Informed Consent: A Mandatory Step in Clinical Trials.
Journal Title: Journal of Biomedical and Pharmaceutical Research - Year 2012, Vol 1, Issue 2
Abstract
Voluntary written consent given by potential subjects to participate in a clinical trial is known an informed consent. The informed consent process is designed keeping in mind the safety, benefits and rights of the research participants. Participants should sign the informed consent form only after they have thoroughly read and understood the content given in informed consent form and they should be able to utilize all the benefits and rights mentioned in the form. Research team should make an attempt to clarify the potential subjects about the difference between Clinical trial and Pharmacotherapeutics. This article contains the history, key elements, basic requirements, influential factors and obstacles of informed consent process.
Authors and Affiliations
Kamlesh Garg*| MD, Assistant Professor, Department of Clinical Research, Jamia Hamdard University, New Delhi, Veena Verma| MD, Professor, Department of Pharmacology, VMMC and Safdarjung Hospital, New Delhi, Surinder Kumar| MD, Medical officer, Department of Anesthesia, VMMC and Safdarjung Hospital, New Delhi, Ruchika Nanda| MD, Assistant Professor, Department of Pharmacology, Dr HSJ Institute of Dental Sciences, Panjab University, Chandigarh
Keywords
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