Overview of the National Ethics Committee Registry for Biomedical and Health Research in India Stepping up to safeguard the ethical aspect of research involving human participants (Record no. 20818)
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| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20240330135854.0 |
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| fixed length control field | 240330b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 23128 |
| Author | Venugopal, Balu |
| 245 ## - TITLE STATEMENT | |
| Title | Overview of the National Ethics Committee Registry for Biomedical and Health Research in India Stepping up to safeguard the ethical aspect of research involving human participants |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.55(4), Jul-Aug |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Mumbai |
| Name of publisher, distributor, etc. | Wolter Kluwer |
| Year | 2023 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 251-256p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | As notified in the New Drugs and Clinical Trials Rules 2019, ethics committees (ECs), intending to review and oversee the conduct of Biomedical and Health Research (BHR) shall be required to register with the authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research (DHR). The entire process of receiving and processing such applications is done online through the Naitik portal. Vide these rules, it has become mandatory for all institutions/entities whether publicly or privately conducting or intending to conduct BHR involving the human participants, to get their EC, registered with the DHR. A status report of the functioning of the National Ethics Registry and an analysis of ECs registered with the DHR are presented in this manuscript. A workflow of the processing involved in EC registration is given with sectorial segregation, and analysis of data on ECs across the country is made for the dissemination and information. This article elaborates on the registration requirements and process of the EC registry with the necessity of being registered with the DHR. 2100 login requests and more than 1560 applications for registration have been received; private hospitals and medical colleges have been the front-runner in getting their organization registered, and organizations in the commercial sector are faring better in terms of EC registration. Further dissemination and outreach efforts have to be made to draw the attention of various stakeholders regarding this requirement and thereby ensuring that all ECs in the country are registered with the DHR. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4774 |
| Topical term or geographic name entry element | PHARMACOLOGY |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 23129 |
| Co-Author | Nagar, Anu |
| 773 0# - HOST ITEM ENTRY | |
| Place, publisher, and date of publication | Andheri - Mumbai Wolters Kluwer India Private Limited |
| International Standard Serial Number | 0253-7613 |
| Title | Indian Journal of Pharmacology |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://journals.lww.com/iphr/fulltext/2023/55040/overview_of_the_national_ethics_committee_registry.7.aspx |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | School of Pharmacy | School of Pharmacy | Archieval Section | 30/03/2024 | 2024-0339 | 30/03/2024 | 30/03/2024 | Articles Abstract Database |