title: Serious Adverse Events Reports: Analysis and Outcome of Review by an Institutional Ethics Committee of a Tertiary Care Hospital in Mumbai, India.
abstract: The Indian regulations for clinical trials were amended in January 2013 regarding reporting time lines, relatedness, and compensation for Serious Adverse Events (SAEs). Our study assessed the extent of regulatory compliance in reporting SAEs to the Institutional Ethics Committee (IEC) over 4 years (January 2009-January 2013) before and 18 months after (February 2013-July 2014) the amended regulations. SAE reports were studied retrospectively for reporting time lines, relatedness, compensation, and IEC response before and after the law revision. Before 2013 had 89/160 (55.6%) SAEs reports submitted late while in the after period, only 2/11 reports were delayed (18%). In the before period, 26 SAE reports mentioned "relatedness" of which only 15 (57.6%) stated about compensation. After 2013, all the 9 non-death reports were complete. The IEC took median 17 days to respond before 2013, while after 2013 responded within 5 days. Thus, there was poor compliance in terms of SAE reporting time lines before the revision of the law.
authors.affiliation: Seth Gordhandas Sunderdas Medical College & King Edward Memorial Hospital, Mumbai, India lookon@rediffmail.com.
authors.forename: Raakhi K
authors.initials: RK
authors.lastname: Tripathi
authors.affiliation: Seth Gordhandas Sunderdas Medical College & King Edward Memorial Hospital, Mumbai, India.
authors.forename: Padmaja A
authors.initials: PA
authors.lastname: Marathe
authors.affiliation: Seth Gordhandas Sunderdas Medical College & King Edward Memorial Hospital, Mumbai, India.
authors.forename: Sandip V
authors.initials: SV
authors.lastname: Kapse
authors.affiliation: Seth Gordhandas Sunderdas Medical College & King Edward Memorial Hospital, Mumbai, India.
authors.forename: Yashashri C
authors.initials: YC
authors.lastname: Shetty
authors.affiliation: Seth Gordhandas Sunderdas Medical College & King Edward Memorial Hospital, Mumbai, India.
authors.forename: Sandhya K
authors.initials: SK
authors.lastname: Kamat
authors.affiliation: Seth Gordhandas Sunderdas Medical College & King Edward Memorial Hospital, Mumbai, India.
authors.forename: Urmila M
authors.initials: UM
authors.lastname: Thatte
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D035881:Compensation and Redress; D064420:Drug-Related Side Effects and Adverse Reactions; D017041:Ethics Committees; D019983:Guideline Adherence; D006801:Humans; D007194:India; D007883:Legislation, Medical; D061214:Patient Safety / Q000331:legislation & jurisprudence*; D012926:Social Control, Formal; D062606:Tertiary Care Centers
keywords: causality; clinical trials; compensation; law; regulation; research ethics