The SRA Symposium - College of Medicine

Papers
Institutional Audit Findings:
Potential non-compliance issues that are discovered during either the IRB review of research,
previous internal auditing activities conducted by the Center for Clinical Research or by self-disclosure
of the Principal Investigator or research staff, are investigated by the Compliance Officer,
Clinical Research Manager, and Compliance Specialist of the Center for Clinical Research. A thorough
investigation of the non-compliance allegation is conducted and a detailed summary with
supporting documentation is presented to a full IRB committee. The non-compliance allegation is
discussed and deliberated upon and the IRB votes on whether the non-compliance allegation is a
case of non-serious non-compliance, serious non-compliance, or not an issue of non-compliance.
From January 2002 through March 2005, the UHC IRB reviewed 35 non-compliance allegations
(see Table 3). As demonstrated by the data, the majority (74.3%) of the non-compliance allegations
were determined to be non-serious non-compliance. Table 3 also illustrates the overall low
frequency of non-compliance issues that arose for determination by the UHC IRB as compared to
the total number of actions the UHC IRB took during the respective time period.
Of the 26 non-serious non-compliance determinations, the majority (80.8%) of non-serious
non-compliance findings noted during this time period were attributable to the erroneous use of
expired, unapproved and/or unstamped consent forms. In terms of the 5 serious non-compliance
findings, the trends noted ranged from the failure to obtain informed consent to the failure to
report adverse events to the IRB. It should be noted the trends demonstrated in the non-compliance
determinations are consistent with the audit findings of other institutions as presented by the
Department of Health and Human Services Office of Human Research Protections.
Conclusions:
The information outlined in this paper reinforces the basic construct that research compliance
monitoring must span the “entire life of a protocol” (i.e., from the time of receipt in a research
administration office and even after completion of the study). In order for this level of complete
monitoring to occur the review mechanisms must include all areas of research administration and
not merely IRB review.
Historically, the UHC Center for Clinical Research conducted internal auditing of research activities,
but found that when non-compliance allegations arose, the investigations involved were
extremely resource-intensive. Therefore, integral to the development of the Research Compliance
program at UHC was recognizing that dedicated personnel with particular expertise was needed
to staff the program as opposed to further increasing the burdensome work load of IRB coordinators
and specialists. Research compliance offices are now becoming a standard component in most
research institutions and there is momentum toward independent internal review by compliance
specialists who are versed in regulatory compliance for all areas of research administration (Icenogle,
2003).
Of additional importance is to conduct these centralized research compliance monitoring activities
in a prospective fashion for active studies in order to confirm congruence with required study
monitoring plans, Federal regulations, and good clinical practice (GCP) guidelines (Sherwin &
Fromell, 2002). Comprehensive monitoring programs are readily integrated with the operations of
IRBs, grant offices and data and safety monitoring boards in ensuring the responsible conduct of
research across a broad continuum.
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