HS Research Exemption

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

M emorandum

Date

d

September 17, 2018

From

Felecia Peterson

IRB Analyst, Human Research Protection Office

Subject

HRPO Exemption Determination for Protocol #7167, “Understanding multi-sectoral

collaboration for strengthening public health capacities in Ethiopia”

To

Shivani Dama, MPH

OPHPR/DEO

On behalf of the CDC Human Research Protection Office (HRPO), I have reviewed the request to exempt protocol #7167, “Understanding multi-sectoral collaboration for strengthening public health capacities in Ethiopia”, and find that this research activity is exempt under 45 CFR 46.101(b)(2), adults only; data are not identifiable, and find that this research as it is limited to educational tests, surveys, interviews or observations of public health. This determination is valid for a period of three years through 9/16/2021. However, we strongly encourage investigators to close out exempt protocols as soon as CDC staff are no longer engaged in the research activity, rather than waiting for a reminder of the three-year expiration date.

Please be aware that changes to this protocol may not be implemented until they are reviewed by HRPO and determined to be consistent with the exemption categories. You will be reminded in three years (if the study has not been completed and closed) to submit another request for continuation and to confirm that no changes have been made to the protocol or the related science that would affect the ethical appropriateness of the research or this exemption determination.

Please also be advised that investigators remain responsible for the ethical conduct of this study and for ensuring appropriate human research protections even for research that is exempt from the regulations governing the protection of human subjects in research.

If you have questions, please contact your Associate Director for Science, your National Center Human Subjects Contact, or HRPO at huma@cdc.gov, or by telephone at 404-639-4961.

cc: 

OPHPR Human Subjects (CDC)