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How well do institutional review boards work at protecting patient’s rights?

Posted Feb 02 2011 9:49pm

One factor that struck me in the interview that Brian Deer gave recently was the fact that until rather recently, he would have had no method to obtain the ethics committee (in the US institutional review board or IRB) information on Andrew Wakefield’s research. The IRB was internal to the hospital. Without the Freedom of Information Act, he may never have gotten access to these records.

He [Andrew Wakefield] could never have expected when he was doing this research that all of a sudden his funding would be exposed to scrutiny, and also the Ethics Committee. In America called Institutional Review Boards. Bodies of doctors, scientists, others associated with medical centers which give permission for research to take place. The paperwork of that body of the Royal Free Hospital also moved into the public domain by the Freedom of Information Act. I think I was the first person ever to get hold of these kinds of papers.

Andrew Wakefield clearly didn’t take ethics approval seriously. He started his program before the ethics approvals were in place. When asked to explain why he took blood at a birthday party without ethics approval, his explanation was that he didn’t think that ethics approval was needed for people who were not NHS patients.

QDid not that difficulty, which, as I say, appears to have been encountered by researchers other than yourself, indicate to you that there were ethical considerations about undertaking this procedure on normal children?
AYes. The ethical considerations that I considered were clearly that there was full informed parental and child consent. As I have said, my understanding at that time was that ethics committees existed for the protection of NHS patients.

In another infamous example, David and Mark Geier received approval for research from an IRB . The IRB was had David and Mark Geier, Mrs. Geier and other interested parties as members. This would not have come to light without another Freedom of Information Act (US) request. If I recall correctly, the IRB was instituted after the research began as well.

I know that these are pretty egregious examples but I am left wondering—how many researchers consider ethical approval to be just an annoyance? Just some rubber stamp they need in order to do their research? I hope the number is small. I hope that in the day of FOIA requests, institutions and researchers take this seriously.

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  2. sharon:
    I'd like to think most involved in research take the process seriously and have enough professional integrity to ensure that proper procedures are followed. Perhaps those who contemplate the shortcut of avoiding ehtics approval up front will consider that if found out via FoI, the studies findings will be compromised. Lets hope the legacy of Wakefield's exposure as a fraud serves as a warning.
  3. esattezza:
    In my experience, most researchers take ethical considerations very seriously, both when working with humans and animals. That being said, I've also heard many of them complain about the actual IRB process. It's a lot of paperwork and dealing with administration. In other words, we understand the importance of it and will gladly consider the issues involved when designing our research, but we'd much rather be in the lab than dealing with the actual procedure of it all.
  4. sharon:
    esattezza, I think bureacratic processes are a considerable burden in many professions (in a former life I was a clinical social worker in both justice and hospital systems so I know a little about paperwork). But they are also necessary for tranpsparancy and accountability. I just wonder how you ensure people are completely honest about their intentions, and actions?

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