INFORMED CONSENT IN CLINICAL TRIAL
Clinical research is a thoroughly study of new chemical molecule on human being for the purpose of being ascertain the molecule is useful to treat the disease or not. It consists of four phases. The candidate who participate in the study is also known as subject. During first and second phase healthy subjects are needed and in the later phases the unhealthy subjects join in the study. The subjects are provided a complete clear Informed Consent Form (ICF) which elaborate the body of clinical trial where they want to participate.
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| Informed consent form to the subject |
The informed consent is a very essential part of the clinical research body. The Informed Consent Form (ICF) is a subject's written agreement to voluntarily participate in a trial based on full disclosure by the researcher about nature of clinical trial,the trial procedures, financial implications for the appearance in trial, Potential benefits, Potential risks.
The consent process during which information is disclosed is based on interview with the subject/ legally acceptable representative, after which the subject is given reasonable time to clarify doubts.
The purpose of informed consent is to make transparency regarding the trial for the subject and enable subject make an informed choice regarding participation. It is safeguard for the subject as well as the researcher.
Actually the consent form involve in giving subject adequate information concerning the study. ICF also helps in responding to the subject's questions. It must be sure that the subject understand it completely and The subject has to put a sign in ICF.
Generally adult subjects who are capable of joining in the study, legally acceptable representatives of adult subjects who are not competent i.e. Unconscious subjects, Confused subjects etc. and legally acceptable representatives of minors.
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