Attachment F - ERB approval

Attachment F 2005-07 ERB Approval Notice

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Centers for Disease Control and Prevention

National Center for Health Statistics

3311 Toledo Road, Room 1209

Hyattsville, Maryland 20782

MEMORANDUM

May 2, 2007

From: Stephen Blumberg, Ph.D.

Chair, NCHS Research ERB

Anjani Chandra, Ph.D.

Vice Chair, NCHS Research ERB

Continuation of Protocol #2005-07 National Hospital Discharge Survey

To: Carol DeFrances, Ph.D.

The NCHS Research ERB reviewed the request for continuation approval of Protocol #2005-07 National Hospital Discharge Survey, using the expedited review procedure, based on 46.110 of 45 CFR 46(b)(1), category 5 Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes. Continuation of Protocol #2005-07 is approved for the maximum allowable period of one year.

IRB approval of protocol #2005-07 will expire on 05/02/2008.

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 05/02/2008.

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 05/02/2008. It is your responsibility to submit your research protocol for continuing review.

Any problems of a serious nature should be brought to the immediate attention of the Research ERB, and any proposed changes should be submitted for Research ERB approval before they are implemented.

Please submit "clean" copies of the revised protocol or consents and any other revised forms to this office for the official protocol file.

Please call or e-mail Dewey LaRochelle if you have any questions.

Stephen Blumberg, Ph.D.

Chair, NCHS Research ERB

Anjani Chandra, Ph.D.

Vice Chair, NCHS Research ERB