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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

Ethical relationships, ethical research in Aboriginal contexts: Perspectives from central Australia0

Posted by Admin in on November 18, 2018
 

Learning Communities International Journal of Learning in Social Contexts
Special issue: Ethical relationships, ethical research in Aboriginal contexts: Perspectives from central Australia

Number 23 – November 2018

CONTENTS
Introduction to Special Issue: Being here matters …2
Barry Judd

Editorial….12
Al Strangeways

“You helped us and now we’re going to all help you”: What we learned about how to do research together …16
Lisa Hall, Linda Anderson, Fiona Gibson, Mona Kantawara, Barbara Martin and Yamurna Oldfield

Ngapartji ngapartji ninti and koorliny karnya quoppa katitjin (Respectful and ethical research in central Australia and the south west) …32
Jennie Buchanan, Len Collard and Dave Palmer

Researching together: Reflections on ethical research in remote Aboriginal communities …52
Tessa Benveniste and Lorraine King

The dancing trope of cross-cultural language education policy…64
Janine Oldfield and Vincent Forrester

Different monsters: Traversing the uneasy dialectic of institutional and relational ethics …76
Al Strangeways and Lisa Papatraianou

Research for social impact and the contra-ethic of national frameworks…92
Judith Lovell Altyerre

NOW: Arrernte dreams for national reconstruction in the 21st century …106
Joel Liddle Perrurle and Barry Judd

The making of Monstrous Breaches: An ethical global visual narrative…116
Judith Lovell and Kathleen Kemarre Wallace

Read  the special edition

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