- Must investigators obtain IRB approval before involving human subjects in non-exempt research? Yes. Investigators need IRB approval before beginning all human subjects research. Investigators should provide the IRB with sufficient information to allow the IRB to complete a thorough review of the proposal.
- Are investigators responsible for obtaining and documenting informed consent? Yes. Investigators are responsible for obtaining and documenting the informed consent of research subjects or their legally authorized representatives, unless the IRB approves a waiver of informed consent or documentation of informed consent.
- What should investigators do if they want to revise an IRB approved research study? Should you wish to modify an already approved research study, you should submit a request to the IRB and receive IRB approval before implementing the proposed modification.
- Are investigators responsible for obtaining continuing review of research? Yes. Investigators are responsible for fulfilling requirements associated with continuing review in time for the IRB to carry out review prior to the expiration date of the current IRB approval.
- What are investigators’ responsibilities once a study is completed? If all research-related activities have been completed, including data analysis and paper writing the investigator is no longer required to obtain continuing review approval for the study. Investigators should request a termination of the study by notifying the IRB of the study’s completion.
IRB System FAQs
Q. Are there new IRBs?
A. No. The IRBs remain the same. Although the new IRB system is a collaborative effort with MedStar, the IRBs remain the same. The policies for which IRB you submit, remain the same.
Q. When will training for the new system be available?
A. Additional communication will be sent soon regarding dates, times and locations for training opportunities.
Q. How much longer will eRIC be available for the creation of new studies, amendments, continuing reviews, and adverse events?
A. As of November 12, the ability to create any new item in eRIC will no longer be available. Important things to keep in mind:
All items requiring full board review must be submitted in eRIC by November 12. That is the submission deadline for all December full board meetings. Anything requiring full board review and submitted after November 12 will not be processed by the IRB Office for review. Any full board item to be reviewed at a January full board meeting will need to be submitted in the new system after the go live date of November 29.
Although November 12 is the last day to create any new item in eRIC, all new items should be SUBMITTED by November 12 as well. This allows time for an administrative review in the IRB Office and review/approval prior to the data migration date of November 21. A study cannot be migrated into the new system if it has any open/unapproved item associated with it.
Q. What happens when I am no longer able to create a new study, amendment, continuing review, or adverse event in eRIC (as of November 12)?
A. Only emergent submissions (e.g., affect subject safety, must be submitted per policy, affect expiration of study, etc.) will be possible from November 12 until November 29 (go live date for new system). Should an emergent submission be necessary, it can be done via email to the IRB Board. The process and associated forms can be found on the IRB website. If a submission is not emergent, it will not be accepted by the IRB Office and will need to be submitted into the new IRB system after November 29.
Q. What happens if I need to submit something to the IRB while the system is down for data migration (11/22-28)?
A. Only emergent submissions (e.g., affect subject safety, must be submitted per policy, affect expiration of study, etc.) will be possible while the system is down for data migration. Should an emergent submission be necessary, it can be done via email to the IRB Board. The process and associated forms can be found on the IRB website. If a submission is not emergent, it will not be accepted by the IRB Office and will need to be submitted into the new IRB system after November 29.
Q. What happens to my protocol after November 29?
A. Protocols in an approved state that do not have an open/outstanding action, will have been migrated into the new system. All other protocols will remain in eRIC until any outstanding action has received an approval. Once outstanding actions have been approved, they will be migrated in batches. Please note that any study that has outstanding items after November 29 risks the chance of not having the actions approved for migration prior to eRIC no longer being available.
Q. When does the ability to submit any created item in eRIC permanently go away?
A. On December 5 the ability to submit any created item in eRIC permanently goes away. It is HIGHLY encouraged that all unsubmitted items be submitted to the IRB by November 12, or as close to that date as possible to allow adequate time for review and approval.
Q. Why is December 21 so important?
A. eRIC will no longer be available for any actions as of December 21. All outstanding items MUST be approved by this date for the study to be migrated to the new system. Failure to do so will result in the withdrawal of the unapproved item so the study can be migrated into the new system. The withdrawn item will then need to be created/submitted in the new system after the study has been migrated from the old system to the new.
Q. What will my migrated study look like in the new system? What will I need to do with my study once it is migrated into the new system?
A. Detailed information regarding what migrated studies will ‘look like’ in the new system, and what actions may be needed, will be provided during training. Dates, times and locations for training will be available soon.