Please contact our IRB Administrator/Compliance Director directly and
she will try to answer your questions.  Her name is Marta Leinberger and
her email is xxxxxx@jaeb.org

Lesley S. Zajac
Director, Research Administration
Jaeb Center for Health Research
15310 Amberly Drive, Ste 350
Tampa, FL 33647
Tel: 813.975.8690
Fax: 813.975.8761
email: xxxxxx@jaeb.org

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@hrinet.org] On
Behalf Of Habel Anne
Sent: Monday, May 04, 2009 2:55 PM
To: xxxxxx@hrinet.org
Subject: [RESADM-L] HIPAA

We are in the process of developing Sponsor SOPs for Investigator
Studies.
These studies will take at multiple locations. Our organization is a
non-profit
research organization and is not a covered entity. Sites that we are
working
with provide both health care and are involved in research. We are
unsure
about our responsibilities as the study sponsor to HIPAA and need some
guidance.

All study procedures required by the protocol are funded so none of the
tests
are done standard of care.

The sites are paid per subject visit.

Is the determination regarding covered entity occur at the overall level
or can
the determination be made per study?

Any advice that you can provide will be greatly appreciated.

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 subscription information and a web-searchable archive, are available
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