Att 10_IRB Approval Letter

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

Memorandum

Date

d

December 8, 2015

From

Denise Marshall, BS

IRB Administrator, Human Research Protection Office

Subject

IRB Approval of CDC Protocol #6812, "THE STUDY TO EXPLORE EARLY EVELOPMENT (SEED): PHASE 3” (Expedited)

To

Laura Schieve, PhD

NCBDDD/DD

CDC’s IRB-C has reviewed the request for approval of new protocol #6812, " THE STUDY TO EXPLORE EARLY EVELOPMENT (SEED): PHASE 3*” and has approved the protocol for the maximum allowable period of one year. CDC IRB approval will expire on 12/07/2016. The protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), Categories 2, 3, 4, 6 and 7. The IRB determined the study to be not greater than minimal risk to subjects.

The IRB has approved the targeted inclusion of children under Subpart D, 45 CFR 46.404

The IRB has approved the request for waiver of documentation of informed consent for the invitation phone call and maternal interview for all participants under 45 CFR 46.117(c)(2).

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 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 12/07/2016.

Any problems of a serious nature must be brought to the immediate attention of the CDC IRB, and any proposed changes to the protocol are required to 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) 639-7570 or e-mail: [email protected].

cc:

Scott Campbell, (CDC)

Amy Sandul, CIP, MPH, DHSc