Process for application of ethical clearance and conducting research in CIHSR, Dimapur
Step 1: The requirements and guidelines for formation of the ethics committee and the process of ethical clearance are regulated by the ‘New Drugs and Clinical Trials Rules 2019’ under Drugs and Cosmetic Act, 1940. Go through the Ethical issues and responsible conduct of Researchers in the latest version of ICMR ‘National Ethical Guidelines for Biomedical and Health Research Involving Human Participants,2017’ and the ‘Declaration of Helsinki.’
- New Drugs and Clinical Trials Rules 2019 (1)
- National Ethical Guidelines for Biomedical and Health Research Involving Human Participants,2017’ (2)
- Declaration of Helsinki. (3)
Step 2: Documents are to be submitted in the appropriate formats. The formats can be downloaded in the IRB webpage intranet.
- Cover letter for initial review.
- Application for Initial review form.
- Informed consent document.
- Application for Social research form.
The study protocol should contain the ‘Essential components for study protocol’. See the list in the intranet and Guideline on writing the research protocol by WHO (4)
Step 3: For full board review, the committee sits four times in a year (see table below). The protocol and required documents have to be submitted atleast 1 month in advance to the IRB office and the official email.
|MEETING NUMBER||MONTH AND WEEK|
|1||February 3rd week|
|2||May 3rd week|
|3||August 3rd week|
|4||November 3rd week|
There are three type of review system:
1.Exemption from review; Proposal with less than minimal risk* where there are no linked identifiers.
- Expedited review; Proposal that pose no more than minimal risk*.
- Full committee review; All research proposal presenting more than minimal risk that are not covered under exempt of expedited review.
*See type of risk under National Ethical Guidelines for Biomedical and Health Research Involving Human Participants by ICMR, 2017
Step 4: Acknowledgement of receipt will be provided and a unique study proposal number will be given to the principal investigator (PI) once all required documents are checked by the IRB secretariat for completeness. The date for full board meeting will be intimated to the PI in advance. The PI should be ready with a short PPT of the study project for 5 min presentation. The clearance for study proposal is given in one sitting. Any amendment, if suggested, and subsequent contacts are done through electronic communication.
Step 5: The IRB requires from the PI a 6 months’ study report.
The IRB is to be informed of any amendment (s) in the study protocol, study completion or termination of study. The following format for reporting should be used.
Note: The overview of the whole process is given in a process map format ‘IEC initial review flowchart’