Quality Improvement Program (QIP)
The Quality Improvement Program (QIP) is a unit within the Office of Human Research Administration (OHRA), independent of the IRB. QIP’s mission is two fold: 1) To liaise between investigators and the IRB and 2) To provide institutional regulatory compliance.
QIP can assist investigators by:
- Providing general guidance or study specific services at study startup or throughout the course of a study. These services can include Routine 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.
- Providing training and education to the research community.
- Providing confidential discussion and correspondence which does not become part of the IRB records or file.
- Review/edit human subjects portion of grant applications.
QIP ensures institutional regulatory compliance by:
- Conducting Directed (for-cause) Audits at the request of the HSPH, HMS/HSDM Institutional Officials. Directed Audits focus on areas of concern that have been identified by a variety of entities, i.e., federal, state or institutional.
- Recommending action to the IRB, based on onsite observations during Directed (for-cause) Audits.
- Investigating allegations and findings of non-compliance.
- Reporting potential serious or continuing non-compliance to the IRB and/or HSPH, HMS/HSDM Institutional Officials and proposing corrective actions.
Contact Leslie Howes, QIP Director, to learn more about how QIP can benefit you and your research team.