09AF_Att6a_CDC IRB Approval

“Evaluation of Pharmacy Syringe Access Linked to HIV Testing for
Injection Drug Users in New York City (Pharm-HIV)”
Attachment 6A
IRB Determination – Centers for Disease Control and Prevention

DATE:

9/4/2008

FROM:

IRB Administrator
Human Research Protection Office
Office of the Chief Science Officer, OD/CDC

SUBJECT:
IRB Approval of New Protocol #5425, "Evaluation of Pharmacy
Syringe Access Linked to HIV Testig for Injection Drug Users in New York City
(Pharm-HIV)" (Expedited)
TO:

Paul Weidle, Pharm.D., MPH,
NCHHSTP/DHAP/IRS

New protocol #5425 has been approved by CDC IRB "B" for the maximum allowable
period of one year and it will expire on 9/3/2009. The protocol was reviewed
in accordance with the expedited review process outlined in 45 CFR
46.110(b)(1), categories 2b, 6, 7.
Collaborator Site Restriction: Study activities may not begin with the
following collaborators/sites until documentation indicating current IRB
approval has been received by CDC’s Human Research Protection Office and is
on file:
NY Academy of Medicine
If other institutions involved in this protocol are being awarded CDC funds
through the CDC Procurement and Grants Office (PGO), you are required to send
a copy of this IRB approval to the CDC PGO award specialist handling the
award. You are also required to verify with the award specialist that the
awardee has provided PGO with the required documentation and has approval to
begin or continue research involving human subjects as described in this
protocol.
As a reminder, the IRB must review and approve all human subjects research
protocols at intervals appropriate to the degree of risk, but not less than
once per year. There is no grace period beyond one year from the last IRB
approval date. It is ultimately your responsibility to submit your research
protocol for continuation review and approval by the IRB. Please keep this
approval in your protocol file as proof of IRB approval and as a reminder of
the expiration date. To avoid lapses in approval of your research and the
possible suspension of subject enrollment and/or termination of the protocol,
please submit your continuation request at least six weeks before the
protocol's expiration date of 9/3/2009.
Any problems of a serious nature should be brought to the immediate attention
of the IRB, and any proposed changes to the protocol should be submitted as
an amendment to the protocol for IRB approval before they are implemented.
If you have any questions, please contact the Human Research Protection
Office at (404) 639-4721 or e-mail: [email protected].