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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(China/Gene) Chinese scientist who produced genetically altered babies sentenced to 3 years in jail – Science (Dennis Normile | December 2019)0

Posted by Admin in on January 5, 2020
 

He Jiankui, the Chinese researcher who stunned the world last year by announcing he had helped produce genetically edited babies, has been found guilty of conducting “illegal medical practices” and sentenced to 3 years in prison.

Given the degree of recklessness and premeditation, the lifetime health effects and that the genetic modifications are inheritable, some may feel an even harsher sentence would have been warranted.  Nevertheless, it is welcome to see the Chinese court impose large fines and prison sentences.

A court in Shenzhen found that He and two collaborators forged ethical review documents and misled doctors into unknowingly implanting gene-edited embryos into two women, according to Xinhua, China’s state-run press agency. One mother gave birth to twin girls in November 2018; it has not been made clear when the third baby was born. The court ruled that the three defendants had deliberately violated national regulations on biomedical research and medical ethics, and rashly applied gene-editing technology to human reproductive medicine.
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All three pleaded guilty, according to Xinhua. The court also fined He, formerly of the Southern University of Science and Technology (SUSTech) and known as JK to friends and colleagues, 3 million Chinese yuan ($429,000). His collaborators were identified as Zhang Renli, of a medical institution in Guangdong province, and Qin Jinzhou, from a Shenzhen medical institution; Zhang received a 2-year prison sentence and was fined 1 million yuan, according to Xinhua, whereas Qin was given 18 months in prison with a 2-year reprieve, and a 500,000 yuan fine.
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Read the rest of this news  story

Sample and data sharing barriers in biobanking: consent, committees, and compromises (Paper: Flora Colledge MA, et al | December 2013)0

Posted by Admin in on January 2, 2020
 

Abstract

The discussion in this paper is not particularly new or surprising but it does highlight yet again that HRECs can often be out of touch with donors wishes.  We have included links to ten other papers on consent and biobanking.

The ability to exchange samples and data is crucial for the rapidly growth of biobanking. However, sharing is based on the assumption that the donor has given consent to a given use of her or his sample. Biobanking stakeholders, therefore, must choose 1 of 3 options: obtain general consent enabling multiple future uses before taking a sample from the donor, try to obtain consent again before sharing a previously obtained sample, or look for a legally endorsed way to share a sample without the donor’s consent. In this study, we present the results of 36 semistructured qualitative interviews with Swiss biobanking stakeholders regarding these options and the role of ethics committees in the process of authorizing sharing. Our results show that despite a lack of legal or guideline-based barriers to general consent, some stakeholders and ethics committees have reservations about this method of consent. In most cases, however, a general consent form is already in use. Many interviewees describe processes involving the ethics committees as time-consuming and cumbersome and their requirements as too demanding for donors/patients. Greater awareness of donors’ opinions and preferences and the content of guidelines and recommendations could therefore be helpful for a better justified perspective of biobanking stakeholders and ethical committee members, equally. Finally, it may be necessary to differentiate between procedures governing future samples, where general consent is clearly desirable, and the use of old yet still relevant samples, where the option of using them without consent can be highly beneficial for research.
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Keywords
Biobank, Informed consent, Ethics committee, Data sharing, Sample sharing

Colledge F, Persson K, Elger B, Shaw D. (2014) Sample and data sharing barriers in biobanking: consent, committees, and compromises. Annals of Diagnostic Pathology 18:78-81
Publisher: https://www.sciencedirect.com/science/article/abs/pii/S1092913413001524?via%3Dihub

Holiday funny – New Years resolutions for your research ethics committee0

Posted by Admin in on December 31, 2019
 

Cartoon by Don Mayne www.researchcartoons.com
Full-size image for printing (right mouse click and save file)

Anyone who has served on, supported or observed meetings of research ethics committees will recognise these unhelpful behaviours.  The full-sized version might be a fun and cheeky cover page for your first meeting in the New Year.  Send an email to enquiry@ahrecs.com if you would like to discuss coaching or professional development for your research ethics committee.  This can be done remotely via video link.

International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials (Papers: Tanya J. Symons, et al | November 2019)0

Posted by Admin in on December 17, 2019
 

Abstract

There is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise.

This article examines whether international ethical guidelines and the policy frameworks in three countries—the United States, England, and Australia—permit altered and waived consent for minimal-risk pragmatic trials conducted outside the emergency setting. Provisions for both are clearly articulated in U.S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible.

The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent.

Symons, T.J., Zeps, N., Myles, P.S., Morris, J.M. & Sessler, D.I. (2019) International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials. Anesthesiology 2020;132(1):44-54. doi: https://doi.org/10.1097/ALN.0000000000003020.
Publisher: https://anesthesiology.pubs.asahq.org/article.aspx?articleid=2756350

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