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What is Assessment of Patient Capacity

Ethics in Research Practice and Innovation
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.
Published in Chapter:
Addressing Research Ethics in Clinical Trials in Four of the Former Communist European Countries: A Shared Responsibility
George Florian Macarie (University of Medicine and Pharmacy “Carol Davila” Bucharest, Romania) and Ana Voichita Tebeanu (University Politehnica of Bucharest, Romania)
Copyright: © 2019 |Pages: 21
DOI: 10.4018/978-1-5225-6310-5.ch007
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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