Abstract
This chapter considers the problematic of ethics in clinical research in the countries that are new in terms of implementation or building an adequate structure. The chapter intends to assess the extent to which the clinical trials performed in four former communist East-European countries considered the ethical norms into their research procedures. A framework of existing literature on ethics in clinical research, along with the regional context, is discussed in the next section. The methods section includes the instruments, sources, and procedures for data collection. The data analysis procedures and structure are further explained and grounded relative to the study main purpose. The next section includes the facts and figures on the presence of ethical requirements in clinical trials in the specific political and cultural background in a number of former European communist countries. Finally, a number of suggestions and recommendation are also discussed.
TopIntroduction
The ethical issues have been approached for decades in all medical research when human subjects were involved. International bodies concerned with research ethics need to confront the greatest ethical challenge - the enormous inequities in global health research (Benatar & Singer, 2000). Despite increasing awareness in scientists and researchers from the medical field about the necessity of substantiate their research on ethical grounds (for example the referral of the research proposal or scientific paper to an institutional review board or a committee with similar functions, potential impact of financial conflicts of interest on biomedical research, proper formulation and delivery of the informed consent documents, assurance of voluntariness and non-coercion in research participants, especially in the vulnerable individuals and groups, and so on) no comprehensive synthesis of the body of evidence relating to all these issues has been performed on an uniform, coherent and systematic manner in Europe in the last decade.
The twentieth century saw the acceleration of medical progress, as well as an expansive development of the concept of human rights. These advances led to various codes of ethics for experimentation in the scientific disciplines. According to Rohrich (2007), the medical progress is based on research which ultimately must rest in part on experimentation involving human subjects- so special caution must be exercised in the conduct of research, which may affect the integrity, dignity and well-being of participants.
Despite the increase knowledge and inclusion of ethical issues in medical research on human subjects, there is no systematic evaluation about the mentioning of ethical requirements and/or how are they approached in the clinical trials performed in former communist countries, now members of the European Union. Following this, our study aims to evaluate how the ethical issues are taken into consideration in clinical research made in countries where presumably the introduction of these principles has been delayed due to a specific background (political and cultural).
Key Terms in this Chapter
Informed Consent: Term used for medical treatment but also in research- refers to an autonomous authorization (respect for persons, autonomy, liberty interests) and to social rules of consent (i.e., consent for minors, witnesses); in essence has to disclose the nature of the proposed intervention, procedures and alternatives, potential risks and benefits, assurance that participation is voluntary, and protection of confidentiality, all concisely explained and written in a document understandable by a person with basic education.
Assessment of Patient Capacity: A (semi-) structured evaluation of the participant’s ability to understand relevant information and appreciate reasonably foreseeable consequences with regard to the specific treatment decision. In the shared decision-making process, the physician or researcher must take into consideration that capable patients have the legal and ethical right to make their own treatment decisions, and incapable patients cannot give a valid consent, so someone else must make the decision on the patient’s behalf.
Conflict of Interest: Situation occurred when an employee, researcher, physician, etc. is involved in a particular matter as part of his/her official duties with an outside organization with which he/she also has a financial interest, or one which is imputed to him/her. The conflict can be real or apparent. Ideally the conflict is disclosed to the Ethics Coordinator or principal investigator to obtain a waiver or authorization, otherwise the employee should be disqualified from participating in particular matters concerning the outside entity.
Ethical Commission Review: An evaluation of a research project proposal made by a board or specialized commission in a university setting, research institute, a structure of the National Ministry of Health or Education. Ideally a research project can only be carried out if it has received a favorable opinion from such committees.
Research Ethics: A set of methods, procedures, or perspectives used by people for deciding how to act and for analyzing complex problems and issues related to research. They also may take into consideration moral and social values that lead to norms for conduct that distinguish between acceptable and unacceptable behavior before, during, and after the completion of a research, in areas such as participants’ selection, collecting, storing, and using data; privacy and confidentiality; collaboration with colleagues or undergraduate students; publication; and so on.
Risk-Benefit Balance: An assessment (made by the researcher, physician, but also by the participant) about risk of loss of privacy and confidentiality, risk of infringing on the autonomy of subjects, risk of unethical doubt manufacturing and conflict of interest, on one hand, and benefit of health advancement and prevention, benefit of cost-effectiveness, better future research and study design, social acceptance of sustaining emerging disciplines, on the other hand. This evaluation should be personalized for each study and participant and it can be included in the informed consent form.
Institutional Review Board: ( IRB): A research ethics committee that provides a core protection for human research participants through advance and periodic independent review of the ethical acceptability of proposals for human research. Its functioning is widely required by law or regulation in jurisdictions globally.
Patient Capacity: The ability (here, of a patient) to make a decision. If a person lacks capacity, he/she has an impairment or disturbance that leaves him/her unable to make a decision relative to the treatment or the participation in a medical trial, a research project and so on. The loss of capacity could be partial or temporary. It is possible for a person to lack capacity to make one specific decision but not about another; each specific situation must be carefully weighed. Assessing the patient’s capacity is a delicate task for the investigator/physician.