Informed consent - the farce.
I am concerned about medical trials. Typically for a new medicine, we unleash new chemicals whose effect we do not know, on certain types of bodies as specified by the study criteria. What that boils down to is, if you’re sick with a particular disease, maybe from a particular background (eg. anaemia in labourer class, or STDs in monogamous people), you’re offered the option of enrolling in a clinical trial.
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?
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?
Labels: brownskinspeak
scribbled by m. at 1:33 am
7 Comments:
Very nicely written. Even a chap like yours truly, who does not read the newspaper (except for the comic strips), could get the gist of the stuff.
True - a good system can only take us so far. Finally it comes down to the personal ethics of the people involved. And as Vitalstatistix says, the end-user needs to be cautious, too. Mostly people like me - I don't even know what my tax liability is. I blindly go with what my CA says, and I'm pretty sure it's going to land me in the soup some day. But apathy is a difficult habit to kick...
actually.....the problem with the legal system is that it can be twisted in anyway u want.....when the law gets smarter.....u'll have people trying to exploit it....
take the dowry law for instance...not that I am against it or something....but actually know cases where this was used the wrong way...
but for these kinda things, .....a better law system sure is needed....
I am sure everyone agrees that human clinical trials is a necessity and which cant be eliminated or replaced (atleast not yet) The points you raised are really valid.
But till someone comes up with a better suggestion as to how it can be implemented, I will accept the present setup as the better one.
Very valid concerns. Can't disagree with you here (I suddenly feel awkward!! ;-)
So what would you suggest is the way out?
1. Have an informed group of participants per issue/pharma company who are completely made aware and are hence in a better position to decide?
2. Have audio-visual recordings for each document which basically explains the details in simple language (the video can be ratified by some HR organisation) and have a person there to help in fielding questions?
3. Record conversations between advisor and participant and hand it over to the participant. The recordings would contain the explanation process and finally what the participant has understood. Hence, any issues later could be settled with the help of this?
4. Ensure that a company lays out the risk factors in plain simple language before explaining other thing? Maybe benefits to the community followed by risk factors?
@vitalstatistix: yesh. we dont... its such a sad waste - so few people are privileged enough to be able to study, we MUST make the most of whatever weve learnt...
@senthil: you too?! - i read sainath editorials and C&H! :d yeah general blind faith is more comfy but not very dependable!
@archstorm: shucks, im equally stunned! ;) hmm. as much moral ed may make a difference, i think the system must be altered to protect against the people who learn nothing in those classes!
@phobiac: yesh, the legal system is a nightmare... ditch the substance, the language alone is enough to put you off... ugh!
@baejaar: everyone minus one? :d well.. i guess its easier to be tolerant when its an abstract concept. unfortunately ive seen the faces so it makes my blood run cold.
@wooaaooww: you read it eh! i was wondering if youd remember a certain conversation... consider this the explanation i couldnt give then :)
@eroteme: gosh im overwhelmed... you AGREE?!! ;) i like your idea of making it compulsory for companies to disclose risks in simple language. i think it should be extended to the person conducting the study as well.
theres something called an ethical committee that usually monitors the studies : the selection criteria are pretty good on paper, but i think there should be one more aspect : that the person shouldnt be working with the guys doing the study in any other area (neutrality should be maintained).
i think that this may also help: any study found to violate human rights should be barred from publication and the learnings of that study must not be made available - nullify the study completely.
Been a while, hasn't it? Time for a new post...
Just tagged you.
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