Version
2.3
Date Updated
Sunday, April 29, 2012
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#:  126
AAHRPP Elements:  I-2, I.4.B.,I.5.A., I.5.B.


POLICY


  1. The Associate Director of External Relations and Quality Assurance designs
    and implements the OPRS internal compliance plan; leads the research
    accreditation process; drafts policies and procedures and compliance tools; creates
    and implements auditing and monitoring plans; provides regulatory support to OPRS
    staff and IRB members as needed; reviews and updates JBVAMC-related policies
    and procedures as needed, and evaluates the UIC HSPP.
  2. Detailed for-cause and not-for-cause audit findings and quality improvement
    activities, as applicable, are reported to the Director of OPRS on a semi-annual, or as needed, basis. The report will include proposed corrective actions and possible solutions from which
    the Director of OPRS may choose, when applicable. The Director of OPRS will
    respond in writing to the findings or quality improvement activities and provide the
    affected personnel and/or their supervisor with the information needed to apply
    corrective actions.
  3. A general summary report of identified risk areas, compliance program structure and
    progress, general audit findings and their resolution, quality improvement initiatives,
    corrective action plan updates, and any other related compliance information will be
    provided to the Institutional Official on an annual or, as necessary, more frequent
    basis.
  4. If the audit involves a protocol where the JBVAMC is a performance site, the written
    report will also be sent to the JBVAMC ACOS for R&D and the EC.
  5. The Associate Director of External Relations and Quality Assurance will work with the Assistant Director responsible for
    education to communicate auditing and monitoring findings when appropriate and
    collaborate on educational programs for OPRS staff based on these findings.
  6. If the Associate Director of External Relations and Quality Assurance reasonably believes that the OPRS Director is not taking appropriate action with respect to noncompliance with policies and procedures and/or federal, state, or accreditation requirements, then the Associate Director of External Relations and Quality Assurance consults the Office of University Counsel to determine the significance of the matter.  If after consult with the Office of University Counsel the Associate Director of External Relations and Quality Assurance reasonably believes that greater attention is needed as to noncompliance with policies and procedures and/or federal, state, or accreditation requirements, then the Associate Director of External Relations and Quality Assurance may at his or her discretion bring the matter to the attention of the Institutional Official.
  7. Noncompliance findings are handled in accordance with the UIC HSPP policy,
    Handling Complaints and Allegations of Potential Non-compliance with Human
    Subject Protection Regulations.