Research Ethics Review

1

Attachment 5c Research Ethics Review Board Approval
Date:

June 21, 2013

From:

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

To:

Marcie Cynamon, M.A.

Subject: Continuation of Protocol #2009-16 “National Health Interview Survey”

The NCHS Research ERB reviewed the request for approval of Continuation of Protocol #2009-16 “National
Health Interview Survey”, using the review process based on 46.110 of 45 CFR 46(b)(1), categories 7
(research employing survey or interview methods) and 9 (continuing review of research , not under IND/OSE,
where categories 2 through 8 do not apply but the IRB has determined and documented at a convened
meeting that the research involves no greater than minimal risk and no additional risks have been identified).
Continuation of Protocol #2009-16 is approved for the maximum allowable period of one year.
IRB approval of protocol #2009-16 will expire on 06/23/14.
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 06/23/14.
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 06/23/14. 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 me or Verita Buie, Dr.P.H., if you have any questions.

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