IRB Approval Letter

F E N WAY H E A LT H
Institutional Review Board
1340 Boylston Street
Boston, Massachusetts 02215
Telephone 617 927-6400
Facsimile 617 267-0764
www.thefenwayinstitute.org

DATE:

September 6, 2017

TO:
FROM:

Sean Cahill, PhD
Fenway Community Health IRB

PROJECT TITLE:
SUBMISSION TYPE:

[919387-10] Developing HIV prevention strategies to engage adolescent
MSM and transgender youth
Amendment/Modification

ACTION:
APPROVAL DATE:
EXPIRATION DATE:
REVIEW TYPE:

APPROVED
September 6, 2017
October 4, 2017
Expedited Review

Thank you for your submission of Amendment/Modification materials for this project. The Fenway
Community Health IRB has APPROVED your submission. This approval is based on an appropriate risk/
benefit ratio and a project design wherein the risks have been minimized. All research must be conducted
in accordance with this approved submission.
This submission included the following project documents:
• Abstract/Summary - Protocol Summary - TRACK CHANGES.doc (UPDATED: 09/5/2017)
• Abstract/Summary - Protocol Summary.doc (UPDATED: 09/5/2017)
• Advertisement - Att 5a. Focus Group Recruitment Ads - TRACK CHANGES.pptx (UPDATED:
09/5/2017)
• Advertisement - Att 5a. Focus Group Recruitment Ads.pptx (UPDATED: 09/5/2017)
• Application Form - Amendment Application - 9.5.17.docx (UPDATED: 09/5/2017)
• Consent Form - Att 4b. Informed Assent.docx (UPDATED: 09/6/2017)
• Consent Form - Att 4a. Informed Consent.docx (UPDATED: 09/6/2017)
• Consent Form - Att 4b. Informed Assent - TRACK CHANGES.docx (UPDATED: 09/6/2017)
• Consent Form - Att 4a. Informed Consent - TRACK CHANGES.docx (UPDATED: 09/6/2017)
• Other - Att 5b. Recruitment Language - TRACK CHANGES.docx (UPDATED: 09/5/2017)
• Other - Att 5b. Recruitment Language.docx (UPDATED: 09/5/2017)
• Other - Att 3b. AMSM Focus Group Guide.docx (UPDATED: 09/5/2017)
• Other - Att 3b. AMSM Focus Group Guide - TRACK CHANGES.docx (UPDATED: 09/5/2017)
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• Protocol - Protocol.docx (UPDATED: 09/5/2017)
• Protocol - Protocol - TRACK CHANGES.docx (UPDATED: 09/5/2017)
This submission has received Expedited Review based on the applicable federal regulations.
Please remember that informed consent is a process beginning with a description of the project and
insurance of participant understanding followed by a signed consent form. Informed consent must
continue throughout the project via a dialogue between the researcher and research participant. Federal
regulations require each participant receive a copy of the signed consent document.
Please note that any revision to previously approved materials must be approved by this office prior to
initiation. Please use the appropriate revision forms for this procedure.
All Unanticipated Problems, Serious Adverse Events, Major Protocol Violations and Research Related
Incidents must be reported promptly in accordance with Fenway IRB reporting requirements. Please use
the appropriate reporting forms for this procedure. All FDA and sponsor reporting requirements should
also be followed.
This project has been determined to be a Minimal Risk project. Based on the risks, this project requires
continuing review by this committee by October 4, 2017. Please use the appropriate forms for this
procedure. Your documentation for continuing review must be received with sufficient time for review and
continued approval before the expiration date of October 4, 2017.
Please note that all research records must be retained for a minimum of three years after the completion
of the project.
If you have any questions, please contact the Manager of Research Integrity and Compliance
at regulatory@fenwayhealth.org. Please include your project title and reference number in all
correspondence with the regulatory office.

This letter has been electronically signed in accordance with all applicable regulations, and a copy is retained within Fenway
Community Health IRB's records.

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