![]() In countries like India, the clinical investigations are based on regional values and practices, the concept of disease as perceived through social values and power hierarchies in family of villages based on cultural systems. ![]() Subjects in the study must participate willingly only after consenting based on the information given. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, the procedures to be undergone, the potential risks and/or benefits of participation and alternative treatments available if any. Informed consent is not only required for clinical trials but is an essential prerequisite before enrolling each and every participant in any type of research involving human subjects including diagnostic, therapeutic, interventional, bioequivalence, social and behavioral studies and for all research conducted domestically or abroad. It also describes the obligation of the investigator to inform the subject about personal benefits and risk, individual faces in study. In reality, informed consent is the process that applies to each communication to participants, commencing with the subject recruitment material and the initial telephone screening of potential subjects through the conclusion of the study. The goal of the informed consent process is to provide sufficient information to a potential participant, in a language which is easily understood by him/her, so that he/she can make the voluntary decision regarding “to” or “not to” participate in the research study.Ĭonventionally informed consent is thought to be in terms of the documents signed and dated by participants, setting forth the purpose, benefits, risks and other study information necessary to allow the participants to make an informed and voluntary decision to participate in the clinical study. The informed consent is described in ethical codes and regulations for human subject's research. As no individual has right to infract fundamental rights of another person for the sake of fulfilling his own purpose, so an important tool called “informed consent” came into existence. Clinical trial is a term used to describe all research related activities, which use human being as subjects. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.įor a drug to get approved and enter into the market it has to prove its safety and efficacy in clinical trials. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. ![]() Informed consent is an ethical and legal requirement for research involving human participants. ![]()
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