It will also expose the investigators who are not following the informed consent process properly. This will help India have a different standard over and above International Conference on Harmonisation of Technical Requirements http://www.selleckchem.com/products/Pazopanib-Hydrochloride.html for Registration of Pharmaceuticals for Human Use (ICH) countries. Improvement in informed consent documents The task of conveying the concept of research and basic scientific terms (blinding, confidentiality, randomization, and others) to a scientifically na?ve population is a major challenge of informed consent process.[5] AV recording may enable researchers to identify areas poorly grasped by the potential research participants. This information can be used for further simplifying the informed consent documents/counseling.

Confirmation of informed decision After delivering all information, to complete the cycle of communication, it is important to assess how far the message has reached the participant.[5] AV recording can help confirm the understanding, if the researcher asks the participant to demonstrate their understanding of information conveyed to them. If this is achieved, it would be fair to assume that AV recording has helped the participant to take an informed decision. FORESEEABLE CHALLENGES Infrastructure Infrastructure is a main point of discussion when anybody tries to think of implementation of AV recording of the informed consent discussion. Not many government-funded clinical trial sites have appropriate infrastructure required to make AV recording at the sites possible.

If we think of infrastructure, a minimum requirement would be separate room for consent with minimum background noise and equipment to record the consent process, which could be a simple camera. In the absence of any regulatory specifications about the type of recording, for example what all should be seen in the recording full/half face, side view, rear view, and so on further clarity is required on what is expected and acceptable. Brefeldin_A Consideration should be given for patients who are immobile, as there may be need for a movable set-up to record their consent. Indian culture Indian culture has tradition of ladies using ghunghat (a veil or headscarf worn by South Asian women to cover their head and often their face) and burkhas (enveloping outer garment worn selleck compound by women in some Islamic traditions to cover their bodies when in public) especially in rural India. In rural parts of the country, women avoid eye contact with men. If we are now asking these individuals to give consent on camera, it will be a time-consuming process for the site staff. Patients who are uncomfortable will simply refuse and this may impact recruitment adversely.