Human Research Protection Program

HITECH Act

Research Quality Assurance &Compliance (RQA&C)

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:

  • Ensure compliance with University policies, procedures which can be found here: http://www.yale.edu/hrpp/policies/index.html and federal regulations;
  • Serve as a resource for the Yale research community regarding regulations and policies applicable to human subjects research (HSR);
  • Educate and collaborate with the IRBs (HIC & HSC) and investigative community at Yale to continually improve upon the quality of research; and
  • Review and respond to concerns of potentially serious and/or continuingnoncompliance, potentially serious concerns expressed by subjects or non-subjects, and study suspensions or terminations by one of the Yale IRBs.

 

Activities of RQA&C include but are not limited to:

  • Conducting For-Cause (FC) reviews of HSR studies in response to concerns of potentially serious and/or continuing noncompliance
  • Developing corrective action/preventive action (CAPA) plans for studies that are found to have noncompliance
  • Conducting Not-For-Cause (NFC) reviews of HSR studies approved by the IRB to assess compliance with University policies, procedures and Federal regulations
  • Providing follow-up oversight monitoring for studies with serious noncompliance and for which the HIC or HSC requests or requires such monitoring
  • Reviewing Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO), and deviations, that indicate possible serious noncompliance or that are reported to the IRB outside of the required reporting window
  • Working with the Health Insurance Portability and Accountability Act (HIPAA) office at Yale to investigate HIPAA research noncompliance concerns.
  • Reporting noncompliance to Federal agencies, such as FDA and OHRP, when appropriate
  • Investigating and responding to complaints from study subjects and others
  • Identifying the educational needs of the Yale research community and the IRB in an effort to continually improve processesand increase awareness of institutional policies and procedures.
  • Developing and providing ongoing training sessions for the Yale research community
  • Assisting the research community in preparing for and responding to external audits (including FDA inspections)
  • Aiding in the revision of Yale HRPP/IRB policies and standard operating procedures (SOPs)

Members of RQA&C are available to Yale researchers, IRB members, sponsors, students and study participants to answer questions orconcerns.

 

Reviews/Audits Conducted by RQA&C

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

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

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.

EducationalResources

Common Rule: 45 CFR 46 ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html )

FDA Regulations:

21 CFR 50 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50 )

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 )