* Please scroll to the bottom of the page for special instructions regarding submitting requested revisions or post-approval requests for projects that you have already submitted via IRBNet.
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.
- *Note: Statement of Assurance forms are no longer requried. Signatures are now collected by Sharing the Package with all members of the research team and having each member Sign the Package. This includes personnel changes on Post-Approval Requests.
Notes: Templates are updated frequently. For each submission, always download the necessary documents from this website or through IRBNet. (Go to Forms for Initial Submissions.) It is not against copyright laws to submit scanned files of measures for IRB review.
Please provide the exact documentation (both in content and formatting) you wish to use with participants. (This includes your informed consent, permission, and assent forms as well as all study measures, recruitment materials, and additional appendices.) 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.
The only exceptions to this are when the documentation is electronic or oral or when the IRB has explicitly approved the use of unstamped materials (including copyrighted measures or documents used in some cultural or international settings).
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.
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.
To make sure that your proposal clearly addresses all of the issues that are relevant to the IRB, we recommend looking at the Proposal Writing: Guidance for Investigators tip sheet. It should help you to focus the description of your study on the elements that are of particular concern during an IRB review.
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.
The informed consent, permission, and assent documents should not include any identifying information beyond the participant’s signature and printed name. This includes the addition of study protocol numbers, participant numbers, birthdates, contact information, and so on. Use the participant contact information form to gather identifying information from your participants or directly input contact information into 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, they must match precisely. While you may not need to provide the same level of detail in your informed consent document as you do to the IRB in your proposal, 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 www.irbnet.org.
For instructions regarding how to log into IRBNet, refer to the IRBNet Registration and Training Resources available on our homepage.
Step 3: Upload your NIH certification.
Even if we already have your NIH certification on file, you are required to upload it to the IRBNet system. Refer to the IRBNet Registration and Training Resources available on our homepage for further information about uploading certification.
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.
Refer to the IRBNet Registration and Training Resources available on our homepage for instructions on how to create a study.
IRBNet will assign you a unique IRBNet number. The IRB office will also assign an internal IRB number.
Step 5: Design your study by uploading your documentation.
Refer to the IRBNet Registration and Training Resources available on our homepage for instructions on how to design a study.
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 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.
Refer to the IRBNet Registration and Training Resources available on our homepage for instructions on how to share a study.
Step 7: Sign your study.
This step is mandatory. Your electronic signature is accepted as a legal signature.
All investigators and faculty advisors must sign the package.
Faculty advisors must sign all student studies before they will be accepted.
Refer to the IRBNet Registration and Training Resources available on our homepage for instructions on how to sign a study.
Step 8: Submit your study.
Refer to the IRBNet Registration and Training Resources available on our homepage for instructions on how to submit a 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.
Submitting Revisions and Post-Approval Requests for Proposals 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:
1. Prepare your documentation (revised materials or post-approval request documents).
2. Click on your original IRBNet submission for your project (e.g., 123456-1).
3. Click on Project History on the lefthand side of the page.
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.
5. Your new package for your project will be followed by a -2, -3, etc., as appropriate (e.g., 123456-2).
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.
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.