ORARC Quality Improvement Services


The Quality Improvement Program (QIP) is a unit within the Office of Regulatory Affairs and Research Compliance, 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. The QIP offers a number of services that can be very helpful to investigators at all stages of research planning and implementation. Some resources, such as the Study Coordinator Loaner Program, are particularly helpful to investigators who are new to human subjects research or who are conducting pilot research on very tight budgets. Services include:

  • Routine On-site Review: The QIP team will review  study documentation to ensure regulatory compliance including protocol adherence, accurate record keeping, and appropriate informed consent process.
  • Study Consultation:  QIP can help anticipate and resolve regulatory issues that may hinder the IRB review and approval process.
  • In-Service and Study Staff Orientation: Small group training sessions are offered on a variety of topics (e.g., Exemptions, Informed Consent, and Regulatory Documentation) relating to research compliance, policies, and good clinical practice.  Attendees  earn Human Research Training credit for their participation.  QIP is also available to meet with new study staff to orient them to OHRA policies and procedures, and to share best practices.
  • IRB Submission Assistance: QIP can draft or review IRB submissions, transfer information into new IRB forms, provide recommendations, or help respond to questions posed by the IRB.
  • Study Coordinator Loaner Program: QIP has study coordinators who can work with PIs on all aspects of study development and implementation. This is especially useful for small, under-funded studies, or investigators who are relatively new to human research.
  • Study Management Tools: QIP offers a variety of easy to use study management tools to assist research sites in maintaining and organizing essential study documents.  These templates can be downloaded and tailored to specific study needs.

For more information, contact QIP staff at qip@hsph.harvard.edu or 617-384-8546.