Instructions for Study Submissions

Application Checklist for New Study Submissions

The IRB 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.

SUBMISSION/CONTACT INFORMATION

E-mail electronic submission documents to:

Paper copies can be mailed or hand delivered to: PHC Institutional Review Board

(if hand delivering, please call ahead 104 W. Fifth Ave., Suite 340W

to ensure staff will be available) Spokane, WA 99204

See website at https/irbspokane.phc.org for additional contact information

Full Board Review

Contact the IRB as soon as possible to schedule a 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, if not already on file with the IRB. 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 template, language and guidelines

For Investigation New Drug (IND) studies, also provide

Investigator’s Brochure – 3 copies plus 1 electronic copy

If extremely large document, please contact IRB to discuss

FDA approval letter with Investigational New Drug (IND) number – 1 copy

For Investigational Device Exemption (IDE) study, also provide -

If sponsor and/or FDA determinations device is a significant risk, submit copy of FDA approval letter

If sponsor has determined device is a non-significant risk device, 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 Review

Expedited reviews are reviewed on a first come, first served basis. If you have an imminent deadline for your study, you MUST contact the IRB 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

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 template, language and guidelines

Recruitment materials and/or items to be given to subjects

Advertising materials

Additional Information

Credentialing in Research – Providence Health Care Ministry -

All investigators and key research personnel listed on the IRB application and conducting any part of the research within a Providence Health Care ministry or a Providence Health Care Medical Group clinic must complete Providence Research Credentialing in accordance with the Providence Administrative Policy - “Performing Research with Human Subjects at Providence”. Please contact Providence Medical Research Center for assistance.

Conflict of Interest in Research – Providence Health & Services -

All investigators and key research personnel listed on the IRB application and conducting any part of the research within a Providence Health & Services ministry must complete the Conflict of Interest in Research (COIR) training and disclosure.

Conflict of Interest in Research – Non Providence Investigators/Key Research Staff -

Non-Providence Investigators and key research staff must complete and submit a Conflict of Interest Disclosure Statement for each person listed on the IRB application. (see IRB website)

Training Requirement

All investigators and key research personnel are required to complete the Collaborative Institutional Training Initiative (CITI). Refresher courses must be completed every 3 years. The IRB 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 are 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.

Mailing Address: 104 W. Fifth Ave., Suite 340W, Spokane, WA 99204 Version 6-15

Fax: 509-343-2123 Page 3 of 3

Electronic submission:

Website: http://irbspokane.phc.org