International Journal of Clinical Trials | July-September 2014 | Vol 1 | Issue 2 Page 49
International Journal of Clinical Trials
Pazare PK et al. Int J Clin Trials. 2014 Aug;1(2):49-54
http://www.ijclinicaltrials.com pISSN 2349-3240 | eISSN 2349-3259
Research Article
Are we requesting the right consent?
Pradeep K. Pazare, Vithalrao P. Dandge*, Nilofer S. Mujawar, Meenakshi Girish
INTRODUCTION
In modern days, the doctor is no longer held in high
esteem. The faith in the healer has been slowly waning.
The gentleman’s agreement no longer holds true and
every agreement is now in black and white. Today the
doctor is viewed with suspicion and the doctor too
safeguarding himself or herself prefers to have a consent
for everything. Consent is an ethical principle. Medical
treatment can only be administered with consent of a
competent patient. Giving the treatment without consent
is failure to respect patient’s autonomy; violating an
individual’s right to self-determination. Any medical
treatment given without consent is an action for trespass
where damages are payable.
Patients are admitted in hospitals wherein they undergo
therapy in the form medications, investigations which
could be invasive non-invasive or interventions or
surgeries. In all the above mentioned situations the
patient has to agree to the required therapy. When a
patient walks into a doctors’ office, it is understood that it
is a voluntary act and he/she implies that he/she is willing
to undergo a clinical examination by the doctor and
accept the treatment prescribed thereof. But if a person is
admitted in a hospital, the person has to be informed at
every step the findings of the clinical examination and
consent obtained for further therapy. This is done by
obtaining his/her signature to consent to any treatment.
This important piece of paper is called a consent form.
METHODS
We conducted a cross sectional study to evaluate the
consent forms from various hospitals. We designed an
ideal consent form which covered 20 ethical and medico
legal aspects. This was validated by experts in the clinical
field, lawyers and medico legal expert. In the city of
ABSTRACT
Background: Medical treatment can only be administered with consent of a competent patient. Giving the treatment
without consent is failure to respect patient’s autonomy; violating an individual’s right to self -determination.
Methods: We conducted a cross sectional study to evaluate the consent forms from various hospitals. Consent forms
of 372 out of 750 medical institutes in Nagpur were evaluated under 20 ethical and medico legal aspects of an ideal
consent form.
Results: Most of the consent forms lack important clauses of an ideal consent form that can go against the treating
doctors in the court of law.
Conclusions: Doctors need to be trained to design a consent form. They need to be made aware of the medico legal
rights of the patient. The consent form is for the patients to acknowledge that the nature and purpose of treatment has
been fully explained, understood and consented to. Remember patients never consent to doctor’s negligence but only
to risks and complications.
Keywords: Consent, Medico legal
Department of Paediatrics, NKPSIMS & LMH, Nagpur, Maharashtra, India
Received: 5 July 2014
Accepted: 20 July 2014
*Correspondence:
Dr. Vithalrao P. Dandge,
E-mail: dandge_vp@yahoo.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI: 10.5455/2349-3259.ijct20140803