Frequently Asked Questions (FAQs)
1) How do I get an ethical clearance for my research study?
• You need to submit the following documents to the CIHSR IEC office (hard copy) and soft copy to [email protected].
- Initial review form (Available for download at CIHSR-IRB webpage)
- Cover letter (Available for download at CIHSR-IRB webpage)
- Curriculum Vitae (CV) (Format available for download but a modified format is also acceptable provided it has all the required details, refer Box 5.1 in page 50 of ICMR ethical guidelines 2017)
- Proforma / protocol of the study
- Informed consent document
- Questionnaires of the proposed study
2) Can I request ethical clearance for clinical trials study?
- The New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Acts 1940 has given separate distinction between biomedical research and clinical trials. The CIHSR IEC only reviews studies that involves human beings which qualifies as Biomedical research (see definition in the CIHSR-IRB home page)
3) What necessary certification is required for researcher?
- The review board will take into consideration as part of the ethical review whether the investigators are qualified for the particular study. Good clinical practice certification is desirable from the principle investigator/s.
4) I want to conduct research outside the hospital premises, can I get IRB approval?
- IRB approval can be requested for studies done outside the hospital premises. The IRB main issue will be the feasibility of site monitoring. If site monitoring is not possible for the CIHSR IEC request maybe rejected.
5) What are the levels of ethical review?
• There are there levels of ethical review depending on the risk involved in the study:
- Full board review
- Expedited review
- Exemption from review
For more detail read the table 2 of initial review of submitted protocol under Standard operating procedure. Generally retrospective studies can be reviewed under expedited review to reduce the time.
6) How long will the entire process of IRB review take?
- The process starting from submission of study protocol to the final approval depends on the type of ethical review. Full board review generally takes the longest time with average duration of 1 week to 30 days.
7) How do I ensure that there is no delay in the processing of the IRB application?
- You have to make use of the checklist provided in the initial review forms for completeness of the IRB application. The CIHSR IEC has both ethics and scientific reviewing members, however it is desirable to submit or note critical appraisal of the study from unbiased sources.
8) What do I have to note after IRB ethical clearance?
- The duration of the ethical clearance is only for a period of 1 year. After expiry a fresh clearance is required using the continuing report form. Fresh full board review maybe be required depending on the report. Mandatory submission of the final report is required using the final report form.
9) Do I have to communicate to the IRB if there are any changes (amendments) in my study design after the ethical clearance?
- It is mandatory to communicate to the IRB for any amendments. You can use the protocol amendment form. Depending on the amendments if there is a serious deviation of the study methods, the IRB can stop the study and a fresh review will be required.
10) Do case studies require IRB approval?
- Case studies may not require IRB approval. Kindly contact [email protected].
11) Do I need to get IRB approval for my class project as I have to collect data from people?
- Class projects do not qualify as research and therefore it does not need IRB approval.
12) Do I need to get IRB approval from CIHSR IEC if I am collaborating with a study done elsewhere?
- Unless you plan to recruit participant within the premises of the hospital an IRB approval is not required.
13) What are the need to know information before I apply for IRB approval?
- Basic understanding of conducting research is required. Certification courses are available at https://swayam.gov.in/. It is necessary for researchers to know the issue in studies involving humans (kindly read ‘responsible conduct of research’ under conducting research in CIHSR).