Forms, templates & addenda

For review applications, post-review requests, reports, and consent forms

Our forms and templates are undergoing revisions. Before taking action on a prospective or ongoing study, please check our site for updates on the latest versions. Feel free to contact us if you need additional information or assistance at irb@wsu.edu.

Forms

Determine your need for review

Human Subjects Research Determination (docx)
If you are unsure whether you need HRPP/IRB review, you can fill out this brief form and visit our Do I Need IRB Review? resource page. If you have completed this process and the HRPP determines that your project requires review, please use the forms below.

Applications for review

Exemption Determination Application (docx)
The HRPP will determine if your research is exempt from federal regulations. Limited IRB Review (LIR) may be required for some exempt studies.

Non-exempt application (docx)
For studies that do not meet exemption criteria or present more than minimal risk to participants. Please refer to the Types of Review page for more information.

Templates

Use these templates as guides to create consent, assent, and permission forms. Refer to the consent form guidance to ensure that your consent forms fulfill requirements for formatting, readability, accessibility, and content.

Exempt consent template (docx)
Adult consent template (docx)
Child assent template, ages 7–10 (docx)
Child assent template, ages 11–14 (docx)
Child assent template, ages 15–17 (docx)
Parent permission form template (docx)

Addenda

One or more addenda may need to accompany your application to the IRB if your study involves certain special conditions or types of subjects. Notes in the applications will instruct you when to complete an addendum.

Limited IRB Review Addendum for Exempt Projects (docx)
This is only for Exempt projects under categories 2 or 3 that collect both sensitive AND identifiable data. Please submit this addendum to clarify your data security. More information can be found on our Types of Review page.

Addendum 1 (docx)
Expedited categories and determinations

Addendum 2 (docx)
Research with children

Addendum 3 (docx)
Research with prisoners

Addendum 3A (docx)
Research with prisoner data sets collected for purposes other than research

Addendum 4 (docx)
Alteration of informed consent process

Addendum 5 (docx)
Waiver of documentation of informed consent process

Addendum 6 (docx)
Waiver of informed consent process

Addendum 7 (docx)
HIPAA authorization form & Appendix A

Addendum 8 (docx)
Investigational drugs, other drugs, and devices

Addendum 9 (docx)
Blood, tissue, bodily fluids, or other biological specimens

Addendum 10 (docx)
Confidentiality agreements

Post-review forms

Amendment request (docx)
To seek changes to an IRB-approved study

Continuing review request (docx)
For seeking renewal of an expiring IRB approval

Closeout report (docx)
For studies concluding or transferring to another institution

IRB/HRPP Reporting Form (doc)
Use this form to report all research related events including adverse events, unanticipated problems involving risks to subjects or others (UPIRSO), and protocol deviations. Please refer to our Reporting Events & Deviations page for more information.

118 Designation

For researchers seeking a grant from a federal department or agency, it may be unclear if the study will be funded. In these situations, the agency may require the investigators to submit a letter from the IRB indicating that the project will be reviewed if the grant is awarded. Under the regulations, the IRB can issue a 118 Designation for the investigators to include in their grant proposal. This designation does not constitute a full review and approval. If the grant is awarded, the investigators are required to submit the project to the IRB for review prior to beginning human subjects research activities.

Please use the 118 Designation Form to apply.

Guidance Documents

As we develop guidance, we will post the documents here.

Recruitment and Advertising Guidance (pdf)

PI Eligibility and Attestations

Use the forms below only in cases where the PI’s appointment does not explicitly include conducting research on behalf of WSU. Examples include but are not limited to Adjunct, Adjoint, Part-Time, Emeritus, Visiting, Clinical, or other special appointments. These PIs must obtain written support from their department and/or the Vice President of Research (VPR). Please refer to the Standard Operating Procedure for more details: Verifying Principle Investigator Eligibility for Human Subjects Research Protocols (pdf)

Please note: These situations are approached on a case-by-case basis. Our office will work with you to quickly clarify any questions and determine what is needed. Contact us at irb@wsu.edu for further guidance.

PI Eligibility Form (docx)
Please complete this form and send it to the appropriate signatory official for your department (e.g. Department Chair or Dean).

Protocol Attestation Form (docx)
To be used when a protocol needs written confirmation that the research is being conducted under the auspices of WSU. This requires a signature from a WSU signatory official such as the VPR, Department Chair/Dean, VP, or Chancellor.