Behind Closed Doors: IRBs and the Making of Ethical Research (Morality and Society Series)

Stark, Laura
University of Chicago Press, Chicago
2012
9780226770864 (hb)

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Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009

Schrag, Zachary M.
The John Hopkins University Press, Baltimore and London
2010
9780801894909 (hb)

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Cover of book

Cover of book


Joint Review

Stark, L. (2012) Behind Closed Doors: IRBs and the Making of Ethical Research
and
Schrag, Z. (2010) Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009.

In Ethical Imperialism Zachary Schrag offers a historical perspective on the development of the North American 'Institutional Review Board' (IRB), broadly comparable to the UK's 'Research Ethics Committees' (REC). However, his purpose is not simply to present the historical specificities of their emergence but to consider its relationship to the ongoing struggle over their role and remit in the ethical governance the social sciences. In Behind Closed Doors Laura Stark takes up the historical perspective developed by Schrag, adding further important details of her own, and offers a sociological analysis of the so-called ethical decision making of IRBs based on her ethnographic research. She provides a socio-historical perspective on the development of the IRB in America as well as an illuminating analysis of their practice. Together they illustrate the nature of ethics as an aspect of research governance fundamentally contributing to our understanding of the phenomena in a manner that goes beyond the relatively limited or restricted consideration offered by applied ethical analysis.

Schrag's main purpose is to demonstrate the failure of those developing and institutionalizing research ethics as an administrative and bureaucratic phenomena to either address directly the practices of social scientific research, despite some opportunity and, one might think, responsibility to do so, or to rule the social sciences to be beyond the remit of their policies. Whilst it is clear that the supposition of a direct lineage between the Nuremberg Code, the Declarations of Geneva and Helsinki and the American development and institutionalization of IRBs as the form of research ethics governance achieved by the Belmont Report is a historically flawed perspective they are nevertheless all centrally concerned with the ethics of biomedical research. However, it is only with the genesis of the Belmont Report, and its subsequent impact on the governance of 'research ethics' sui generis, that the behavioral and social sciences have been brought within the ambit of (bio)ethical assessment. For me the question at stake when reading both authors is whether the contemporary American IRB is well suited to the ethical governance of biomedical, behavioral and social scientific research. Schrag addresses this concern both here and in his rewarding blog (see: http://www.institutionalreviewblog.com/) and one can interpret him as thinking the IRB, at least in its current form, is not well suited to social scientific research.

Stark however comes at this question more tangentially and whilst she is aware of some difficulties she does seem broadly in favor of the current arrangements. Nevertheless she acknowledges that their particular form is highly contingent and that therefore they could be differently constituted. Furthermore we might understand her main conclusion to be that the IRB exhibits a tendency to subsume their embodiment of a 'casuistical ideal' to the genetic reproduction of ethical decision-making largely based on administrative precedent and procedural concerns. In the case of the former particular IRBs develop template decisions through which subsequent applications and problems are perceived. In the case of the latter correct or, rather, incorrect completion the administrative requirements, even things as banal as spelling mistakes, becomes a proxy that informs a moral judgement of the researcher and, by implication, their research (Stark 2012, 17). Thus Stark concludes that whilst IRBs are granted "a good deal of discretion [they] rarely use this legal flexibility" (Stark 2012: 161). Those who developed the IRB as a bureaucratic approach to research ethics sought to mitigate a determinate reading of the ethical principles and 'best practices', such as always securing a written record of informed consent, by attempting to encode 'flexibility' in constitutive bureaucratic documents. Nevertheless both Schrag and Stark argue that, in the actual practices of the IRB, this flexibility is conspicuous by its absence. Instead IRB's tend to develop relatively determinate and static positions on particular issues raised by research ethics that, once inaugurated, become generically applied across research proposals in a variety of disciplines.

The IRB, or Clinical Research Committee (CRC) as it was then termed, was first conceived in 1953 at the National Institutes of Health (NIH), Bethesda, Maryland, USA. Stark argues that the initial inception of this ethically 'declarative body' (Stark) sought to reflect the moral and ethical climate of the place of its birth (Stark, 2011: 81). Nevertheless this approach has been widely exported. In short the administrative ethical framework conceived by a particular body became attached to the external funding offered by that same body. It was then exported across America and the wider world and, as Hedgecoe (2009) has convincingly demonstrated, this includes having an early and substantial influence on the origins of the UK's RECs. However in exporting this 'group consideration' approach to the governance of research ethics the NIH ultimately repurposed what was initially a defensive response to legal intrusion into its own research activities into an offensive response to potential legal liabilities regarding the external research activities it funded. Subsequently, in the wider context, this has encouraged a defensive approach to the ethical governance of research as the conditions of funding were, of course, primarily enforceable by the threat and actuality of its removal. Over time the supposed flexibility built into the IRB has become the flexibility to over, rather than under, comply, even to the extent of unnecessarily reviewing some social scientific research (Schrag 2010, 7 & 177). The problem directly identified by Schrag and a range of others (Dingwall 2006a; Stanley & Wise 2010; Murphy & Dingwall 2007) is that the ethics of social scientific research have not be sufficiently assessed on their own terms and so the administrative approach conceived on this basis is flawed. Elsewhere Dingwall (2006b; 2008), Hammersley (2009; 2010) Hammersley and Traianou (2011) seem to go further arguing against regulation and ethical governance per se whilst, on the basis of empirical research, Hedgecoe (2008) offers good reason to think these concerns may be overblown.

It is clear that there is a diversity of opinion on the matter. What we can say is that the consideration and deliberation about research ethics by those who have inaugurated the approach taken by research governance has largely been restricted to biomedical research. Ethical Imperialism is a book length demonstration of this fact and one that endeavors to show that in the history of IRB development there have been various missed opportunities where disciplinary ethical difference could have been at a minimum acknowledged if not directly addressed and explored. Schrag convincingly shows how the administrative and bureaucratic burden imposed by IRBs has gradually sprawled from biomedical research into the social sciences without proper consideration for the particulars of this domain. This is a view of ethical creep that has concerned Haggerty (2004) in the context of Canadian research in the social sciences.

The question we might consider is what lessons do these tales of the particular socio-historical development and contemporary practice of the American IRB have for the ethical governance of research beyond the borders of the USA? The UK equivalent of the American IRB was initially constituted as part of the NHS. This continues to be the case and, post the Rawlins' Report (2011), this looks set to continue being the case. Thus the gradual, unreflexive, spread of biomedical research ethics into the social sciences as research ethics per se has been limited as only social scientific research in and on medicine and health care has been subject to such review. Nevertheless this been cause for concern to many (Reed 2007; Fistein & Quilligan 2011). As such we might lament the fact that the Rawlin's committee missed the opportunity to address the ethical governance of social scientific research in the context of biomedicine despite the Academy of Social Sciences submission providing a justification for doing so [1]. This omission echoes the events documented by Schrag. Furthermore we might question whether the flexibility built into the ESRC's Framework for Research Ethics (previously the Research Ethics Framework) will carry over into practice. The apparent approach by UK HEIs (Higher Education Institutions) has been to constitute discipline specific research ethics committees offers more hope in this regard than that which apparently occurs within institution wide IRBs. Nevertheless applied ethical discourse is not often noted for embracing flexibility and it is essential that a variety of disciplinary experts engage with the contemporary bureaucratic institutionalization research ethics in higher education sector of the UK and the administrative tasks local to their own HEIs and departments. Furthermore if social science research ethics is to be constituted as an ethical perspective distinct from biomedical research ethics then there must be some minimum theoretical criteria for this difference. If this is to be fully articulated then social scientists must bring their expertise to bear on academic debates regarding the ethics of research and engage with that peculiarly modern phenomenon; the academic (bio)ethicist.

Nathan Emmerich
Queen's University Belfast

Notes

1 The Times Higher Education. 20th of January 2011. http://www.timeshighereducation.co.uk/story.asp?sectioncode=26&storycode=414904 Accessed February 2012.

References

DINGWALL, R. (2006a) "Confronting the Anti-Democrats: The Unethical Nature of Ethical Regulation in Social Science", Medical Sociology Online. Vol. 1 Issue 1: pp 51-58. <http://www.medicalsociologyonline.org/archives/files/MSoVol01Issue1.pdf#page=56>

DINGWALL, R. (2006b) "An Exercise in Fatuity: Research Governance and the Emasculation of HSR", Journal of Health Services Research & Policy. Vol. 11, Issue 4 (October 1, 2006): pp 193 -194.

DINGWALL, R. (2008) "The Ethical Case Against Ethical Regulation in Humanities and Social Science Research", Twenty-First Century Society. Vol. 3, Issue 1: pp. 1-12.

FISTEIN, E. and Quilligan, M. (2011 Online First) "In the Lion's Den? Experiences of Interaction with Research Ethics Committees", Journal of Medical Ethics. Online First: <http://jme.bmj.com/content/early/2011/11/01/medethics-2011-100124.abstract>

HAGGERTY, K. D. (2004) "Ethics Creep: Governing Social Science Research in the Name of Ethics", Qualitative Sociology. Vol. 27, Issue 4: pp 391-414.

HAMMERSLEY, M. (2009) "Against the Ethicists: On the Evils of Ethical Regulation", International Journal of Social Research Methodology. Vol. 12, Issue 3: pp 211-226.

HAMMERSLEY, M. (2010) "Creeping Ethical Regulation and the Strangling of Research", Sociological Research Online. Vol. 15, Issue 4: http://www.socresonline.org.uk/15/4/16.html.

HAMMERSLEY, M. and Traianou, A. (2011) "Moralism and Research Ethics: a Machiavellian Perspective", International Journal of Social Research Methodology Vol. 14, Issue 5: pp 379-390.

HEDGECOE, A. (2008) "Research Ethics Review and the Sociological Research Relationship." Sociology. Vol. 42, Issue 5: pp 873-886.

HEDGECOE, A. (2009) "'A Form of Practical Machinery': The Origins of Research Ethics Committees in the UK, 1967-1972", Medical History. Vol. 53, Issue 3: pp 331-350.

RAWLINS, M. (2011) A New Pathway for the Regulation and Governance of Health Research. London: The Academy of Medical Sciences.

REED, K. (2007) "Bureaucracy and Beyond: The Impact of Ethics and Governance Procedures on Health Research in the Social Sciences," Sociological Research Online Vol. 12, Issue 5: http://www.socresonline.org.uk/12/5/18.html.

STANLEY, L., and Wise, S. (2010) "The ESRC's 2010 Framework for Research Ethics: Fit for Research Purpose?" Sociological Research Online. Vol. 15, Issue 4: http://www.socresonline.org.uk/15/4/12.html.

MURPHY, E and Dingwall, R. (2007) "Informed Consent, Anticipatory Regulation and Ethnographic Practice." Social Science & Medicine. Vol. 65, Issue 11: pp 2223-2234.