Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies


  • K. O. Zupanets National University of Pharmacy,
  • V. Ye. Dobrova National University of Pharmacy,
  • T. Yu. Kolodyezna National University of Pharmacy,



Clinical Trials, Presumed Consent, Subjects Research, Quality Of Life


Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects) is one of the basic principles of clinical trials (CT) management.

Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS) three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC) at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey.

Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality.

It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them.

Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those parties of human activity, which could be affected by human health.


(2002) European Medicines Agency Guideline for Good Clinical Practice.

(1997) Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.

(2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS.

(2009) Nakaz Ministerstva okhorony zdorovia Ukrainy «Pro zatverdzhennia Poriadku provedennia klinichnykh vyprobuvan likarskykh zasobiv ta ekspertyzy materialiv klinichnykh vyprobuvan i Typovoho polozhennia pro komisii z pytan etyky» vid 23.09.09 r. №690 (zi zminamy, vnesenymy zghidno z nakazamy №523 vid 12.07.12 r., №304 vid 06.05.14 r., №966 vid 18.12.14 r.) [On approval of Procedure for Holding Clinical Trials of Medicinal Products and expertise of clinical trials and Model Regulations of the Ethics Committee: order of Ministry of Public Health of Ukraine № 690 from 23.09.2009 (amended in accordance with orders №523 from 12.07.12, №304 from 06.05.14, №966 from 18.12.14)]. Retrieved from

World Health Organization. Guidance on provider-initiated HIV testing and counseling in health facilities. Retrieved from hiv/pub/vct/pitc/ru/.

Afanas'eva, Ye. A. (2010) Ocenka kachestva zhizni, svyazannogo so zdorov'em [Evaluation of Quality of life related to health]. Kachestvennaya klinicheskaya praktika, 1, 36–38.

Rand Health. Retrieved from


World Health Organization. Retrieved from mental_health/publications/whoqol/en/.

How to Cite

Zupanets KO, Dobrova VY, Kolodyezna TY. Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies. Zaporozhye Medical Journal [Internet]. 2016May23 [cited 2024Jul.17];18(2). Available from:



Original research