ERB Approval Notice

Attachment 4

Text of approval notice issued by the National Center for

Health Statistics (NCHS) Research Ethics Review Board (ERB) for

full implementation of the 2009-2010 NS-CSHCN

From: LaRochelle, Dewey H. (CDC/CCHIS/NCHS)
To: Cynamon, Marcie L. (CDC/CCHIS/NCHS)
Cc: Minino, Arialdi M. (CDC/CCHIS/NCHS); Blumberg, Stephen J. (CDC/CCHIS/NCHS); Chandra, Anjani (CDC/CCHIS/NCHS); Madans, Jennifer H. (CDC/CCHIS/NCHS); Moien, Mary (CDC/CCHIS/NCHS)
Sent: Wed Jan 28 15:40:15 2009
Subject: Protocol #2009-04 Dress Rehearsal and Main Implementation of the 2009-2010 SLAITS National Survey of Children with Special Health Care Needs

January 28, 2009

From:   Anjani Chandra, Ph.D.
        Co-Chair, NCHS Research ERB

Protocol #2009-04 Dress Rehearsal and Main Implementation of the 2009-2010 SLAITS National Survey of Children with Special Health Care Needs

To:     Marcie Cynamon, MA

The NCHS Research Ethics Review Board reviewed the request for new Protocol #2009-04 Dress Rehearsal and Main Implementation of the 2009-2010 SLAITS National Survey of Children with Special Health Care Needs, using the review process, based on 45 CFR 46.

Protocol #2009-04 is approved for the maximum allowable period of one year.

IRB approval of protocol #2009-04 will expire on 12/04/2009.

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 12/04/2009.

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 12/04/2009.  It is your responsibility to submit your research protocol for continuing review.

Any problems of a serious nature resulting from implementation of this protocol should be brought to the 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, 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.

Anjani Chandra
Vice Chair, NCHS Research ERB