Frequently Asked Questions (FAQs)
1. What types of studies ethical approval by the RERC?
The Research Ethics Review Committee (RERC) reviews all types of studies involving human participants and their identifiable private information, human material or specimen, or any data through intervention or interaction with the human participants (Refer to CRERC SOP 3.1).
2. Who can submit research proposals for ethical review?
Any of the following can submit research proposals for ethical review:
• MDMRCI & ARMCI employees (paramedical and medical nurses, allied health administrative) doing research within and outside the hospital.
• Researchers from outside MDMRCI who will involve MDMRCI & ARMCI employees and patients.
• Researchers endorsed by other institutions with no Research Ethics Review Committee, provided they will accept the review done by and agree with the rules and regulations as practiced by MDMRCI & ARMCI CRERC.
• Refer to CRERC SOP 3.1.
3. What are the requirements for submission of research proposals for ethical review?
A complete protocol packet that includes the following:
• Cover Letter (addressed to the RERC Chair)
• CRERC Forms
• Protocol Synopsis
• Full Study Protocol (with version number, date and page number).
• Other Documents (refer to the CRERC SOP 3.1 and CRERC Form 3.4 Document Checklist for a complete list of documents).
4. How do I submit the protocol package?
Submit application for initial review through email with subject INITIAL SUBMISSION -NAME OF PRINCIPAL INVESTIGATOR Wait for the confirmation email from the CRERC if submission is complete When deemed complete, CRERC shall notify the Principal Investigator of the next step (refer to SOP 3.1 for Initial Review, SOP 4.4 for Review of Resubmission, SOP 7.4 for Review of Protocol Amendment, SOP 7.2 for Continuing Review Application, SOP 7.3 for Review of Final Report, SOP 7 4 for Review of SAE Report, SOP 7.5 for Review of Protocol Violation/Deviation Report and SOP 76 for Review of Early Study Termination Report).
5. When is the deadline of submission to be included in a full board review?
REC regular full board meetings are scheduled every first Tuesday of the month Protocols requiring full board review should be submitted 15 days before the date of the review meeting.
6. What is the turn-around time of the approval of the protocol?
Refer to the Review Process Flow Chart for Initial and for Post Approval Reviews.
7. I already have ethical approval from another REC, should I still submit protocol for RERC review?
Yes, if the ethical approval was given by another REC The CRERC will review the entire protocol document package again before it can issue an ethical approval.
If the ethical approval was given by the Single Joint Review Ethics Board (SJREB) CRERC will only review the Study Participant Recruitment Plan (which includes a description of the informed consent process), the ICF/s, and the qualification and disclosure of COI of the Researcher/Pl of the local study site. The Lead/Coordinating Researcher PI or the CRO must present the Certificate of Approval from SJREB.
8. The initial review of the protocol requires modifications, how many days do I need until I resubmit the revisions?
Protocol revisions in response to the requirements of the Primary Reviewers during the initial review should be submitted within 90 days after receipt of the notification (Refer to SOP 4.4).
9. What happens when I do not submit revisions within the specified time?
The Principal Investigator is given ninety (90) calendar days from the date of the Notification of CRERC decision of the review of the last resubmission (with or without letter of request to withdraw from the review process) to comply with the requirements suggested by the Primary Reviewers. If this is not met, the study protocol is deemed inactive and will be archived (Refer to SOP 9.3 Archiving of inactive Protocols).