Phila IRB Approval

October 1, 2015

Kathleen Brady, MD
Principal Investigator
AIDS Activities Coordinating Office
Philadelphia Department of Public Health
1101 Market Street, 8th Floor
Philadelphia, PA 19104
Re: Cooperative Re-Engagement Controlled Trial (CoRECT)
Dear Dr. Brady:
The Public Health Management Corporation (PHMC) Institutional Review Board (IRB) has
reviewed the non-exempt human subjects research protocol entitled “Cooperative ReEngagement Controlled Trial Study.” In accordance with U.S. Department of Human Services
Office for Human Research Protections Guidance on Engagement of Institutions in Human
Subjects Research http://www.hhs.gov/ohrp/policy/engage08.html, PHMC has determined that it
is not engaged in this research study.
In the event that there are changes to the study protocol that could affect the not engaged
determination, it is the responsibility of the engaged institution (PDPH/AACO) and Principal
Investigator (Dr. Brady) to notify PHMC’s IRB prior to implementation of these changes so that
the IRB can appropriately review the study. Some examples of such changes could include
involving PHMC personnel in recruiting or consenting participants, or in delivering the
intervention.
Should you have any questions or require further information regarding the review of your
protocol, please contact me at lisab@phmc.org or 215-985-2531.
Please share this determination with your co-investigators and colleagues as appropriate.
Thank you for your cooperation with the PHMC Institutional Review Board.
Sincerely,

Lisa Bond, PhD
PHMC IRB Administrator

PHMC IRB#
PHMC FWA#

00002451
00021142