University of Washington
Human Subjects Manual

VIII. FORMS

UW13-11f form - Status Report Form - Certificate of Exemption
Adverse Event Report - Sample Consent Format
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1. UW 13-11 application form: Use this form for activities eligible for minimal risk review and for activities requiring review by the full Human Subjects Review Committee.
   
   
2. Status Report: Use this form to request continuing review. As a courtesy, the Human Subjects Division will send investigators a Status Report for their approved activities approximately two months before the end of the current approval period. However, it is the investigator's responsibility to make sure that the Status Report is submitted at least four weeks before the end of the approval period. Investigators who have not received a Status Report from the Human Subjects Division should contact the Division and request a Status Report.
   
   
3. Certification of Exemption: Use this form to request Departmental level approval for activities eligible for Departmental-level review. Send a copy of the approved form to the Human Subjects Division.
   
   
4. Adverse Event Report: Use this form to report adverse events to the Human Subjects Review Committee. First, contact the Human Subjects Division as soon as you learn that an adverse event has occurred. Then, complete and submit the requested number of copies of the form plus a copy of the consent form signed by the subject who suffered the adverse event.
   
   
5. Sample Consent Format: This sample consent format includes the required elements of consent in a lay-out that is preferred by the Human Subjects Review Committees. Use this format as the basis for drafting consent and assent forms.

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   Section IX: Laws, and Regulations