On An Ethics Committee

            When I agreed to be on a medical (clinical research) Ethics Committee as a lay person, I hadn’t a clue what it was going to entail. I had to read the consent forms that patients were given when a new drug (=medicine) was being tried out. If I understood what was written, they were sure anyone could. (Advantages of having a low IQ, I thought, get to be on a committee and all!!). Sounded easy.

Wasn’t.

I sat uncharacteristically silent through a couple of meetings because I couldn’t understand a word of what was being heatedly discussed. 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.

I worked hard at understanding what Clinical Trials were all about. They were/are happening all over the country, some involving multi-national pharmaceuticals. Since India needs to protect its own, there are guidelines and protocols to follow, chalked out by the ICMR. The ECs, 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’. In a country where literates are a minority (hey, we should demand some benefits!), this signing on forms business is a (sad) joke. Now some bright minds have figured that having video’d consent is better. Saves paper, too. And space. It will also document who’s taking the consent and how.

Crooked people will use loopholes; but it’s heartening to note that there are seriously concerned persons who want to protect the interests of patients participating in such trials.

There were lay persons on other ECs who were as lost as I was, so some senior doctors decided there should be training for them. I had acquired just enough knowledge to be kicked up from the chair to the stage and was on the Faculty (sounds great? It involved days of slogging to make 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 ‘social worker’ 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. 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 research trials were fair.

Conversant with the topic, I arrived in Goa four years ago. One hospital invited me to ‘advise’ it on the protocol to start and run an Ethics Committee. All there on the internet, I said, for free. But come, someone invited, so I went. I learned that the wife of the guy chairing the committee was the Principal Investigator of one project. He shouldn’t be taking a decision when her project was being considered, because there would be a conflict of interest, I said. I got cold stares for saying so. Another person, a doctor, wanted to be a lay member of the committee. If you’re a doctor, you’re not a lay (pun unintended), I said. He said, I’ll say I’m a BSc, won’t submit my certificates. That’s not ethical, I countered. The stares froze.   

I returned, sad at my helplessness, glad to be out of there, gladder that Goa has a literate and questioning population.

(feedback: sheelajaywant@yahoo.co.in)