ERB Approval

Attachment 10

ERB Approval

Date:   October 26, 2017

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.

George Zipf, M.S.

David Woodwell, M.P.H.

Susan Lukacs, D.O.

             

Subject: New Protocol #2018-01 The National Health and Nutrition Examination Survey

The NCHS Research Ethics Review Board reviewed the request for new Protocol #2018-01 The National Health and Nutrition Examination Survey, using the full board review process based on 45 CFR 46, at the October 18, 2017 Board Meeting. Protocol #2018-01 is approved for the maximum allowable period of one year.

ERB approval of Protocol #2018-01 will expire on 10/26/2018.

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 10/26/2018.

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 10/26/2018.  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 Craver, M.A.A.

Vice Chair, NCHS Research ERB