III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies

Abstract

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects' first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies. (REV INVEST

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

“…Prospective review of clinical research is the well-established means by which RECs/IRBs execute their responsibilities to researchers and participants (Aguilar-Salinas et al, 2019;London, 2012). The emphasis on prospective review has its foundation in the origin of RECs/IRBs at the National Institute of Health in the 1950s (Hedgecoe, 2009;Moon & Khin-Maung-Gyi, 2009;.…”