SOP: Monthly Evaluations of the Human Research Protection Program
NUMBER / DATE / AUTHOR / APPROVED BY / PAGE
HRP-011 / 4/10/14 / C. Bienstock / J. Silverstein / 1 of 2
1PURPOSE
1.1This procedure establishes the process to conduct continuous quality improvement (QI) of the human research protection program.
2REVISIONS FROM PREVIOUS VERSION
2.1Revisions to quality improvement activities and tools used to document QI activities
3POLICY
3.1The goal of the quality improvement plan is to maintain compliance with and to achieve targeted improvements in the levels of quality, efficiency, and effectiveness of the HRPP.
3.2The objectives of the quality improvement program are to provide continuous monitoring and improvement in three main areas:
3.2.1Efficiency, quality and consistency across the HRPP
3.2.2Documentation compliance (e.g. minutes) with regulatory standards
3.2.3HRPP compliance by investigators within their areas of responsibility
4RESPONSIBILITIES
4.1Assistant Director of Regulatory Affairs ensures completion of these procedures.
5PROCEDURE
5.1Complete Worksheet: Agenda Quality Improvement Assessment on the board meeting agendas of the previous month to assess accuracy and completeness, including actions made via expedited review procedures.
5.1.1If the results are outside performance target, implement an intervention to achieve performance target.
5.2Complete Worksheet: Exempt Determination Quality Improvement Assessment on 10% of all exempt determinations made in the previous month to assess accuracy of determination and sufficiency of information obtained to support the determination.
5.2.1If the results are outside performance target, implement an intervention to achieve performance target.
5.3Complete Worksheet: Minutes Quality Improvement Assessment on the minutes of the previous month. Track compliance and the days required to complete minutes.
5.3.1If the results are outside performance target, implement an intervention to achieve performance target.
5.4Review internal audit findings with the Research Compliance and Education Program director for significant trends.
5.4.1If the results demonstrate a need for additional education/training, implement an intervention to achieve increased investigator compliance and to increase effectiveness of the HRPP.
5.5Review PPHS weekly productivity report and monthly statistics report to access efficiency and workload.
5.5.1If reports indicate any negative trends, consider implementation of intervention to reverse trend or re-balance workload.
6MATERIALS
6.1QI Worksheet: Minutes Quality Improvement Assessment
6.2QI Worksheet: Exempt Determination Quality Improvement Assessment
6.3QI Worksheet: IRB Meeting Agenda Quality Improvement Assessment
6.4PPHS weekly and monthly metrics reports
6.5Quarterly QI Worksheet: Quarterly Review of QI Assessments
7REFERENCES
7.1AAHRPP Standard I-5, Elements I.5.A and I.5.B