Research Quality Assurance & Compliance (RQA&C), which is part of the Yale University HRPP, is dedicated to assisting investigators in their efforts to ensure the safety of human subjects who participate in research at Yale, as well as the integrity of the research conducted at Yale. RQA&C administers a comprehensive compliance program within the HRPP, which is accomplished by partnering with the five (5) Institutional Review Boards (IRBs) at Yale (four biomedical IRBs, known as the Human Investigation Committees (HICs), and one social, behavioral and educational (SBE) IRB, the Human Subjects Committee (HSC)), as well as senior leadership within HRPP and University to:
Members of RQA&C are available to Yale researchers, IRB members, sponsors, students and study participants to answer questions orconcerns.
Research Quality Assurance & Compliance (RQA&C) conducts two different types of internal reviews of human subjects research studies conducted at the University:
Not-for-cause (NFC) reviews of human subjects research studies are conducted by the RQA&C for the following reasons:
1. To ensure the protection of human subjects;
2. To demonstrate that research conducted at the University adheres to all applicable policies and procedures; and
3. For educational and outreach purposes.
Studies selected for a NFC review are not typically chosen based on any evidence of a concern. NFC reviews can be targeted with a specific scope or can be comprehensive and include a review of all activities in a particular study.NFC reviews are typically scheduled by a member of the RQA&C within 2 weeks of contacting the study PI. [NOT bold or italicized]
For-cause (FC) reviews are conducted in response to a concern of potentially serious and/or continuing noncompliance, at the request of the IRB or senior leadership, or as the result of a complaint. FC reviews are not routine compliance reviews.
FC reviews are typically scheduled by a member of the RQA&C promptly upon receipt of the concern.
NOTE: The Principal Investigator (PI) is ultimately responsible to ensure compliance with federal regulations and policies and procedures.
Common Rule: 45 CFR 46 ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html )
Investigational Drug Trials: 21 CFR 312 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312 )
Investigational Device Trials: 21 CFR 812 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812 )