The activities of ethics committees in the WHO benchmarking assessment – a webinar for members of local ethics committees took place at the Center. Representatives of 35 healthcare institutions took part.
The training was organized by the Center's Agency under the leadership of its head, Doctor of Pharmaceutical Sciences, Professor Oleksandr Pavlovych Hudzenko. The webinar speakers are specialists of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials of Medicinal Products, the Division of Audit of Laboratory and Clinical Practices (GLP, GCP), and the Unit of Methodological Support on Quality Issues of the Center.
The main objective of the meeting was to review the indicators of the WHO benchmarking tool for assessing the performance of local ethics committees operating at healthcare facilities where clinical trials of medicinal products are conducted. To provide expert recommendations to LEC members on proper preparation for the assessment.
The Global Benchmarking Tool is the main instrument by which the WHO objectively assesses regulatory systems. The Head of the Division for Methodological Support on Quality Issues, Olha Sadovnycha, emphasized that oversight of clinical trials of medicinal products is one of the key sections in the assessment system. 20% of the total number of questions in this section concern the assessment of the work of ethics committees.
Head of the Division for Coordination of the Work of Local Ethics Committees and Monitoring of Adverse Reactions of the Center Yurii Shemetyllo in his presentation focused on the main indicators of the WHO questionnaire concerning the activities of LECs:
- ensuring independent status;
- criteria for selecting candidates for membership of ethics committees;
- responsibility at each stage of conducting a clinical trial;
- implementation of policy in the area of conflict of interest;
- transparency in funding sources.
Emphasized the strict observance of international recommendations and national regulatory legal acts governing the activities of local ethics committees at all stages of a clinical trial.
Provided recommendations in accordance with legislative norms on the following important aspects:
- of the LEK composition;
- mandatory availability of and compliance with SOPs – detailed written instructions describing the processes and procedures of activity;
- duties and procedures;
- adherence to the principles of independence, openness, and transparency of activities;
- implementation of the conflict of interest policy;
- informing about adverse events and reactions.
Yurii Shemetylo reminded that the Center provides ongoing methodological recommendations on conducting preclinical and clinical trials and also regularly publishes recommendations for ethics committees on its website https://www.dec.gov.ua/…/metodychne-zabezpechennya…/…
The most typical remarks identified by the Center during clinical audits of clinical trials (CT) were also presented to those in attendance. Serhii Rasputniak, Head of the Directorate for Audit of Laboratory and Clinical Practice (GLP, GCP), advised participants to work on the mistakes and to systematize the necessary documentation: documents regulating activities, SOPs, documents accompanying clinical trials, and financial documents.
The Head of the Division of Clinical Audit of Clinical Trials, Lesia Yankova, emphasized the need for proper storage and archiving of documents, as well as ensuring openness and transparency of activities.
Summing up the meeting, Taisa Herasymchuk, Director of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials for Medicinal Products, expressed hope that ethics committees would be properly prepared for the procedure of evaluating their activities using the WHO benchmarking tool. She assured that the Center was ready to provide all the necessary methodological and advisory assistance.
The result we expect based on the benchmarking carried out:
- raising Ukraine’s global rating as a country with a strong regulatory system;
- recognition of the compliance of Ukrainian legislation in the field of regulation of medicinal product circulation with European legislation, which will accelerate Ukraine's accession to the EU;
- expanding the possibilities of providing patients with innovative medicinal products and vaccines.
For your information, Ukraine began the WHO assessment of the national regulatory system in 2021 and plans to complete it in 2024. In July 2023, a pre-benchmarking procedure was conducted. The date of the benchmarking itself will be determined shortly.
