title: Ethical and legal aspects of conducting clinical trials in alcohol withdrawal syndrome.
abstract: Alcohol Withdrawal Syndrome (AWS) is a condition where the patients will be mentally unstable initially and where later, with therapy, they gradually return to normalcy. As AWS comprises two stages; a mentally unstable state and a normal state of mind, the ethical and legal issues behind recruitment of these subjects become a little ambiguous in a clinical trial. This study was taken up to clarify the uncertainty regarding the biphasic states of minds (i.e. unstable mind and sound mind) of the subjects who were involved in a clinical trial done on AWS. Law and ethics regarding the clinical trials which involve psychiatric subjects need to be strengthened and amended from time to time, in order to protect the interests of both patients and physicians.
authors.affiliation: Postgraduate Student, Department of Pharmacology, Kempegowda Institute of Medical Sciences , Bangalore, India .
authors.forename: Vikram
authors.initials: V
authors.lastname: Reddy K
authors.affiliation: Postgraduate Student, Department of Pharmacology, Kempegowda Institute of Medical Sciences , Bangalore, India .
authors.forename: Harsha
authors.initials: H
authors.lastname: R
keywords: Alcohol withdrawal syndrome; Clinical trials; Ethics; Law; Off label use