title: Are institutional review boards prepared for active continuing review?
abstract: Continuing review is an important responsibility of Institutional Review Boards (IRBs). Though being mentioned by many of the national and international guidelines, it is carried out routinely only in UK. The reasons may be inadequate training, overworked IRBs, less enthusiasm among the IRB members, cost bearing, etc. So, the oversight mechanism at the local site, which is the responsibility of IRB is not fulfilled. Are there any solutions to overcome these difficulties? The IRBs should have a Standard operating procedure for continuing review, members can be regularly trained, institutions can create their own internal Data and Safety Monitoring Boards who will only monitor studies where monitoring systems are non-existing and there can be budget allocated at the start of the study by the sponsor or the institution. In this way, we can try to safeguard the rights and well-being of the study participants.
authors.affiliation: Department of Pharmacology and Therapeutics, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Parel, Mumbai, Maharashtra, India.
authors.forename: Yashashri C
authors.initials: YC
authors.lastname: Shetty
authors.affiliation: Department of Pharmacology and Therapeutics, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Parel, Mumbai, Maharashtra, India.
authors.forename: Kshitij S
authors.initials: KS
authors.lastname: Jadhav
authors.affiliation: Department of Pharmacology and Therapeutics, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Parel, Mumbai, Maharashtra, India.
authors.forename: Aafreen A
authors.initials: AA
authors.lastname: Saiyed
authors.affiliation: Department of Pharmacology and Therapeutics, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Parel, Mumbai, Maharashtra, India.
authors.forename: Akshay U
authors.initials: AU
authors.lastname: Desai
keywords: Continuing review; ethics; institutional review boards; monitoring; site visit