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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(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.
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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…

Contents

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

Appendix:
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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What information and the extent of information research participants need in informed consent forms: a multi-country survey (Juntra Karbwang, et al | 2018)0

Posted by Admin in on October 7, 2018
 

Abstract

Background
The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research.

Methods
This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).

Results
Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be ‘moderately important’ to ‘very important’ for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).

Conclusions
Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.

Keywords
Consent forms, Informed consent, Disclosure, Information, Ethics, Research subjects

Karbwang, J., et al. (2018). “What information and the extent of information research participants need in informed consent forms: a multi-country survey.” BMC Medical Ethics 19(1): 79.
Publisher (Open Access): https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0318-x#Decs

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