(3 May ’09)
When I agreed to be on
an ethics committee as a lay person, I hadn’t a clue what it was going to
entail. I was told I needed to read the consent form for patients (this was a
medical ethics committee). If I understood what was written, they were sure
anyone could. (Advantages of having a low IQ, I thought to myself, get to be on
a committee and all!!). Sounded easy.
Wasn’t.
For a couple of times I sat
uncharacteristically, perfectly silent through the meetings because I couldn’t
understand a word of what was being heatedly discussed. Later I came to know
that this was amongst the most debate-filled committees in the city. Advantage
mine. Over a period of time, I added words to my vocabulary: placebo,
randomized study, double-blinded, unblinding, multi-centre, exclusion criteria.
I learnt to improve my diction by saying pharmacogenetics and epidemiological.
The consent form that I
was supposed to read came with 10-40 attached pages of
Greek-Latin-Japanese-Eskimo-Sanskrit sounding words, quite unpronounceable and
certainly impossible to spell on one’s own: drug names. Drugs means medicines
in this context. I worked hard at understanding what ‘this’ was all about.
‘This’ means clinical trials. They were/are happening all over the
country, involving multi-national pharmaceuticals. Since India needs to protect
its own, there are (really good) guidelines and protocols to follow, chalked
out by the ICMR. The Ethics Committees, which comprise a mix of medical,
pharma-, legal and lay persons, ensure that the participants aren’t subjected
to unsafe practices or unnecessary risks. It’s not a question of gut-feeling,
intuition, “I think this is wrong” but clear scientific reasoning, calculated
risk-taking, logical steps involved. Hence the tomes to read before one can
give ‘informed consent’.
No doubt there are loopholes that crooked people will use, but it’s
heartening to note that there are several seriously concerned persons (amongst
doctors and others) who want to protect the interests of participants and are
doing something about it.
There were obviously other lay persons on other such committees who were
as lost as I was, so Dr. Urmila Thatte of KEM hospital Mumbai and her team
decided there should be training for them. I had acquired just enough knowledge
to be kicked up from the chair to the stage side and was on the Faculty (sounds
great, but involved days of hard work making a presentation). The topics
covered what bio-medical research was, evolution of research ethics, components
of a research protocol, compensation issues and my baby: the informed consent
process.
Occasionally, the attendees threw up questions. One diamond-stud wearing
‘social worker’, possibly in her ‘sixties, was more concerned about the fact
that we lay persons were called ‘non-scientific members’. I don’t think she
knew the meaning of lay, else she wouldn’t have insisted on being called one.
Some wondered why Indian lives weren’t compensated in dollars. Were our human
lives worth any less? That was a topic for a sub-debate. Who monitors/audits
the committees themselves? A sub-sub-debate followed. The sponsoring company
had its own point of view. And the arguments veered way away from the main
subject every time and had to be dragged back by the moderators. The more I
interact with the medical community, the more I find that there are as many
very concerned practitioners as greedy unethical ones. Here, too, I was
reassured by the reactions of those present that they wouldn’t let the bad eggs
get away. Not an easy task in India. It’s easy to be cynical, difficult to
fight the system, and these were fighting hard to make sure clinical trials
were fair.
Now, armed with a little more information than before, am looking
forward to more meetings, waiting to learn about what’s happening in the field,
in the country, of a subject that’s excitingly new here.
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