ATT 6 - Pittsburgh IRB approval

University of Pittsburgh
Institutional Review Board

3500 Fifth Avenue
Ground Level
Pittsburgh, PA 15213
(412) 383-1480
(412) 383-1508 (fax)

MEMORANDUM
TO:

Lewis H. Kuller, MD, DrPh

FROM:

Christopher Ryan, PhD, Vice Chair

DATE:

August 17, 2007

SUBJECT:

IRB #950706: The Cardiovascular Health Study

Your renewal with modifications of the above-referenced proposal has received expedited review and
approval by the Institutional Review Board under 45 CFR 46.110 (9).
Please include the following information in the upper right-hand corner of all pages of the consent
form(s).
Approval Date: August 15, 2007
Renewal Date: August 14, 2008
University of Pittsburgh
Institutional Review Board
IRB #950706
Please note that it is the investigator’s responsibility to report to the IRB any unanticipated problems
involving risks to subjects or others [see 45 CFR 46.103(b)(5) and 21 CFR 56.108(b)]. The IRB
Reference Manual (Chapter 3, Section 3.3) describes the reporting requirements for unanticipated
problems which include, but are not limited to, adverse events. If you have any questions about this
process, please contact the Adverse Event Coordinator at 412-383-1504.
The protocol and consent forms, along with a brief progress report must be resubmitted at least one
month prior to the renewal date noted above as required by FWA00006790 (University of Pittsburgh),
FWA00006735 (University of Pittsburgh Medical Center), FWA00000600 (Children’s Hospital of
Pittsburgh), FWA00003567 (Magee-Womens Health Corporation), FWA00003338 (University of
Pittsburgh Medical Center Cancer Institute).
Please be advised that your research study may be audited periodically by the University of
Pittsburgh Research Conduct and Compliance Office.
CR:kh