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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Disgraced tracheal transplant surgeon is handed 16 month prison sentence in Italy (Papers: Michael Day | November 2019)0

Posted by Admin in on December 5, 2019
 

Disgraced surgeon Paolo Macchiarini, who faked research relating to dangerous and largely discredited tracheal transplants, has been handed a 16 month prison sentence in Italy for forging documents and abuse of office.

Macchiarini made headlines around the world after claiming a major breakthrough for patients with failing windpipes, by “seeding” an artificial scaffold with a patient’s own stem cells, to generate a functioning trachea.

But excitement at the prospect of a genuine medical advance turned to scandal when it emerged that Macchiarini had falsified results and misled hospital authorities regarding the health of those receiving the experimental procedures. The revelation prompted his research centre, the Karolinska Institute, to eventually disown his …

Day, M. (2019) Disgraced tracheal transplant surgeon is handed 16 month prison sentence in Italy. BMJ. 367:l6676. doi: 10.1136/bmj.l6676. No abstract available. PMID: 31767600
Publisher: https://www.bmj.com/content/367/bmj.l6676

What’s the Harm? The Coverage of Ethics and Harm Avoidance in Research Methods Textbooks (Papers: Shane Dixon and Linda Quirke | June 2017)0

Posted by Admin in on December 3, 2019
 

Abstract
Methods textbooks play a role in socializing a new generation of researchers about ethical research. How do undergraduate social research methods textbooks portray harm, its prevalence, and ways to mitigate harm to participants? We conducted a content analysis of ethics chapters in the 18 highest-selling undergraduate textbooks used in sociology research methods courses in the United States and Canada in 2013. We found that experiments are portrayed as the research design most likely to harm participants. Textbooks overwhelmingly referred to high-profile, well-known examples of harmful research. Chapters primarily characterize participants as at risk for psychological and physical harm. Textbooks engage in detailed discussions of how to avoid harm; informed consent figures prominently as an essential way to mitigate risk of harm. We conclude that textbooks promote a procedural rather than nuanced approach to ethics and that content in ethics chapters is out of step with scholarly research in research ethics.

Keywords
ethics, research methods, textbooks, harm, participants

Dixon, S., & Quirke, L. (2018). What’s the Harm? The Coverage of Ethics and Harm Avoidance in Research Methods Textbooks. Teaching Sociology, 46(1), 12–24. https://doi.org/10.1177/0092055X17711230
Publisher (Open Access): https://journals.sagepub.com/doi/10.1177/0092055X17711230

Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking (Papers: Tristan McCaughey, et al | 2016)0

Posted by Admin in on December 1, 2019
 

Abstract
The ability to generate human induced pluripotent stem cells (iPSCs) has opened new avenues for human disease modelling and therapy. The aim of our study was to determine research participants’ understanding of the information given when donating skin biopsies for the generation of patient-specific iPSCs. A customised 35-item questionnaire based on previous iPSC consent guidelines was sent to participants who had previously donated samples for iPSC research. The questionnaire asked pertinent demographic details, participants’ motivation to take part in iPSC research and their attitudes towards related ethical issues. 234 participants were contacted with 141 (60.3 %) complete responses received. The median duration between recruitment and follow-up questioning was 313 days (range 10–573 days). The majority of participants (n = 129, 91.5 %) believed they understood what a stem cell was; however, only 22 (16.1 %) correctly answered questions related to basic stem cell properties. We found no statistically significant difference in responses from participants with different levels of education, or those with a health sciences background. The poor understanding amongst participants of iPSC research is unlikely to be unique to our study and may impact future research if not improved. As such, there is a need to develop an easily understood yet comprehensive consent process to ensure ongoing ethical progress of iPSC biobanking.

Keywords
Stem cell, Informed consent, HeLa, Biobank

McCaughey T., Chen C.Y., De Smit E., Rees G., Fenwick E., Kearns L.S., Mackey D.A., MacGregor C., Munsie M., Cook A.L., Pébay A. & Hewitt A.W. (2016) Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking. Cell and Tissue Banking. 17: 449. https://doi.org/10.1007/s10561-016-9563-8
Publisher: https://link.springer.com/article/10.1007%2Fs10561-016-9563-8

Breakthrough Gene Therapy Clinical Trial is the World’s First That Aims to Reverse 20 Years of Aging in Humans – CISION (Osvaldo R. Martinez-Clark | November 2019)0

Posted by Admin in on November 28, 2019
 

This is the world’s first IRB-approved clinical trial aimed at reversing aging by at least 20 years; it is also the world’s most expensive pay-to-play trial with a one million price tag to enroll.

This isn’t a human research ethics vignette/scenario, but could very easily be used as the basis for a discussion with researchers, research ethics reviewers, research ethics advisers, or research office staff about:
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  1. Pay-to-play clinical trials
  2. Appropriate recruitment materials
  3. The use of ethics approval as a sales tool
  4. The conduct of trials in another country

MANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ — Libella Gene Therapeutics, LLC (“Libella”) announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world’s only treatment to cure and reverse aging by 20 years.
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Under Libella’s pay-to-play model, trial participants will be enrolled in their country of origin after paying $1 million. Participants will travel to Colombia to sign their informed consent and to receive the Libella gene therapy under a strictly controlled hospital environment.
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Traditionally, aging has been viewed as a natural process. This view has shifted, and now scientists believe that aging should be seen as a disease. The research in this field has led to the belief that the kingpin of aging in humans is the shortening of our telomeres.
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Telomeres are the body’s biological clock. Every time a cell divides, telomeres shorten, and our cells become less efficient at dividing again. This is why we age. A significant number of scientific peer-reviewed studies have confirmed this. Some of these studies have shown actual age reversal in every way imaginable simply by lengthening telomeres.
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