Title

The High Costs of Getting Ethical and Site-Specific Approvals for Multi-Centre Research

Document Type

Article

Publication Date

12-2016

Publication Details

This article was originally published as:

Barnett, A. G., Campbell, M. J., Shield, C., Farrington, A., Hall, L., …Graves, N. (2016). The highs costs of getting ethical and site-specific approvals for multi-centre research. Research Integrity and Peer Review, 116. doi:10.1186/s41073-016-0023-6

ISSN: 2058-8615

ANZSRC / FoR Code

060502 Infectious Agents| 111799 Public Health and Health Services not elsewhere classified| 220106 Medical Ethics| 220107 Professional Ethics (incl. police and research ethics)

Reportable Items

C1

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.

Comments

Used by permission: the authors

© The Author(s). 2016 This article is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.