Attachment 7 IRB/ERB Letter

Attachment 7 - ERB Letter

______________________________________________

From: LaRochelle, Dewey H. (CDC/CCHIS/NCHS)

Sent: Tuesday, May 29, 2007 3:48 PM

To: Cynamon, Marcie L. (CDC/CCHIS/NCHS)

Cc: O'Connor, Kathy (CDC/CCHIS/NCHS); Blumberg, Stephen J. (CDC/CCHIS/NCHS); Chandra, Anjani (CDC/CCHIS/NCHS); Madans, Jennifer H. (CDC/CCHIS/NCHS); Zarate, Alvan O. (CDC/CCHIS/NCHS)

Subject: Protocol #2007-27 2007 Survey of Adult Transition and Health (SATH)

May 29, 2007

From: Anjani Chandra, Ph.D.

Co-Chair, NCHS Research ERB

Protocol #2007-27 2007 Survey of Adult Transition and Health (SATH)

To: Marcie Cynamon, MA

The NCHS Research Ethics Review Board reviewed the request for new Protocol #2007-27 2007 Survey of Adult Transition and Health (SATH) using the review process, based on 45 CFR 46 at the 05/16/2007 convened meeting.

Protocol #2007-27 is approved for the maximum allowable period of one year.

IRB approval of protocol #2007-27 will expire on 05/16/2008.

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 05/16/2008.

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 05/16/2008. 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