ERB Approval

Attachment 6 ERB

Approval

Date:       December 4, 2015

From:      Stephen Blumberg, Ph.D.

               Chair, NCHS Research ERB

               Arialdi Miniño, M.P.H.

               Vice Chair, NCHS Research ERB

To:          Kathryn Porter, M.D., M.S.

George Zipf, M.S.

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 21, 2015 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 11/10/2016.

If it is necessary to continue the study beyond the expiration date, a request for continuation approval should be submitted about 6 weeks prior to 11/10/2016.

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 continuation request at least six (6) weeks before the protocol's expiration date of 11/10/2016.  It is your responsibility to submit your research protocol for continuing review.

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.

Stephen Blumberg, Ph.D.

Chair, NCHS Research ERB

Arialdi Miniño, M.P.H.

Vice Chair, NCHS Research ERB