OHRA Research Quality Program (RQP) Oversight Activities
The Human Research Protection Program (HRPP) is responsible for evaluating and improving the conduct of research it oversees to protect the safety of participants and the reliability or validity of study data. Consistent with this responsibility, the RQP may perform a targeted audit or a quality assurance (QA) review of any human research study being conducted at Boston Medical Center/Boston University Medical Campus or at another site when any member of the faculty and/or staff of BMC or BUMC is engaged in the research.
Routine Quality Assurance (QA) Reviews
QA reviews are performed to ensure that the rights and welfare of study participants are protected. QA reviews of new and ongoing research studies ensure that IRB-approved research is conducted in compliance with applicable federal and state regulations, BMC/BUMC HRPP institutional policies, policies of the IRB of record (if ceded), and other guidance.
Additional goals of a routine QA review are as follows:
- Provide study teams with practical, targeted education on best practices based in Good Clinical Practice (GCP).
- Identify and help study teams correct potential problems with study conduct, documentation, or process, including problems arising from IRB noncompliance.
Studies are selected for routine QA reviews based on 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 with a conflict of interest management plan
- Multi-site studies where the Principal Investigator has the responsibility for overseeing all sites
- Other characteristic indicating that a QA review would be appropriate
Even if a study is not selected for a routine QA review, any study team looking for feedback on their research conduct and processes may reach out to us to request a QA review at any time. Please see our email addresses below.
Further information about the QA review process is available on the Quality Assurance Reviews FAQs page.
Targeted Audits
A study may be selected to undergo a targeted audit (also called for-cause audit) if the HRPP receives information indicating that there may be a risk to subject safety or to the validity of study data or indicating non-compliance with BMC/BUMC HRPP Policies & Procedures. 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 and in related studies as warranted.
You can also contact a Human Research Quality Manager for more information.
Emily Crowley: eacrow@bu.edu or Alyssa Pingitore: aping@bu.edu