Crazy ideas for obtaining informed consent
I just read an article in Economic
times dated September 12, 2013 which says that obtaining an audio-visual
informed consent of every patient who agrees for being part of a drug trial is
proposed to be made mandatory.
As India moves towards becoming one of the first countries to mandate that audio-visual consent has to be taken for patients enrolled in clinical trials, pharmaceutical companies and contract research organisations warn that maintaining heaps of confidential electronic data would emerge as a massive challenge.
“An audio-video of the informed consent process of individual subject, including the procedure of providing information to the subject and his understanding on such content, shall be maintained by the investigator for record,” said a recent draft notification of the health ministry.
What do you think of the above
proposal?
Several questions crop up in my
mind:
- Is it practical?
- Will the patients agree to be filmed?
- What will be the cost implications?
- How are all these audio-visual evidence going to be preserved and for how long?
- What happens to privacy issues?
- Can we be sure that the audio-visual evidence will not be misused or abused?
- Who will have access to the above evidence?
- Who is going to monitor the implementation of the proposal?
I guess that this is as crazy a
proposal as I've ever heard.
The doctor readers of my blog ought to
raise their voices against this proposal in the appropriate forum.
Regards,
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