Submission Guidelines

Find below instructions for (A) New Submissions, (B) Creating an additional Package for a Project, and (C) Submitting Post-Approval Requests for Proposals Not Yet in IRBNet.

(A) New Proposals

Follow these steps for new proposals (not previously submitted to the IRB).

Step 1: Prepare your study documentation.

The IRB needs enough information about your study to review it for human subjects' protection and to offer you advice, as needed, on ways to improve human subjects' protection. When you submit your proposal to the IRB, please include the following:

  • The proposal template (appropriately chosen and completed);
  • Informed consent, permission, and assent forms (as appropriate);
  • Relevant appendices (e.g., those specific to medical device studies or studies with prison populations, audio and photographic releases, etc.); and
  • Supporting documentation, including copies of measurement instruments to be administered to participants, recruitment flyers and materials, letters of support from outside organizations indicating that they have agreed to work with you, and any other relevant information.

It is not against copyright laws to submit scanned files of measures for IRB review.

Stamped Documentation:

Please provide the exact documentation (both in content and formatting) you wish to use with participants for all forms and additional materials. Exact documentation is necessary because the IRB stamps it with approval once review of the study is complete. The stamped documentation must be used with participants. When appropriate, the IRB can approve use of unstamped materials (ie. copyrighted measures, online materials, etc.).

In these instances, the investigator still must keep the stamped documentation on file, although it will not be distributed. As necessary, this content should be made available to individuals who wish to confirm IRB approval of it.

Online Materials:

If you are conducting an online survey, please create your survey in the online platform (e.g., SurveyGizmo, SurveyMonkey, etc.) prior to submitting your proposal to the IRB. When you submit your proposal, please include (a) a link to the live survey and (b) a PDF copy of the online survey for the IRB files. The IRB must be able to verify that the informed consent language and process are presented appropriately in the online environment.

Note: All online survey platforms will allow you to print or generate a PDF copy of the online survey. If you have questions about how to do this, please contact the IRB.

For the proposal, assume your audience is intelligent, but naive to the subject area. Disciplinary jargon should not be used. Refer to Proposal Writing: Guidance for Investigators tip sheet for help preparing your proposal.

For the informed consent, permission, or assent documents, write at an eighth grade reading level (or lower when appropriate) and in the second person (e.g., you are invited to participate in a study, your records will be kept private, etc.). Assent documents may need to be written at an even lower reading level. Consent documents should include only the participant's printed name and signature. And additional information should be collected on the Participant Contact Information form when a study requires this information for a Master Key.

For more information on the use of a master key, please visit our Data Security guidance page.

Your proposal and informed consent documents must be very consistent. Although these documents are largely independent and serve different objectives, a research subject reading the consent document must have the same understanding of the terms of their participation — and the risks and benefits thereof — as does the IRB.

Step 2 : Connect to IRBNet.

Go to the IRB website.

Create and account. Be sure to associate your profile with Pacific University. Use the IRBNet training resources on the IRB's homepage for additional assistance.

Step 3 : Upload your NIH certification.

  1. Click on your User Profile in the upper right hand corner of IRBNet.
  2. Scroll down to Add a New Training & Credentials Record.
  3. Upload a screenshot/PDF/etc. of your certificate and enter the required information.

*Even if we already have your NIH certification on file, you are required to upload it to the IRBNet system.*

If you cannot find your certification, we ask that you complete the training again as a refresher course. This serves two purposes. It ensures that you are up-to-date in regard to human ethics research and greatly helps the Office of Research during this time of transition.

Please see NIH Ethics Training for more information.

Step 4 : Create your study.

  1. Click on "Create New Project" on the left hand side of the page.
  2. 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.]

Step 5: Design your study by uploading your documentation.

  1. Gather all of your prepared documentation to upload to IRBNet.
  2. On the Designer page, upload all study documentation.

Step 6: 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 advisorsmust 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 IRB.

*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 certification.

Step 7: Sign your study.

This step is mandatory. Your electronic signature is accepted as a legal signature. Your proposal will not be reviewed until all signatures are provided.

All investigators, research assistants, and faculty advisors must sign the package.

Faculty advisors must sign all student studies before they will be accepted.

Step 8: 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 IRB.

Step 9: 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. Please allow 2-4 weeks for processing.

An electronic IRBNet notification will be sent to your email confirming that the IRB has received your study.

For questions about submission requirements, please contact your school's IRB representative or irb@pacificu.edu.

(B) Submitting Additional Packages in IRBNet

If you have already submitted a project via IRBNet and are required to submit revisions or you are submitting a post-approval request for a project that has already been reviewed on IRBNet, please carefully follow these instructions:

Step 1: Prepare your documentation (revised materials or post-approval request documents).
Step 2: Click on your original IRBNet submission for your project (e.g., 123456-1).
Step 3: Click on Project History on the left hand side of the page.
Step 4: Scroll down on the Project History page until you see a button that says "Create a New Package."
Clicking this button will create a new package within your project. This allows the IRB to access historical documents and reference previous board decisions, as well as help the IRB maintain complete records for tracking and audit purposes.
Step 5: Your new package for your project will be followed by a -2, -3, etc., as appropriate (e.g., 123456-2).
Step 6: Once all materials are uploaded, sign the package as the PI. Only one PI signature is required UNLESS the PI is a student. If the PI is a student, the Faculty Advisor is also required to sign the package containing the revisions.
Step 7: Submit the second package for review.

***Do NOT create a new project on IRBNet. This will not allow us to review your submissions properly and you will required to resubmit materials following the instructions above.

(C) Post-Approval Requests for Proposals Approved Prior to IRBNet

Follow these instructions for all post-approval requests for projects approved by the IRB prior to August 26, 2013.

Step 1: Prepare your documentation.

For a post-approval request, this will typically consist of (1) the post-approval request form, (2) an updated version of your proposal documents or the most recent version, as appropriate, and (3) additional documentation required by any revisions.

Step 2: Connect to IRBNet.

Go to the IRB website.

Create and account. Be sure to associate your profile with Pacific University. Use the IRBNet training resources on the IRB's homepage for additional assistance.

Step 3: Upload your NIH certification.

While the IRB will have your NIH on file from your initial submission, all members of the research team are required to make IRBNet accounts and upload their NIH certification to their User Profiles, as well as sign the package (see below). The IRB will need all researchers in IRBNet for tracking and audit purposes as we move forward.

  1. Click on your User Profile in the upper right hand corner of IRBNet.
  2. Scroll down to Add a New Training & Credentials Record.
  3. Upload a screenshot/PDF/etc. of your certificate and enter the required information.

*Even if we already have your NIH certification on file, you are required to upload it to the IRBNet system.*

Step 4 : Create your study.

  1. Click on "Create New Project" on the left hand side of the page.
  2. IRBNet will assign your project a unique IRBNet number. [NOTE: Once you have submitted your project via IRBNet, the IRB will associate the IRBNet number with your internal IRB number from your initial submission.]

Step 5: Design your study by uploading your documentation.

  1. Gather all of your prepared documentation to upload to IRBNet.
  2. On the Designer page, upload all study documentation.

Step 6: 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, especially new members of the research team.

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 IRB.

*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 certification.

Step 7: Sign your study.

This step is mandatory. Your electronic signature is accepted as a legal signature. Your proposal will not be reviewed until all signatures are provided.

All investigators, research assistants, and faculty advisors must sign the package.

Faculty advisors must sign all student studies before they will be accepted.

Step 8: Submit your study.

After all signatures have been obtained, submit your study. Be sure to select Pacific University Institutional Review Board (IRB), Forest Grove, OR from the available drop-down menu or your study will not be sent to the appropriate IRB.

Step 9: 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. Please allow 2-4 weeks for processing.

An electronic IRBNet notification will be sent to your email confirming that the IRB has received your study.