Re: What is Informed consent?

[Guest guest]

Hi,

In medical research, unfortunately informed consent has been most underused,

misused and abused. Investigators just use it as another item of paper work, to

be merely filled. The participants are marginalised, their rights ignored,

ethics violated and truthfully speaking instead of sharing the information, all

information is withheld from them. Instead of empowering the participants it is

used to curb their rights. The signature of participants on the dotted line is

obtained by various tricks of the trade.

Vijay

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>  

> What is Informed Consent?

> Informed consent is one of the most important facets of bioethics.

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> Informed consent in research is ethically important, but imperfectly realized.

>  

> Informed consent is designed to protect individuals participating in clinical

research trials.

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> The process of obtaining informed consent (IC)  from participants is a

critical point of entry for research participants.

> Clinical research guidelines require that every adult volunteer must agree to

participate in writing before he or she can enroll in a clinical trial.

>  

>  Obtaining a signature on a consent document is important, but it is just one

step in the continuous process of IC.

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> These are challenging times in clinical research. The coordinator has an

ever-increasing load of regulations to deal with in an environment of severe

time constraints. While there are many regulations governing the content of

consent forms, there is very little to guide the process. With the emphasis on

the patient as participant/subject, it is easy to overlook the patient as human.

> This further raises concern because most clinical investigators in India lack

formal training in bioethics and research methodology. They depend upon

pharmaceutical companies to receive crash courses in conducting clinical

trials. 

>  

> Before we go on to discuss about the process of IC, I would like to know from

you about  some incidents from history which really resulted into this process

gaining such importance which otherwise was never considered seriously.

>  

> Dr. Smita

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