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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Informed consent in international normative texts and biobanking policies: Seeking the boundaries of broad consent (Papers: Palmira Granados Moreno and Yann Joly | 2016)0

Posted by Admin in on March 11, 2020
 

Abstract
With the progress in bioinformatics, genomics, and epidemiology, biobanks, as repositories of populations’ biological samples as well as of personal and medical information, are becoming an essential research tool. Despite the potential benefits biobanks may bring and the options presented by some of the current biobanks’ consent policies, there remain ethical concerns regarding the autonomy and dignity of research participants if consent is not fully informed as dictated in the terms of traditional informed consent. This article aims at providing an overview of the approaches taken by the main international norms with respect to informed and broad consent and how well these norms are integrated by biobanks or biobank consortia. We conclude that broad consent could be an important tool to achieve the benefits of large-scale biobanks projects. If it is to be accepted, its regulation and implementation need to be mindful of the participant’s dignity and autonomy and sensitive to the need for international coherence and harmonization.

Keywords
Broad consent, comparative analysis of informed consent practices in international biobanks, international biobanks, international biobanks informed consent policies, international biobanks informed consent regulations

Moreno, P.G. and Joly, Y (2016) Informed consent in international normative texts and biobanking policies: Seeking the boundaries of broad consent.  Medical Law International.  7(35) https://doi.org/10.1177/0968533215626773
Publisher: https://journals.sagepub.com/doi/10.1177/0968533215626773

When medical information comes from Nazi atrocities (Papers: Susan E Mackinnon | January 2020)0

Posted by Admin in on March 10, 2020
 

The nerve surgeon Susan Mackinnon discovered that an old but precise textbook she relied on was created by a Viennese anatomist who had dissected Hitler’s victims to produce his detailed illustrations. Should we still be using the illustrations, she asks

I first met the Atlas of Topographical and Applied Human Anatomy1 in 1982, when I was 32, during my hand fellowship at the Curtis National Hand Center in Baltimore. The atlas became my dissection partner during the many long hours spent in the anatomy laboratory at Johns Hopkins Hospital and later at the University of Toronto.

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Also see:
Response to Medical information from Nazi atrocities transgresses the Nuremberg Code by Simon Gordon, Thomas Kadas, Peter Lantos and Afsana Safa

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For several years, I knew the Pernkopf atlas (named after its author, Eduard Pernkopf, chair of anatomy and president of the University of Vienna) only as a unique and valued piece of science and art. However, in the late 1980s, I came across essays by Gerald Weissman, an Austrian born US physician-scientist at New York University, and David Williams, a medical illustrator of Purdue University, Indiana, exposing the origin of my dissection partner,23 calling it the “atlas of the Shoah,” derived during the Holocaust.
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Once I, a gentile, came to know the truth of its origin, my attitude changed. I secured the atlas in my operative room locker, with printed copies of Weissman’s and Williams’s essays slipped into the atlas as a marker to anyone who might use it and a warning to “enter with caution.”
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However, having already spent many years with the atlas, still the most detailed anatomy book I’ve ever seen, I continued to feel the need to refer to it occasionally for the sake of improving my patients’ surgical outcomes. Several times a month, while operating, I would struggle with the anatomical nuances of nerve pathways. The atlas showed me the way—an exact and safe surgical approach to the …
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Mackinnon, S. E. (2020) When medical information comes from Nazi atrocities BMJ 368:l7075
Publisher: https://www.bmj.com/content/368/bmj.l7075

Australian biobank repatriates hundreds of ‘legacy’ Indigenous blood samples – Science (Dyani Lewis | December 2019)0

Posted by Admin in on January 28, 2020
 

The return is part of a groundbreaking approach that could inspire other institutions grappling with how to use historical samples ethically in research.

Last month, the Galiwin’ku community of Elcho Island off the coast of northern Australia celebrated the return of more than 200 vials of blood that were collected from their ancestors half a century ago, before modern research principles on informed consent existed. Unbeknownst to the Galiwin’ku community, the blood vials had been in freezers at the Australian National University in Canberra ever since.

It is great to see community activism and voice finally achieve an ethical outcome on a historical wrong.

Many Indigenous Australian communities believe that the remains of their people, including blood and hair, must return to their ancestral home, or Country, to be at peace. Having the blood vials returned “meant a lot to us”, says Ross Mandi Wunungmurra, chair of the Yalu Aboriginal Corporation, the community organization that helped negotiate the samples’ return. Mandi is one of several hundred living community members whose own blood was collected after a typhoid outbreak in 1968.

Before the samples of the deceased were repatriated, the relatives gave permission for DNA to be extracted from the blood, while those still alive offered fresh samples. The genetic information will be stored in the biobank of the National Centre for Indigenous Genomics (NCIG), which the Australian National University (ANU) established specifically to manage its historical samples.
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Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error (Papers: Ruth Macklin, Charles Natanson | January 2020)0

Posted by Admin in on January 7, 2020
 

Abstract
Comparative effectiveness studies, referred to here as “usual-care” trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains “unusual” care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects’ safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents.

KEYWORDS:
Human subjects research; IRB (Institutional Review Board); informed consent; risk/benefit analysis

Macklin, R. & Natanson, C. (2019) Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error. Americaan Journal of Bioethics. 20(1):31-39. doi: 10.1080/15265161.2019.1687777.
Publisher: https://www.tandfonline.com/doi/full/10.1080/15265161.2019.1687777

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