Appendix D IRB letter

Appendix D

IRB Approval Letter

M emorandum

S

Date

d

eptember 7, 2011

From

Felecia Peterson

IRB-G Administrator, Human Research Protection Office

Subject

IRB Approval of Continuation of CDC Protocol #4064, "Healthy Homes and Lead Poisoning Surveillance System (HHLPSS)" (Expedited)

To

Mary Jean Brown, ScD, RN

NCEH/EEHS

CDC's IRB-G has reviewed and approved your request to continue protocol #4064 for the maximum allowable period of one year and it will expire on 10/23/2012. The protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), categories 5 and 7. Study is not designed to involve research-related contact with participants (e.g., research using existing records); study activities involve only access to or analysis of data or biological specimens and writing reports.

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 awardees 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 along with available IRB approvals from all collaborators. 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 along with all completed supporting documentation at least six weeks before the protocol's expiration date of 10/23/2012.

Any problems of a serious nature must be brought to the immediate attention of the CDC IRB, and any proposed changes to the protocol should be submitted as an amendment to the protocol for CDC IRB approval before they are implemented.

If you have any questions, please contact your National Center Human Subjects Contact or the CDC Human Research Protection Office (404) 639-4721 or e-mail: [email protected].

cc:

NCEH/ATSDR Human Studies Review (CDC)

Carolyn Guenther-Grey