Cerda CBI, Garrocho RJA, Pozos GAJ

Language: Spanish
References: 15
Page: 301-305
PDF size: 174.68 Kb.

ABSTRACT

Clinical research in dentistry or indeed any other health science requires that every subject involved in a study sign an informed consent before they can be included. In order to obtain such consent, the researcher must first acknowledge and grant the subject the right to freely and voluntarily decide whether or not they wish to take part. The researcher must also clearly explain all aspects of the study to the subjects, including the benefits and risks involved should they choose to participate. To fulfill these obligations, the researcher provides what is known as an «informed consent» form; a legal document drafted in accordance with national and international standards that protect both the researcher and the subject. This study describes the historical background to various cases of high-risk and ethically unacceptable research on human subjects that led to the creation and establishment of the concept of informed consent in research around the world. Furthermore, it explains the importance of informed consent for clinical dental researchers, as well as for the subjects participating in clinical trials. We also look at the content of informed consent forms, based on Mexican public health standards. This study serves as a guideline for the use of informed consent forms in clinical research in the field of dentistry.

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