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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight (Papers: Holly Fernandez Lynch, et al | December 2018)0

Posted by Admin in on January 13, 2019
 

Abstract

Is your research ethics committee effective? Even deciding what effective means in this context isn’t easy. If effectiveness means research being conducted more ethically, how do judge that? This great paper should be seen as a springboard into an important discussion.

There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs “work” requires empirical evaluation of whether and how well they actually achieve what they were designed to do. In other words, it is critical to examine their outcomes and not only their procedures and structures. In this response to Tsan, we argue that the concept of IRB and HRPP quality entails three dimensions: (1) effectiveness, (2) procedures and structures likely to promote effectiveness, and (3) features unrelated to effectiveness but nonetheless essential, such as efficiency, fairness, and proportionality. Because not all types of quality necessarily guarantee or entail effectiveness, we suggest that broad quality assessments, including such features as regulatory compliance and other procedural measures suggested by Tsan, are unhelpful as the first step in evaluating IRBs and HRPPs. Instead, we must start with outcomes relevant to effectiveness. To do this, we launched the Consortium to Advance Effective Research Ethics Oversight (AEREO), with a mission to define and specify ways to measure relevant outcomes for research ethics oversight, empirically evaluate whether those outcomes are achieved, test new approaches to achieving them, and ultimately, develop and implement empirically-based policy and practice to advance IRB and HRPP effectiveness. We describe several anticipated AEREO projects and call for collaboration between various stakeholders to more meaningfully evaluate IRB and HRPPs.

Keywords
Institutional Review Board, research ethics oversight, effectiveness, quality, empirical evaluation

Lynch, H. F., Nicholls, S., Meyer, M. N., & Taylor, H. A. (2018). Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight. Journal of Empirical Research on Human Research Ethics. https://doi.org/10.1177/1556264618812625
Publisher: https://journals.sagepub.com/doi/abs/10.1177/1556264618812625#articleCitationDownloadContainer

The Ethical Governance of German Physicians, 1890-1939: Are There Lessons from History? (Papers: Robert Dingwall & Vienna Rozelle | 2011)0

Posted by Admin in on December 20, 2018
 

The limitations of the traditional historiography of the ethical regulation of biomedical research are becoming increasingly well recognized. A simplistic history has been used to justify a simplistic policy, in the elaboration of regulatory instruments associated with a bureaucracy of administration and enforcement that has acquired its own material interests in self-perpetuation and jurisdictional expansion. The official history of institutionalized ethical regulation sees a clear and self-evident line of descent from the Nazi experiments of World War II to the various legal and quasi-legal instruments that now govern most scientific and, increasingly, social scientific practice. Without regulatory interventions, it is claimed, researchers will revert to barbarism.

Many of us point to the Nuremberg Code as the first formal attempt to govern the ethical conduct of human research.  While the atrocities committed by the Nazi scientists are no less horrific, this paper by Robert Dingwall and Vienna Rozelle paints quite a different picture of the early evolution of the governance of ethics in bio-medicine. The lessons and implications should cause us pause. Perhaps regulation is not a safeguard against ethically compromised research and we need to stop referring to the inhuman acts of the Nazis to justify our current human research ethics arrangements.

This version of the “rise of bioethics” tends to place considerable emphasis on the Nuremberg Doctors Trial, and the Nuremberg Code promulgated at its conclusion, and to use these as an “origin myth” that legitimizes its professional project. As a narrative, it says little, for example, about the lengthy gap between the conclusion of the Nuremberg trial in 1948 and the development of regulatory interventions for medical research in the victor countries during the 1960s. It tends not to acknowledge the evidence, from writers like Henry Beecher in the United States and Maurice Pappworth in the United Kingdom, that ethically questionable experiments continued in the victor countries well after World War II, a phenomenon explored further by Tal Bolton in a recent PhD. thesis and her article in this journal issue. However, it also tends to equate an absence of regulation with an absence of ethical concern, despite the evidence from Susan Lederer and Sydney Halpern about the effective operation of informal social controls in the United States before World War II. Most crucially, it neglects Jenny Hazelgroves exploration of the difficulty that the prosecutors faced in framing charges against the Nuremberg defendants because they were unable to point to any clear set of regulations or standards in any country other than Germany that could be said to have been violated.
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The publication of further analyses of the pre-World War II German experience provides an additional resource for the critical examination of the claims being made about the importance of formal regulation in the maintenance of ethical standards in biomedical research. This body of work has documented the rise of attempts at ethical research governance in Germany from the late nineteenth century through to the 1930s. In so doing, it may seem to provide us with an opportunity to explore the limits of regulation. Why did it fail to protect the victims of the Nazi medical experiments? Why did it seemingly attract so little international interest, despite Germany’s leading role in science and biomedicine over much of this period? However, as a number of influential historians of late nineteenth- and early twentieth- century Germany have observed, the study of this period has suffered from the imposition of narrative arcs, influenced by sociology or political science, that see it only as the precursor to the disaster of the Nazi regime. No actor at the time consciously sought this end for their actions: even the Nazi leadership sought power rather than defeat. Accounts that find a logic in the events from the late nineteenth century to the end of World War II may overlook the unintended consequences of actors dealing with contingent events on the basis of partial information interpreted according to what were contemporaneously considered valid knowledge or theories. It is important, then, to avoid constructing an equally simplistic counter-narrative about the general ineffectiveness of regulation.

Dingwall, R and Rozelle, V (2011) The ethical governance of German physicians, 1890–1939: Are there Lessons from History? Journal of Policy History 23(1): 29-52. http://irep.ntu.ac.uk/id/eprint/16649/1/205167_7323%20Dingwall%20Publisher.pdf

Vulnerability in research subjects: a bioethical taxonomy (Kenneth Kipnis | 2001)0

Posted by Admin in on November 30, 2018
 

The concept of vulnerability appears to have been grandfathered into the lexicon, lore, and literature of research ethics without undergoing stringent certification. And yet the need for some such notion has long been appreciated. More than 50 years ago, reflecting on the ethical implications of the Nazi medical experiments, the authors of the Nuremberg Code emphasized the necessity of the subject’s informed consent, too hastily ruling out, as it quickly became apparent, medical research on children and those with cognitive impairments.

In the United States, widely studied episodes such as Willowbrook,1 the Brooklyn Jewish Chronic Disease Hospital Case,2 and the Tuskegee Syphilis Study3 provoked debates that eventually gave birth to our current methods for ensuring the ethical conduct of research. But despite the remarkable circumstances of the subjects involved in those studies—institutionalized children, hospitalized elderly, and impoverished and poorly educated black Alabama males—it is not much of an exaggeration to say that in the minds of many investigators the paradigmatic research subject remains more or less a mature, respectable, moderately well-educated, clearthinking, literate, self-supporting U.S. citizen in good standing—that is, a man who could understand a 12- page consent form and act intelligently on the basis of its contents. While I shall assume in what follows both that the existing guidelines are sufficient to deal ethically with the paradigmatic research subject, and, further, that all those standard protections are reliably in place, the vulnerable research subject nonetheless requires ethical consideration going beyond that baseline.

More recently, in the wake of the Nuremberg Code’s shortcomings, systematic attention has been accorded to a motley collection of vulnerable subpopulations. In 1979, for example, the seminal Belmont Report4 briefly considered children, the institutionalized mentally ill, and prisoners, mentioning dependency and compromised capacity for consent as representative hallmarks of vulnerability. There was no effort to be comprehensive. The more recent Federal Regulations on the Protection of Human Subjects (45 CFR 46) implement the requirement that Institutional Review Boards (IRBs) take into account the “special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons” (46–111). Criteria for vulnerability are not discussed although subparts are included with supplementary regulations for some of these groups. Finally, the Final Report of the Advisory Committee on Human Radiation Experiments,5 after reviewing patterns of unethical misconduct in military research, recommended special protections for enlistees.

Read the rest of this commissioned  paper

Kipnis K. (2001) Vulnerability in research subjects: a bioethical taxonomy. In: National Bioethics Advisory Commission, editor. Ethical and policy issues in research involving human participants. Bethesda: National Bioethics Advisory Commission. pp. G1–G13. http://www.aapcho.org/wp/wp-content/uploads/2012/02/Kipnis-VulnerabilityinResearchSubjects.pdf

Constructive Voices: Panel discussion about institutional implementation of the National Statement (2007 updated 2018)0

Posted by Admin in on November 24, 2018
 

On 22nd of november, AHRECS hosted its second Constructive Voices panel. These panels aim to create an opportunity for open discussion about human research ethics and research integrity among researchers, policymakers, research managers, research ethics reviewers and other stakeholders.

The first panel featured:

  • Jeremy Kenner, Expert Advisor – Ethics at NHMRC
  • Wendy Rogers, Chair NSWG, Macquarie University
  • Pamela Henry, Chair ECU HREC
  • Gary Allen, Co-Chair Chapter 3.1 drafting committeer,  Senior Consultant, AHRECS

A video-recording of the discussion will be available for streaming for 90 days for free from the here. It will then be moved to the AHRECS subscribers’ area.

By becoming a subscriber (from USD1/month) you will not only gain access to a growing library of high-quality resources (two or more items are added every month), but you will also be supporting events like the Constructive Voices panel discussions. A subscription of USD15/month provides access to all the materials.

We are also happy to hear ideas for panels and speakers for 2019. We agree that there is a need for communities of practice to develop further around research ethics. We recognise that AHRECS could do more to stimulate this and we would like to find partners who would resource this.

AHRECS has been working with Australian universities and other research institutions to respond to the recent changes to the National Statement and the new Australian Code. You can find out more about the services offered by AHRECS at https://ahrecs.com/our-services.

Regards from Mark, Gary and Colin on behalf of the AHRECS team

Items left by the speakers

Mark’s welcome and intro slides

— NHMRC —

Jeremy’s presentation slides

Jeremy’s full version slides

National Statement on Ethical Conduct in Human Research (2007 Updated 2018)

— WENDY ROGERS —

Wendy’s presentation

— PAMELA HENRY —

Pamela’s presentation

— GARY ALLEN —

Gary’s slides

Recording of event

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