Attachment H
NCHS Ethics Review Board Approval documentation
for research involving human subjects

From: Minino, Arialdi M. (CDC/OPHSS/NCHS) 
Sent: Tuesday, December 12, 2017 11:46 AM
To: Whitaker, Karen R. (CDC/OPHSS/NCHS) <krs0@cdc.gov>; Miller, Kristen S. (CDC/OPHSS/NCHS) <ktm8@cdc.gov>; SCANLON, PAUL J. (CDC/OPHSS/NCHS) <wyv6@cdc.gov>; Massey, Meredith (CDC/OPHSS/NCHS) <wnx6@cdc.gov>
Cc: Craver, James (CDC/OPHSS/NCHS) <ewf6@cdc.gov>; Madans, Jennifer H. (CDC/OPHSS/NCHS) <jhm4@cdc.gov>; Miller, Donna M. (CDC/OPHSS/NCHS) <zsk9@cdc.gov>; Queen, Susan G. (CDC/OPHSS/NCHS) <sgq1@cdc.gov>; Joestl, Sarah S. (CDC/OPHSS/NCHS) <wpl8@cdc.gov>
Subject: Continuation of Protocol #2016-16 NCHS Laboratory-Based Questionnaire Design
Importance: High

Date:       December 12, 2017

From:      Arialdi Miniño, M.P.H
               Chair, NCHS Research ERB

               James M. Craver, M.A.A..
               Vice Chair, NCHS Research ERB 
                               
To:          Kristen Miller, Ph.D.
               Karen Whitaker, B.S.

Subject:   Continuation of Protocol #2016-16 NCHS Laboratory-Based Questionnaire Design

The NCHS Research Ethics Review Board reviewed the request for continuation of Protocol #2016-16 NCHS Laboratory-Based Questionnaire Design, using the Full Board review process based on 45 CFR 46 at the November 22, 2017 convened Board meeting. Protocol #2016-16 is approved for the maximum allowable period of one year.

The Board’s review included letters, telephone scripts, questionnaires, recruiting materials and consent forms used in this study. The Board continues to believe that this protocol operates at a level of risk to participants that is no more than minimal, as defined by 45 CFR 46 and existing guidelines. 

ERB approval of protocol #2016-16 will expire on 12/01/2018.

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