title: Mandating audio-video recording of informed consent: are we right in enforcing this?
abstract: Medicines are the result of experimentation carried out in animals and humans. However, there are numerous instances in the history of medicine where humans were subjected to undue risks and abuses, requiring regulations for their safety. Idea of informed consent has found its presence in medical literature from the times of Hippocratic Oath propagating principles of '...never do harm to anyone' and physician directed care of patients. This was revived in post-world war II era in the form of Nuremberg code and the declaration of Helsinki in response to various debilitating experimentations done on prisoners in concentration camps and elsewhere. Complete information and voluntary participation forms the ethical tenets of these acts and the same has been reflected in various guidelines enacted worldwide, which are sufficient to make sure that patient consent is obtained in fair and just manner. Despite this, there have been undesirable lapses in the conduct of clinical trials. This situation worsens, when intentional lapses in conduct of trial hamper the ability of socially and economically disadvantaged communities in developing countries to make free and informed decision.
authors.affiliation: SIRO Clinpharm, DIL Premises, Thane, India.
authors.forename: A R
authors.initials: AR
authors.lastname: Agrawal
authors.forename: R P
authors.initials: RP
authors.lastname: Joshi
authors.forename: V
authors.initials: V
authors.lastname: Shah
mesh_terms: D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D014741:Video Recording / Q000941:ethics / Q000706:statistics & numerical data* / Q000639:trends