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The Committee for Control and Supervision of Experiments on Animals (CCSEA), a statutory Committee of Department of Animal Husbandry and Dairying (DAHD) constituted under the prevention of Cruelty to Animals (PCA) Act, 1960, has announced the schedule for inspection of animal facilities of Clinical Research Organisations (CROs), Research and Development (R&D) laboratories and other research establishments, along with guidelines and Standard Operating Procedures (SoPs) for inspection.
The move is to streamline the processes of inspection, protocol review, institutional feedback and ethical compliance, said the Committee while announcing the structured processes. The guidelines and directions are for immediate implementation by all the establishments registered with the CCSEA and nominees of the Committee.
"All establishments shall ensure full cooperation, availability of responsible personnel, access to facilities and records, and adherence to all regulatory requirements, during inspections," said the Committee.
According to the schedule, the first inspection will be conducted by all nominees of the Institutional Animal Ethics Committee (IAEC), the second mid term inspection to check the status of animal facilities and research protocols to be conducted after six months from the first inspection, and the third inspection after six months from the second inspection.
In the first inspection, the inspection report shall be submitted by the main or link nominee and the inputs of scientists from outside to Institute and Socially Aware Nominee shall be included in the reports.
Further, scientist from outside the Institute or Socially Aware Nominee should submit their observations online, and in cases where they have no comments, they should specifically record that "there is no comment to offer," it added.
The second inspection is scheduled to be held under the aegis of the members of the CCSEA, consultant of CCSEA, and main nominee of the respective establishment. The third inspection has to be conducted by the main nominee of the CCSEA.
The Committee also released a standard proforma for obtaining feedback from registered establishments on the functioning, conduct, and compliance support provided by the CCSEA nominees, in order to strengthen transparency and improve oversight quality. It directed that all establishments should submit a completed proforma, annually.
The establishments registered with the CCSEA shall also mandatorily obtain the 'Statement of confidentiality and conflict of interest' statement in a prescribed format, duly signed by all nominees of CSEA appointed to their IAECs.
The Committee elaborated on the SoPs for processing of research protocols involving large animals.
The SoP advices that the establishments shall submit the research protocols on large animals by seventh of every month for consideration of the Committee in its meeting. If seventh happens to be a holiday, then the next working day would be considered as last date for accepting the research protocols for that particular month.
In case of any deficiencies, queries will be raised through the website of CCSEA, and the establishments need to submit response within two working days. The protocol will not be considered in the meeting of the respective month, if the establishment does not submit the receipt in the prescribed time line.
Protocols shall be evaluated by the sub-committee within seven working days, which would be followed by the meeting of sub-committee for scrutiny of the research protocols. The deficiencies and queries raised by the sub-committee will also be forwarded through the CCSEA website within three working days and the establishments need to submit response within two working days through the website. The research protocols shall be placed before the Committee every month for decision, it added.
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