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Epub 2013 Oct 5

122 Clinical Trials in Vulnerable Populations

**Chapter 8**

**Provisional chapter**

**Ethical Aspects of Vulnerable Group of Patients in**

The current publication aims to review and analyse the ethical aspects and regulations to protect the category of vulnerable patients, as defined in the European legislation. These patients need special protection and require more detailed approach throughout

According to the National Institutes of Health USA, the number of clinical trials shows a stable trend for growth. Nearly 28% of all clinical trials worldwide are conducted in Europe [1]. It is therefore important that clinical trials are regulated legally and monitored with needed level of detail. They must also comply with the ethical standards that promote respect for

Often, researchers included patients who are vulnerable and need special protection. The chapter aims to provide an overview of the ethical issues in clinical trials with vulnerable patients. Based on European legislation, specifically Regulation (EU) No. 536/2014 of the European Parliament and Council and ICH GCP E6 (R1), several categories of so-called vulnerable

**Keywords:** clinical trials, vulnerable patients, ethical aspects, informed consent

**Ethical Aspects of Vulnerable Group of Patients in** 

DOI: 10.5772/intechopen.70318

© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution,

© 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,

distribution, and reproduction in any medium, provided the original work is properly cited.

and reproduction in any medium, provided the original work is properly cited.

Ekaterina Ivanova, Ilko Getov and Hristina Lebanova

Additional information is available at the end of the chapter

human beings and protect their health and well-being.

Additional information is available at the end of the chapter

Ekaterina Ivanova, Ilko Getov and Hristina

http://dx.doi.org/10.5772/intechopen.70318

the clinical trials' life cycle.

groups of patients might be defined: **1.** Pregnant or breastfeeding women

**Clinical Trials**

**Abstract**

**1. Introduction**

**2.** Minors

Lebanova

**Clinical Trials**

**Provisional chapter**
