List of documents required for Ethics committee (EC) submission

There are two types of ethics committees(EC) 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(IEC) 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

List of Ethics committee documents

  1. Protocol
  2. Case record form
  3. Informed consent form or site specific informed consent form (English copy along with copies in Vernacular languages)
  4. Patient information sheet ( English copy along with copies in vernacular languages)
  5. Patient diary (English copy along with copies in vernacular languages)
  6. Investigator’s brochure
  7. Proposed methods for patient recruitment (Advertisements, Posters etc.)
  8. Clinical Trial Agreement
  9. Protocol signature page
  10. Investigator’s undertaking
  11. Principle Investigator’s Curriculum vitae
  12. Principle investigator’s medical registration certificate
  13. Principle Investigators No conflict of interest statement
  14. Study Insurance
  15. Letter of Indemnification

After completion of submission process along with processing fee cheque, EC will review the documents.

Note: A few ethics committees will have Scientific research society / scientific review board / scientific committees. They will screen and study the submitted documents then forward the project to Ethics committee.

Related: Types of clinical trials

EC 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

  1. Approved
  2. Queries raised
  3. Conditionally approved
  4. Rejected

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. 

Queries raised: In this scenario, EC may raise the queries regarding the study from any point of view (patient safety/ study protocol etc.).

For eg.

1. Explain why ‘n’ numbers of blood tests will be done in short period of time.

2. Explain the rationality for studying the combination of these x and y drugs. Etc.

Receiving queries from the Ethics committee, sponsor need to respond with proper explanation. Required supported documents should be produced in front of EC in the next scheduled meeting with amendment fee.   

Conditional approval: In this case, Ethics committee is okay with the study procedure. EC may instruct that after fulfilling the particular requirement only, this approval is valid.

Rejected: 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.