants be informed of developments in the research and its ongoing effects?
- Presentation of Research Outcomes: how will findings from the research be developed and disseminated? How will the storage and ongoing use and interpretation of data proceed?
The Australian Government National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007/2018) provides an indicative illustration of how these principles are articulated in contemporary codes and guidelines:
The relationship between researchers and research participants is the ground on which human research is conducted… respect for human beings, research merit and integrity, justice, and beneficence help to shape that relationship as one of trust, mutual responsibility and ethical equality…
The values of respect, research merit and integrity, justice, and beneficence have become prominent in the ethics of human research in the past six decades, and they provide a substantial and flexible framework for principles to guide the design, review and conduct of such research. (p. 9).
We note that particular attention toward respect, merit, integrity, justice and beneficence frame these considerations. For instance, this sentiment is outlined in the National Health and Medical Research Council’s (2018) accompanying Australian Code of Responsible Conduct of Research, (2018). The code highlights that attention should be given to ensuring the following:
• Respect for research participants, the wider community, animals and the environment.
• Treat human participants and communities that are affected by the research with care and respect, giving appropriate consideration to the needs of minority groups or vulnerable people.
• Ensure that respect underpins all decisions and actions related to the care and use of animals in research.
• Minimise adverse effects of the research on the environment. (p. 5).
As an indication of the minimum requirements for the constitution of a review board, the Australian Government National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007/2018) details the following membership requirements:
The constitution of the ethics review board is an important aspect of the review process. A wide range of expertise and disciplinary knowledge is typically sought in the membership, with ‘pastoral’ and ‘lay’ membership also a feature of most review boards’ constitution. The Australian Government’s National Health and Medical Research Council’s (2007/2018) National Statement on Ethical Conduct in Human Research for example highlights that review board membership should include the following:
Composition of Human Research Ethics Committees [HREC].
5.1.29 The minimum membership of an HREC is eight. As far as possible:
(a) there should be equal numbers of men and women; and.
(b) at least one third of the members should be from outside the institution for which the HREC is reviewing research.
5.1.30 This minimum membership is:
(a) a chairperson, with suitable experience, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under this National Statement;
(b) at least two lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work;
(c) at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, a nurse or allied health professional;
(d) at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion;
(e) at least one lawyer, where possible one who is not engaged to advise the institution; and.
(f) at least two people with current research experience that is relevant to research proposals to be considered at the meetings they attend. These two members may be selected, according to need, from an established pool of inducted members with relevant expertise.
5.1.31 No member may be appointed in more than one of the categories listed in paragraph 5.1.30, but institutions are encouraged to establish a pool of inducted members in each category.
These members may attend meetings as needed to meet minimum HREC requirements, and may also be available to provide expertise for the research under review.
5.1.32 Wherever possible one or more of the members listed in 5.1.30 should be experienced in reflecting on and analysing ethical decision-making.
5.1.33 The institution should ensure that the HREC has access to the expertise necessary to enable it to address the ethical issues arising from the categories of research it is likely to consider.
This may necessitate going outside the HREC membership. (p. 87).
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Hickey, A., Davis, S., Farmer, W. et al. Beyond Criticism of Ethics Review Boards: Strategies for Engaging Research Communities and Enhancing Ethical Review Processes. J Acad Ethics 20, 549–567 (2022). https://doi.org/10.1007/s10805-021-09430-4
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DOI: https://doi.org/10.1007/s10805-021-09430-4