World Cancer Leaders’ Summit 2015
International collaboration on data and bio specimen exchange
Dr Anil D’Cruz - Tata Memorial Centre, Mumbai, India
The session I’m going to speak on is about collaboration and data and bio specimen exchange between countries. I’m going to give a perspective on how it affects low and middle income countries. So we’ve got a whole load of examples as to how collaboration helps the development of science as well as the population where these collaborations come along. But we have certain concerns of data and bio specimens being used outside the country in low and middle income countries so basically my talk this afternoon will focus about those concerns and some solutions to the problem.
There is a smell of exploitation here.
Correct, and that’s because in our parts of the world we have legislation but sometimes the framework isn’t too tight and people could exploit this. At the same time there is vulnerability on the population that is part of these studies. So, yes, there is a chance of exploitation and that’s exactly what I’m going to speak about this afternoon.
In the western countries there’s now a growing suspicion and distrust of scientists – what are they going to do with my piece of tissue and so on. The informed consent forms are getting longer and longer and longer. How do you handle this issue of trust? Do you involve patients in the discussions about what is most important to do with their blood samples or liquid biopsies or whatever?
I must tell you that there was a large HPV vaccination study, a post-marketing observational study, HPV study, that was conducted in two states in our country, Andhra Pradesh and Gujarat. This was funded by the Bill and Melinda Gates Foundation that was part of the ICMR, that’s the Indian Council of Medical Research, and the two state governments. The trial fell in disrepute because of the 22,000 odd that they vaccinated on the HPV vaccine there were seven deaths. Then bells started ringing, there was a PIL filed, a Public Interest Litigation, all trials were put on hold. There was no gross violation vis-à-vis the trial but the informed consent process came under scrutiny and that’s predominantly because the target population were adolescent girls. So here they were, some of them who had given consent without really understanding what was happening, some of them had just put a thumb impression and, worst still, in some cases the hospital wardens where these people stayed had given consent. So, yes, informed consent is a problem in our part of the world. But then the government put legislation in place, now we have an informed consent process in place where, particularly for pharma-funded international trials, we audio-visually record all our informed consents.
For me as a researcher, and I do a fair amount of clinical research, the best is to counsel the patient in his or her language and always have an external person who is part of the informed consent process and we give them the consent form, tell them to take it back home, discuss with relatives, friends, their family physician, and as a researcher I never have the informed consent form signed on the day that I explain them. So I give them adequate time to digest everything, come back with 150 questions, then get them to sign it. I think that’s the safe way of doing it. I always say that I agree with you that informed consent forms are getting larger and larger but that’s again to protect people, and rightfully so, but I always say when you do research if you do it with a clean heart and with a scientific benefit and not personal gain, and I don’t mean financial personal gains. Many people do research just to further their academic career and that, to me, is a stronger conflict of interest than just financial issues.
