Description
International Strategic Fund Award from RED, University of Bristol towards below.Title: Collaboratively developing and/or informing guidelines for recruitment conduct and informed consent in clinical trials in India
Overview: 1. The visit to India is intended to initiate/develop collaborations for a future project that aims to develop guidelines for recruitment conduct and informed consent in clinical trials (CTs) in India. 2. The visit to Vietnam is aimed at learning from a similar project (run by the Oxford University Clinical Research Unit – OUCRU, Vietnam) but in a different LMIC (lower and middle-income country) context, and establishing collaborations for future synthesis of findings across the two countries.
Research context: India opened its doors to international CTs in 2005. However, with inadequate regulations and monitoring frameworks in place, unacceptable ethical practices, such as failure to obtain participants’ informed consent, began to be frequently reported. This led to a brief halt of CTs in 2013 in response to concerns for patient autonomy/safety.
Research problem: Findings from a systematic review currently underway (led by applicant) indicates that there is little research exploring the informed consent process, particularly the consultation where CT information is discussed with patients.
Proposed aims/methods of future study: Drawing from the know-how developed by experts in India and the accumulated expertise gained by the QuinteT team at the Bristol Medical School, the project will aim to understand the recruitment and informed consent process for CTs in India and (collaboratively) develop/provide tailored suggestions/guidelines to optimise it. The study will adapt QuinteT-developed innovative approaches to addressing the research problem, such as audio-recording and/or observing the informed consent appointments, if these are feasible in the Indian context. The findings will then be used to inform existing attempts at developing guidelines for recruitment within the country, by providing an empirical understanding of the informed consent process for clinical trials in India. The visits are aimed at initiating and/or confirming collaborations that would progress the proposal towards a grant application.
| Period | 1 Dec 2018 → 15 Dec 2018 |
|---|---|
| Visiting | Cancer Institute, Adyar, Chennai, Tamilnadu, India |