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Audits, Quality Assurance, and Quality Improvement

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Audits, Quality Assurance, and Quality Improvement

Conduct of Quality Assurance/Quality Improvement Activities for IRB and OPRS Operation

The OPRS staff will conduct audits of ongoing research when the IRB directs an audit be conducted or a complaint or allegation of non-compliance is received. In addition, the staff will conduct “for cause” and “not for cause” audits of research.

On an annual basis, the University will perform a review of the human research protections program.  The goal of this review is to measure the effectiveness of the human protections program with respect to achieving and maintaining compliance. Some examples of such measures might include the number of lapses in research approval, changes in consent documents made prior to IRB approval, changes in key personnel made without submission of a Research amendment, etc. This will include a review of the following elements as described in written documents and as implemented in practice:

  • Institutional and IRB policies and procedures for protecting human subjects;
  • Organizational issues affecting systemic protections for human subjects;
  • IRB documentation and records-keeping practices;
  • Adequacy of IRB forms and templates;
  • Standards and practices for initial and continuing IRB review;
  • Standards and practices for obtaining and documenting informed consent;
  • Standards and practices for monitoring compliance with IRB determinations;
  • Standards and practices for monitoring unanticipated problems and adverse events.

The review may also include surveys of investigators or record audits for the purpose of assessing the overall human research protection program including the effectiveness of communication between the IRB and investigators; assessment of the training and education needs of investigators; to evaluate the effectiveness of the IRB website and resources; to solicit investigator satisfaction in general; to measure the submission to approval turnaround time; recordkeeping of reported incidents, etc.

All recommendations for improvement in the human research protections program will be considered by the IO and the Director.  Changes in the program will be presented to the IRB for review prior to implementation.