Attachment 6a
Date: February 3, 2015
From: Stephen Blumberg, Ph.D.
Chair, NCHS Research ERB
Arialdi Miniño, M.P.H.
Vice Chair, NCHS Research ERB
To: Christine Lucas, M.P.H., M.S.W.
Denys Lau, Ph.D.
Subject: New Protocol #2015-03 NAMCS Supplement on Primary Care Policies for Managing Patients with High Blood Pressure, High Cholesterol, or Diabetes
The NCHS Research Ethics Review Board reviewed the request for new Protocol #2015-03 NAMCS Supplement on Primary Care Policies for Managing Patients with High Blood Pressure, High Cholesterol, or Diabetes at the December 17, 2014 convened ERB meeting using the review process, based on 45 CFR 46. Protocol #2015-03 is approved through 10/23/2016.
ERB approval of protocol #2015-03 will expire on 02/03/2016.
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 02/03/2016.
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 10/23/2016. 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 or consents and any other revised forms to this office for the official protocol file.
Please call me or Andrea MacKay, M.S.P.H., if you have any questions.
Stephen Blumberg, Ph.D.
Chair, NCHS Research ERB
Arialdi Miniño, M.P.H.
Vice Chair, NCHS Research ERB
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