QIP offers a variety of services to the HSPH research community.  To request any of the below, contact QIP at qip@hsph.harvard.edu or 617-384-8546. 

Routine On-site Review

At the request of the Principal Investigator or study staff member, QIP is available to conduct both domestic and international on-site review of study documentation to ensure regulatory compliance including protocol adherence, accurate record keeping, and appropriate informed consent process.  During the on-site review QIP will provide corrective actions and offer quality improvement recommendations.

Study Consultation

At the time of study start-up or throughout the life of a protocol, QIP is available to meet with the research team and help anticipate and resolve regulatory issues that may hinder the IRB review and approval process.

In-Service

Upon request, QIP staff is available to conduct small group training sessions on a variety of topics relating to research compliance; Institutional, School, and OHRA policy; and good clinical practice.  These sessions (e.g., Exemptions, Informed Consent, and Regulatory Documentation) are catered to the study site and/or intended audience. Attendees will earn Human Research Training credit for their participation. 

IRB Submission Assistance

To facilitate the IRB review and approval process, QIP is available to draft or review IRB submissions, transfer information into new IRB forms, provide recommendations, or help respond to questions posed by the IRB.

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 specific study needs.  Check our website regularly for new and updated tools.  Submit your request for a new tool here.

Study Staff Orientation

Upon request, QIP is available to meet with new study staff (PIs, Coordinators, etc.) in order to familiarize them with OHRA policies and procedures with a focus on the IRB review and approval process.  In addition, QIP will share services that may benefit the participant and/or their research team.  A Regulatory Binder will be provided when appropriate.

This page is maintained by the Office of Human Research Administration. For web-related suggestions, comments, and questions, please email the OHRA webmaster.

For any other questions, please contact OHRA.