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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The high costs of getting ethical and site-specific approvals for multi-centre research (Papers: Adrian G. Barnett, et al | 2016)0

Posted by Admin in on December 22, 2016
 

Abstract

Background
Multi-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.

Methods
We collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.

Results
The total costs of gaining approval were 38 % of the budget for a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety.

Conclusions
Improvements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked.

Keywords
Research ethics Ethical review Multi-centre study Australia

Barnett A, Campbell M, Shield C, Farrington A, Hall L, Page K, Gardner A, Mitchell B, Graves N (2016) The high costs of getting ethical and site-specific approvals for multi-centre research. Research Integrity and Peer Review. 1(16)
Publisher (Open Access): http://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-016-0023-6#Abs1

Caring for Data: Law, Professional Codes and the Negotiation of Confidentiality in Australian Criminological Research. Report for the Criminology Research Council (Australia) (Papers: Robert Chalmers and Mark Israel | 20050

Posted by Admin in on December 18, 2016
 

Summary

In this report, we offer guidance to criminologists attempting to navigate, and manage the impact of, laws that relate to the protection and disclosure of confidential and personal information that they gather in the course of their research.

We start by providing examples of the impact of relevant laws on the practice of criminologists to set this work in it proper context, and then provide a general overview of laws relating to issues such as privacy, confidentiality and compelled disclosure. Drawing on this background, Section Three provides brief responses to Frequently Asked Questions covering the ways researchers gather, store, use, disclose and reuse information. We conclude by examining possible future developments.

Throughout the report we attempt to illustrate how the practice of criminological research practically intersects with relevant laws. This intersection can be painful as relevant laws are by no means tailored to suit the environment of such research. However, our aim is to help criminologists and their institutions reach better informed decisions about management of legal risks although, of course, this report is not a substitute for specific advice.

Chalmers, R & Israel, M (2005) Caring for Data: Law, Professional Codes and the Negotiation of Confidentiality in Australian Criminological Research. Report for the Criminology Research Council (Australia). 57 pages. http://crg.aic.gov.au/reports/200304-09.pdf

500+ Resources – Part Three of Nominations of best resources0

Posted by Admin in on December 12, 2016
 

This third nomination of favourite resources is from one of the AHRECS  senior consultants Associate Professor Martin Tolich. This week we’re going to be sharing some more nominations of people’s nomination of favourite resources? Got your own favourite? Drop us a line to gary.allen@ahrecs.com with your suggestion.

Extremism is a research ethics minefield | AHRECS Resource Library entry

Researchers work through sensitive topics when researching children and death thinking they have advanced along the continuum reaching the third untouchable rail. In the United States Social Security is the untouchable third rail that politicians will not touch. In Canada no government dares to touch health care. In research ethic committees their third rail is death. Their resistance to permitting researchers to engage the bereaved in research, working from the self-fulfilling prophecy that any study investigating the vulnerability of the bereaved is undermined by the participants’ acute vulnerability. What the Norwegian article demonstrates is there are other third rails along the continuum. In Extremism is a research ethics minefield” the resource expands what there is to know about research ethics.

An Argument for Fewer Clinical Trials (Papers: Kirstin Borgerson 2016)0

Posted by Admin in on December 11, 2016
 

Abstract

The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I consider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible.

The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated.

Borgerson K (2016) “An Argument for Fewer Clinical Trials,” Hastings Center Report 46 1–11. DOI: 10.1002/hast.637
Publisher: http://onlinelibrary.wiley.com/doi/10.1002/hast.637/full

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