Guest guest Posted August 4, 2010 Report Share Posted August 4, 2010 Voluntariness Although informed consent for participation in research was recorded in 1900, the Nuremberg Code highlighted the essentiality of voluntariness of this consent. In 1948, Universal Declaration of Human Rights (adopted by the General Assembly of the United Nations) expressed concern about rights of human beings being subjected to involuntary maltreatment. In 1966, the International Covenant on Civil and Political Rights specifically stated, ‘No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his/her consent to medical or scientific treatment.’ An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to obtain influence. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward in order to obtain compliance. Participants should not be subjected to “force, fraud, deceit, duress or coercionâ€. When a researcher is also study participant’s physician, teacher or employer, such a relationship can generate unjustifiable pressures, conflicts and should be specifically considered. One must make sure that no participant carries a feeling that failure to participate in the study might affect them and threaten their relationship with the researcher. Patients can say no to someone they do not expect to see in the future, but it is very difficult for people to say no when they rely on someone for ongoing medical care (doctor-patient), their academic career (teacher-student) or employment (employer-employee). Special attention is required for these categories who may be subject to giving consent under duress, for those who will not benefit personally from the research and for whom research is combined with care. Source: Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ 1996; 313:1445-1447 Kalantri SP. Informed consent and clinical trials.Indian J. Anaesth. 2004; 48 (3) : 192-195 Dr. Smita Quote Link to comment Share on other sites More sharing options...
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