Informed Consent: A Mandatory Step in Clinical Trials.

  • *Kamlesh Garg1, Veena Verma2, Surinder Kumar3, Ruchika Nanda4 1MD, Assistant Professor, Department of Clinical Research, Jamia Hamdard University, New Delhi 2MD, Professor, Department of Pharmacology, VMMC and Safdarjung Hospital, New Delhi 3MD, Medical officer, Department of Anesthesia, VMMC and Safdarjung Hospital, New Delhi 4MD, Assistant Professor, Department of Pharmacology, Dr HSJ Institute of Dental Sciences, Panjab University, Chandigarh

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.

 

Published
2012-10-30
How to Cite
Surinder Kumar3, Ruchika Nanda4 *Kamlesh G. V. V. (2012). Informed Consent: A Mandatory Step in Clinical Trials. Journal of Biomedical and Pharmaceutical Research, 1(2). Retrieved from http://www.jbpr.in/index.php/jbpr/article/view/473
Issue
Vol. 1 No. 2 (2012)
Section
Short Communications

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