When

Effective June 16th, 2008, the Human Subjects Division has moved to the UW Tower, located at the corner of NE 45th Street and Brooklyn Avenue NE.

Expected Delays

Due to our move, packing, and unpacking of HSD files, please expect some delay in processing and/or review from Wednesday, June 11 through Wednesday, June 18.

Building Entrances

• Main entrance at the corner of Brooklyn Ave NE and NE 45th Street
• Second entrance from parking garage via skybridge over 12th Ave NE

Business Hours

While HSD business hours are 8:00 am to 5:00 pm, the UW Tower is open from 6:00 am to 6:00 pm, Monday through Friday.

Visitor Access

University affiliated visitors with a Husky Card will have access to the UW Tower during business hours and will need to swipe their card through the turnstile magnetic card readers upon entry.

Non-University affiliated visitors will be required to check-in with a photo ID at one of the two staffed visitor desks. One is located in the main lobby in the Tower atrium; the other is located inside the building just across the sky bridge from the parking garage.

Studies that use UW Medicine clinical facilities (including Harborview & SCCA) will soon be required to add a Research Care Plan to subjects’ medical records, using a predefined template. The purpose is to improve patient safety and to help researchers fulfill Medicare requirements for documenting and billing for services related to research. The Research Care Plan lists appropriate contact information for the study. In addition, it will include the study name (in an abbreviated manner), the sponsor name, and the protocol number - as this is information required by Medicare. Most ongoing studies covered by this policy will need to revise their consent forms, and some may also need to re-consent subjects. A special page has been established with more details, forms, and instructions.

On February 4, 2008, the Human Subjects Division deployed a new internal database. The number assigned to your IRB application (e.g., 07-1234-A 01) has changed to a new, 5-digit number. Both the old and the new numbers are available to you in the document New DORA Study Numbers and Old HSD Application Numbers, which also includes the name of the PI and the IRB Committee.

Please use your new application number on all correspondence and submissions to HSD after 2/4/2008. However, be assured that the new number will be linked to the old number in our new database, and HSD staff will have the capability to look up/reference the previous number.

The Confidentiality Agreement form has been revised, following consultation with the UW Attorney General’s division. The Agreement is now required for access to only UW records. This includes SCCA records, but does not include records from the VA, school district records, Puget Sound Blood Center, etc. The revised policy is incorporated into the form instructions. Please review both new documents, the Confidentiality Agreement and the Confidentiality Agreement Guidance, carefully for significant changes to this process. In recognition of the time it can take to obtain all required signatures on the form, old versions of the Confidentiality Agreement form will accepted until March 1st. Existing Confidentiality Agreements do not need to be replaced.

The following documents have been posted to the Policy & Procedures page , making them available to HSD staff, IRB members, researchers, and participants in research:

• Subject Payment Procedure
• Subject Payment Guidance
• Subject Payment, Confidentiality, and Income Tax

In response to requests from several UW research groups, the Human Subjects Division has examined the regulations and regulatory guidance about the research use of public data sets. A new Public Data Sets Policy describes the results of the analysis. It confirms that there are specific public data sets whose research use does not require review and approval by the UW Institutional Review Board (IRB), because the data sets do not involve ‘human subjects’ as defined by federal regulations. The associated Public Data Sets Procedure describes the procedure for nominating public data sets for addition to the list. It also describes the procedures for researchers to follow if they require documentation (for example, for funding agencies) that proposed public data set research activities do not require IRB approval or certification from exemption.