By Sharon Tasman Prysant | December 02, 2013 at 03:30 PM EST | No Comments
On November 19, 2013, the India Office of Drugs Controller in New Delhi, India, issued an Order requiring that audio-visual recordings be made of all clinical study subject informed consent interviews, in addition to having signed written informed consent documents. (See the full order HERE) The purpose of the new requirement is to help ensure that study subjects' informed consent is truly freely given.
It will be important to balance this new requirement for making an audio-visual recording with the fact that the informed consent interviews will certainly contain personally identifiable information and need to be kept confidential. In the age of easily transmittable digital media, this will be even more difficult to accomplish.
One way to help accomplish this would be to provide clinical study sites in India with a pre-approved script that should be read at the beginning of each interview addressing these concerns, and providing uniformity on how your clinical trial is managed. Such a statement will both help limit improper dissemination of the interviews and demonstrate compliance with the India Order.
Please contact the firm for guidance on how to craft a script for your specific needs.