Research Protocol Ethics Assessment

Institutional Review Boards. In university clinics and other hospitals engaged in research, ethics committees (also called Institutional Review Boards, IRBs) have been formed over the last three decades to monitor clinical research activities from scientific, legal, ethical and social viewpoints. All protocols relating to clinical trials must be submitted to these committees, which are generally made up of one or several doctors, a lawyer, a representative of the nursing staff and also community representatives such as priests. This composition forces clinical researchers to set out their intentions in such a way as to be clear enough for a lay person to understand and to assess whether the inconvenience and risks involved for the patient are in a reasonable relationship to the possible benefit of the planned trial. 

All clinical protocols and supporting documents are reviewed and approved internally by a group of senior Clinical Research Development managers. This group assesses the overall study design and ability of the study to meet its objectives, as well as the quantity and quality of the data. In addition, the group reviews the procedures for the safety and welfare of the subjects to ensure compliance to good clinical practices and ethical principles. 

Other findings indicate that many researchers and organizations failed to comply with clinical protocols for carefully assessing and selecting patients for the trials and for monitoring them thereafter. Additionally, it was found that many doctors had failed to fully inform prospective patients of uncertainties about the benefits and risks of the therapies or other relevant information (e.g., that other enrolled patients and test animals had suffered adverse events). Thus, doctors had enrolled patients without their informed consent to medical experimentation in violation of clinical protocols and medical ethics. 

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