IRB approval

Attachment G

From:

Buie, Verita (CDC/OSELS/NCHS)

Sent:

Tuesday, January 15, 2013 1:11 PM

To:

Cynamon, Marcie L. (CDC/OSELS/NCHS); O'Connor, Kathy (CDC/OSELS/NCHS)

Cc:

Blumberg, Stephen J. (CDC/OSELS/NCHS); Chandra, Anjani
(CDC/OSELS/NCHS); Madans, Jennifer H. (CDC/OSELS/NCHS); Powell-Griner,
Eve (CDC/OSELS/NCHS)

Subject:

Continuation of Protocol #2011-05 "Main Implementation, 2011 SLAITS
National Survey of Children’s Health (NSCH)"

Date:

January 15, 2013

From:

Anjani Chandra, Ph.D.
Vice Chair, NCHS Research ERB

To:

Marcie Cynamon, M.A.

Subject: Continuation of Protocol #2011-05 “Main Implementation, 2011 SLAITS National Survey of
Children’s Health (NSCH)”

The NCHS Research Ethics Review Board reviewed the continuation request for Protocol #2011-05
“Main Implementation, 2011 SLAITS National Survey of Children’s Health (NSCH)”, using the expedited
review procedure, based on 46.110 of 45 CFR 46(b)(1), category 8c continuing review of research
previously approved by the convened board where the remaining research activities are limited to report
writing. Continuation of Protocol #2011-05 is approved for the maximum allowable period of one year.
Protocol #2011-05 is approved for the maximum allowable period of one year.
IRB approval of protocol #2011-05 will expire on 01/24/2014.
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 01/24/2014.
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 01/24/2014. It is
your responsibility to submit your research protocol for continuing review.
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 Verita Buie, DrPH, if you have any questions.

Anjani Chandra, Ph.D.
Vice Chair, NCHS Research ERB