Att 12_IRB

Institutional review board notification of
IRB decision of research study proposal
Solutions Institutional Review Board
4925 Copper Creek Lane
10-08-15

Little Rock, AR 72223

Genevieve Martinez-Garcia Healthy Teen Network, 1501 Saint Paul
Street, Suite 124, Baltimore Maryland 21202

IRB Identifier 1510060, The Girl Power Project
Dear Genevieve Martinez-Garcia,
You are hereby notified that the IRB APPROVED, by expedited board review modification to the
above referenced Protocol on 10/08/15. The level of risk is no more than minimal and is
consistent with 45 CFR 46.404. The expedited review category applicable to the study approval is: 7.
Future continuing reviews will be due, October 7, 2016.
Based on the information provided to us, the proposed research has been deemed to be in
compliance with the OHRP for the Protection of Human Subjects (45 CFR 46).
•

The modifications include minor revisions to existing questions and the addition or
new questions.

•

This project should be conducted in full accordance with all applicable laws and
regulations, and must adhere to the project plan that has been approved by Solutions
IRB. You must notify Solutions IRB immediately of any proposed changes that may affect
the status of your approval or the risk to participants. You must also report any
unanticipated problems involving risk to participants or others to Solutions IRB
immediately.

•

Upon any inquiries or reports about the conduct of this study, or on the receipt of any
participant or other complaints, or in conjunction with a routine compliance audit, you may
be asked to provide documentation to Solutions IRB related to this study and are
expected to immediately comply with any such requests.

•

If this project continues beyond the approval expiration date indicated above, Solutions
IRB will require continuing review of the project. You must submit continuing review
materials at least ten (10) business days prior to the expiration date to allow time for
review and avoid the lapse of approval.

•

Upon completion of the research project, please notify Solutions IRB so that we can
close out your study as appropriate.

We look forward to continuing to partner with you to ensure the ongoing protection of
participant rights. If you have any questions or need additional information, please contact us
at [email protected] or call 1-855-226-4472.
Sincerely,
Digitally signed by Dana Gonzales, PhD
DN: cn=Dana Gonzales, PhD, o=Solutions IRB, LLC,
ou, [email protected], c=US
Date: 2015.10.26 21:30:55 -05'00'

Dana Gonzales
IRB Chair
FWA00021831
IORG0007116
IRB00008523