Att. E. IRB approval

ATTACHMENT E:

CDC #2003-06 IRB Approval for Continuation of Protocol

May 6, 2009

From: Stephen Blumberg, Ph.D.

Chair, NCHS Research ERB

Anjani Chandra, Ph.D.

Vice Chair, NCHS Research ERB

Protocol #2003-06 National Hospital Ambulatory Medical Care Survey (NHAMCS) Amendment #11 Modification of NHAMCS Survey Procedures and Materials

To: Paul Beatty,

The NCHS Research Ethics Review Board reviewed the request for amendment of Protocol #2003-06 National Hospital Ambulatory Medical Care Survey (NHAMCS) Amendment #11 Modification of NHAMCS Survey Procedures and Materials, using the expedited review process, based on 46.110 of 45 CFR 46(b)(2), minor change to previously approved research protocol.

Description of proposed modification:

Amendment #11 Modification of NHAMCS Survey Procedures and Materials

Protocol #2003-06 Amendment #11 is approved.

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 submit "clean" copies of the revised protocol, consent forms, and any other revised materials to this office for the official protocol file.

Please call me or Dewey LaRochelle if you have any questions.

Stephen Blumberg, Ph.D.

Chair, NCHS Research ERB

Anjani Chandra, Ph.D.

Co-Chair, NCHS Research ERB