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.

Yes. There are Job Aids available provide instructions for using the electronic IRB system, as well as instructions on how to submit a study to the IRB. Updated job aids can be found in the IRB library/PI guides tab.

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.

Submissions are on a ‘first-in, first-out’ basis (i.e. studies are reviewed in the order they were received. It is highly recommended that you do NOT plan your travel until you talk to your IRB Administrator.

Please note that "expedited review" means review by one IRB member on behalf of the Board. Expedited review is available for some human subjects research applications, based on risk level and certain other characteristics. It does NOT necessarily imply faster processing.

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. DOE Order 443.1C, Chg. 1 (or current version), requires that all research using public data about individuals which includes social media data must be submitted to the IRB for review and determination. Reach out to the IRB Administrator to discuss before submitting anything in the electronic IRB system.

Federal regulations require HSR to be reviewed and approved by the IRB, while activities that are solely Quality Improvement (QI)/Quality Assurance (QA)/Program Evaluation (PE) do not require IRB oversight. Some QI/QA/PE activities may also be research and therefore need IRB approval. Do not attempt to determine that your project is not research involving human subjects. If you have a project that involves contacting people or using their data or biospecimens (e.g. data collection from medical charts), contact the IRB Administrator/Staff.

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

Yes. There are Job Aids available provide instructions for using the electronic IRB system, as well as instructions on how to submit a study to the IRB. Updated job aids can be found in the IRB library/PI guides tab.

Any change to your approved study. Modifications can be:

• Change in PI, addition/removal of study staff
• Change in research design/methodology/procedure
• Change in # of participants and/or their data
• Changes in consent form/recruitment material/
• Changes in data collection/analysis/protection, etc.

Note: this is not the full list. Please contact the IRB Administrator if you have questions.

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. Anyone involved in the review or involved in the design, conducting, analyzing data, 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.

All researchers and staff must be current on their Collaborative Institutional Training Initiative (CITI) training before their study can be approved by the IRB. Additional training may be required at your Institution.

Training requirements vary by group and 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.

Additional training may be required at your Institution. For example, for ORAU researchers, ORAU policy requires Responsible Conduct of Research (RCR) training through CITI.

Refer to the CITI section in the Education and Resources page. Instructions for registering/using CITI can be found on this page.