IRB Exemption

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 Initial Study Exemption Determination
November 8, 2016
Elena Savoia
[email protected]
Protocol Title:

Participatory Mapping to Identify and Support at-Risk Populations in
Emergency Preparedness
Principal Investigator: Elena Savoia
Protocol #:
IRB16-1789
Funding Source:
CDC/Coordinating Office for Terrorism Preparedness and Emergency
Response- 3U90TP124242-05S1 (Active)
IRB Review Date:
11/8/2016
IRB Effective Date:
11/8/2016
IRB Review Action:
Exempt
This Initial Study submission meets the criteria for exemption per the regulations found at 45
CFR 46.101(b)(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 selecting the Create Modification activity.
If unsure, contact the Harvard T.H. Chan School of Public Health IRB office.
The IRB made the following determinations:
 Research Information Security Level: The research is classified, using Harvard’s Data
Security Policy, as Level 2 Data.
Please contact me at 617-432-5174 or [email protected] with any questions.
Sincerely,
Keren-Nicole Insalaco
Sr. IRB Review Specialist

University Area IRB http://cuhs.harvard.edu
Longwood Medical Area IRB http://www.hsph.harvard.edu/ohra/