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| Dublin Core | PKP Metadata Items | Metadata for this Document | |
| 1. | Title | Title of document | Impact of recent regulatory notifications on an institutional ethics committee |
| 2. | Creator | Author's name, affiliation, country | Shruti S Bhide; Seth GS Medical College and KEM Hospital, Parel, Mumbai, 400 012,; IN |
| 3. | Subject | Discipline(s) | |
| 3. | Subject | Keyword(s) | |
| 4. | Description | 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. |
| 5. | Publisher | Organizing agency, location | Forum for Medical Ethics Society |
| 6. | Contributor | Sponsor(s) | |
| 7. | Date | (YYYY-MM-DD) | 2016-11-30 |
| 8. | Type | Status & genre | |
| 8. | Type | Type | |
| 9. | Format | File format | HTML , PDF |
| 10. | Identifier | Uniform Resource Identifier | https://www.issuesinmedicalethics.org/articles/impact-of-recent-regulatory-notifications-on-an-institutional-ethics-committee/ |
| 11. | Source | Title; vol., no. (year) | Indian Journal of Medical Ethics;: Ethics and medical education |
| 12. | Language | English=en | en |
| 13. | Relation | Supp. Files | |
| 14. | Coverage | Geo-spatial location, chronological period, research sample (gender, age, etc.) | |
| 15. | Rights | Copyright and permissions | All articles published in IJME are available on its website free of charge. The copyright for published material belongs to IJME/FMES. IJME freely permits the reprint (or reproduction on a website) of articles from the journal, as long as this is for non-commercial use and appropriate credit is given to the author and the journal and publication details are mentioned. The commercial use of our content can be made only after obtaining permission from and on payment to IJME. This is intended to support production of the journal. |