Office of Human Research Administration (OHRA)

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 liase 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 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 Institutional Officials and proposing corrective actions.

Contact Leslie Howes, QIP Director, to learn more about how QIP can benefit you and your research team.

 

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