Research Determination

Att H Human Subjects ERB Letter.docx

[NCHS] Data Collection for the Residential Care Community and Adult Day Services Center Components of the National Post-acute and Long-term Care Study

Research Determination

OMB: 0920-0943

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Attachment H Human Subjects/ERB letter

Date:      April 26, 2024

From:      Catherine Simile, Ph.D.

                Chair, NCHS ERB

               Kimberly Daniels, Ph.D.

               Vice Chair, NCHS ERB



Subject:   Protocol #2022-01 NPALS Amendment #1 Residential Care Community and Adult Day Services Center Surveys (OCD20240327.03).



The NCHS Human Subjects Contact determined that the Protocol #2022-01 NPALS Amendment #1 Residential Care Community and Adult Day Services Center Surveys, is a public health surveillance activity under the 2018 requirements of the Common Rule (45 CFR 46.102(l)(2)).



The NCHS Ethics Review Board reviewed the request for approval of Protocol #2022-01 NPALS Amendment #1 Residential Care Community and Adult Day Services Center Surveys, using the expedited review process based on 46.110 of 45 CFR 46(b)(2), minor change to previously approved protocol.



Description of proposed modification:



Amendment #1 Residential Care Community and Adult Day Services Center Surveys

Protocol #2022-01 NPALS Amendment #1 Residential Care Community and Adult Day Services Center Surveys is approved.



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.



Catherine Simile, Ph.D., Chair, NCHS ERB

Kimberly Daniels, Ph.D., Vice Chair, NCHS ERB

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorCaffrey, Christine (CDC/IOD/OPHDST/NCHS)
File Modified0000-00-00
File Created2024-08-01

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