The weird world of US ethics regulation

There has been a lot of interest over the past week in the Burzynski Clinic, a US organisation that offers unorthodox treatment to those with cancer. To get up to speed on the backstory see this blogpost by Josephine Jones.

As someone who spends more of my time than I’d like grappling with research ethics committees, there was one aspect of this story that surprised me. According to this blogpost, the clinic is not allowed to offer medical treatment, but is allowed to recruit patients to take part in clinical trials. But this is expensive for participants. The Observer piece that started all the uproar this week described how a family needed to raise £200,000 so that their very sick little girl could undergo Burzynski’s treatment.

I had assumed that this trial hadn’t undergone ethical scrutiny, because I could not see how any committee could agree that it was ethical to charge someone enormous sums of money to take part in a research project in which there was no guarantee of benefit. I suspect that many people would pay up if they felt they’d exhausted all other options. But this doesn’t mean it’s right.

I was surprised, then, to discover that the Burzynski trial had undergone review by an Institutional Review Board (IRB - the US term for an ethics committee). A letter describing the FDA’s review of the relevant IRB is available on the web. It concludes that “the IRB did not adhere to the applicable statutory requirements and FDA regulations governing the protection of human subjects.”  There’s a detailed exposition of the failings of the Burzynski Institute IRB, but no mention of fees charged to patients. So I followed a few more links and came to a US government site that described regulatory guidelines for ethics committees, which had a specific section on Charging for Investigational Products. It seems the practice of passing on research costs to research participants is allowed in the US system.

There has been considerable debate in academic circles about the opposite situation, where participants are paid to take part in a study. I know of cases where such payments have been prohibited by an ethics committee on the grounds that they provide ‘inducement’, which is generally regarded as a Bad Thing, though there are convincing counterarguments. But I am having difficulty in tracking down any literature at all on the ethics of requiring participants to pay a fee to take part in research. Presumably this is a much rarer circumstance than cases where participants are paid, because in general people need persuading to take part in research. The only people who are likely to pay large sums to be a research participant are those who are in a vulnerable state, feeling they have nothing to lose. But these are the very people who need protection by ethics committees because it’s all too easy for unscrupulous operators to exploit their desperation. Anyone who doesn’t have approval to charge for a medical treatment could just redescribe their activities as a clinical trial and bypass regulatory controls. Surely this cannot be right.