Attachment 6 - IRB Letters of Approval

Attachment 6 of Supporting Statement

IRB Letters of Approval for Research Involving Human Subjects

for

Evaluation of the Successful Business Strategies to Prevent Heart Disease and Stroke Toolkit

CDC Task Order Officer (TOO): Dyann Matson Koffman

National Center for Chronic Disease Control and Health Promotion

TOO Contact Information: 770-488-8002 (phone), 770-488-8151(fax)

Copy of Letter of Approval from the Office of the Director, Human Research Protection Office, CDC:

DATE:   1/18/2007

FROM: IRB Administrator Office of Chief Science Officer, OD Human Research Protection Office, CDC

TO:     Dyann Matson Koffman, NCCDPHP

SUBJECT:   Approval to continue relying on the American Inst for Research in Behavioral Sciences’ IRB for review of Protocol # 4914: Evaluating the Heart Disease and Stroke Prevention Toolkit: Employer Evaluations

Your request to continue Protocol #4914 has been approved utilizing the American Inst for Research in Behavioral Sciences IRB.  CDC has approved this protocol for review by American Inst for Research in Behavioral Sciences’ IRB in accordance with the process outlined in 45 CFR 46.114 and the signed/approved IRB Authorization Agreement (IRB AA) on file with CDC and American Inst for Research in Behavioral Sciences.

This protocol was reviewed and approved by the American Inst for Research in Behavioral Sciences’ IRB with an expiration date of 11/27/2007.  CDC is authorizing you 30 additional days from the expiration to submit a CDC 'Request for Continuing Review of Protocol' form (CDC 0.1251) with copies of the American Inst for Research in Behavioral Sciences’ IRB approval letter/report and copies of the current consent forms.  If the reviewing IRB does not approve this protocol by the actual expiration date, this protocol will be considered out of compliance. You are required to notify me immediately should this happen and CDC will be required to suspend the protocol.

Please keep this approval letter in your protocol file as proof of IRB approval and as a reminder of the expiration date. To avoid lapses in approval of your research and the possible suspension of subject enrollment and/or termination of the protocol, please submit your continuation request at least six weeks before the protocol's expiration date of 11/27/2007.

You must then submit a 'Request for Continuing Review of Protocol' form (CDC 0.1251) to continue the protocol IRB Authorization Agreement between CDC and the American Inst for Research in Behavioral Sciences’ IRB. Please include the following documents:

1. a current letter of IRB approval by the American Inst for Research in Behavioral Sciences
2. copy of the relevant meeting minutes
3. copy of current consent forms (if applicable), and
4. any changes or amendments to the protocol or other required documents.

Serious problems must be immediately reported to this office. Any proposed changes to the existing protocol must be submitted as an amendment to the protocol and must be approved by the IRB before they are implemented. Once the amendment is approved by the American Inst for Research in Behavioral Sciences IRB, please submit to us the 'Request for Amendment Approval of Protocol' form (CDC 0.1252) along with a copy of the amended protocol, changed consent forms, any relevant meeting minutes and a copy of the current American Inst for Research in Behavioral Sciences IRB approval letter. Changes cannot be initiated until CDC has also approved the amendment(s) to the protocol.

Please forward a copy of this e-mail to the local American Inst for Research in Behavioral Sciences investigator and if you have any questions, please send an e-mail referencing the protocol number to ahsubject@cdc.gov.

Please direct all emails regarding assurances and human subject issues to the ahsubjects@cdc.gov mailbox.
Thank You, 

Constance M. Bonds, MPA
IRB Administrator, Assurances and Reliance Relationships
Centers for Disease Control
Office of the Chief Science Officer
Human Research Protection Office
1600 Clifton Rd. NE, M/S D-73
Atlanta, GA. 30033
Phone: (404) 639-4967 Fax: (404) 638-5333

Copy of Letter of Approval from the American Institutes for Research IRB:

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