Submission Guidelines | IRB

The Institutional Review Board accepts all submission through IRBNet, our online submission system. All proposals (for Full, Expedited, or Exempt review), Authorization Agreements, Requests for Determination of IRB Jurisdiction, and Post-Approval Requests (Continuing Reviews, Modifications, Project Closures, Incident Reports, and Audits) must be submitted through IRBNet in order to be considered by the IRB.

Preparing a New Submission to the IRB

  1. 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 and with the correct Pacific University committee. Use the IRBNet training resources on the IRB's homepage for additional assistance.
    • Complete human subjects research training and upload your certificate and information to your User Profile in IRBNet (upper right hand corner). 
       
  2. Prepare your study documentation.
    • Refer to Forms and Templates for a description of the various IRB forms, instructions for completing the forms, and templates of well-prepared proposals (coming soon to IRBNet!).
    • All IRB documents are housed within IRBNet. You can access all forms by clicking on Forms and Templates at the bottom of the blue sidebar once you are logged into your account. Download the necessary forms pertaining to your study.
    • NOTE: 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 IRB is unable to provide the document in any other format.
         
  3. Create an IRBNet package.
    • Click on "Create New Project" on the left hand side of the page.
    • IRBNet will assign your project a unique IRBNet number. [NOTE: Once you have submitted your project via IRBNet, the IRB office will also assign an internal IRB Number.]
       
  4. Designer: Upload your study documentation.
    • ​​When submitting, you will have the New Proposal PDF, as well as supporting letters, authorizations, study measures, etc., depending on the nature of your study. 
    • Please leave the PDF proposal as is; do not try to add pages to the document. All supporting materials should be uploaded in groupings (put all recruitment pieces in one document, for instance) to make it easier for the IRB to review and confirm all necessary information has been provided.  
       
  5. 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.
    • 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 faculty standing with the IRB. Faculty are ultimately responsible for all submissions on which they are a listed researcher and are considered by the IRB to be the principal investigator. 
    • 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.
       
  6. Sign your study.​
    • All investigators, research assistants, and faculty advisors must sign the package. 
    • Faculty advisors must sign all student studies before the IRB 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.
       
  7. Submit your study.
  • ​​After all signatures have been obtained, submit your study. Be sure to select Pacific University Institutional Review Board (IRB), 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 IACUC or IBC.
  • If you do not click "Submit this Package," the IRB will not be notified of your submissioon.
  1. 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 IRB.
  • Once the IRB 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), Exempt or Approved.

Preparing an Additional Package for a Previously-Submitted Project in IRBNet

  1. 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, audits, 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).
  2. 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 OR click the Create New Package button on the lefthand side (recent update from IRBNet).
    • 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.
  3. Upload your documents.​​​
    • ​​Once you have prepared the required documentation, click on Designer (on the left in the blue bar). 
    • Upload all required documents.
  4. 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.
  5. 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.
  6. 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.

Unlocked Studies - Why is my study unlocked and what do I do?

Sometimes the IRB will unlock a package you have submitted for review. The most frequent reasons a study is unlocked by the IRB 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 IRB that your study is unlocked and requires attention, please follow these steps:

  1. Read all communications from the IRB (the Unlock message, as well as any Review documents).
  2. 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 IRB. The IRB will be able to flag the most recent version once you submit.
  3. To resubmit, you must click "Mark Revisions Complete" at the top of the Designer page. If you do not complete this step, the IRB will receive no notification in IRBNet that you have completed the request. This is a required step, even if you email the IRB to say you have completed the revision. Your proposal is not placed in the queue until properly submitted.