The unethical waste of research dollars

Applying for ethics approval cost Adrian Barnett's research group $348,000 in staff time, and delayed the research by six months.

18 January 2017

COMMENT

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For researchers, gaining ethics approval has become mired in bureaucracy.

Since the Nuremberg Code was drafted after the second world war as a guiding set of principles for research involving human participants, ethics have underpinned health and medical research. But, gaining ethics approval has become so mired in bureaucracy that hundreds of thousands of valuable research funding dollars are being wasted in box-ticking exercises that could be more efficient.

Last month my colleagues and I calculated how much time and money we had spent gaining ethics approval for two large studies that aimed to reduce infections in Australian hospitals. Because we recruited multiple hospitals for these studies, we were required to gain ethics approval from all the local ethics review committees to demonstrate that the studies met national standards.

One study recruited fifty hospitals, which meant applying to more than 50 committees. The process cost us a whopping $348,000 in staff time, or 38% of our study’s budget. The second study recruited 11 hospitals and cost less, partly because we were more prepared, but for both studies the time needed to get the approvals delayed the research by six months.

It is common in medical research for studies to run at multiple sites across the country because to study an uncommon disease, for example, we may need to work with doctors from many hospitals to recruit enough patients.

But each site has its own set-up and running costs, local ethics approval is one among many. While this is a vital step, and researchers are trained in ethical procedures and have a personal responsibility to ensure their studies are equitable and safe, the process involves multiple detailed forms and scrutiny from an experienced ethical review committee.

When it comes to studies involving multiple centres the approval process is unnecessarily repetitive. Once one committee has decided that a study is ethical, does it really need to be re-approved by another? The issue is that ethics committees have no incentive to reduce costs for applicants as they are focused on minimising their own risks.

If you multiply the time and money we spent gaining ethics approval for our study by the hundreds other groups doing multi-centre studies, it is not hard to imagine that millions of dollars is being wasted. This duplicated approval doesn't make study participants safer.

But it also is wasteful to have so many researchers spending their time on repetitive forms. They would much rather be doing more valuable work, and I’m sure the public would agree, especially as their tax dollars and philanthropic donations provide much of the funds.

To reduce the burden of ethical review committees, national statistics on review times should be introduced. This would identify committees that take significantly longer than others, and encourage them to become more efficient.

Dr Adrian Barnett is a statistician who works in meta-research at the Queensland University of Technology, Brisbane. He tweets @aidybarnett