Under martial law, ensuring an adequate level of ethical review of clinical trials is extremely important. The purpose of such review is to prevent possible risks to trial subjects and to monitor compliance with ethical, moral and legal principles during clinical trials. The effectiveness of ethics committees depends on the competence of committee members in matters of ethical review, which is largely determined by their training and methodological support.
Special attention must be paid to establishing a system of ethical review. Such an organization will include: basic principles of operation, criteria for the quality functioning of ethics committees, and continuous improvement of the ethical review process.
In Ukraine, the requirements for the ethical review of clinical trial materials by ethics committees at healthcare facilities are established at the legislative level (Art. 7, 8 of the Law of Ukraine "On Medicinal Products", 1996 (as amended)).
Currently, Ukraine has a regulatory framework that establishes the basic requirements for the functioning of ethics committees and for their assessment of the ethical and moral-legal aspects of clinical trials, namely:
- Procedure for conducting clinical trials of medicinal products and expert evaluation of clinical trial materials and the Model Regulation on Ethics Committees, approved by MoH of Ukraine Order No. 690 of 23.09.2009, as amended;
- "Guideline. Medicinal Products. Good Clinical Practice. ST-N MOZU 42–7.0:2008", approved by MoH of Ukraine Order No. 95 of 16.02.2009, as amended by MoH of Ukraine Order of 26.09.2017 No. 1169.
The above documents have been developed taking into account the requirements of generally recognized international principles for conducting clinical trials of medicinal products involving human subjects.
When training new specialists and improving the training of committee members who participate in the expert evaluation of clinical trial materials, there is a need for a deeper study of the ethical principles that matter in conducting clinical trials.
A more detailed interpretation of these principles is set out in the following international documents, namely:
- Declaration of Helsinki of the World Medical Association "Ethical Principles for Medical Research Involving Human Subjects" 1964–2013 (http://uacm.kharkov.ua/download/2014_11/22.pdf);
- International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences (CIOMS)
(https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf) (Eng) and (https://doi.org/10.56759/rgxl7405 (Ukr);
- The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
(http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html);
- Nuremberg Code (The Nuremberg Code.(1947).
A brief guide on amending existing standard operating procedures when accelerating the ethical review of studies of new medicinal products and vaccines would also be useful. Such practices will be useful for organizing the work of an ethics committee under martial law.
The war in Ukraine, given the large number of ongoing clinical trials, the importance of clinical research for so many patients, and its impact on public health, requires a reassessment of fundamental ethical principles and of the overall role played by clinical research in society. These issues are addressed in the article "Continuing Clinical Trials During War: The Need for Developing Ethical and Context-Adapted Guidelines for Clinical Research," created by a group of clinical research and ethics specialists and published on 16 September 2022 by Frontiers.
(https://www.frontiersin.org/articles/10.3389/fmed.2022.966220/full)
More detailed information can be found in the manual "General Principles of Organizing the Activities of Ethics Committees at Healthcare Facilities Where Clinical Trials of Medicinal Products Are Conducted," 2017, developed by the State Enterprise "State Expert Center of the Ministry of Health of Ukraine" for members of ethics committees at healthcare facilities, investigators, sponsors, applicants and other interested persons who participate in the expert evaluation.
(https://www.dec.gov.ua//wp-content/uploads/2019/08/posibnykn.pdf)
