FORMS

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.

DETERMINE YOUR NEED FOR REVIEW

Not Human Subjects Research (NHSR) Determination (docx)
If you are unsure whether you need HRPP/IRB review or if you are requesting documentation that your planned project does not require HRPP/IRB review, please complete this brief form. 

APPLICATIONS

Exempt 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. 

ADDENDA

Addendum: Limited IRB Review (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. 

Addendum: Informed Consent – Minimal Risk (docx)
Waiver/Alteration of informed consent for minimal risk research

Addendum: Informed Consent – More Than Minimal Risk (docx)
Waiver of documentation of informed consent process for more than minimal risk research

Addendum: Confidentiality Agreement (docx)
Confidentiality agreements

Addendum: HIPAA Authorization (docx)
HIPAA authorization form

Addendum: FDA Drugs, Devices, Biologics, & Biospecimens (docx)
Investigational drugs, devices, other drugs, and biospecimens

Addendum: Research With Children or Wards of the State (docx)
Research with children or wards of the state

Addendum: Research With Prisoners (docx)
Research with prisoners

CONSENT/ ASSENT TEMPLATES

Exempt consent template (docx)
Non-exempt 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)

GUIDANCE

Recruitment and Advertising Guidance (pdf)

Informed Consent Guidance (pdf).

Assent Guidance (pdf).

Tools/Measures Guidance *Coming Soon!

Research with Children Guidance *Coming Soon!

Research with Prisoners Guidance *Coming Soon!

Research with AN/AI Persons Guidance *Coming Soon!

Research with Pregnant Persons Guidance *Coming Soon!

Research with Students Guidance *Coming Soon!

AMENDMENT

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

ANNUAL CHECK-IN/CR/ CLOSEOUTS

Exempt Annual Check-In (docx)
To submit an annual check in or closeout an approved Exempt protocol.

Non-Exempt Annual Status Update/Renew/Closeout (docx)
To submit a status update, seek renewal of an expiring Non-Exempt IRB approval, or closeout an existing approved protocol

EVENTS & DEVIATIONS

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. 

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.