Informed consent - the farce.
For some medicines, there’s the option of animal testing, where you first subject a whole lot of animals to the trial drug and study them (a procedure fraught with ethical complications) before testing on humans. For many if not most medicines, it doesn’t matter how many animals you try it on, you still have to test on humans to know the effect. (It’s hard to defend a medicine that kills a human saying but it didn’t harm my chimps.)
Informed consent is the process by which you obtain permission from a person to enrol them in a study. The term means that the person is fully aware of the risks, benefits and details of the study and has consented on the basis of this knowledge.
Sounds fabulous on the face of it - but not so fast, Batman! I’m going to pick the field I’ve seen this at work in - HIV.
The informed consent form is a written document. That assumes that all people participating in the trial can read. Sure, we have a stipulation that the consent form must be in the local language as well. Not bad. What if it’s a language like tamil? As an uneducated person, I may speak only tamil, but would I understand pure tamil even if it is read out to me? Because in some languages, ability to speak them is no guarantee of ability to understand their formal version. And if I can’t understand what is being read out to me, I must take the word of another person that it is in my best interests to join the trial.
Some trials also hold out tantalising tidbits. If I turn up for the trial visits regularly, then I get paid this much per visit. Sometimes I may even get free medicines during the trial. Now the second sounds great, because how much ever cash I get, its never going to be enough to cover my medical bill right? But in HIV once I start ART, I have to keep on eating the stuff the rest of my life. If I miss my dosages, theres the threat of viral mutation looming over my head. The trial may give me free medicine, but what happens when the study is concluded? Who looks out for me then?
Literacy plays a humungous role in our ability to protect ourselves, in our awareness of rights. Education, for all its flaws in the current system, helps us ask the right questions: who will help me? Do I have a right to the treatment I need? What are my rights as a study participant? Whom do I contact if something goes wrong?
But even as a literate person, if I have to read a medical document, how much sense would I be able to make of it? There’s much scope for fogging with jargon – instead of saying “if both have the same HIV status” I may chose to say “if both parties are seroconcordant”. Simple things, but they make a big difference to the reader. And here I am not questioning the ethics of the person drafting the form: I’m assuming a case where the person means no harm. There’s plenty of scope for politics in this trials business for the sheer prestige and money involved!
As you can see, in the current system, there are endless loopholes and several issues which have not been addressed. The personal ethics of the researcher who administers the consent plays a large role. To really protect the participant however, the system should be revamped so that even if the person administering the consent is unethical, the system has rules which cover the contingencies and do not allow the vulnerable people to be manipulated. Until then, how safe is it to hold clinical trials in developing countries with large illiterate populations? Isn’t it a potential human rights nightmare?