The Foundation BEBO initiated in Assen a non-institution-linked, independent Medical Review and Ethics Committee (MREC), to review biomedical scientific research in human subjects. These reviews are done at the request of pharmaceutical and related industries, contract research organisations (CRO’s), as well as for researchers or institutions in health care.
These research activities are carried out with patients and/or healthy subjects (hereafter referred to as subjects) on the basis of voluntary participation. The MREC of foundation BEBO reviews whether scientific protocols regarding the research in human subjects provide sufficient protection to the subjects, and assesses whether they are based on adequate ethical, statistical/methodological, juridical and scientific grounds.
The MREC protects the safety, health, rights and the privacy of the human subjects while observing the applicable rules and guidelines for scientific research (including ICH, GCP, FDA, WMO), as well as the importance of the research. The MREC is guided by the care for integrity and well-being of the subjects and is aware of their potential vulnerabilities. The review of the submitted dossier is independent, careful, and based on applicable regulations.
The operational processes of the MREC are documented in a so-called Standard Operating Procedure (SOP). The objective of the SOP is to use the information in the SOP in combination with the necessary information to be able to achieve a sound judgement.
The SOP only addresses concerns that are directly related to the review process. Other topics are documented in the Memorandum of Association MREC of foundation BEBO and the Charter of the Foundation BEBO, including the Members of the MREC.