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

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
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.