Human Research Protection Program

HITECH Act

Institutional Review Board Compliance

Welcome to the Yale Institutional Review Board (IRB) Compliance Home Page. Our goal is to help ensure compliance with University and Federal policies and regulations through education and collaboration with the investigative community. In this section we provide self-assessment checklists and sample regulatory documents for investigators to use in evaluating their studies and creating and maintaining accurate study records. We also provide links to forms and helpful information such as QA/QI, FAQs related to noncompliance, AE reporting, UPIRSO reporting and COI. The IRB Compliance Program is dedicated to assisting investigators in their efforts to ensure the safety of human subjects and the integrity of the research performed at Yale. Please feel free to contact us with any questions or concerns at (203) 785-4688.

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Checklists and Forms

The following documents are meant to provide investigators with tools to use for assessing and monitoring their own studies and for maintaining accurate organized study records.

Study Documentation Templates:

Quality Assurance/Quality Improvement Reviews

The IRB has initiated a Quality Assurance/ Quality Improvement (QA/QI) Program designed to evaluate and monitor research studies on a routine basis. The objective of the QA/QI Program is to ensure that proper scientific, ethical, and regulatory requirements are being adhered to by evaluating investigators’ documentation, record keeping, data analysis, and compliance with all components that constitute sound research practice. The program is designed to continually evaluate and improve the research process, thereby providing more thorough understanding by investigators and a higher degree of safety to research participants.

If your protocol has been selected for a QA/QI Review, here’s what to expect: The Compliance Manager will scheduled a pre-review meeting with the PI and any research staff to discuss the audit process. This meeting generally takes about a half hour. During the pre-review meeting you will have an opportunity to ask questions and discuss any issues you are already aware of.

The actual QA/QI Review will generally take one full day. The PI does not need to be at the site the whole time but should plan to be there at the beginning and end of the review. A research team member knowledgeable about the study should be available during the day of the review. The PI should ensure that there is a work space available for the Compliance Manager and that the subject charts, consent forms, and the IRB files are accessible for review.

Presentations

Useful Links

Request a QA/QI Review