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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

(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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How about personally optimized treatment? – The Ethics Blog (Pär Segerdahl | March 2019)0

Posted by Admin in on December 31, 2019
 

It is well known that patients who are asked to participate in cancer trials are tempted by the therapeutic misconception. They believe they are offered a newer and better treatment, when in fact it is about research into an untested treatment. When researchers use genetic tests to develop personalized oncology, even more misconceptions can arise. I will soon explain. But first, what is personalized cancer treatment? Here is an example.

Patients whose tumor is to be operated may undergo preparatory radiation or chemotherapy. Since the preparatory therapy has severe side effects, one wants to avoid giving it to patients whose tumors do not respond to it. The challenge is to distinguish patients who respond to treatment from patients who do not. This is to be accomplished through, among other things, genetic tests on the tumor cells. If this works, you can develop personalized cancer treatment. Patients with the “right” tumor cell genetics receive the preparatory therapy, while patients who, according to the genetic tests, only get the side effects, with no effect on tumor growth, do not receive the therapy.

What are the misconceptions that can arise in patients who are asked to participate in research on personalized cancer treatment? Here are some examples.

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(Europe) Psychology researcher committed misconduct, says university – Retraction Watch (Adam Marcus | December 2019)0

Posted by Admin in on December 24, 2019
 

A Dutch university has found a former psychology researcher at the institution guilty of misconduct for several offenses, including lack of ethics approval for some of her studies and fabricating results in grant applications.

In a Nov. 11, 2019, report, officials at the University of Leiden stated that the researcher, whom it does not identify, violated academic integrity in the following ways:

(1) research with blood samples taken from test subjects without the approval of the Medical Ethical Committee (METC), (2) negligence in listing co-authors, (3) data manipulation, and (4) submitting grant applications with incorrect (incomplete and manipulated) research data. 

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