title: Impact of recent regulatory notifications on an institutional ethics committee.
abstract: The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court's orders and a Parliamentary Standing Committee's report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee's (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants' safety and well-being.
authors.affiliation: Department of Pharmacology and Therapeutics; Associate Professor, Seth GS Medical College and KEM Hospital, Parel, Mumbai, 400 012, India,. shrutibhide72@gmail.com.
authors.forename: Shruti S
authors.initials: SS
authors.lastname: Bhide
authors.affiliation: Assistant Professor, Seth GS Medical College and KEM Hospital, Parel, Mumbai, 400 012, India,. sharmila_jalgaonkar@rediffmail.com.
authors.forename: Sharmila V
authors.initials: SV
authors.lastname: Jalgaonkar
authors.affiliation: Administrative Officer; Department of Clinical Pharmacology, Institutional Ethics Committee, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400 012, India,. nayanvkatkar@gmail.com.
authors.forename: Janhavi V
authors.initials: JV
authors.lastname: Katkar
authors.affiliation: Assistant Professor, Seth GS Medical College and KEM Hospital, Parel, Mumbai, 400 012, India,. yashashrirajit@gmail.com.
authors.forename: Yashashri C
authors.initials: YC
authors.lastname: Shetty
authors.affiliation: Associate Professor, Seth GS Medical College and KEM Hospital, Parel, Mumbai, 400 012, India,. lookon@rediffmail.com.
authors.forename: Raakhi K
authors.initials: RK
authors.lastname: Tripathi
authors.affiliation: Additional Professor, Seth GS Medical College and KEM Hospital, Parel, Mumbai, 400 012, India,. pam2671@gmail.com.
authors.forename: Padmaja A
authors.initials: PA
authors.lastname: Marathe
authors.affiliation: Professor and Head, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400 012, India,. urmilathatte@gmail.com.
authors.forename: Urmila M
authors.initials: UM
authors.lastname: Thatte
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000941:ethics*; D003365:Costs and Cost Analysis; D026724:Ethical Review / Q000191:economics; D017041:Ethics Committees / Q000191:economics; D028744:Ethics Committees, Research / Q000191:economics; D033161:Government Regulation; D006801:Humans; D007194:India; D061214:Patient Safety