Audits for Research Oversight

The Human Research Protection Program (HRPP) has the responsibility to evaluate and improve the conduct of research that it oversees. Consistent with this responsibility, the HRPP may perform a targeted audit or a Quality Assurance (QA) review for human research studies being conducted here or elsewhere when any member of the faculty and/or staff of Boston Medical Center or Boston University Medical Campus is engaged in the research.

Targeted Audits

The goal of targeted audits (also called for-cause audits) is to investigate a situation in which a member of the HRPP has obtained information that indicates that there may be a risk to subject safety or to the validity of study data or that there may be noncompliance within the Human Research Protection Program. Targeted audits are intended to evaluate the specific issue(s) that caused the need for the audit, as well as overall compliance in the targeted study or IRB process and in related studies or processes as warranted.

Quality Assurance (QA) Reviews

The goal of routine QA reviews is to help investigators and study staff perform IRB-approved research in compliance with the applicable regulations, policies, and guidance in order to protect the safety of participants or the reliability or validity of study data. Routine QA reviews are intended to be educational and consultative in nature. The educational component involves providing the study staff with up-to-date information on best practices based in Good Clinical Practice (GCP). The consultative aspect is to find and help correct potential problems in study conduct, documentation, or process, including problems arising from IRB noncompliance.

QA reviews are most beneficial when performed soon after enrollment has begun but may be done at any time during the study. Investigators can request a QA review or the HRPP selects QA reviews to be done. Recently-approved studies are prioritized for selection according to their potential for risk to subject safety or data integrity, based on having one or more of the following characteristics:

  • Greater than minimal risk
  • Investigator-initiated
  • Interventional clinical trials
  • First time Principal Investigators
  • Studies where the Principal Investigator holds the IND or IDE
  • Studies having a conflict of interest management plan

Other information is available at the QA reviews Frequently Asked Questions (FAQs) page. You can also contact a Human Research Quality Manager for more information.

Jung Lee: jung@bu.edu or 617-358-7555