Services

QIP offers a variety of research support services and education to the HSPH research community in order to assist investigators and their research staff with maintaining compliance with federal regulations, state and local laws, and institutional policies.  To request any of the services below, please complete the Service Request Form and a QIP staff member will contact you.

Research Support Services

Human Subjects Grant Review

QIP staff is available to review and edit human subject sections of grant applications. Make sure that your grant identifies and addresses all the necessary human subjects issues by taking advantage of this service.

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 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 (i.e. recruitment, consenting and study management).  Typical request  include a maximum of 10 hours per week during normal business hours.  Other times and/or longer term requests are negotiable.  Contact Leslie Howes at 617-432-2153 to learn more about the service.

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, provide recommendations, 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. In addition QIP staff is available for general consultations ranging from topics such as IRB submission assistance requirements, record keeping, to submission of adverse events and other reportable new information.

Educational Offerings

QIP Education Series

Each season, QIP offers a different education series with sessions focusing on various topics ranging from IRB submissions, study management, informed consent process to IRB submission types.  Those who attend 3 sessions will receive Human Research Training refresher credit.  Attendance is open to all and participants can RSVP for any specific session(s) they choose.  Check out the 2012/2013 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, School, and ORARC 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. 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 ORARC policies and procedures with a focus on the IRB review and approval process.  In addition, QIP will provide services and study management tools that will facilitate the research.  A Regulatory Binder will be provided, when appropriate.

Quarterly Investigator Series 

The Investigator Series is designed for Principal Investigators and their senior staff (i.e Project Managers, Senior Coordinators, etc.) who may be assumming some principal investigator responsibilities. The series will educate attendees on Principal Investigator duties and responsibilities as well as provide tips and tools for effective study management and monitoring/oversight. Sessions will also assist PI’s in determining which responsibilities can be appropriately delegated to study staff, and how to document such delegation.

IRB 101 

“IRB 101 is an introductory workshop intended for new HSPH research staff and investigators; however, those familiar with ORARC but would like a basic refresher are welcome to attend, as well. The session will be a didactic hands-on workshop on a variety of human subject research and IRB related topics that will give new research staff a good groundwork to begin their work with the HSPH IRB.  Attendees will learn best practice tips and have the opportunity to meet the IRB Review Specialists.  In addition, an overview of the IRB policies and forms will be provided during the session so that the new staff and investigators will have a good idea of what will be expected when it comes to IRB submissions.”