Frequently Asked Questions

Contact the ORSIRB Administrator. The IRB Administrator will create an account for you.

On the main login page of the electronic IRB system, click “Forgot password.” The electronic IRB system will send you an email with instruction to log into the system.

For all pre-submissions that are not submitted or request for additional time is not received in 30 days, the submission will be discarded. Please check to make sure you submitted the study. If you have submitted the study, contact the IRB Administrator.

An IRB determination is required BEFORE starting any study. This is very important. If you begin your research and start collecting data or biospecimens for human subjects without prior IRB determination, you risk losing all of that data/biospecimens and must begin again with the collection process.

If you have a project that involves contacting people or using their data or biospecimens, contact the IRB Administrator/Staff. No human subjects research can start without prior IRB review and determination (or an institutional review). Do not attempt to determine that your project is not research involving human subjects.

Yes. All studies that interact or use data about people must be reviewed by the IRB. Reach out to the IRB Administrator to discuss before submitting anything in the electronic IRB system.

According to federal regulations, all key project records must be retained for three years following project closure.

Key project records include the following:

• Correspondence with the IRB
• Copies of the latest IRB approved protocol, consent form, and any other documents reviewed/approved by the IRB
• Summary project data
• If consent forms are used, copies of all signed consent forms

If you are a PI proxy for the study, you are able to submit a Modification – other parts of the study. If there is no PI proxy for the study, contact the IRB Administrator.

The PI or PI proxy submits Modification – Study team member information.

If you have to submit a continuing review or annual review, it will be stated on the study’s determination letter. Generally, studies that fall under the Pre-2018 Common Rule will have to submit a continuing review. Studies that fall under the 2018 Common Rule will have to submit an annual review.

Yes. If you fail to submit a continuing review form to close out the study, the IRB will not review any additional submissions that you submit until the closure has been received.

Yes, this is considered a subject complaint and must be reported. The PI is responsible to report to the IRB:

• Unanticipated problems
• Adverse events
• Non-compliance
• Subject complaints
• Protocol deviations
• Loss or potential loss of PII
• Premature suspension or termination of protocol by the sponsor, investigator or institution.

Any of the above must be reported to the ORSIRB Administrator immediately.

Immediately upon a finding of a suspected or confirmed data breach involving personally identifiable information (PII) in printed or electronic form, the incident must be reported to the DOE-Cyber Incident Response Capability in accordance with the requirements of DOE Order 206.1. The ORSIRB Administrator must also be notified of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.

Yes, if you receive a determination of human subjects research. Those involved in the review or involved in the design, conduct, or reporting of the research or who participate in those aspects of the research that involve contact with human subjects or their data or biospecimens must complete initial training along with applicable federal and state laws and institutional policies regarding human subjects research.

There are different training. Training requirements for each group are listed in the HRP-422-CHECKLIST-Required Training document found in the IRB library in the electronic IRB system. Contact the IRB Administrator before starting training to identify which group training you need.