Office of Research Assurances

Institutional Review Board (IRB)

Human Subject Forms & Templates


On January 19, 2018, changes to the Federal Policy for the Protection of Human Subjects (also known as the Revised Common Rule) were scheduled to take effect. However, the US Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays the implementation and compliance date for the revised Common Rule to July 19, 2018. This delay provides regulated entities such as WSU with additional time to prepare to implement the revisions. The IFR announcement also indicates the possibility of further delay. The IFR has now been posted by the Office of the Federal Register, and can be accessed at: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.

Note that per the IFR, WSU researchers must continue to comply with the existing Common Rule. As new information is received, or if WSU Human Research Protection Program (HRPP) implements any changes in the human subject research review process that do not interfere with the revised Common Rule, the information will be promptly shared with the WSU research community. For further questions, please contact the WSU HRPP at irb@wsu.edu or contact the WSU Human Subjects Protection Manager, Malathi Jandhyala at 509-335-3668.


Forms
Exemption Determination Application   DOC (revised June 6, 2017)
Non-Exempt Application   DOC (revised Oct 16, 2015)
Amendment Request   DOC  
Personnel Amendment   DOCX  
Continuing Review Form   DOC  
Closeout Report Form   DOC  
Adverse Event Form PDF RTF  
Reporting Deviations   DOC  
Templates
Guidance on Writing Consent Forms PDF    
Consent Template   RTF  
Assent Template (Ages 7-10)   RTF  
Assent Template (Ages 11-14)   RTF  
Assent Template (Ages 15-17)   RTF  
Parent Permission Form Template   RTF  
Addendums
Addendum 1 Expedited Categories and Determination   DOC  
Addendum 2 Research with Children   DOC  
Addendum 3 Research with Prisoners   DOC  
Addendum 3A Research with Prisoners   DOC  
Addendum 4 Alteration of Informed Consent Process   DOC  
Addendum 5 Waiver of Documentation of Informed Consent Process   DOC  
Addendum 6 Waiver of Informed Consent Process   DOC  
Addendum 7 HIPAA Authorization Form & Appendix A   DOC  
Addendum 8 Investigational Drugs, Other Drugs, & Devices   DOC  
Addendum 9 Blood, Tissue, Bodily Fluids, or Other Biological Specimens   DOC  
Addendum 10 Confidentiality Agreement   DOC  
Guidance
Application Instructions and Guidance PDF    
Adult Informed Consent Checklist PDF    
Parental Permission & Child Assent Checklist PDF    
Application Review Checklist PDF    
Office of Research Assurances, P.O. Box 643143, Neill Room 427, Washington State University, Pullman WA 99164-3143
If you have any questions, please contact the IRB at irb@wsu.edu or (509) 335-7646.