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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Prominent UCSD eye doctor ‘on leave’ after inewsource investigation – inewsource (Jill Castellano & Brad Racino | April 2019)0

Posted by Admin in on May 14, 2019
 

Dr. Kang Zhang, chief of eye genetics at the University of California San Diego, is “on leave” after an inewsource investigation exposed how the doctor put medical research subjects in harm’s way for years while pulling in millions of federal dollars for the institution.

This case demonstrates why an institution’s monitoring arrangements need to escalate consistent nonadherence and include random audits

In a new development, inewsource obtained an inspection report from the U.S. Food and Drug Administration that detailed more problems with one of Zhang’s studies. The report, compiled in 2016, described one incident in which Zhang poked a hole in a study participant’s eye with a needle, causing a cataract that had to be fixed with surgery.
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The person wasn’t supposed to be enrolled in the study, according to the report, and the injury allegedly occurred because Zhang was in a hurry to take a trip to China.
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Australian Mental Health Consumer and Carer Perspectives on Ethics in Adult Mental Health Research (Papers: Alyssa R. Morse, et al | April 2019)0

Posted by Admin in on May 5, 2019
 

Abstract
Barriers to research arise when national ethical guidelines governing the inclusion of consumers in mental health research are implemented at the local level. Equivalent guidelines for research involving carers are not available. A social science investigation of Australian mental health consumer and carer perspectives on research ethics procedures was conducted in two interlinked stages: (a) a discussion forum with consumers, carers, and lived-experience researchers and (b) in-depth interviews with consumers and carers. Data collection and analysis drew strongly on methodological features of grounded theory. Privacy, confidentiality, and stigmatizing ethics procedures were key issues for consumer and carer participants. Recommendations for research practice include the following: considering the impact of information sharing on participants’ relationships and adopting individual-focused approaches to managing research risks.

Keywords:
caregiver; carer involvement; consumer involvement; mental health; research ethics; service user

Morse, A. R., Forbes, O., Jones, B. A., Gulliver, A., & Banfield, M. (2019). Australian Mental Health Consumer and Carer Perspectives on Ethics in Adult Mental Health Research. Journal of Empirical Research on Human Research Ethics. https://doi.org/10.1177/1556264619844396
Publisher: https://journals.sagepub.com/doi/abs/10.1177/1556264619844396

(US/UK) Data suggest US, UK universities fall woefully short on reporting clinical trial results – Endpoints News (Natalie Grover | March 2019)0

Posted by Admin in on April 9, 2019
 

Clinical trial data are used by patients, doctors and policymakers to make informed choices about the benefits and safety of interventions — while the methods and results of all trials are crucial to the pace and direction of scientific progress. However, there is a large body of evidence that suggests that completed clinical trials are commonly left unreported, and educational institutions in the United States and the United Kingdom — arguably the two biggest regions that breed the bulk of medical innovation — have emerged as one of the key culprits guilty of these violations.

In the United States, Congress passed a law in 2007 requiring trial sponsors — including universities — to post the results of certain clinical trials on clinicaltrials.gov within a year of trial completion, and a decade later in January 2017 the rule was finalized. Since 2017, 40 leading US universities should have posted the results of 450 clinical trials — but over a third (31%) of those results are missing, according to an analysis by Universities Allied for Essential Medicines (UAEM) in partnership with non-profit research advocacy group TranspariMED.

The violators include some of the most active trial sponsors: For example the MD Anderson Cancer Center, which has only reported 77% of due trials, Mayo Clinic (42%), UC San Francisco (37%), New York University (21%), and Columbia University (17%).

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Publish and Perish: The Dangers of Being Young and in a Hurry (Papers: James S. Huntley | February 2019)0

Posted by Admin in on April 5, 2019
 

Abstract

Publications in peer-reviewed journals are a key and official requirement for progression to a consultant surgeon post. Paradoxically, a stipulation that should enhance the importance of surgical research may, in fact, contribute to a pressure that is one of the causes of research misconduct. Consultant trainers can go some way to mitigating against this danger with appropriate teaching and an emphasis on the core values surrounding research ethics.

Huntley J S (February 19, 2019) Publish and Perish: The Dangers of Being Young and in a Hurry. Cureus 11(2): e4098. doi:10.7759/cureus.4098
Publisher (Editorial): https://www.cureus.com/articles/17575-publish-and-perish-the-dangers-of-being-young-and-in-a-hurry

This paper about early career researchers in the surgical field make points that hold true across most (sub)disciplines. It points to the importance of having collegiate Research Integrity Advisers, mentors and resources that support practice (rather than just state the rules).  AHRECS would be delighted to assist your institution with that – https://ahrecs.com/our-services.  We’ve included links to 19 great tips for early career researchers and institutions.

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