Initial IRB review
Once a new study application is completed by the PI, it is submitted via the ABHATH E-submission system for review and approval. For all research team members, an immediate supervisor or chair must sign off on the protocol prior to participate in the study.
The research application must go through multiple levels of review processes (scientific, hospital governance, budget, legal) prior to the IRB review (please refer SOP #302 for MRC Review Process). Once the all aforementioned reviews are completed and the study is moved to IRB, the research application will be evaluated by an IRB Review coordinator for completeness and clarity. The coordinator may notify the PI with an initial correspondence and may request preliminary submission edits. The IRB coordinator will work with the PI to resolve the clarification/edits to finalize the submission.
All research studies involving human subjects are reviewed in one of three ways, Exempt Review, Expedited Review, and Full Review. The time from IRB submission to approval varies depending upon the type of review conducted by the IRB. The IRB coordinator is responsible for reviewing the submission and determining the appropriate level of review for the study as well as assuring that all necessary documents are included.
The principal investigator must prepare the required IRB documents in accordance with submission requirements of MRC. For more information related to submission process, please refer to SOP# 301 New Study Submission Process.
For research submissions meeting any one of the exempt categories, IRB will issue an exempt approval.
- If the protocol does not require Expedited or Full Board Review, MRC will confirm that the study is exempt from further review after all documents are in order. For research submissions meeting any one of the exempt categories, IRB will issue an exempt approval letter.
- If the protocol requires an Expedited Review, IRB coordinator will forward the complete submission to the IRB office. The Expedited Review is conducted by the IRB Chair or his/her designee. The IRB member(s) will prepare his/their pre-review and this will be forwarded to the HMC-IRB chair for final decision and approval. This can take up to 14 working days.
- If the study requires full board review by the HMC-IRB, then the study documents will be sent to one of the HMC-IRB members (keeping the HMC-IRB chair in the loop of their review) for their review and presentation of the study during the forthcoming IRB meeting. IRB Meetings are scheduled to occur biweekly and hence full board studies may take up to 30 working days for approval.
For further information regarding IRB review process please refer to MRC-SOP. Continuing review process
MoPH regulations require that IRB approved research be reviewed by the IRB no later than one year from the date of approval - or sooner if the IRB determines that the nature of the research warrants shorter review intervals. No study may continue beyond the one-year approval until the IRB has reviewed the continuation request. Researchers are also reminded that the IRB may conduct audits at intervals sooner than continuing review periods.
In order to allow for review and approval of a continuation request, investigators are advised to submit the Progress Report for Continuing Review of IRB Approved Studies and all appropriate documentation by no later than two months before the expiration of the protocol’s approval date. Progress Reports and related documents need to be submitted at least 60 days prior to study expiry date so as to allow sufficient time for continuing review and approval.
Please note, if the initial study submission was processed via ABHATH-Research Software, continue to use the system for completing the Progress Report forms as well. If you completed your initial submission form via the old paper format, please communicate with the MRC office via AbhathSupport@hamad.qa
prior to the submission of this form.Revisions/Amendments
If the investigator, during the course of conducting the research, revises the research protocol (e.g. makes changes to the study design, informed consent form, data collection instruments used, or number and nature of subjects), the principal investigator should notify the MRC office immediately as an amendment. MRC will determine whether the requested amendment needs to go through Scientific or Hospital Governance review again before moving the same to IRB. The IRB Chair will determine the need for additional review, the type of review required (full or expedited) and notify the IRB members.
It is important to note that:
1) The principal investigator will have a provision in the online system to submit the request to make any changes in the protocol via amendment request in ABHATH
2) No changes can be implemented until the Chair and/or the IRB Committee accept/approves the changes
3) Failure to do so may result in the protocol’s suspension and/or termination.
4) Requests for review of amendments follow the same review process and amendments submitted as "minor" for full reviewed studies may be determined as requiring full reviewFinal reports
If and when a PI wishes to close his/her study they need to fill up the Final Report form and provide the same with additional requested documents to the IRB. The Final report is reviewed by the Chair and Closure letter communicated from the IRB. IRB Review Process Map
The following link provides an overview of the review process from the initial submission of your research protocol to the final approval.IRB Guidelines WorkflowPlease Note: The MRC Office is no longer accepting Research Protocol Submissions via the paper format. All new submissions must be submitted using the new E-Submission System – ABHATH. Please see our ABHATH Electronic Submission System page for more information regarding the E-Submission.