INFORMED CONSENT STATUS IN OBSERVATIONAL STUDIES WITH RETROSPECTIVE DESIGN: A POOR SHOW


Parveen Bansal, Supreet Kaur Gill, Vikas Gupta

Abstract


ABSTRACT
Objective: Informed consent is very important to protect the rights of patients and is obtained as a vital component of any clinical study. Requirement
of patient consent in retrospective research continues to stir controversy even today. Some of directions of regulatory authorities even waive off the
consent for retrospective studies, whereas few recommend that at least clearance from the Ethical Review Board may be taken or information to
patient may be given or oral consent must be given by patient for usage of the data in any retrospective study. The aim of this study was to analyze the
current status of informed consent procedures in observational studies with retrospective design.
Methods: This review was intended to find out the current status of procedures involved in informed consent in India and abroad. A total of 100
retrospective studies were searched for this objective from the internet and other literature sources.
Results: Data show that in 65% of studies neither informed consent/oral consent nor ethical clearance was taken. Only 1% of studies have been
conducted with informed consent as well as ethical clearance. Only 14% of studies were conducted with informed consent and 21% with ethical
approval.
Conclusion: The study reflects very poor status of informed consent in retrospective studies and noncompliance of ICH guidelines for clinical research
in relation to informed consent.
Keywords: Clinical research, Informed consent, Retrospective studies.


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About this article

Title

INFORMED CONSENT STATUS IN OBSERVATIONAL STUDIES WITH RETROSPECTIVE DESIGN: A POOR SHOW

DOI

10.22159/ajpcr.2017.v10i3.16588

Date

01-03-2017

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Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 10 Issue 3 March 2017 Page: 480-487

Print ISSN

0974-2441

Online ISSN

2455-3891

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89 Views | 146 Downloads

Authors & Affiliations

Parveen Bansal
University Center of Excellence in Research, Baba Farid University of Health Sciences, Faridkot
India

Supreet Kaur Gill
University Center of Excellence in Research, Baba Farid University of Health Sciences.
India

Vikas Gupta
University Center of Excellence in Research, Baba Farid University of Health Sciences.


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