Affiliation:
1. University of Medicine and Pharmacy “Carol Davila” Bucharest, Romania
2. University Politehnica of Bucharest, Romania
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.
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