Who participates in clinical trials?

It has been more than 70 years since the US Public Health Service started documenting the effects of syphilis on 399 human test subjects — all of them black, all of them poor and most of them illiterate. None of them were informed that they were infected with syphilis, nor were they told the real purpose behind the experiment (1). The world has been aware of the horrible truth of Tuskegee since 1972. Since then we have come a long way in terms of monitoring of clinical trials and observing ethical guidelines for experiments on human subjects.

Still, innumerable trials are done, especially by pharmaceutical industries and commercial research organisations that do not follow ethical norms. Often, participants are not fully informed of the risks involved, while the benefits are over-stated. These are examples of ethical misconduct.

This article does not talk about such trials but rather about committed research institutes and researchers who strive to conduct research following ethical norms. In such trials research protocols are reviewed and approved by ethical review committees. Issues of informed consent, disclosure of risks and benefits to participants, their rights, and so on, are addressed. It is also ensured that benefits for participating in the trial are not an undue enticement for an individual to participate and face unknown risks.

We are a non-governmental, not for profit organisation working on medical and social issues related to HIV/AIDS.As a part of our work we interact with various stakeholders of such trials. We are confronted with ethical issues involving such research as a part of our work.

The question that comes to our mind is: “Why should people participate in any research that can expose them to the unwanted effects of the drug or vaccine?”

The usual answer we get when we ask this question is: “they participate for the up gradation of science,” indicating that participants’ motives are mostly altruistic. When science is for the betterment of humanity it is the responsibility of all of us to contribute in it.

But when we look at the profile of the majority of participants of such trials we see that they are from economically backward strata in society. They are less educated and rarely are professionally related to the topic of the research. Is science is the sole responsibility of these people? Surely not.

We need to examine the motives behind people’s participation in such trials. Are there other advantages in participating? Or do they have a sense of obligation towards the person who motivates them to participate? Do hierarchy and power structures operate in spite of the researchers’ good intentions? Is it enough to take participants’ ‘informed consent’ or do we need to do more?

Why do those involved with such research not participate in these trials? Those who are involved in conceptualising, designing as well as implementing research are in the best position to understand all the risks and benefits of the study, and its importance to build scientific knowledge. During informal discussions with such people they point to ‘conflict of interest’ as a reason for non-participation. Could this issue be addressed differently? If at all there is a conflict of interest, researchers working on the project should refrain from participating, but other colleagues from the institutions or their relatives/friends can surely participate. This would actually motivate outsiders as well.

This raises many questions: Do participants receive true and complete information. regarding the trial’s safety? Are the benefits of participating in the study over-emphasised? Are we taking advantage of people’s emotional and/or financial status to increase participation in the study? Would a detailed understanding about the issue discourage people from participation?

We must take action against blatantly unethical trials. We must also take a second look at research that may be questionable even though it seems to follow ethical guidelines.