Application Checklist for New Study Submissions
IRB-Spokane meets on the second Thursday of every month. Incomplete submission packets will be returned to investigator for completion, this may delay review of your project. Check calendar on website for submission deadlines.
Full Board Review
Contact the IRB as soon as possible to schedule a full board review date for all new studies requiring full board review.
1 Copy
A cover letter to include Principal Investigator, name of study and items in submission packet
Curriculum Vitae for Principal Investigator current within 2 years, if not already on file with the IRB
Current professional license for the Principal Investigator. It is the responsibility of the PI to ensure that all sub-investigators and key research personnel have the required/current licensure to perform the duties delegated to them.
Sponsor’s informed consent template
3 Copies plus 1 electronic copy
Protocol
Recruitment materials and/or items to be given to subjects
Advertising materials
25 Copies plus 1 electronic copy
IRB Application signed by the principal investigator and authorized representative* for each facility where research will be conducted
*See website (Home page) for contact information regarding those authorized to give approval for conduct of studies Providence Holy Family Hospital, Providence Sacred Heart Medical Center, and St. Luke’s Rehabilitation Institute.
Consent with HIPAA authorization
See website for IRB approved template, language and guidelines
For DRUG studies, also provide
Investigator’s Brochure – 3 copies plus 1 electronic copy
If extremely large document, please contact IRB to discuss
FDA form 1572 – 1 copy
FDA approval letter with Investigational New Drug (IND) number – 1 copy
For DEVICE study, also provide (final determination of risk will be made by the IRB)
If sponsor has determined is a significant risk device study, submit copy of FDA approval letter
If sponsor has determined is a non-significant risk device study, submit all documentation to support this determination
If sponsor has determined is exempt from IDE requirements, submit the reference for exemption category being claimed and provide sufficient justification to support the exemption category
Instructions for Use, if applicable – 3 copies plus 1 electronic copy
Report of Prior Investigators, if applicable – 3 copies plus 1 electronic copy
Expedited or CIRB Facilitated Review
Expedited and CIRB Facilitated new studies are reviewed on a first come, first served basis. If you have an imminent deadline for your study, you MUST contact the IRB administrator to discuss.
1 Copy
A cover letter to include Principal Investigator, name of study and items in submission packet
Curriculum Vitae for Principal Investigator current within 2 years, if not already on file with the IRB
Current professional license for the Principal Investigator. It remains the responsibility of the PI to ensure that all sub-investigators and key research personnel have the required/current licensure to perform the duties delegated to them.
IRB Application signed by the principal investigator and authorized representative* for each hospital where research will be conducted
*See website (Home page) for contact information regarding those authorized to give approval for conduct of studies at Providence Holy Family Hospital, Providence Sacred Heart Medical Center, and St. Luke’s Rehabilitation Institute.
Protocol
Consent with HIPAA authorization
See website for IRB approved template, language and guidelines
Recruitment materials and/or items to be given to subjects
Advertising materials
Additional Information
Credentialing and Conflict of Interest in Research – Providence facilities
All investigators and key research personnel listed on the IRB-Spokane application and conducting any part of the research within a Providence facility or a Providence Medical Group clinic must complete the Providence Research Credentialing in accordance with the Providence Administrative Policy, “Performing Research with Human Subjects at Providence” (separate from IRB requirements) credentialing process as well as Conflict of Interest in Research (COIR) training and disclosure. Please see IRB website for contact information or contact the IRB staff for assistance with an introduction.
**Link to “Performing Research with Human Subjects at Providence” policy: http://pp.phc.org/docs/Administrative/Joint%20Policies/Performing%20Research%20with%20Human%20Subjects.docx
Training Requirement
All key research personnel are required to complete the Collaborative Institutional Training Initiative (CITI). Refresher courses must be completed every 3 years. IRB-Spokane contracts with the University of Miami for this course. The website belongs to and is maintained by the University of Miami. A link to CITI is provided on our website.
Review and approval of your project will be delayed if CITI training is not current for all key research personnel.
Please contact the IRB if any key personnel have completed human subjects training for another entity. Acceptance of a training completion certificate may be reviewed on a case by case basis.
Meeting Attendance
The principal investigator is expected to present the study at an IRB meeting. Exceptions will be made only after discussion with IRB staff.
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