Submission Process | IBC
All submissions to the IBC must be submitted via IRBNet. This includes all proposals , agreements with other institutions, and Post-Approval Requests (Annual Renewals, Modifications, Project Closures, and Adverse Events).
Preparing a New Submission to the IBC
Create and IRBNet account.
- Go to IRBNet and create a new profile with your Pacific University email address. Be sure to associate your profile with Pacific University IBC. Use the IRBNet training resources on the IBC's homepage for additional assistance.
Complete appropriate CITI training and upload your certificate and information to your User Profile in IRBNet (upper right hand corner). NOTE: You will be notified by the IBC if training is required.
Prepare your study documentation.
- All IBC documents are housed within IRBNet. You can access all forms by clicking on Forms and Templates at the bottom of the blue sidebar. Download the necessary forms pertaining to your study. DO NOT submit per the instructions on the form. Follow the instructions on this page.
NEW FORMS COMING SOON: The new PDF documents may not open easily on your computer. If this is the case, please follow the following steps:
- Launch Adobe Reader. Make sure you have the current version of Adobe Reader.
- Find Open, then search for the document where you have saved it (in Downloads, Desktop, etc.).
The PDF form should open when following these steps. The IBC is unable to provide the document in any other format.
Create an IRBNet package.
- Click on "Create New Project" on the left hand side of the page.
- PRINCIPAL INVESTIGATOR: The PI must be a faculty member. Enter the faculty member when queued to enter the PI information. Any Student Principal Investigator can be indicated as such in the proposal materials.
IRBNet will assign your project a unique IRBNet number. [NOTE: Once you have submitted your project via IRBNet, the IBC office will also assign an internal IBC Number.]
Designer: Upload your study documentation.
- When submitting, you will have the New Proposal PDF, as well as supporting letters, authorizations, study measures, licenses, etc., depending on the nature of your study.
Do not put all documentation in one single file. Please leave the PDF proposal as is.
Share your study.
- All members of your research team must be shared on your project. This includes investigators, co-investigators, faculty advisors, or research assistants.
- If you wish, you can send a quick email to these individuals through the IRBNet system informing them that the study is ready for their review and electronic signatures.
- All investigators that will be directly interacting with participant and/or participant data must be shared on the study. Sharing your study allows others to sign the package.
- Students must share their studies with their faculty advisors. Faculty advisors must review all study documentation with their students before studies are submitted via IRBNet. If studies consistently are incomplete or poorly prepared, it will impact your standing with the IBC.
Note: To share a study with others, they must be register with IRBNet and activate their accounts. Please ask all members of your research team to register on IRBNet and upload their NIH/CITI certification.
Sign your study.
- All investigators, research assistants, and faculty advisors must sign the package.
- Faculty advisors must sign all student studies before the IBC will review a submission.
- This step is mandatory. Your electronic signature is accepted as a legal signature. Your proposal will not be reviewed until all signatures are provided.
By signing this IRBNet package, each investigator is certifying all listed on the signature page, and confirming that all conflicts of interest have been disclosed in the proposal.
- Submit your study.
- After all signatures have been obtained, submit your study. Be sure to select Pacific University Institutional Biosafety Committee (IBC), Forest Grove, Ore. from the available drop-down menu or your study will not be sent to the appropriate review board. Make sure the you have not selected the Pacific University IRB or IACUC.
- If you do not click "Submit this Package," the IBC will not be notified of your submission.
- You made it!
- You may review your study to see what has been sent. Your study will be under "Pending Review" status until the review has been completed.
- An electronic IRBNet notification will be sent to your email confirming that the package has been submitted to the IBC.
- Once the IBC has processed your study for initial review, you will receive an "Acknowledged" notification. Other notifications you receive throughout the process may be Forwarded (sent to other reviewers), Referred to Full Board (for studies requiring review by the full board), Information Required (revisions needed), or Approved.
Preparing an Additional Package for a Previously-Submitted Project in IRBNet
In IRBNet, select the project for which you wish to submit additional materials (significant revisions or any submission after initial approval - continuing review, modifications, adverse events, project closures, etc.)
- The IRBNet project number is the 6-digit number followed by a dash. Click on the most recent package within the project (the package with the highest number following the dash).
Create a New Package for the project.
- Once you are in the most recent package of your IRBNet project, click the tab Project History on the left hand side of the page in the blue bar.
- On the Project History page, scroll to click the "Create New Package" button.
- NOTE: If you have previously created a new package but did not submit the package, you will not have a Create New Package button. Instead, the list of packages for the project at the top will have one that says Work In Progress. Proceed by selecting that package.
Upload your documents.
- Once you have prepared the required documentation, click on Designer (on the left in the blue bar).
- Upload all required documents. ALSO, please upload the must recent stamped proposal to allow the committee to update the stamp.
Share the package.
- For many, there is rarely a need to share a new package with additional members of the research team. If, however, you are adding researchers to the proposal or had not initially shared the study with all collaborators, then you will need to search for their names in order to share the study with these individuals. Make sure that the collaborators have associated with Pacific and with the correct committee in order for you to be able to find them.
Sign the package.
- A faculty signature is required on every package received by the IRB. For student projects, the student is welcome to sign, but a faculty signature is still required.
- Any time a new member of the research team is added to a study, the new researcher must (1) have an IRBNet account, (2) upload their human subjects research training certification, and (3) sign the IRBNet package after ensuring any conflicts of interest have been disclosed in the proposal.
Submit the package.
Once everyone has signed the package and all materials are in order, be sure to click the "Submit this Package" tab in the blue sidebar. **Important** - If you skip this step, the IRB will not receive your package and materials. Your proposal is not placed in the queue until properly submitted. You can check to make sure that you submitted it correctly by:
- Clicking on Project History.
- Make sure that the most recent package lists the current date and says Acknowledged under the Status.
- If there is a Work In Progress package instead of as described above, click on it, double check that it's complete, and click submit.
- Once everyone has signed the package and all materials are in order, be sure to click the "Submit this Package" tab in the blue sidebar. **Important** - If you skip this step, the IRB will not receive your package and materials. Your proposal is not placed in the queue until properly submitted. You can check to make sure that you submitted it correctly by:
Unlocked Studies - What is my study unlocked and what do I do?
Sometimes the IBC will unlock a package you have submitted for review. The most frequent reasons a study is unlocked by the IBC is because the submission was incomplete and additional materials are needed, the study wasn't shared with all of the members of the research team at the time of submission, or the study is ready to be approved with just a minor administrative edit.
When you receive a message from the IBC that your study is unlocked and requires attention, please follow these steps:
- Read all communications from the IBC (the Unlock message, as well as any Review documents).
- Follow the specific instructions provided. If you are being asked to upload additional documents or a revised version, DO NOT DELETE any document you have already uploaded and submitted to the IBC. The IBC will be able to flag the most recent version once you submit.
- To resubmit, you must click "Mark Revisions Complete" at the top of the Designer page. If you do not complete this step, the IBC will receive no notification in IRBNet that you have completed the request. This is a required step, even if you email the IBC to say you have completed the revision. Your proposal is not placed in the queue until properly submitted.