Forms and Templates for Initial Submissions

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 school and/or college IRB representative or contact the IRB office at irb@pacificu.edu.

 

Complete Submission Example

Click on the following links to download an example of an IRB submission that follows the necessary guidelines in an easy-to-view (and review) format.

Formatting Example - Microsoft Word

Formatting Example - PDF

Note: As you will see, the investigators did not include Microsoft Word documentation for their informed consent and study measures as the Microsoft Word format was not relevant to their online survey. Instead, they directly embedded their content into the online survey. (Whether or not you are conducting an online survey, you should only include the exact documentation you wish to use as it minimizes the confusion that can arise from including extraneous paperwork.)

 

Step 1: As you prepare your documenation, review these checklists to ensure you provide a complete submission. The IRB will not process your submission until it meets these standards.

Proposal Writing: Guidance for Investigators (updated 01/22/2013)

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

Initial Submission Checklist (updated 05/06/2013)

Use this checklist to ensure that you have completed all required steps and documentation prior to submitting your proposal to the IRB.

Step 2: Use this template to organize your submission before sending it to the IRB.

Formatting Template (updated 05/06/2013)

If you are unsure of how to use this template, please refer to the complete submission example provided at the top of this page. (As per the requirements, it is provided in both Microsoft Word and PDF formats.)

Step 3: Determine if your activity requires IRB review. (Skip this step if you know that review is required.)

Request for Determination of IRB Jurisdiction (updated 01/22/2013)

If you are unsure as to whether your activity meets the regulatory definition of "human subjects research", or if you believe that it does not, complete this worksheet and submit it to the IRB for an official determination.

Step 4: Complete the appropriate research proposal template.

Request for Exemption (updated 01/22/2013)

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 (updated 01/22/2013)

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

Request to Alter or Waive Informed Consent (updated 01/22/2013)

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 (updated 01/22/2013)

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 (updated 01/22/2013)

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 (updated 01/22/2013)

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

Statement of Assurance (updated 01/22/2013)

This form is required for all submissions.

Medical Device or Drug Study Information (updated 01/22/2013)

Use this form if you are studying a medical device, drug, biologic, or other food product for human consumption.
International Research (updated 01/22/2013)

Permitted Research Involving Prisoners (updated 01/22/2013)

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

HIPAA-1 (updated 01/22/2013)

HIPAA-2 (updated 01/22/2013)

HIPAA-3 (updated 01/22/2013)

Use one of these forms if you are using data covered by the HIPAA Privacy Rule. Visit our HIPAA Overview to determine which form is appropriate.

FERPA-1 (updated 01/22/2013)

FERPA-2 (updated 01/22/2013)

FERPA-3 (updated 01/22/2013)

Use one of these forms if you are using data that is covered by FERPA. Visit our FERPA Overview to determine which form is appropriate.
Verified Translation Statement (updated 01/22/2013)
Audio Recording Release (updated 01/22/2013)
Photograph and Video Recording Release (updated 01/22/2013)
Participant Contact Information (updated 01/22/2013)