How to Submit to the IRB
The Oak Ridge Sitewide Institutional Review Board's electronic IRB system is a Huron Click Commerce-based software used by DOE’s Central and Site IRBs for processing IRB studies. Researchers submit studies for IRB review via this system, and IRBs can review the studies using this system.
Details for how to use the IRB system, submissions, and required documents can be found in the IRB library in the electronic IRB system. Job aids on using the system and making various submissions can be found in the IRB library or in the job aids.
Contact the IRB Administrator to set up your account if you do not have one.
Note: Submitting or emailing a study to the IRB coordinator is NOT submitting the study to the IRB. Please submit your study in the electronic IRB system.
How to Submit a New Study
First, make sure you use the most current version of the documents, which are updated periodically. The most current version of required documents can be found in the IRB library.
Once you are in the electronic IRB system, begin the submission by clicking the “Create New Study” button. Follow the SmartForm and attach all requested documents. To submit the study, click the “Submit” button on the study workspace. Maintain electronic copies of all information submitted to the IRB in case revisions are required. If revisions are needed to documents already in the electronic system, submit a clean version of the document by using the “Update” button next to the document. Do not upload a track-changed document.
Note: If you start a submission and do not submit it to the IRB within 30 days, the submission will be discarded. If the study is created but not ready for submission, the researcher must provide a comment within the IRB system to avoid the study being discarded.
Note: The IRB administrator may ask for additional information (clarification request). If response is not received in 14 days, the submission will be discarded permanently. The study submission can be recreated when the staff are ready to respond to the clarification. If the study is a new submission the discarded submission can be copied from the original study workspace using the copy button.
How to Submit a Modification
NOTE: If your study is open for more than 10 years, a new protocol must be submitted to the board using an updated protocol template.
Once you are in the electronic IRB system, begin the submission by clicking the “Create Modification/CR” button on the parent study and select the type of modification. Follow the SmartForm and attach all requested documents. To submit the study, click the “Submit” button on the study workspace. Maintain electronic copies of all information submitted to the IRB in case revisions are required. If revisions are needed to documents already in the electronic system, submit a clean version document by using the “Update” button next to the document. Do not upload a track-changed document. Updates to the list of study personnel must be submitted as a modification. Please note that research must continue to be conducted without inclusion of the modification until IRB determination is received.
How to Submit a Continuing Review
NOTE: If your study is open for more than 10 years, a new protocol must be submitted to the board using an updated protocol template.
Once you are in the electronic IRB system, begin the submission by clicking the “Create Modification/CR” button on the parent study and select continuing review. Follow the SmartForm and attach all requested documents. To submit the study, click the “Submit” button on the project workspace. Maintain electronic copies of all information submitted to the IRB in case revisions are required. If revisions are needed to documents already in the electronic system, submit a clean version of the document by using the “Update” button next to the document. Do not upload a track-changed document.
If you would like to request modifications of previously approved research at the time of a continuing review, submit those as separate requests. Submit the continuing review first for determination before submitting a separate modification.
Note: If a continuing review is required but not submitted by the expiration date, the study will be out of compliance. Your study will be automatically administratively closed. A new submission will be required to continue the study.
How to Submit an Annual Check-In
NOTE: If your study is open for more than 10 years, a new protocol must be submitted to the board using an updated protocol template.
The HSRD Annual Check-in occurs when a continuing review is NOT required for studies that follow the 2018 regulations. For studies that follow the pre-2018 regulations or a 2018 regulation study requiring continuing review, the HSRD Annual Check-in does not apply because the data is captured in the continuing review process. The regulation for your study is listed at the top right of the parent page under “Regulatory authority.”
According to DOE Order 443.1C, Chg. 1 (or current version), the status of all human subject research studies (including exempt) must be reported annually for the Human Subject Research Database (HSRD). In order to meet this requirement, the HSRD Annual Check-in was created.
The annual check-in should be annually based on the initial approval date of the study regardless if a Modification has been submitted. For example, if your study was initially approved June 18, 2022, then an annual check-in should be done June 18, 2023, June 18, 2024, etc. until the study is closed.
Once you are in the electronic IRB system, begin the update by clicking the “Update HSRD Information” link on the parent study. Once all information has been entered, click the “OK” button at the bottom to close the pop-up window.
How to Submit a Closure
A closure must be submitted for studies that follow the pre-2018 or 2018 regulations.
Once you are in the electronic IRB system, begin the submission by clicking the “Create Modification/CR” button on the parent study and select continuing review. Follow the SmartForm and attach all requested documents. Project status/results must be updated to include annual results/scientific findings to date. When requesting a closure, the first four study milestones in question three must be checked and acknowledge the study will be closed. To submit the study, click the “Submit” button on the project workspace.
If you fail to submit a continuing review form to close out the study, the IRB will not review any submissions until the closure for the study is received.