Kasturba Medical College and Kasturba Hospital Institutional Ethics committee.
The Institutional Ethics committee of Kasturba Medical College and Kasturba Hospital reviews and oversees biomedical and health research projects of the staff and students of Kasturba Medical College as well as other institutions of Manipal Academy of Higher Education. The committee also oversees device projects both regulatory and grant projects through ICMR, BIRAC, DST, DBT etc. with focus on implementation of uniform ethical standards to all projects. Even though the committee has had regular review of projects since August 2000, the KMC and KH IEC was formally registered under CDSCO since 2013.
The KMC and KH Institutional Ethics committee has reviewed over 900 projects per year consistently since 2015. The committee revises its SOP in keeping with the latest guidelines and is currently compliant with the ICMR 2017 guidelines for biomedical and health research, The Medical Device Rules 2017 and its amendments, the NDCT Rules of 2019 and the Guidelines for Ethics committees during COVID-19 pandemic. The SOP is currently in its 10th Version. In addition to registration under the CDSCO, the committee has received the mandatory provisional registration status under DHR (ICMR) in January 2020 with a formal recognition of fully registered status in January 2022. The committee has received NABH accreditation status in February 2019.
The Ethics committee in compliance with ‘Green’ university policy migrated to soft copy submission of projects in 2013 and email submissions from 2015. The Ethics committee ventured in to a dedicated software “IEC Interface” for project submission and first review system active since way back in April 2018 and is currently in its complete version with all IEC processes including periodic reviews, continuing approvals, communications to researchers, approval of amendments, tracking of project updates and search features embedded into the software.
The Ethics committee also conducts awareness programs in collaboration with the research cell of the various constituent institutes of MAHE. The committee members attend periodic update programs on Ethics and undergo yearly certification for GCP in collaboration with the Centre for Bioethics, MAHE. The committee pushes for mandatory GCP certification for students and faculty involved in academic trials and interventional studies.
The Ethics committee in order to ensure quality review, approval and monitoring process while dealing with the huge number of projects, registered a second ethics committee under DHR in December 2021, dedicated for reviewing low risk projects submitted by students of the constituent institutes of MAHE. The faculty projects, PhD projects and high-risk projects continue to be reviewed by the existing ethics committee.
Ethics committee members
IEC – 1 Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee.
Link: Ethics Committee 1
IEC – 2 Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee – 2 (Student Research)
Link: Ethics Committee 2
Institutional Animal Ethics Committee (IAEC)
The Institutional Animal Ethics Committee (IAEC) of Kasturba Medical College, Manipal was constituted and registered with the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) in 1999. It is renewed every five years. The registration number of the IAEC is 94/P/ReBi/S/99/CPCSEA.
Functions of the IAEC –
- The IAEC reviews and approves all types of protocols for research involving small animal experimentation before the start of the study.
- Ensures that every experiment is performed by or under the supervision of a duly qualified person.
- Ensures that experiments are performed in a humane manner and as far as possible experiments involving operations are performed under anesthetics approved by CPCSEA to prevent the animals from feeling pain.
- Ensures that experiments on animals are avoided wherever it is possible to do so and that experiments are not performed merely for the purpose of acquiring skills.
- Ensures that suitable records are maintained with respect to experiments performed on animals.
- IAEC members periodically visit animal house facility where the experiments are conducted. The Chairperson and Member Secretary review the CCTV footage of the animal house facility every fortnightly.
- Ensures that the concept of 4Rs (reduce, refine, replace, rehabilitate) is implemented to the best extent possible in animal experiments.
IAEC Members - Click here
For further details visit - https://cpcsea.nic.in/Auth/index.aspx
To download Form B click on - https://cpcsea.nic.in/WriteReadData/userfiles/file/New%20Form%20BFeb_2022.pdf