Quality Assurance / Quality Improvement Program

Brown’s Quality Assurance / Quality Improvement Program (QA/QI Program) is housed within the Office of Research Integrity.  The goal of this program is to promote a culture of integrity and excellence at Brown related to human and animal subject research, and to provide exceptional support and services to our research community in the form of training and outreach.

The QA/QI Program objectives are two-fold:

  1. To support institutional regulatory compliance; and

  2. To educate and assist the Brown research community in the conduct of compliant research to promote research excellence and reduce administrative burden

Associated with these overarching objectives, the QA/QI Administrator will facilitate the conduct of research at Brown by serving as a resource to researchers and conducting post-approval monitoring of protocols.  The QA/QI Administrator is available to conduct individual and group training sessions related to human and animal subject research.

The QA/QI Administrator welcomes your feedback and suggestions for additional services.

QA/QI Activities

  • Conduct random on site reviews to assess regulatory compliance and human/animal subject safety and to provide support to research teams in maintaining compliance

  • Conduct directed (for-cause) audits at the request of the IRB /IACUC or authorized Institutional Official. Directed audits focus on areas of concern that have been identified by a variety of entities.

  • Recommend action to the IRB / IACUC, based on onsite observations during directed (for-cause) audits.

  • Investigate allegations and findings of non-compliance.

  • Report potential serious or continuing non-compliance to the IRB / IACUC and Institutional Official and propose corrective actions.

  • Provide general guidance or study specific services at study start-up or throughout the lifetime of a project.  These services can include On-site Reviews, Study Consultations, In-services, IRB Submission Assistance, External Audit Preparation, and Study Management Tools

  • Providing investigators with quality improvement recommendations to ensure that research is conducted in accordance with best practices.