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Human Research News v8,n6: New Quality Improvement Program

November 19, 2008

Good Afternoon and welcome to UCLA Human Research News,

Background

UCLA’s primary purpose as a public research university is the creation, dissemination, preservation, and application of knowledge for the betterment of our global society. Human subjects research is an important element in support of the University’s purpose. The University has established policies, procedures, and programs for the oversight of human subject research to ensure the continued support of its mission to promote the ethical conduct of research, safeguard integrity in the protection of human subjects and maintain stringent compliance with regulatory standards.

UCLA has been proactive in providing the operational structure required for an effective Human Research Protection Program (HRPP) and its oversight. Leadership places high priority on compliance and regulatory monitoring to ensure that all aspects of research integrity are valued and that the proper mechanisms are in place for education, training and continuing review.

Quality Improvement Program

On behalf of the UCLA Human Research Protection Program (HRPP), I would like to introduce the Quality Improvement Program (QIP) for human subjects research. The QIP will provide internal oversight and education for the UCLA research community. The implementation of this program is part of UCLA’s initiative to meet the Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards, accreditation, and to further UCLA’s commitment to build upon our excellence, strengthen the system of protections and enhance best research practices.

• The QIP includes the direct assessment of research practices by conducting on-site reviews. Areas to be reviewed include, but are not limited to, the informed consent process, regulatory documentation and subject research records. The process of determining which studies identify for a routine on-site review will be clinical medical research studies that undergo full IRB committee review, and are not reviewed under other quality assurance programs.
• A Department Chair may request an on-site review for any clinical research studies in their department.
• IRB Chairs and/or Committees can request on-site reviews for issues that have been previously identified by the IRB.
• Any for-cause on-site review request from other internal entities will be forwarded to the IRB for final determination for the need to review the study.

The Principal Investigator will receive written notification of the on-site review at least three weeks prior to the actual visit. The Quality Improvement (QI) Review forms (to be completed by QI reviewer) will be sent at the time of notification to ensure the PI and research team’s awareness of the documents that will need to be available for the review.

The QIP will operate under the purview of the Office for Protection of Research Subjects, (OPRS). For further information or questions, please contact me or Marcia Malmet, Manager Quality Improvement Program at mmalmet@oprs.ucla.edu.

Regards,
Judith L. Brookshire, Director