ERB Approval

Attachment C

ERB Approval

Date:  October 19, 2016

From: Arialdi Miniño, M.P.H.

         Chair, NCHS Research ERB

            James Craver, M.A.A.

Vice Chair, NCHS Research ERB

To:       Kathryn Porter, M.D., M.S.

Duong T. Nguyen, D.O.

Subject:   Continuation of Protocol #2011-17 The National Health and Nutrition Examination Survey (NHANES)

The NCHS Research Ethics Review Board reviewed the request for approval of Continuation of Protocol #2011-17 The National Health and Nutrition Examination Survey (NHANES) at the convened Board meeting on October 19, 2016 using the review process based on 45 CFR 46. Continuation of Protocol #2011-17 is approved for the maximum allowable period of one year..

ERB approval of protocol #2011-17 will expire on 11/10/2017.

If it is necessary to continue the study beyond the expiration date, a new protocol should be submitted about 6 weeks prior to 11/10/2017.

There is no grace period beyond one year from the last approval date.  In order to avoid lapses in approval of your research and the possible suspension of subject enrollment, please submit your new protocol at least six (6) weeks before the protocol's expiration date of 11/10/2017. 

Any problems of a serious nature resulting from implementation of these changes should be brought to the attention of the Research ERB, and any additional proposed changes should be submitted for IRB approval before they are implemented.

Please call me or Andrea MacKay, M.S.P.H., if you have any questions.

Arialdi Miniño, M.P.H.

Chair, NCHS Research ERB

James Craver, M.A.A.

Vice Chair, NCHS Research ERB