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Human Subjects Review Procedures
(Department of Health Services Only)

UPDATED 1/2011

FOR ALL DEPARTMENT FACULTY, STAFF AND STUDENTS:

This page serves as notice and explanation of Department of Health Services procedures for requesting approval from the University's Human Subjects Division.

HUMAN SUBJECTS REVIEW TIMELINE
IMPORTANT NOTE ABOUT
STUDENT APPLICATIONS:

All student applications must be approved by the Faculty Sponsor before submission for Departmental review (and before starting the research), as stated in the Faculty Handbook.

Please make sure students and faculty are informed of this requirement.

The biggest concerns for getting through Human Subjects Review are setting a realistic timeline and following proper procedure.

Because . . . You MAY NOT proceed
with your study until you have received an approval number from the UW Human Subjects Division.

(This includes Exempt as well as Minimal Risk and Full Review applications.)

If you ignore this, your project will not be approved after the fact and it may jeopardize the completion of thesis projects and graduation plans as well as publication of manuscripts.

To allow enough time for the entire process, we recommend, a timeline minimum of two months for an Exempt Application and up to four months for a Minimal Risk or Full Review Application.

This includes the writing of the protocol and application forms, requesting letters of permission from outside collaborators or agencies, review and sign off by faculty thesis advisors (for students), sign off by the Department (at least a week), and then time for the UW review committee's questions and final approval.

Final approval by the UW Human Subjects Division may take as little as one week as is typically the case with concurrence for most exempt applications, but typically requires two months to process minimal risk and full review applications. If your Exempt application is denied and ends up being referred to the Minimal Risk review committee, you will need the extra time.

 

Please familiarize yourself with the Human Subjects Division process for IRB review, research definitions and exemption criteria:

 

GENERAL PROCESS FOR ALL PROJECT TYPES
Including Student, Faculty, Exempt, Minimal Risk (Expedited) and Full Review

Step One - Determine which application to submit:

If you believe your research will be exempt from full review: If you need to submit your application for full or minimal-risk review:
  • Complete the Full Human Subjects Application Form ( UW Form 13-11 )

 

Step Two - Make Copies and Submit:
Submit a packet containing all signed forms and copies to:

Yuki Durham
Box 357660

or deliver to H-668E in the Health Sciences Bldg.

Packet should contain:
  • One original form (ink signatures)
  • One copy of the original form
  • One original and one copy of the thesis/project proposal
  • Additional copies as required for the review level you are requesting. (Minimal Risk or Full Review)

 

Step Three - Wait for Approval to Begin Work:
  • For the IRB Initial Application Request for Determination of Exemption:
    You will receive an email confirmation when exemption review is completed. (You cannot start your project until you receive that confirmation.)

  • For Full and Minimal Risk Applications:
    The Chair's office will review for the essential information and whether the required signatures have been obtained and then forward the application to the Human Subjects Division. If there are additional questions, you will be contacted directly by the HSD reviewer.

 

REQUIRED TRAINING FOR KEY FACULTY AND STAFF:

Specialized training in human subjects research in human subjects research is required for faculty and staff who are considered key personnel on federal grant funds (either directly or from subcontracts), where there are human subjects involved. (This includes research that is considered exempt, unless it qualifies under exemption #4.)

Please check the HSD training web site below to check your certification status or schedule to complete the training.

 

IF YOU HAVE FURTHER QUESTIONS PLEASE CONTACT:

Yuki Durham ( yukid@u.washington.edu )

You may also contact faculty who currently serve on the Department's review committee:

 

ADDITIONAL INSTRUCTIONS AND FORMS