Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We found a large number of shortcomings (...) in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees. (shrink)

On site monitoring of research is one of the most effective ways to ensure compliance during research conduct. However, it is least carried out primarily for two reasons: presumed high costs both in terms of human resources and finances; and the lack of a clear framework for undertaking site monitoring. In this paper we discuss a model for research site monitoring that may be cost effective and feasible in low resource settings.

This article introduces _the Ethics Laboratory_ as an inter-sectorial and cross-disciplinary dialogical forum which can be viewed as an educational tool for moral learning. _The Ethics Laboratory_ represents a platform for the informal, collaborative investigation, in strict confidentiality, of ethical questions that have social consequences and/or legal concerns and bridges boundaries between research communities, institutions and patients. Its methodological structure proposes an experimental, open-ended way of unpacking implied assumptions, underlying values, comparable notions and observations from different professional fields. In connection (...) with a large social science project on precision medicine, we conducted four Ethics Laboratories followed by eight interviews with a selected number of participants. Through these interviews we learnt how this exploratory dialogical forum heighten moral awareness on issues that are shared among stakeholders who work to implement precision medicine in Denmark. Though the framework was developed specifically to foster ethical reflection within precision medicine, its dialogical structure lends itself to other professional areas and can easily be adopted and carried out. (shrink)