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ResourcesHuman Research EthicsIs Research Ethics Committee review of most clinical trials fundamentally broken? – BMJ Blog (Mark Yarborough | June 2020)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Is Research Ethics Committee review of most clinical trials fundamentally broken? – BMJ Blog (Mark Yarborough | June 2020)

 


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Imagine that you suffered from a fatal neurodegenerative disorder like Alzheimers or ALS, or that you had a serious chronic condition like hypertension or heart disease. Imagine further that you were asked to participate in a clinical trial related to your disease. Finally, imagine that the person recruiting you into the trial reassured you that the study had been vetted by a research ethics committee (REC) tasked with protecting your welfare, rights, and interests.

For more than a century combined, we have chaired, served on, supported, written about and consulted on/for research ethics committees.  And we have served on NHMRC committees.  So it will not come as a complete surprise that we don’t entirely agree with this provocative piece.  But it does raise issues worthy of sober and informed discussion.

 

Of course, countless people in these exact same circumstances routinely get recruited into REC-approved trials. While many or perhaps even most of them may have never heard of RECs and the role they play in clinical research, they nevertheless are likely to implicitly trust that the trials they are being recruited into are both important and ethical to conduct. Such trust should be warranted since that is what REC approval is meant to certify.
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But does REC approval reliably certify this? I suspect that many readers of this journal believe that they do and thus rarely if ever truly ponder the question. I know this used to be true for me, in large part due to my own personal experiences working on RECs and seeing the hard work and dedication of committee members and staff. Today, though, I am convinced that the question is one of the most central ones there is in research ethics. After all, the trustworthiness of the clinical research endeavour is in large part a direct outcome of the strength of the accountability measures in place to support it and REC review is at the heart of those accountability measures.

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