IRB Approval

Attachment M– IRB Approval Letter

Date:    March 16, 2017

From:   Arialdi Miniño, M.P.H.

            Chair, NCHS Research ERB

            James Craver, M.A.A.

            Vice Chair, NCHS Research ERB

                              

To:       Carol DeFrances, Ph.D.

            Ninee Yang, Ph.D.

              

Subject:   Protocol #2016-07 National Electronic Health Records Survey (NEHRS) Amendment #1 Updated 2017 National Electronic Health Records Survey (NEHRS) and advance letters

The NCHS Research Ethics Review Board reviewed the request for Protocol #2016-07 National Electronic Health Records Survey (NEHRS) Amendment #1 Updated 2017 National Electronic Health Records Survey (NEHRS) and advance letters, using the expedited review process based on 46.110 of 45 CFR 46(b)(2), minor change to previously approved research protocol.

Description of proposed modification:

Amendment #1 Updated 2017 National Electronic Health Records Survey (NEHRS) and advance letters

Protocol #2016-07 National Electronic Health Records Survey (NEHRS) Amendment #1 Updated 2017 National Electronic Health Records Survey (NEHRS) and advance letters.

ERB approval of protocol #2016-07 will expire on 02/09/2018.

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 02/09/18.

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 02/09/18.  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 ERB approval before they are implemented.

Please call me or Andrea MacKay, M.S.P.H., if you have any questions.

Arialdi Miniño, M.P.H.

Chair, NCHS Research ERB

James Craver, M.A.A.

Vice Chair, NCHS Research ERB