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

Improving the process of research ethics review (Papers: Stacey A. Page and Jeffrey Nyeboer | 2017)0

Posted by Admin in on September 14, 2017
 

Abstract

Background
Research Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met.

Main body
Concurrent with the growing volume of human participant research, the workload and responsibilities of Research Ethics Boards (REBs) have continued to increase. Dissatisfaction with the review process, particularly the time interval from submission to decision, is common within the research community, but there has been little systematic effort to examine REB processes that may contribute to inefficiencies. We offer a model illustrating REB workflow, stakeholders, and accountabilities.

Conclusion
Better understanding of the components of the research ethics review will allow performance targets to be set, problems identified, and solutions developed, ultimately improving the process.

Keywords
Research ethics, Research Ethics Boards, Research Ethics Committees, Medical research, Applied ethics, Institutional Review Boards

Page SA and Nyeboer J (2017) Improving the process of research ethics review Research Integrity and Peer Review 2(1) 14.
Publisher (Open access): https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-017-0038-7

(Australian case) Authors withdraw study, citing “accidentally duplicated” images – Retraction Watch (Victoria Stern | September 2017)0

Posted by Admin in on September 13, 2017
 

Researchers in Australia have withdrawn a 2006 paper in The Journal of Biological Chemistry (JBC), citing image duplication.

In the withdrawal notice, published July 14, 2017, the authors claim that the “errors do not impact the underlying scientific findings of the article.”

Although the notice does not mention an investigation, a comment on PubPeer on March 2017—signed by Mark Hargreaves, the vice-chancellor at the University of Melbourne—indicates that the university conducted an investigation to assess the issues in the paper and determined that research misconduct “did not occur.”

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Friday afternoon’s funny – Medical devices0

Posted by Admin in on September 8, 2017
 

Cartoon by Don Mayne www.researchcartoons.com

The issue we are most familiar with is when it comes to the end of a clinical trial will participants still have access to the trialled drug when the trial concludes (I know well a heart-wrenching story of a family who lost access to a life saving treatment). Device-based trials raise completely different questions: Can it/should it be removed? If so, what are the risks and who pays? But if not, who monitors and services the device? And who pays for that?

NIH Blood Transfusion Trial’s Ethics Questioned – MedPage Today (Larry Husten | August 2017)0

Posted by Admin in on September 3, 2017
 

Public Citizen demands halt to study comparing transfusion strategies after MI

Public Citizen is calling for the immediate suspension of a large NIH-sponsored trial comparing blood transfusion strategies after heart attacks. The Myocardial Ischemia and Transfusion (MINT) trial should be halted “because of potentially serious ethical violations,” said the consumer advocacy group in a letter sent to the Office for Human Research Protections and the VA’s Office of Research Oversight.

The MINT trial started earlier this year in April and is expected to be completed in 2021. The trial plan calls for 3,500 hospital patients with acute MI who have blood counts below 10 g/dL to be randomized to either a liberal or restrictive transfusion strategy with red blood cells. The primary endpoint is the composite outcome of all-cause mortality or nonfatal MI at 30 days.

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