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Year : 2009  |  Volume : 7  |  Issue : 14  |  Page : 20-25

Understanding Informed Consent

1 Department of Public Health Dentistry, Faculty of Dentistry, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Medical Sciences (Deemed University), Sawangi (Meghe), WARDHA - 442 004, Maharashtra, India
2 Department of Public Health Dentistry, College of Dental Sciences, Davangere - 577 004, Karnataka, India

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The backbone of patients participation in a clinical study is informed consent. The Belmont Report suggests that informed consent should consist of three components: information about the research that is going to take place, evaluation of risks and benefits, and the ability of the participant to knowingly volunteer. The idea of informed consent in research is multifactorial and includes issues beyond an agreement to participate. The principles that rule the conduct of modem medicine, i.e. autonomy, beneficence and justice, should be implemented in decision-making. There is a need to improve informed consent documents in terms of their length and also their perceived purpose, which is to explain full details of the research.. Difficulties faced with vulnerable populations, ethnicity and cultural beliefs, language, a patient's educational level, children, pregnant women, prisoners, warrant a simplification of the consent forms. Informed consent is essential to protect the participants, not the researchers and institutions.

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