QIP - Services

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QIP offers a variety of human research support services and education to the Harvard Longwood Medical Area (HSPH, HMS,HSDM) research community in order to assist investigators and their research staff and facilitate compliance with federal regulations, state and local laws, and institutional policies.  To request any of the services below, please complete the Service Request Form or contact a member of the QIP team directly.

Research Support Services

Human Subjects Grant Review

Enlist the QIP staff to draft, review/or edit the human subject section to sure that your grant properly identifies and appropriately addresses all the necessary human subjects concerns.

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 your specific study needs.  Check our website regularly for new and updated tools.  Submit your request for a new tool here.  If you would like for QIP to customize one of our existing tools to fit your study needs, ask QIP to help by completing a Service Request Form.

Floating Research Coordinator/Project Manager Support

Obtain temporary floating research coordinator/project manager support for the implementation of HSPH, HMS, HSDM IRB-approved protocols at no cost.  Research Coordinators/Project Managers are Masters level individuals who have an in-depth understanding of both institutional policies and federal regulations. They are available to provide short or long-term coverage for a variety of research related services, including recruitment, obtaining consent, and study management.

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.

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, navigate and submit through ESTR, or help respond to questions posed by the IRB.

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.

QIP Education Series

Each season, QIP offers a different education series with sessions focusing on various topics including IRB submission requirements, study management, and informed consent process. Those who attend 3 sessions during an academic year will receive Human Research training refresher credit.  Attendance is open to all.  Check out the 2013/2014 Education Series schedule and register here.

In-Service

Upon request, QIP staff is available to conduct small group training sessions on a variety of topics relating to research compliance; Institutional and School Policy; and good clinical practice.  These sessions (e.g., Exemptions, Informed Consent, Regulatory Documentation) are developed to meet the specific needs of the study site. Depending on the depth and length of the In-service, attendees may earn Human Research training credit for their participation.

One-on-One 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 including the IRB review and approval process.  Participants will learn about available human research support services and study management tools.