An online meeting with members of local ethics committees took place at the Center – they discussed the protection of the rights of subjects participating in clinical trials of medicinal products in Ukraine.
The meeting was organized by the Agency for Methodological and Scientific-Practical Work of the Center in cooperation with specialists of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials and the Audit Directorate of the Center.
The main focus was on compliance with ethical and moral-legal principles when conducting clinical trials of medicinal products in special groups of patients – with the participation of young children and minors, legally incapacitated persons (including persons in critical and emergency conditions), pregnant and lactating women, military personnel, persons serving sentences in places of imprisonment, and others.
Opening the meeting, the Head of the Agency, Doctor of Pharmaceutical Sciences, Professor Oleksandr Hudzenko emphasized that the Center stands for supporting and developing the field of clinical trials in Ukraine in line with the best international practices and Good Clinical Practice (GCP). At the same time, the protection of the rights, safety, and well-being of trial subjects must always prevail over the interests of science and society.
Head of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials of the Center, Candidate of Pharmaceutical Sciences Taisa Herasymchuk highlighted the importance of ethical issues in the conduct of clinical trials and presented the main regulatory aspects of the ethical review of clinical trials that prevent possible risks to study participants.
Deputy Head of the Unit for Coordination of the Work of Local Ethics Committees and Monitoring of Adverse Reactions Daria Andrieieva spoke in more detail about the international and national documents that regulate the ethical principles of conducting clinical trials.
Head of the Department for Coordination of Local Ethics Committees and Monitoring of Adverse Reactions of the Center Yurii Shemetyllo presented in detail the specifics of conducting clinical trials involving special (vulnerable) groups of patients. He reminded of the powers of sponsors, investigators, and ethics committees operating at healthcare institutions regarding the mandatory provision of general and special measures to protect the rights of trial subjects.
The Head of the Clinical Audit Department for Clinical Trials of the Center, Lesia Yankova, drew the attention of those present to certain regulatory aspects concerning the verification of compliance with ethical and moral-legal principles during clinical audits of clinical trials of medicinal products.
During the meeting, participants were able to discuss difficult issues arising in the activities of local ethics committees (LECs), receive professional answers from the Center, and coordinate cooperation.
Taisa Herasymchuk drew the attention of representatives of local ethics committees to the Center's provision of continuous informational and methodological support on the conduct and evaluation of clinical trials, regular thematic trainings, meetings, and seminars on GCP, and offline and online consultations.
Any questions following the meeting and within the scope of the activities can be sent to the Department’s e-mail addresses dec@dec.gov.ua, clinic@dec.gov.ua. Wishes and recommendations regarding further trainings – to the Agency’s address amsw@dec.gov.ua.
