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Ethics of informed consent in CT

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Provision of additional information to participants:

The participants have a right to ask for any additional information relating to

the CT. They can ask for detailed references, copies of the research

publications, protocol approval from EC, sponsor commitment,insurance policy and

any document that may be connected to the CT. The participants' quest for

knowledge about ensuring own safety and security, care and compensation,

experimentation skills and expertise of investigators, time line and termination

of CT, has to be met. In case participants demand copies of some documents

relating to this, they have the right to get the same.

Dr Vijay Thawani

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