Perspectives in Clinical Research

ETHICS EDUCATION
Year
: 2018  |  Volume : 9  |  Issue : 2  |  Page : 91--94

Monitoring of approved studies: A difficult tightrope walk by Ethics Committees


Sanish Davis 
 Senior Medical Director and Head, Clinical Operations, Covance India Pharmaceutical Services Pvt. Ltd; General Secretary, Indian Society for Clinical Research, Mumbai, Maharashtra, India

Correspondence Address:
Dr. Sanish Davis
1803, Sapphire, Nirmal Lifestyle, Mulund West, Mumbai - 400 080, Maharashtra
India

Continuing review of studies approved by the Ethics Committees (ECs) involves review of the progress of the study, annual reports, protocol deviations/violations, serious adverse event monitoring, and on-site monitoring. International and national regulations and guidelines for continuing review state that it is an opportunity for the EC to be assured that risks to subjects are minimized and is are reasonable in relation to anticipated benefits if any to the subjects and the knowledge it will generate. There are several barriers (e.g. lack of workforce, lack of training of members for conducting onsite review, and poor infrastructure) for ECs to do ongoing review of projects approved by them. Industry is an important stakeholder for the research enterprise in India and strongly advocates that ECs should at a minimum have pragmatic standard operating procedures for continuing review/monitoring of studies initially approved. ECs which deal with larger volume of studies with well-functioning secretariat, appropriately trained EC members and funding should definitely conduct onsite review/monitoring in addition to the ongoing review.


How to cite this article:
Davis S. Monitoring of approved studies: A difficult tightrope walk by Ethics Committees.Perspect Clin Res 2018;9:91-94


How to cite this URL:
Davis S. Monitoring of approved studies: A difficult tightrope walk by Ethics Committees. Perspect Clin Res [serial online] 2018 [cited 2019 Oct 20 ];9:91-94
Available from: http://www.picronline.org/article.asp?issn=2229-3485;year=2018;volume=9;issue=2;spage=91;epage=94;aulast=Davis;type=0