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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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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Why research ethics should add retrospective review (Papers: Angus Dawson, et al | October 2019)0

Posted by Admin in on October 26, 2019
 

Abstract
Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a ‘tick box’ exercise to get over the ‘hurdle’ of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people’s capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project’s ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others’ perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion.

Dawson, A., Lignou, S., Siriwardhana, C. and O’Mathúna, D.P. (2019) Why research ethics should add retrospective review. BMC Medical Ethics 20: 68
Publisher (Open Access): https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-019-0399-1

(Australia) Unauthorised survey asked students to rate Chinese people out of seven – Sydney Morning Herald (Nick Bonyhady | September 2019)0

Posted by Admin in on October 13, 2019
 

An unauthorised survey delivered to students at the University of Sydney under the university’s official logo asked them to rate the attractiveness and intelligence of Chinese people out of seven.

It is interesting this story doesn’t mention the National Statement (2007 updated 2018), the Australian Code (2018) or research misconduct though this may be encapsulated by the reference to suspension and investigation. The reported questions raise concerns as to the merit of the work, respect, justice and the troubling spectre of the alt-right.

The survey was delivered by both paid and volunteer pollsters to students voting in student representative council elections at the university this week. It claimed to be “approved in principle by the University of Sydney’s ethics committee” and “endorsed by the political science department.”
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A University of Sydney spokeswoman said the university had “very strong concerns” about the content of the survey, which it was not aware of until contacted by the Herald on Wednesday, and how it was delivered.
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“An initial inquiry indicates ethics approval was not obtained for the study and our logo has been used without permission,” the spokeswoman said. “We are formally contacting the staff and student involved today to advise them the matter may be subject to disciplinary proceedings.”
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Payment of participants in research: information for researchers, HRECs and other ethics review bodies (NHMRC | September 2019)0

Posted by Admin in on October 3, 2019
 

Purpose and scope
This document is designed to provide information for researchers and reviewers of research to assist in decision-making about when payment of participants in research is ethically acceptable.

The approach taken in this document rests on the assumption that participation in research is desirable and a benefit to both the scientific community and the community at-large. This information also takes into account three core ethical principles of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) (National Statement): respect, beneficence and justice. Respect requires recognition that participation in research is voluntary and based on sufficient information about, and an adequate understanding of, both the proposed research and the implications of participating in it. Beneficence requires that the potential benefits of the research must justify the risks of participation. Justice requires that the benefits and burdens of research must be shared equitably and that opportunities for participation in research not be unjustly denied to those who are eligible for participation.

The payment models and options presented in this document are intended to reflect what may be reasonable and justifiable in the context of a specific research project, not what is required or expected. It remains the remit of Human Research Ethics Committees (HRECs) and other ethics review bodies to determine whether, for each research project, payment is ethically appropriate and, if so, whether the type/s and amount/s of payment proposed are optimal or acceptable.

The information in this document is not intended to replace or override guidance provided in the National Statement and should be understood as providing additional information to assist those designing and reviewing human research.

Contents

Purpose and scope 1

Explanation of key terms 1

Guidance statements 2

Context and explanation 3

Considerations for researchers and reviewers 5

Resources 6

Appendix 1: Examples of payment models 7

Appendix 2: Case studies 8

Access the guidance document

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