The SRA Symposium - College of Medicine

For benchmarking and self-evaluation purposes the data from the methodological activities
described herein have been collected and analyzed to ensure a continuous quality improvement
process. These data are described in detail below.
Results:
Institutional Quality Improvement Review Findings:
Papers
The UHC Center for Clinical Research has collected data on informed consent documents, via a
JCAHO tool, during monthly audits conducted from January 1999 through March 2005. In that
time period, 911 informed consents were audited from 731 different clinical research protocols.
On average, 150 consent forms are reviewed annually at UHC. During the JCAHO audits, the
informed consents are reviewed for the following required elements:
• Description of benefits to be expected
• Description of potential discomforts and risks
• Description of alternative services
• Full explanation of procedures to be followed
• Assurance of right to refuse to participate
• Name of person who supplied prospective participant with information
• Date form was signed
• Address the right to patients’ right to privacy and confidentiality
Eighty-eight percent of the deficiencies or missing required elements of the informed consent
noted were readily correctable issues in the content of the informed consent document itself. Only
12% of deficiencies noted were in the supporting medical documentation of the informed consent
process. Of the deficiencies noted, the “description of alternative services” was the most frequently
noted discrepancy (see Figure 1).
In terms of trends across the time period (i.e., 6 years and 3 months), the data reveals significant
decreases beginning in the second year of auditing through the fourth year of auditing. The decreases
are by approximately one-third of the total number of discrepancies found during that four
year period starting in 2000 through 2003. However, there was a significant increase in the number
of discrepancies found in 2004 raising the total for that year to be equal to the baseline years of
1999 and 2000. It is believed that this increase back to the baseline periods is in part attributable to
changes in auditing personnel that occurred in 2004. It is expected that the raw number of identified
discrepancies will continue to increase in 2005 (projected annualized total of 28 which would
be greater than any of the previous year total to date) and beyond as a function of the development
of specialized clinical research monitoring functions with additional personnel specifically trained
to identify such discrepancies (see Figure 2).
More importantly, the overall level of discrepancies found by number of consent forms and protocols
audited over the six year period is very low. Only 11.6% of the total consent forms had some
level of inadequacy and 14.4% of the protocols (see Table 2). Again, the discrepancies found were
readily correctable and none were deemed serious discrepancies. These data show that the overall
protocol review and monitoring systems is performing well with the expectation of continued
improvement over time.
2005 Symposium Proceedings Book 71