Last Updated on November 6, 2024 by The Health Master
DTAB
The Drugs Technical Advisory Board (DTAB) has taken a significant step to simplify the registration process for ethics committees involved in biomedical and health research.
In its latest meeting, the DTAB approved a proposal to amend the New Drugs and Clinical Trials (ND&CT) Rules, 2019 (ND&CT Rules) eliminating the need for a two-step issuance of certificates for registration.
This decision aims to streamline the process and reduce administrative burdens for these committees.
The Current Registration Process
Under the existing ND&CT Rules, ethics committees seeking registration on the Naitik portal are required to submit an application in Form CT-01 to the Department of Health Research (DHR).
Upon review, the DHR grants a provisional registration valid for two years. Subsequently, a final registration is issued after a thorough scrutiny of the committee’s documents and compliance with the rules.
Related news: DTAB recommends changes to New Drugs and Clinical Trials Rules
DTAB’s Proposed Amendments
The DTAB has proposed amendments seek to consolidate the registration process into a single step.
By eliminating the requirement for both provisional and final certificates, the Board aims to reduce duplication of efforts and expedite the registration process.
The proposed changes involve modifying Rule 17 of the ND&CT Rules to allow the DHR to directly grant final registration to ethics committees upon review of their application.
If the committee fails to meet the required standards, the application will be rejected.
Rejection of Fee Implementation
In addition to the registration process, the DTAB also considered a proposal to introduce fees for registration and re-registration of ethics committees.
However, the Board rejected this proposal, emphasizing that ethics committees play a crucial role in safeguarding the rights and well-being of trial participants.
They are not business entities and should not be subjected to fees.
Recommendations for Ethics Committee Inspection
While rejecting the fee proposal, the DTAB recommended conducting regular inspections of ethics committees along with experts.
These inspections will help ensure that committees are adhering to the necessary standards and guidelines for ethical research.
In conclusion, the DTAB’s decision to streamline the ethics committee registration process is a positive development for the field of biomedical and health research.
By simplifying the process and eliminating unnecessary steps, the Board has made it easier for ethics committees to obtain the necessary approvals and contribute to ethical research practices.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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