`Informed consent does not make unethical study ethical'

ANUPAMA KATAKAM

Interview with Dr. Richard Cash of the Harvard School of Public Health.

Dr. Richard Cash is a senior lecturer in International Health at the Department of Population and International Health at the Harvard School of Public Health. He has been associated with ethics in research projects in the United States and in the developing world. In the recent past he was the principal investigator of the Applied Diarrhoeal Disease Research Project, a programme that assisted developing-country scientists in conducting their own research projects. Cash has been to India several times to help promote ethics in both domestic and international research projects. In an interview to Anupama Katakam, Cash spoke about ethical medical research in India and the global bioethics movement. Excerpts:

India is increasingly becoming a preferred destination for medical research and clinical trials. Is it because of the facilities and infrastructure offered? Or, is it because of the huge and diverse and easily available population on which trials can be conducted?

I can't tell you the exact reasons, but I can postulate. Biomedical research enterprise is expanding globally. Companies are setting up units not just in India but in other developing countries as well. Although, definitely, it is expanding greatly here.

Certainly India has very skilled individuals and that gives it an advantage. However, is it less expensive to do research here? Are research subjects easily available? These are possibilities. Also, health issues have a role to play. The diseases we have in the West, like cardiovascular ones, are affecting millions of people here too. Diseases in India are no longer restricted to cholera or leprosy. There is a rapidly growing middle class where individuals are developing problems as rapidly as the country grows. Large segments of the population are seeing diet changes, exercise pattern changes. Many conditions that run rampant in our society are doing the same thing here.

I suppose you could make the connection that why shouldn't we test out medicines and drugs that are used there over here.

What would be the ethical issues involved here?

The ethical dilemmas that are raised here are: Should the same guidelines that are used in the U.S., for instance, be used here? Some would argue that the issues are not exactly the same as India has its own unique culture. For instance, you can't have an 18-page consent form (as they do in the West). You need something everyone can understand.

Issues like should you test a product in a country where it is unlikely that the product will be used. Or that it is so expensive that an average Indian cannot afford it.

Issues of standards of care, what is available to people, what should be tested in this country are some examples. Are people being exploited simply because they are poor or are regulatory mechanisms not really in place? The Ethical Review Board may simply be one in name but not in function.

How do you see the bioethics movement working globally? After all, it seems to be a collaboration of countries.

My own sense is that over time there will be a harmonisation. Because if you want a product approved, let's say through the FDA in the U.S., and you are going to use a study in India as evidence of effectiveness, that study has to meet the same criteria and the standards prescribed by the U.S. FDA. Which is why in some ways there is an increasing interest in bioethics in India or a country like China. If they are going to be players, then they have also got to have proper ethical review, proper ethical guidelines; otherwise the research carried out here will not be accepted. That is why there is this whole bioethics movement.

There is another movement as well. Not all of these studies are to test out a good product. There are some out there trying out things that are not acceptable because they can't do studies in their own countries. They are trying out a bunch of things and see what works. This needs to be checked.

Also, as the world becomes more globalised you will want to transfer that scientific knowledge. If I want to do a study here and I want it to be published in the U.S., it should conform to the ethical guidelines of the U.S. Remember the last gatekeepers are the journals. The journals have it in their best interest to make certain that what they publish meets both scientific and ethical criteria. Nobody wants to be on the front page of The New York Times for something they did wrong, like treating subjects unethically.

Do you agree with outsourcing research?

I am not opposed to research in India. But it should be done with good science. It should be on an issue that is important to this country. The benefits should outweigh the risks. Individuals should give their consent. But informed consent does not make an unethical study ethical.

What is the medical ethical review set-up in the U.S?

Medical ethics, particularly review boards, is almost like an industry. If you err you could lose funding. The government [will] shut you down. There are real consequences. That doesn't mean it doesn't happen. Some of the worst violations take place over there. But I would say it is getting fewer because rules have become tighter. Some institutions have even been made to shut down because of bad research ethics. So those examples have put some fear in studies involving bad practices.

There is another issue, which you don't have much of in India. That is the legal issue. We can sue. This is not very well established over here.

Where do you think India is in the global bioethics movement?

I think the development of bioethics is gathering momentum. Since I started teaching here five-six years ago, there has been an explosion in courses, in workshops. Awareness has certainly increased.

Now I find a lot more emphasis on ethical review boards. If I am from the U.S. and want to start a trial, not only does my ethical review board have to approve but so does the Indian board. And both ethical review boards have to be approved by both governments. You can't just get together a bunch of associates and form an ethical review board.

India has still to address a lot of issues such as conflicts of interests, policies on medical research and regulation. Over the next 10 years we may see exposes and scandals but this will decrease eventually. But the movement is gaining pace and it is definitely moving in the right direction.