REPORT
One Day Dissemination Program on “ICMR National Ethical Guidelines for Biomedical and Health Research” was held on 19th September 2019 in Golden Jubilee Block, St John’s Medical College, Bangalore.
The Symposium started with session at (1:30-1:35pm) by Dr. Karuna ramesh kumar, by welcome notes to guests and participants. After that history of research ethics video was shown (1:35-1:50pm). Next session was given by Dr. Vasantha Muthuswamy (chairperson) on topic of “ overview of ICMR National Ethical Guidelines and newer initiatives of ICMR bioethics unit”. She spoke about the newer attachment and exclusion of guidelines with their benefits. Second session(02:45-03:15 pm) was given by Dr. Urmila Thatte (professor and head department of clinical pharmacology, seth GS medical college and KEM hospital Mumbai), on “update of new drugs and clinical trials rules and GCP GUIDELINES”. She informed about approval, new rules, compositions and procedures according to ICH. Open house discussion was started (03:15 -04:30 pm) by chairpersons of sub committees and members of advisory group. ethics committee, informed consent, public health research, collaboration, vulnerable population, bio banking and some other topics were discussed by Dr. Vasantha Muthuswamy, Dr.Urmila Thatte , Dr. Nandini kumar, Dr. Bikash Medhi, Dr. Savitha D, Dr. Pratibha Pereira. Benefits risk assessment, distributive justice, payment for participation, compensation for research related harm; ancillary care etc. was discussed by Dr. Vasantha Muthuswamy.
Dr.Urmila Thatte discussed about principles of public health research, ethical issues of epidemiological and public health research study design, use of administrative and other data sources for research, role of ethical committee, informed consent, stakeholder in public health research.
Dr. Nandini kumar gave information about informed consent requisites, information for prospective research participants, documentation of informed consent process, waiver of consents and other related issues.
Dr. Bikash Medhi informed about vulnerability, principles, protection or additional safeguards, duties of stakeholder, women in special situation, research among tribal population and among se workers, patients who are terminally ill.
Dr. Savitha D, Dr. Pratibha Pereira gave overview of bio banking, storage of specimens, ethical issues to donors and research, data of forensic departments of laboratories, governance of biobank, contingency plan etc.
Dissemination program ended at 4.30pm and delicious meal was provided.
Attended by: Mr. Ashish kumar