Ethics Review Board Approval

Attachment 6

Research Ethics Review Board Approval

Attachment 6. Research Ethics Review Board Approval

Date: December 6, 2016

From: Arialdi Miniño, M.P.H

Chair, NCHS Research ERB

James M. Craver, M.A.A.

Vice Chair, NCHS Research ERB

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

Chia-Yih Wang, Ph.D.

Subject:   New Protocol #2017-01 NHANES Longitudinal Study – Feasibility Component

The NCHS Research Ethics Review Board reviewed the request for new Protocol #2017-01 NHANES Longitudinal Study – Feasibility Component, using the Full Board review process based on 45 CFR 46 at the November 16, 2016 convened Board meeting. Protocol #2017-01 is approved for the maximum allowable period of one year.

ERB approval of protocol #2017-01 will expire on 12/06/2017.

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 12/06/2017.

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 continuation request at least six (6) weeks before the protocol's expiration date of 12/06/2017.  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 ERB 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 M. Craver, M.A.A.

Vice Chair, NCHS Research ERB