IRB Exemption Letter

August 11, 2015
Archana LaPollo, MPH
Senior Project Director and Co-Investigator
Public Health Management Corporation
1500 Market Street
Philadelphia, PA 19102
Dear Ms. LaPollo:
On August 7, 2015 the Public Health Management Corporation (PHMC) Institutional Review
Board (IRB) reviewed the research protocol entitled “Examination of Jail and Prison Policies
Related to STD Prevention“. In accordance with federal regulation 46.101(b)(2) of 45 CFR 46,
the IRB has determined that your study meets the criteria for exempt status. This approval is
effective for a period of three years, and will expire August 6, 2018.
The IRB has determined that your proposed project employs a survey that poses no more than
minimal risk to the participants. The information will be obtained in such a way that one’s
responses will not be linked to one’s identity or identifying information. Moreover, you are
proposing to interview participants who will be acting in their professional capacity, and who
will not be asked to disclose information of a personal or sensitive nature. Furthermore,
accidental disclosure of the participants’ responses would not have the potential to harm the
person’s reputation, employability, financial status, or legal standing. For these reasons, the
PHMC IRB has determined that your proposed study is exempt from further IRB review.
The designation of exempt status signifies that your research activity will not be monitored by
the IRB. Assuming the project does not change, it also is not subject to continuing IRB
oversight. In the interests of keeping the IRB files current, exempt research is automatically
given a 3-year expiration date. If your research is not completed within the 3-year time frame,
you should request an extension of the exempt approval. Otherwise, the approval will
automatically terminate 30 days after the expiration date.
Exempt status does not lessen the ethical obligations to subjects as articulated in the Belmont
Report. Thus, depending on the circumstances, you may need to make provisions to obtain
informed consent, protect confidentiality, minimize risks, and address problems or complaints.
Furthermore, although your project is exempt from ongoing IRB review, the research must be
conducted according to the proposal submitted to the PHMC IRB. If changes to the approved
protocol occur, a revised protocol must be reviewed and approved by the IRB before
implementation.

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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
C: Carolyn Adams, PhD
Chair, PHMC IRB

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