Forms and Templates | IRB
All forms required for submission to the IRB are housed in IRBNet, the IRB's online submission system. Please refer to the Submission Guidelines tab for instructions. Once in IRBNet, be sure you've affiliated your profile with the Pacific University Institutional Review Board. A Forms and Templates tab will be in the blue bar on the lefthand side of the page. All documents can be downloaded from the Forms and Templates tab.
For all new proposal submissions, please download the New Submission Form. Refer to the Submission Guidelines tab for troubleshooting with the form.
Preparing a Submission to the IRB
Step 1: Determine if your activity requires IRB review. (Skip this step if you know that review is required.) The Request for Determination of IRB Jurisdiction form can assist you in determining if your study qualifies as human subjects research based on some simple questions. If you are unsure as to whether or not your activity meets the regulatory definition of "human subjects research," or if you believe that it does not, complete the Request for Determination of IRB Jurisdiction (available on IRBNet) and submit it to the IRB for an official determination. Submit this form via IRBNet per the instructions provided on the Submission Guidelines page.
Step 2: Prepare your documentation. As you prepare your documentation, review the following materials to ensure you provide a complete submission. The IRB will not process your submission until it meets these standards. [A template with guidance questions will be provided later in October in IRBNet to aid in proposal content development.]
- The IRB has one form for all submissions. Instructions for using the Submission Form are provided under Submission Guidelines.
- The smart form application will queue up the required documents based on your answers to a handful of questions. Be sure to answer every single question (Yes, No, or N/A).
- Once you have entered all the information on the Proposal to Conduct Research and the IRB Submission Guidance Document pages, you will proceed to complete the relevant support documents for your study.
- A template proposal with recommended questions and comments to consider will be provided in late October 2016.
Step 3: Complete the appropriate application sections for your study.
Based on your responses on the Proposal to Conduct Research and the IRB Submission Guidance Document, various sections will appear for you to complete. You are required to complete every section. If a form you believe you need to complete does not appear as part of the document, go back to the Submission Guidance Document section and make sure you checked the correct boxes. The following descriptions provide a general idea of what each section is for and why it may be necessary for your study.
Determination of Request for Exemption Status: If you selected the Request for Exemption on the Proposal to Conduct Research, you will be guided to complete this Determination. Answer all Yes, No, N/A questions (even if not under your category). Based on your responses, you'll either be guided to the Request for Exemption document or will be guided to alter your selection and complete a full proposal.
- Request for Exemption: If you meet one or more of the exemption criteria (on the Determination of Request for Exemption Status), you will be queued to complete the Request for Exemption.
- Proposal to Conduct Human Subjects Research: If your study does not meet the exemption criteria (or if you selected this Proposal on the IRB Submission Guidance Document), you will complete this form, providing all appropriate justifications.
- Request to Alter or Waive Informed Consent: You will complete this form if you are altering the standard consent process in any way (requesting to waive signatures, an online consent, a modified format or content of consent, etc.). You will complete the first section if you are requesting to waive the required documentation of signed informed consent, and the second section if you are requesting to waive or alter the required elements of the informed consent process.
- Informed Consent: Use this form only if you will be collecting data from, or about, adults who are legally capable of providing consent. If you choose to create your own informed consent document, you must complete the Request to Alter or Waive Informed Consent detailed above to make your case for the altered format. Please only submit the document that you plan to use in your research (do not complete and submit this form unless you will be using this form). However, please review the Informed Consent requirements detailed on the website to ensure you have met all required components of a consent. Review the Submission Guidance Document checkboxes if you need to alter your selections.
- Permission: Use this form only if you will be collecting data from, or about, children or adults who are legally incapable of providing consent. You will likely need to pair this with an assent form (see below). If you choose to create your own permission document, please complete the Request to Alter or Waive Informed Consent to justify the change in format and only submit the document that you plan to use in your research (do not complete and submit this template). However, please review this form to ensure that you include required language in your own permission document.
Assent: Use this form only if you will be collecting data from, or about, children or adults who are legally incapable of providing consent. You will need to pair this with a permission form from the guardian or ward of the individual (see above).
- Medical Device or Drug Study Information: Use this form if you are studying a medical device, drug, biologic, or other food product for human consumption. Additional information is provided on the IRB Submission Guidance Document.
- International Research Form: Use this form if you are conducting research outside of the United States.
- Permitted Research Involving Prisoners: Use this form if you are conducting research with an incarcerated population.
- HIPAA-1, -2, or -3 Waiver: Use one of these forms if you are using data covered by the HIPAA Privacy Rule. View our HIPAA Overview to determine which form is appropriate.
- FERPA-1, -2, or -3: Use one of these forms if you are using data that is covered by FERPA. View our FERPA Overview to determine which form is appropriate.
- Verified Translation Statement: Use if conducting your study in a language other than English, or if consent documentation must be provided in a language other than English.
- Audio Recording Release: Use if you will be maintaining Audio files as part of your data records. If you are transcribing audio recordings, then destroying the audio files, then you do not need to complete this form - you will simply add a line on the consent documentation explaining your use of the audio recordings and include information about storage and destruction of file within the consent documentation.
- Photograph and Video Recording Release: Use if you will be collecting photo or video data. Please also add a line in the consent that references this additional permission document.
- Participant Contact Form: Use if you will be collecting participant contact information.
Other forms not included in the fillable PDF:
- Award Prize Form: Use this form if participants in your study will be receiving financial compensation through the Pacific University Business Office. Please refer to Pacific University's Payment of Research Participants policy for further details and guidance.
- Translations of Consent Documents: The IRB is working on, but does not currently have, Spanish versions of consent documentation. The IRB recommends that you follow to format of the current consent and provide a similar header to the standard template. The IRB hopes to have these documents in place by the end of 2016.
- Study Measures
- Recruitment Materials
- Secondary Consent Materials: Sometimes studies require various consent processes for different groups of people. The IRB has provided stand alone consent, permission, and assent forms in IRBNet for use when you need multiple versions of these forms.