IRB Letter

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

FDA CTP 2021 Scholastic Vaping Education Materials Survey

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.

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All researchers must comply with relevant state and federal regulations.

E&I Assigned Study ID:
Date of Certification:
Date of Check-In:

21096 - 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.
Sincerely,

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