MDEs_STAR Draft_Attachment 07 Exp May 2006

ATTACHMENT 7

CDC Institutional Review Board - Approval Notification

From:
Sent:
To:
Cc:
Subject:

Solomon, Laura
Friday, May 13, 2005 12:59 PM
Royalty, Janet
Redmond-Leonard, Joan A; Spira, Thomas; Milton, Micah
1976: IRB Approval of Continuation of Protocol, (Expedited)

DATE:

5/13/2005

FROM:

IRB Administrator
Human Research Protection Office
Office of the Chief Science Officer, OD/CDC

SUBJECT:

IRB Approval of Continuation of Protocol #1976, "Collection and Analysis of
Minimum Data Elements Data Set from the National Breast and Cervical Cancer
Early Detection Program (NBCCEDP)" (Expedited)

TO:

Janet Royalty
NCCDPHP/DCPC

CDC's IRB "B" has reviewed and approved your request to continue protocol #1976 for the
maximum allowable period of one year and it will expire on 5/13/2006. The protocol was
reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1),
Category 5.
If other institutions involved in this protocol are being awarded CDC funds through the CDC
Procurement and Grants Office (PGO), you are required to send a copy of this IRB approval to
the CDC PGO award specialist handling the award. You are also required to verify with the
award specialist that the awardee has provided PGO with the required documentation and has
approval to begin or continue research involving human subjects as described in this protocol.
As a reminder, the IRB must review and approve all human subjects research protocols at
intervals appropriate to the degree of risk, but not less than once per year. There is no grace
period beyond one year from the last IRB approval date. It is ultimately your responsibility to
submit your research protocol for continuation review and approval by the IRB. Please keep this
approval 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 5/13/2006.
Any problems of a serious nature should be brought to the immediate attention of the IRB, and
any proposed changes to the protocol should be submitted as an amendment to the protocol for
IRB approval before they are implemented.
If you have any questions, please contact the Human Research Protection Office at (404) 3715980 or e-mail: huma@cdc.gov.
Laura Solomon
cc:
Joan Redmond-Leonard
Tom Spira
Micah Milton