Ethics committee submission required documents
Ethics committee overview
There are two types of ethics committees available in India. These are Institutional ethics committee and Independent ethics committee. You can also see the more details about these two ECs here. Here we have provided a list of documents required for Institutional ethics committee for protocol review. Documents requirement also differ from each institutional ethics committees. It is defined according to their standard operating procedures(SOPs). These mentioned documents should be produced in ‘n’ number of sets. Along with these documents hard copies, soft copies should be copied to a CD (Compact Disk) for reference.
Overall required documents are as follows
- Case record form
- Informed consent form or site specific informed consent form (English copy along with copies in Vernacular languages)
- Patient information sheet ( English copy along with copies in vernacular languages)
- Patient diary (English copy along with copies in vernacular languages)
- Investigator’s brochure
- Proposed methods for patient recruitment (Advertisements, Posters etc.)
- Clinical Trial Agreement
- Protocol signature page
- Investigator’s undertaking
- Principle Investigator’s Curriculum vitae
- Principle investigator’s medical registration certificate
- Principle Investigators No conflict of interest statement
- Study Insurance
- Letter of Indemnification
After completion of submission process along with processing fee cheque, Ethics committee will review the documents.
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Note: A few ethics committees will have Scientific research society or scientific review board or scientific committee. These will screen and study the documents then forward the project to EC.
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Ethics committee will take final decision. Final decision will be decided by voting of ethics committee members. The decision may be anything. Usually types of responses will be given by an Ethics committee are
- Queries raised
- Conditionally approved
It is a positive decision for sponsor or study personal. Letter will be issued with protocol number, version number and date. It includes all the details about attended members and list of documents reviewed. It also contains general rules. Those are like inform the progress of study/ Serious adverse events should be informed/ follow the ICMR/ ICH GCP/ Schedule Y guidelines/ study should be registered with CTRI etc.
In this scenario, EC may raise the queries regarding the study from any point of view (patient safety/ study protocol etc.).
1. Explain why ‘n’ numbers of blood tests will be done in short period of time.
2. Explain the rationality for studing the combination of these x and y drugs. Etc.
Receiving queries from the EC, sponsor need to respond with proper explanation. Required supported documents should be produced in front of ethics committee in the next scheduled meeting with amendment fee.
In this case, EC is okay with the study procedure. EC may instruct that after fulfilling the particular requirement only, this approval is valid.
If EC not at all satisfied with the study protocol including unethical procedures. EC may reject the study. Rejection letter will be issued with reasons.