We have located links that may give you full text access.
Multi-Centre Ethics and Research Governance Review Can Impede Non-Interventional Clinical Research.
Internal Medicine Journal 2018 November 13
BACKGROUND: The Inter-jurisdictional National Mutual Acceptance (NMA) scheme for Human Research Ethics Committee (HREC) approvals of human research is designed to reduce the reported delays and costs of ethical review. Introduction of the NMA set forth an uncoupling of the ethics and governance review processes, permitting a single ethical review for multiple sites, whilst continuing separate governance review for each centre covering financial and operational aspects of the research project.
AIM: Compare the time required to gain ethics and governance approvals in Australia for a non-interventional investigator-led study from December 2015, to approval times for an earlier pre-NMA study utilising a similar study design and study sites, and evaluate the effect that the NMA has had on total approval time for non-interventional multi-centre projects.
METHODS: We recorded the time taken to obtain ethics and governance approval at 16 sites for our nationwide low-risk non-interventional study looking at the prevalence and aetiology of non-tuberculous mycobacterial infection in people with cystic fibrosis (CF) in Australia.
RESULTS: Applications were submitted to three hospital and one university HREC to conduct our study at 16 hospital sites, HREC approval took from 16 - 79 days (median 28). Subsequent site-specific governance approval at 15 hospital sites took 23 - 225 days (median 83). The entire process of gaining ethical and governance approval to conduct the study at 16 sites took 24 months at an estimated cost of $AUD56000 ($USD 42000).
CONCLUSIONS: Lengthy governance approval processes negate benefits gained from centralised ethics review under the NMA. This article is protected by copyright. All rights reserved.
AIM: Compare the time required to gain ethics and governance approvals in Australia for a non-interventional investigator-led study from December 2015, to approval times for an earlier pre-NMA study utilising a similar study design and study sites, and evaluate the effect that the NMA has had on total approval time for non-interventional multi-centre projects.
METHODS: We recorded the time taken to obtain ethics and governance approval at 16 sites for our nationwide low-risk non-interventional study looking at the prevalence and aetiology of non-tuberculous mycobacterial infection in people with cystic fibrosis (CF) in Australia.
RESULTS: Applications were submitted to three hospital and one university HREC to conduct our study at 16 hospital sites, HREC approval took from 16 - 79 days (median 28). Subsequent site-specific governance approval at 15 hospital sites took 23 - 225 days (median 83). The entire process of gaining ethical and governance approval to conduct the study at 16 sites took 24 months at an estimated cost of $AUD56000 ($USD 42000).
CONCLUSIONS: Lengthy governance approval processes negate benefits gained from centralised ethics review under the NMA. This article is protected by copyright. All rights reserved.
Full text links
Related Resources
Trending Papers
Challenges in Septic Shock: From New Hemodynamics to Blood Purification Therapies.Journal of Personalized Medicine 2024 Februrary 4
Molecular Targets of Novel Therapeutics for Diabetic Kidney Disease: A New Era of Nephroprotection.International Journal of Molecular Sciences 2024 April 4
The 'Ten Commandments' for the 2023 European Society of Cardiology guidelines for the management of endocarditis.European Heart Journal 2024 April 18
A Guide to the Use of Vasopressors and Inotropes for Patients in Shock.Journal of Intensive Care Medicine 2024 April 14
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app