Forms for Initial Submission

***The forms below may not work as they are Word documents. Please create an IRBNet account and download all forms and templates from the IRBNet Forms and Templates library. The IRB will provide updated forms, information, and additional resources on IRBNet in the coming days.

The IRB has created specialized templates tailored to various kinds of research projects and/or populations. Please use the template(s) best suited to your proposed research project. If you need help in selecting the appropriate template, please see your IRB representative, or contact the IRB office at irb@pacificu.edu.

The Statement of Assurance is no longer required as it has been replaced by electronic signatures within IRBNet. It is for this reason that all research personnel and faculty advisors must be shared on and sign a project package.

Preparing a Submission to the IRB

Step 1: 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.

Proposal Writing: Guidance for Investigators (available on IRBNet)

Use this list of questions to ensure that you have addressed all relevant issues in your proposal prior to submitting it to the IRB.

Submission Guidelines

Please carefully review the Submission Guidelines.

Step 2: Determine if your activity requires IRB review . (Skip this step if you know that review is required.)

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. Do no submit this form through IRBNet!

 

Step 3: Complete the appropriate research proposal template .

Request for Exemption (pdf) (updated 10/08/2013)

Use this template only if you are convinced your study meets one or more of the exemption criteria (see Request for Exemption: Eligibility Criteria) and you can provide compelling justification for how your study meets those criteria.

Proposal to Conduct Human Subjects Research  (pdf) (updated 10/08/2013)

Use this template if your study does not meet any of the exemption criteria. You will be able to indicate on the form if you believe your study is eligible for expedited review.

Step 4: Complete or create the informed consent, assent and permission forms that are applicable to your study.

Request to Alter or Waive Informed Consent (pdf) (updated 06/04/2013)

Use this form only if you wish to do one (or both) of the following: (a) waive the required documentation of signed informed consent, or (b) waive or alter the required elements of the informed consent process.

Informed Consent (pdf) (updated 06/04/2013)

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, please only submit the document that you plan to use in your research (do not complete and submit this form). However, please review this form to ensure that you include required language in your own consent document.

Permission (pdf) (updated 06/04/2013)

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 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 consent document.

Assent (pdf) (updated 06/04/2013)

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).

Step 5: Complete the supplementary forms that are applicable to your study.

Medical Device or Drug Study Information (pdf) (updated 06/04/2013)

Use this form if you are studying a medical device, drug, biologic, or other food product for human consumption.

International Research (pdf) (updated 06/04/2013)

Permitted Research Involving Prisoners  (pdf) (updated 06/04/2013)

Use this form if you are conducting research with an incarcerated population.

HIPAA-1 (pdf) (updated 01/22/2013)

HIPAA-2 (pdf) (updated 01/22/2013)

HIPAA-3 (pdf) updated 01/22/2013)

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 (pdf) (updated 01/22/2013)

FERPA-2 (pdf) (updated 01/22/2013)

FERPA-3 (pdf) (updated 01/22/2013)

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 (pdf) (updated 06/04/2013)
Audio Recording Release (pdf) (updated 06/04/2013)
Photograph and Video Recording Release (pdf) (updated 06/04/2013)
Participant Contact Information  (pdf) (updated 06/04/2013)

Award Prize Form (pdf) 

Use this form if participants in your study will be receiving financial compensation through the Pacific University Business Office.

Response to Comments Form (pdf)

If you would like to provide a justifcation in response to a reviewer's comments or request for revisions, please use the Response to Comments form. Copy the review points you would like to address to the Response to Comments document and provide your justification and reasoning.

Important

These forms will be used when submitting to IRBNet. Do not merge these forms in any way. Leave them as separate documents when uploading to IRBNet.