IRB Exemption

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

M emorandum

Date

d

October 2, 2017

From

Jennifer McCleary, BA, CIP

Exempt Administrator, Human Research Protection Office

Subject

HRPO Exemption Determination for Protocol #7057, “Capturing Patient-Reported Outcomes (CapPROs) in Myalgic Encepthalomyelitis/Chronic Fatigue Syndrome (ME/CFS): ME/CFS Healthcare Provider Perspective Interview"

To

Jin-Mann Sally Lin, PhD

NCEZID/DHCPP

On behalf of the CDC Human Research Protection Office (HRPO), I have reviewed the request to exempt protocol #7057, “Capturing Patient-Reported Outcomes (CapPROs) in Myalgic Encepthalomyelitis/Chronic Fatigue Syndrome (ME/CFS): ME/CFS Healthcare Provider Perspective Interview" and find that this research activity is exempt under 45 CFR 46.101(b)(2). This determination is valid for a period of three years through 10/1/2020. 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 [email protected], or by telephone at 404-639-4954.

cc: 

NCEZID Human Studies