UW researchers are already starting to hear from federal funding agencies that they will be receiving ARRA funding.  Because of the very tight time requirements associated with this funding, researchers should contact the Human Subjects Division (HSD) as soon as possible after being notified of the possibility of funding, so that the IRB review process can be responsive to the time requirements.  Do not wait until your IRB application is ready to send to HSD.  Here are the Instructions ARRA Stimulus-Recovery Funding to follow ASAP, to get you started. 

Contact Shannon Sewards by email at ssewards@u.washington.edu or by phone at 206-543-2254.

A checkbox for ARRA funding has been added to each of the documents listed below on March 22, 2009 *:
• Biological Specimens Review Determination Form (Page 5)
• Center Program Training Grant Application (Page 3)
• Human Subjects Review Application: UW 13-11 (Page 3)
• Medical Records Review Form (Page 3)
• Modification Form (Page 16)
• Repository Application (Page 3 & 4)
• Status Report - Renewal or Closeout Form (Page 4)

*  The ARRA checkbox was the only change made to these documents on 3/22/09.

The ARRA Cover Sheet is to be used with all IRB submissions for research funded by the ARRA.

More information about the ARRA, including information about how to apply for the funding and how to administer these grants at the UW is available.

WIRB (Western IRB)
Significant Changes to Submission Process

Effective:  July 1, 2009

Relevance:       This applies only to industry-initiated-and-sponsored clinical trials, which are generally reviewed by Western IRB (WIRB) for the UW IRB.

Purpose of the changes:  

• 1. Reduce HSD screening time, by:
• Allowing the use of email to send documents to HSD, and to return documents from HSD to the researcher
• Reducing the “back and forth” between WIRB, HSD, researchers, and sponsors about certain sections of consent documents
• 2. Enhance compliance oversight

Description of the changes.  The Human Subjects Division (HSD) has always provided an authorization for WIRB’s review, by requiring researchers to fill out and submit a UW / WIRB Cover Sheet.  HSD reviews the Cover Sheet, signs it, and returns it to the researcher.  The researcher includes the Cover Sheet with the application packet that he/she sends to WIRB.  The changes in this process are:

• Electronic transmission. All documents for this process (except Confidentiality Agreements) may now be sent to and from HSD electronically (by email).
• The UW / WIRB Cover Sheet has been revised to include some additional questions.
• New required attachments to the Cover Sheet. All of these attachments are parts of the application packet required by WIRB. Researchers will simply be providing a copy to HSD; there are no new forms to complete.
• The Compensation for Injury section of the consent form template has been revised, to ensure compliance with UW policies and to provide researchers & sponsors with suggested language.
• Screening of consent forms and HIPAA Authorization forms. HSD will screen and evaluated the consent form(s) and HIPAA Authorization form. After screening is completed, HSD will stamp the consent forms and UW HIPAA Authorization form, to signify to WIRB that the Injury Compensation for Injury language in the consent form and the HIPAA language are acceptable and follows UW policies. The stamped versions must be submitted to WIRB together with other WIRB-required documents.

UW / WIRB Cover Sheets submitted to HSD using old versions of forms and procedures will not be accepted after July 1, 2009.

If the current IRB PI does not have a VA appointment, s/he must identify a VA PI, effective July 1

• A Special VA PI Modification Form must be submitted and approved by Committee V, V2, EV or EV2 before July 1 otherwise work at the VA will be halted
• The Special VA PI Modification Form can be found on the VA HSD webpage
• The IRB review of this modification qualifies for review via an expedited process

If the current IRB PI does have a VA appointment, no further action is required.

Additional information is available on the HSD web site, VA Forms & Information Page. A copy of the PowerPoint presentation from the Town Hall Meeting held on Thursday, May 14th is also available: Transition from the UW IRB to an Independent VAPSHCS IRB.

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.

MAIL/DELIVERY OPTIONS
PARKING & TRANSPORTATION

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.