Division of Research

Quality Assurance and Quality Improvement

Part of Research Integrity and reporting to the Senior Director, Brown’s Quality Assurance / Quality Improvement (QA/QI) Program focuses on supporting human subjects research and animal research at Brown.

The goal of the QA/QI 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 the research community in the form of education and outreach.

Program Objectives

The QA/QI Program objectives are as follows:

  • To educate and assist the Brown research community in the conduct of research that is compliant with applicable federal regulations and institutional policies
  • To promote research excellence
  • To reduce administrative burden

QI/QI Activities

Associated with these overarching objectives, the QA/QI managers facilitate the conduct of research at Brown by serving as a resource to researchers, the Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC). Specifically, QA/QI activities include the following:

  • Providing general guidance or study-specific services at study startup or throughout the lifetime of a project (These services can include onsite reviews, study consultations, in-services, external audit preparation and study management tools.)
  • Providing investigators with quality improvement recommendations to ensure that research is conducted in accordance with best practices
  • Assessing the performance of Human Research Protection Program (HRPP) or IACUC operations via metrics and using these data to design and implement targeted and broad-based quality improvement activities
  • Assessing the performance of the IRB, IACUC and their memberships
  • Conducting random onsite 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
  • Conducting 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. Recommended actions to the IRB or IACUC are based on onsite observations.)
  • Investigating allegations and findings of noncompliance
  • Reporting potential serious or continuing noncompliance to the IRB or IACUC and Institutional Official and proposing corrective actions

New Investigator/Research Staff Onboarding Session

If you are a new faculty or staff member, new research advisor or are otherwise new to human subjects research at Brown, schedule an onboarding session with the QA/QI Program Manager. This one-on-one, in-person (or via phone or Zoom) session will assist you in orienting to HRPP/IRB policies, processes and forms.

These sessions provide a one-on-one, in-person (or via phone / Zoom) onboarding 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.