Key topics discussed included audio visual recording of informed consent, reimbursement and compensation for clinical trial-related injuries and recent regulatory changes
Excel Life Sciences, a U.S.-based, India-focussed trial management organisation, hosted an event on May 24, 2014 at Indian Habitat Center to commemorate International Clinical Trials Day(May 20). The aim was to help spread awareness and create a platform for researchers to exchange experience and ideas for better development of clinical research.
The event was well attended by doctors and prominent researchers. Key topics discussed included audio visual recording of informed consent, reimbursement and compensation for clinical trial-related injuries and recent regulatory changes. The panelists tried to answer questions around the following topics: Should audio visual recording of informed consent mean that a sub set of patients are denied the opportunity to participate in research just because they do not agree to be filmed? How should this be addressed given that the guidelines clearly state that patients not comfortable with audio visual recording of informed consent should not be permitted to participate in a clinical trial? What are the options available for patients and researchers?
The need for explicit guidelines regarding reimbursements to be paid to patients in a clinical trial and on compensation for trial-related injuries was also discussed. Improper implementation coupled with pressure to recruit patients within definite time frames in a clinical trial, leads to compensation being used as a bait to lure potential subjects.
The participants shared their experiences during the last one year with the new regulations some of which go against the basic principles of research and have been made in haste with far reaching impact on clinical research in India. It was felt that there is a need to create greater public awareness about research and how it benefits the society. Some suggested strategies included using the outreach of social media to provide information and promote clinical research events.
EP News Bureau Mumbai