Laura,

Our institution's IRB requires a "protocol-specific" disclosure of any
relationships or financial holdings, which could give the appearance of
a Financial Conflict of Interest regardless of sponsorship.  This
information is collected on the IRB application and the disclosure is
required of the Principal Investigator, each co-investigator and any
other person responsible for designing research, directing research,
enrolling research subjects, obtaining subjects’ informed consent,
making decisions related to eligibility to participate in research or
analyzing or reporting research data.

-Dusty Layton

Dusty Layton, BS, CIP
Director, Research Compliance and Assurance
University of South Alabama
CSAB 128
Mobile, AL 36688
251-460-6625

>>> "Koch, Laura A" <xxxxxx@PHCI.ORG> 10/28/2010 4:49 PM >>>
I'm looking for some advice from those of you who oversee NCI funded
cooperative group oncology studies.  We recently centralized our
oversight of research at our community based hospital system.  While
we
have implemented a financial conflict of interest policy, we are still
working to determine how strict this policy needs to be regarding
collecting financial interest disclosures for studies conducted by a
cooperative group.  As you can imagine, there are conflicting opinions
of what meets the federal requirements.

My specific question is, do you require investigators to complete a
disclosure for each study opened within a cooperative group (under the
master agreement with them), or do you accept a blanket disclosure -
one
per investigator, per cooperative group.

I appreciate your feedback.  Feel free to contact me on or off list.

Thank you!

Laura

Laura A. Koch, MBA

xxxxxx@phci.org <mailto:xxxxxx@phci.org>

Ph: 262-928-2738

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