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What is Research on Human Subjects

Chapter 9
Ethics in Research Practice and Innovation
a type of research involving human participants. The research could be in the bio-medical field, but also in psychology, sociology, anthropology, economy and so on. Such research requires a special consideration on the human rights and dignity, estimating the risk the participants might experience and cannot be conducted without the expressed informed consent of the participant(s) or their legal representative.
Published in Chapter:
Informed Consent in Research Involving Human Subjects
Antonio Sandu (University of Suceava, Romania & LUMEN Research Center in Social and Humanistic Sciences, Romania) and Ana Frunza (LUMEN Research Center in Social and Humanistic Sciences, Romania)
Copyright: © 2019 |Pages: 21
DOI: 10.4018/978-1-5225-6310-5.ch009
Abstract
Informed consent (IC) in research is a key element in ensuring the ethical character of any research involving human subjects, either bio-medical or psychosocial. IC involves three elements: validity, communication of information, and deliberation. Obtaining IC is a dynamic process of ethical reflection in order to facilitate the expression of autonomy of the subject involved in research. The process of obtaining the IC must be accompanied by the administrative procedure for completing a consent form signed by both the participant and the researcher. If the participant cannot sign—either because he is a minor or because of the medical condition—a delegated consent signed by the legal representatives of the subject is required.
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