IRB Exemption

Att_4_Harvard_6972 Exempt Granted Memo 29March17.docx

CDC/ATSDR Formative Research and Tool Development

IRB Exemption

OMB: 0920-1154

Document [docx]
Download: docx | pdf

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)


Shape1

M emorandum


Shape2

Date

d

March 29, 2017

Shape3

From


Jennifer McCleary, BA, CIP

Exempt Administrator, Human Research Protection Office

Shape4

Subject


HRPO Exemption Determination for Protocol #6972 “Participatory Mapping to Identify and Support at-Risk Populations in Emergency Preparedness"

Shape5

To


Tracy N. Thomas, MSc, MPH

OPHPR/OSPHP


On behalf of the CDC Human Research Protection Office (HRPO), I have reviewed the request to exempt protocol #6972, “Participatory Mapping to Identify and Support at-Risk Populations in Emergency Preparedness" 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 3/28/2020. 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: 

OPHPR Human Subjects





File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleSeptember 18, 2001
AuthorNIP
File Modified0000-00-00
File Created2021-01-14

© 2024 OMB.report | Privacy Policy