Att H - ERB Approval Notice for NHCS

Attachment H - ERB Approval Notice for NHCS
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Disease Control and Prevention
National Center for Health Statistics
3311 Toledo Road
Hyattsville, Maryland 20782

Date:

February 4, 2021

From:

James M. Craver, MAA
Chair, NCHS ERB
Kathleen S. O’Connor, MPH
Vice Chair, NCHS ERB

To:

Geoff Jackson, MS

Subject: New Protocol #2021-01 National Hospital Care Survey
The NCHS Ethics Review Board reviewed the request for approval of New Protocol #2021-01 National
Hospital Care Survey at the Jan 28th, 2021 convened ERB meeting. The NCHS Human Subjects Contact
determined that the new protocol #2021-01 National Hospital Care Survey is a public health surveillance
activity under the 2018 requirements of the Common Rule (45 CFR 46.102(l)(2)).
Protocol #2021-01 is approved.
This protocol is classified as surveillance under the Revised Common Rule, and as such an annual
continuation review is not required and there is no expiration date. However, the Board requires that any
proposed changes to the NHCS informed consent procedures and data collection activities must be reviewed
and approved prior to implementation.
Any problems of a serious nature should be brought to the attention of the ERB, and any additional proposed
changes should be submitted for IRB approval before they are implemented.
Please contact me or Kyle Wise, if you have any questions.

James M. Craver, MAA
Chair, NCHS ERB

Kathleen S. O’Connor, MPH
Vice Chair, NCHS ERB