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SOP for Nipah related Studies
In response to the resurfacing Nipah outbreak in 2023, various departments and health organizations have intensified their studies on Nipah virus-related contents. Recognizing the need for improved research standards, the State Health Systems Resource Centre (SHSRC) has developed Standard Operating Procedures (SOPs) to bolster studies related to the Nipah Virus.
The SOP is tailored to encompass both Human and Animal Studies. For studies involving Human Participants, an Investigating Team is deemed necessary, led by a Principal Investigator (PI) who may be accompanied by co-Investigators. Either the PI or Co-PI shall represent the Government of Kerala and can be sourced from Health Services, Medical Education, National Health Mission, or the State Health Systems Resource Centre- Kerala.
During the proposal submission stage, SHSRC plays a vital role. Study reports must be submitted to the Government of Kerala and obtain approval before publication. Research proposals under the Directorate of Medical Education (DME) are verified by the respective Human Ethics Committee, while those under the Directorate of Health Services are verified by the Institutional Ethics Committee at SHSRC. Proposals from non-governmental or national-level institutes require clearance from respective HECs or approval from SHSRC-Kerala or the State Board of Medical Research (SBMR).
Key components of a research proposal include Data collection, Study Procedures, Privacy and Confidentiality, Conflict of Interest, and securing Sponsorship, Grant, or funding. Regarding Animal studies in Nipah-related research topics, joint approval from the concerned department and the Director of Health and Family Welfare (DoHFW) is imperative for study conduct. Relevant interim and final study reports are to be communicated to the Department of Health Services (DHS), Directorate of Medical Education (DME), and the Director of Health and Family Welfare (DoHFW).