Quality Assurance / Quality Improvement Program

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

The QA/QI Program objectives are:

  1. To educate and assist the Brown research community in the conduct of  research that is compliant with applicable federal regulations and institutional policies;

  2. To promote research excellence; and 

  3. To reduce administrative burden.

Associated with these overarching objectives, the QA/QI  Managers will facilitate the conduct of research at Brown by serving as a resource to researchers, the IRB and the IACUC.  Specifically, QA/QI activities include:

  • 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, External Audit Preparation, and Study Management Tools.

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

  • Assess the performance of HRPP or IACUC operations via metrics and use these data to design and implement targeted and broad-based quality improvement activities.

  • Assess the performance of the IRB, IACUC and its memberships.

  • Conduct random, on-site reviews to assess regulatory compliance and animal and human subject safety for approved studies and to ensure research teams are maintaining compliance based on IRB and IACUC approvals.

  • 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 or reported. Recommend actions to the IRB or IACUC are based on on-site observations.

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

New Investigator/Research Staff Onboarding Session

New to Brown Research? New to Animal or Human Subjects Research? Come and book an onboarding session with the QA/QI Managers. 

For Human Subjects Research, please contact HRPP QA/QI Manager, Christiana Provencal ([email protected])

For Animal research, please contact the Animal Program QA/QI Manager, Rebecca Poncin ([email protected]).
 

These sessions provide a one-on-one, in-person (or via phone / Zoom) on-boarding meeting to assist in orienting new investigators and staff to the Brown HRPP/IRB or IACUC websites, forms, processes and policies.  Previous participants  in these sessions  have offered very positive feedback, with 94% of respondents providing a rating of "very good" or "excellent" regarding the overall helpfulness of the session and 100% of respondents stating they would refer others to the session.