IRB Letter

IRB Letter.pdf

Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery

IRB Letter

OMB: 0910-0697

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June 4, 2021
Everly Macario, Sc.D, MS, Ed.M
IQ Solutions, Inc.
11300 Rockville Pike, Suite 901
Rockville, MD 20852

FDA CTP 2021 Educational Outreach Focus Groups with Health Educators

Dear Everly Macario:

Using the exemption review process, the E&I administrative review team has accepted your study in
accordance with 45 CFR 46.101(b)(2ii). Please keep this approval document with your study records.
• E&I determined that the study qualifies for an exemption from the need for IRB review.

This determination does not include, and should not be taken to imply, any approval of the study or
its consent process or form.
Researchers are advised that they should adopt the principles in The Belmont Report or an
appropriate ethical code in the conduct of their studies.
Researchers are advised to maintain excellent communication with institutional and site authorities.
All researchers must comply with relevant state and federal regulations.
E&I Assigned Study ID:
Date of Certification:
Date of Check-In:

21095 - 01
June 3, 2021
June 2, 2022

Minimum Responsibilities of the Research Team:
1. Report any protocol violations, and or serious and related unanticipated problems involving risks to
your subjects or others in a timely manner.
2. Submit any desired modifications for review and consideration prior to carrying out such changes.
3. Submit an update of your study activities before the check-in date noted above.
Thank you for choosing E&I and please feel free to contact us anytime, we are here to help.

Teresa Majors
Organizational Official
cc: Lauren Rufino, [email protected]
Rinal Patel, [email protected]
Sarah Byrnes, [email protected]

E&I Business • 14400 East 42nd Street, Suite 240, Independence, MO 64055 • (800) 472-3241

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