Exemption Letter

Att_3_ IRB HSPH_Exemption_Letter_10Oct2019.pdf

CDC/ATSDR Formative Research and Tool Development

Exemption Letter

OMB: 0920-1154

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Harvard T.H. Chan School of Public Health
Office of Human Research Administration
90 Smith Street, 3rd Floor
Boston, MA 02120
Federalwide Assurance FWA00002642
Notification of Modification / Update Exemption Determination
October 10, 2019
Elena Savoia
[email protected]
Participatory Mapping to Identify and Support at-Risk Populations in
Emergency Preparedness
Principal Investigator: Elena Savoia
Protocol #:
IRB16-1789
Submission #:
MOD16-1789-03
Funding Source:
CDC/Coordinating Office for Terrorism Preparedness and Emergency
Response- 3U90TP124242-05S1 (Closed)
IRB Review Date:
10/10/2019
IRB Effective Date:
10/10/2019
IRB Review Type:
Exempt

Protocol Title:

This Modification / Update continues to meet the criteria for exemption per the regulations found at
45 CFR 46.104(d) (2). As such, additional IRB review is not required. For international research, the
Principal Investigator is required to comply with any applicable local laws, legislation, regulations,
and/or policies. Additionally, if local IRB/ethics review is required, it must be obtained before any
human subjects research activities are conducted in the field. If assistance with applicable local
requirements is needed, please contact the Harvard T.H. Chan School of Public Health IRB office.
The determination that your research is exempt does not expire, and you will not file annual
renewals. If changes to the research are proposed that would alter the IRB’s original exemption
determination, they should be submitted in ESTR by using the Modify Study button. If unsure,
contact the Harvard T.H. Chan School of Public Health IRB office.
Please contact me at 617.432.8382 or [email protected] with any questions.
Sincerely,

Elizabeth Ehrlich
IRB Review Specialist

University Area IRB http://cuhs.harvard.edu
Harvard Longwood Campus IRB http://www.hsph.harvard.edu/orarc/irb
HRP-510d: Template v09/02/2019


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File TitleSSA_A_Att_2_ IRB HSPH_Exemption_Letter_10Oct2019.pdf
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