ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The Next Phase of Human Gene-Therapy Oversight – The New England Journal of Medicine (Francis S. Collins and Scott Gottlieb | August 2018)0

Posted by Admin in on October 18, 2018

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have played key roles in the emergence of safe and effective human gene therapies. Now, we are proposing new efforts to encourage further advances in this rapidly evolving field.

The potential to alter human genes directly was first recognized nearly 50 years ago, around the same time as initial groundbreaking advances were being made in recombinant DNA technology. After intense discussions regarding the ethical, legal, and social implications of this technology, conversations were initiated at the NIH that led to the establishment of the Recombinant DNA Advisory Committee (RAC) in 1974. The RAC’s mission was to advise the NIH director on research that used emerging technologies involving manipulation of nucleic acids — a mission that was eventually expanded to encompass the review and discussion of protocols for gene therapy in humans. In 1990, the FDA oversaw the first U.S. human gene-therapy trial, which involved pediatric patients with adenosine deaminase deficiency and was conducted at the NIH Clinical Center in Bethesda, Maryland.

Although no major safety concerns were initially reported, over the course of the 1990s it became evident that many questions regarding the safety and efficacy of gene therapy remained unanswered. These unknowns were brought into sharp focus in 1999 when Jesse Gelsinger died of a massive immune response during a safety trial of gene therapy for ornithine transcarbamylase deficiency.1 This tragic death led to closer scrutiny of the field, including a greater focus on open dialogue and increased regulatory oversight.

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(US) Mount Sinai multiple sclerosis researcher admits to misconduct – Retraction Watch (Ivan Oransky | May 2018)0

Posted by Admin in on October 14, 2018

A researcher who has received millions in funding from the U.S. National Institutes of Health and who runs a lab at the Icahn School of Medicine at Mount Sinai in New York has confessed to falsifying data in a 2014 paper.

Gareth John, who studies multiple sclerosis and other neurological diseases, “has expressed remorse for his actions,” according to a report released last week from the U.S. Department of Health and Human Services’ Office of Research Integrity.

John falsified data in two different figures in a 2014 paper in Development, “Combinatorial actions of Tgfβ and Activin ligands promote oligodendrocyte development and CNS myelination,” according to the report. In one figure, a Western blot, he “removed the lower set of bands, reordered the remaining bands and used those bands to represent the actin control,” among other falsifications, and in another, he cut and pasted bands “onto a blank background and used those false bands to create a graph.”

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Clinical Trials – More Blinding, Less Worry! – Statistically Funny (Hilda Bastian | August 2018)0

Posted by Admin in on October 11, 2018

She’s right to be worried! There are so many possible cracks that bias can seep through, nudging clinical trial results off course. Some of the biggest come from people knowing which comparison group a participant will be, or has been, in. Allocation concealment and blinding are strategies to reduce this risk.

Blinding and randomisation are often held up as best practice for clinical trials, but the reality is a lot less certain than many people realise and the ethical challenges aren’t trivial. We’ve included links to a long list of items reflecting on the ethics of trials.

Before we get to that, let’s look at the source of the problems we’re aiming at here: people! They bring subjectivity to the mix, even if they are committed to the trial – and not everyone who plays a role will be supportive, anyway. On top of that, randomizing people – leaving their fate to pure chance – can be the rational and absolutely vital thing to do. But it’s also “anathema to the human spirit”, so it can be awfully hard to play totally by the rules.
And we’re counting on a lot of people here, aren’t we? There are the ones who enter an individual into one of the comparison groups in the trial. There are those individual participants themselves, and the ones dealing with them during the trial – healthcare practitioners who treat them, for example. And then there are the people measuring outcomes – like looking at an x-ray and deciding if it’s showing improvement or not.

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Ethical Guidelines for Observational Studies0

Posted by Admin in on October 11, 2018

Foreword to the 2012 edition
These Guidelines were first released in 2006; the current document is a revision. The Health Committee’s inquiry into improving New Zealand’s environment to support innovation through clinical trials (June 2011) resulted in significant changes to the ethics review process, as reflected in the revised Standard Operating Procedures (SOPs) for Health and Disability Ethics Committees.

This 2012 revision aims to provide consistency with the SOPs. These Guidelines have been updated to remove process guidance, and ensure that policy previously included in the Operational Standard for Ethics Committees is now addressed by these Guidelines. The revision did not fundamentally change the existing ethical standards and principles set out in these Guidelines.

As previously, the Guidelines are directed primarily to investigators, who have the main ethical responsibility for good study conduct. But the Guidelines also continue to be directed to others with a role in health and disability research ethics – particularly the ethics committees that review studies against established ethical standards. The key objectives of developing national ethical guidelines are to…


Foreword to the 2012 edition iii
Foreword to the 2006 edition iv

1 Introduction 1

2 Guidelines scope and definitions 3
Types of observational research 3
Types of audit or related activity 4

3 Ethics of observational studies 6
Worth of observational studies 6
Ethical requirements of observational studies 6

4 Underlying ethical considerations 8
Respect for people 8
Māori and ethical considerations 8
Justice 9
Beneficence and non-maleficence 9
Integrity 10
Diversity 10
Conflict of interest 10

5 Design of study and protocol 11
Study question 11
Study design 11
Scientifically sound 11
Skills and resources 12
Protocol 12

6 Collecting health information 13
Identifiability of health information 13
Collection of health information directly from individuals 14
Collection of health information from a third party 18

7 Use of information 20

8 Confidentiality of data 21
General considerations 21
Record linkage 22

9 When to reveal information obtained by observational studies 23

10 Communicating study results 24

11 Features of observational studies that pose more than minimal risk 25

12 Additional points 27
Bibliography 28

Joint Health Research Council and NEAC guidance on features of robust peer review for assessing the scientific validity of research 30

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