ArticlePerspectives in clinical research
Status of registration, re-registration, and accreditation of ethics committees with Central Drugs Standard Control Organization, Department of Health Research, and National Accreditation Board for Hospitals and Healthcare Providers - An evaluation of the extent of ethics oversight in the country.
Article in Perspectives in clinical research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Context: The "New Drugs and Clinical Trials Rules 2019" mandates that Ethics Committees (ECs) register with the Central Drugs Standard Control Organization (CDSCO), while ECs overseeing Postgraduate (PG) theses and academic studies must register with the Department of Health Research (DHR). National Accreditation Board for Hospitals and Healthcare Providers (NABH) accreditation of ECs is currently optional. Aim: To evaluate the current status of EC registration and re-registration with CDSCO, DHR and accreditation of NABH as a metric of ethical oversight. Subjects and Methods: Data from January 1, 2019, to September 30, 2022 were collected from the organizational websites and the National Medical Commission (NMC). Registration and re-registration data for ECs were matched against the volume of studies in the Clinical Trials Registry India (CTRI), the number of ECs per state, and state populations. Descriptive and inferential statistics were applied. Results: Of the 770 ECs registered with CDSCO, 38.3% were reregistered. Of the 977 DHR-registered ECs, only 17% were re-registered. Among 370 NMC-recognized PG medical institutes, 49.72% had DHR-registered ECs. Only 13% (186/1400) ECs were NABH accredited from the overall data. A total of 14,551 regulatory studies were registered with CTRI. Among the major states (>4% of Indian population), Maharashtra had the highest percentage of CDSCO-registered ECs at 20% and accounted for 14% of regulatory studies, while states such as Bihar and West Bengal had lower percentages of both CDSCO registered ECs and regulatory studies. Conclusion: The registration, re-registration status of ECs, and accreditation are not commensurate with the quantum of regulatory and academic studies in the country.
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Registered trials
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