Crazy ideas for obtaining informed consent
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.
- 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?