title: Establishing institutional ethics committees: challenges and solutions - a review of the literature.
abstract: This review of the literature was conducted to identify the challenges faced while establishing institutional ethics committees (IECs) as well as to suggest some solutions. The search of the literature was carried out with the help of the PubMed search engine, using “research ethics committees” (MeSH] and “India” (MeSH]) as the key words for articles published between 2004 and 2012. We found 31 articles related to the topic, and the most common challenge mentioned was inappropriate functioning of IECs (n=17), followed by inappropriate structure (n=14). The authors identified many challenges related to the lack of oversight by regulatory bodies (n=14) as well as issues pertaining to the ethical training of IEC members and investigators (n=13). It is evident from the multitude of papers on the issue that the challenges related to the constitution and functioning of IECs must be given the attention they deserve to ensure that research participants in India are better protected.
authors.affiliation: In-charge, Central Sterile Services Department (CSSD), Bhaktivedanta Hospital, Mira-Road (East), Thane, Mumbai, Maharashtra 401107.
authors.forename: Mukta S
authors.initials: MS
authors.lastname: Kuyare
authors.affiliation: Superspeciality Medical Officer, Department of Clinical Pharmacology, 5th Floor, "G" Building, TN Medical College and BYL Nair Charitable Hospital, Mumbai Central, Mumbai, Maharashtra 400 008 INDIA.
authors.forename: Santosh R
authors.initials: SR
authors.lastname: Taur
authors.affiliation: Professor and Head, Department of Clinical Pharmacology, 1st Floor, Multi-storey Building, Seth GS Medical College and KEM Hospital, Parel, Mumbai, Maharashtra 400 012 INDIA e-mail: urmilathatte@gmail.com.
authors.forename: Urmila M
authors.initials: UM
authors.lastname: Thatte
mesh_terms: D017041:Ethics Committees / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards / Q000639:trends; D028744:Ethics Committees, Research / Q000458:organization & administration; D032984:Ethics, Research / Q000193:education*; D006801:Humans; D007194:India; D012108:Research Personnel / Q000193:education / Q000941:ethics