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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Fraud by bone researcher takes down two meta-analyses, a clinical trial, and review – Retraction Watch (Victoria Stern | April 2017)0

Posted by Admin in on April 20, 2017
 

The troubles continue for a bone researcher, who’s lost multiple papers in recent months due to problems ranging from data issues to including authors without their consent.

Now, journals have retracted two more papers by Yoshihiro Sato. And in a sign of the downstream effects that fraud can have, another journal has retracted two meta-analyses by other authors that cited his work.

Earlier this month, the journal Current Medical Research and Opinion retracted the two meta-analyses because they were based on recently retracted papers by Sato, affiliated with Mitate Hospital. The two new retractions of Sato’s papers are a review and a randomized controlled trial.

Read the rest of this news story

Time to publication for publicly funded clinical trials in Australia: an observational study (Papers: Linn Beate Strand, et al | 2017)0

Posted by Admin in on April 16, 2017
 

Abstract

Objective
To examine the length of time between receiving funding and publishing the protocol and main paper for randomised controlled trials.

Design
An observational study using survival analysis.

Setting
Publicly funded health and medical research in Australia.

Participants
Randomised controlled trials funded by the National Health and Medical Research Council of Australia between 2008 and 2010.

Main outcome measures
Time from funding to the protocol paper and main results paper. Multiple variable survival models examining whether study characteristics predicted publication times.

Results
We found 77 studies with a total funding of $A59 million. The median time to publication of the protocol paper was 6.4 years after funding (95% CI 4.1 to 8.1). The proportion with a published protocol paper 8 years after funding was 0.61 (95% CI 0.48 to 0.74). The median time to publication of the main results paper was 7.1 years after funding (95% CI 6.3 to 7.6). The proportion with a published main results paper 8 years after funding was 0.72 (95% CI 0.56 to 0.87). The HRs for how study characteristics might influence timing were generally close to one with narrow CIs, the notable exception was that a longer study length lengthened the time to the main paper (HR=0.62 per extra study year, 95% CI 0.43 to 0.89).

Conclusions
Despite the widespread registration of clinical trials, there remain serious concerns of trial results not being published or being published with a long delay. We have found that these same concerns apply to protocol papers, which should be publishable soon after funding. Funding agencies could set a target of publishing the protocol paper within 18 months of funding.

Strand LB, Clarke P, Graves N, et al Time to publication for publicly funded clinical trials in Australia: an observational study. BMJ Open 2017;7:e012212. doi: 10.1136/bmjopen-2016-012212
Publisher (open access): http://bmjopen.bmj.com/content/7/3/e012212.info

With publically funded research there is not an unreasonable expectation that there should be a public good from the funded research. The reported outcome of a clinical trial is one way in which the public benefits. The delays reported by this paper does beg five questions: (i) what are the reasons (if any) for the delay; (ii) should the research office where the chief investigator is based monitor and chase to ensure the outcome is published; (iii) is the lack of, or delayed, outputs an ethical issue; (iv) do funding bodies have a role to play here; (v) Given the often high price of journal subscriptions should the outcomes of publically funded research be made widely available using open access publications?

Casebook on Ethical Issues in International Health Research (Books: WHO | 2009)0

Posted by Admin in on April 4, 2017
 

This publication is the outcome of a project of the Secretariat of the Research Ethics Review Committee of the World Health Organization in partnership with the University of Geneva, and with the support of the Réseau universitaire international de Genève/Geneva International Academic Network (RUIG/GIAN).

This casebook collects 64 case studies, each of which raises an important and difficult ethical issue connected with planning, reviewing, or conducting health-related research. The book’s purpose is to contribute to thoughtful analysis of these issues by researchers and members of research ethics committees (RECs, known in some places as ethical review committees or institutional review boards), particularly those involved with studies that are conducted or sponsored internationally.

This collection is envisioned principally as a tool to aid educational programmes, from short workshops on research ethics to in-service learning for scientists and REC members, to formal degree or certificate courses. In such settings, instructors will typically select a number of case studies that will be distributed to the participants to provoke and focus discussion. (To assist those using these case studies in their classrooms and workshops, a teaching guide has been included.) Individuals who want to stimulate their own thinking about research ethics or to become more familiar with a range of real-world dilemmas in international health research, especially in developing countries, may also benefit from perusing this book, either on topics of special interest to them or as a whole

WHO (2009). Casebook on Ethical Issues in International Research.
Free download: http://www.who.int/rpc/publications/ethics_casebook/en/

Responsibilities in international research: a new look revisited (Papers: Solomon R Benatar & Peter A Singer | 2010)0

Posted by Admin in on March 30, 2017
 

Following promulgation of the Nuremberg code in 1947, the ethics of research on human subjects has been a challenging and often contentious topic of debate. Escalation in the use of research participants in low-income countries over recent decades (stimulated by the HIV pandemic and the need to carry out clinical trials expeditiously on large numbers of patients), has intensified the debate on the ethics of international research and led to increasing attention both to exploitation of vulnerable subjects and to considerations of how the 10:90 gap in health and medical research (ie, 90% of resources being spent on 10% of the problems) could be narrowed.

In 2000, prompted by the discussions over several years that led to the US NIH launching a capacity building programme on research ethics for members of research ethics committees in developing countries, we advanced a ‘new look’ for the ethics of international research.1 Since then progress has been made on several fronts.

First, our ideas—considered somewhat radical and impractical at the time—have been provocatively addressed by scholars who have either contested them or advanced similar conceptions of what obligations international researchers have to research participants and communities in low income countries before, during and after clinical trials. Second, those researchers who have been sympathetic to our ideas have either endeavoured to put these into practice or have investigated the feasibility of doing so. Third, the intractability of the 10/90 gap and the escalation of interest in global health have sensitised many to the need to amplify the uptake of these ideas in practice

Benatar SR, Singer PA (2010). Responsibilities in international research: a new look revisited. Journal of Medical Ethics 36(4) pp:194-197
Publisher: (Open Access here) http://jme.bmj.com/content/36/4/194.full

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