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Enrolling Patients in Government Hospitals
Following a directive from the Director of Health Services, SHSRC-Kerala formulated a guideline for patient enrolment in Government Hospitals for research studies in Kerala. This draft guideline was crafted by drawing heavily from the latest guidelines published by the Indian Council for Medical Research (ICMR) in 2017, which serves as the premier authority in India for guiding biomedical and health research involving human participants.
The guideline provides a comprehensive overview of the research purposes for enrolling patients in Government Hospitals. It delineates eight distinct procedures to elucidate the topic, covering:
General Procedure for obtaining permissions
Procedure for Obtaining permissions for submissions from outside the Health Department
Permission for participation
Participation enrolment
Payment for participation
Informing participants regarding the end of the study
Publication and dissemination
Special situations
Each topic highlighted in the draft proposal clearly articulates the essential decisions that the principal investigator must consider during the research process. Additionally, the draft proposal includes a clear disclaimer stating that the guideline is subject to amendments, and readers are advised to refer to the latest regulations/guidelines issued by the Government of India (GoI)/ICMR, as well as the most recent version of this guideline.
