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 and their study staff by:
1. Providing general guidance or study specific services at study startup or throughout the course of a study. These services can include Routine On-site Review, Study Consultation, Educational service, IRB Submission Assistance, External Audit Preparation, and Study Management Tools.
2. Drafting/Editing the human subjects portion of grant applications.
3. Providing temporary research coordinator/ project manager support at no cost.
4. Providing investigators with quality improvement recommendations to ensure that research is conducted in accordance with best practices.
5. Providing training and education to the research community.
6. Providing confidential discussion and correspondence which does not become part of the IRB records or file.
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 may 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.