The mission of the HSPP Quality Assurance Audit Team is to advance a culture of research integrity and compliance with applicable laws, regulations, and policies, which govern institutions of higher education through awareness programs, monitoring, and responding to non-compliance. Our commitment to compliance includes the development of educational initiatives and appropriate oversight and monitoring to assist research faculty at Rutgers, The State University of New Jersey, in conducting research activities based upon the highest standards of integrity and excellence through teamwork and professionalism.
The goals of the HSPP Quality Assurance Audit Team are:
- to assess that human subjects are properly protected and that research procedures are carefully documented
- to assist investigators in complying with current regulatory standards for protecting human subjects in research
- to evaluate the Institutional Review Board’s compliance with federal, state, and local regulations
The HSPP Quality Assurance Audit Team functions independently and reports directly to the Vice President of Research Regulatory Affairs.
Types of Audits
The regulations we use in the audit process include:
- Code of Federal Regulations 45CFR and 21CFR
- ICH GCP Guidelines (when applicable)
- Rutgers Policies and Procedures
- State Statutes
- Research Site Standard Operating Procedures
General Overview of the Review Process
- The Chief/Executive Director of the HSPP will send a formal written notification to the Principal Investigator. The memorandum will inform the Principal Investigator that an HSPP Analyst will be contacting him/her within five (5) business days to schedule a visit to conduct an audit.
- A representative from HSPP will contact the Principal Investigator and arrange a time for the audit. The audit will begin with an initial meeting with the Principal Investigator and research team in order to review the audit schedule, procedures, and plan.
The audit consists of:
A review of research documentation:
- a.) all documents pertinent to the study.
- b.) all correspondence between the Principal Investigator and the sponsor and/or the IRB.
- c.) all informed consent forms (ICFs).
- d.) a selection of subject records.
- A tour of the facilities where study procedures are conducted may be performed, as well as interviews with the research staff and a review of any other procedures necessary to understand the conduct of the study.
- At the conclusion of the audit, a closeout meeting or exit interview will be held with the Principal Investigator and the study team to discuss findings and to answer any questions.
- An audit report will be prepared by an HSPP Analyst and presented at either the IRB Executive Committee meeting for review and determination or to the administrator that requested the investigation. The report will be accepted as presented with no further action or a debriefing memo will be generated by the IRB Executive Committee requesting a corrective action plan or additional clarifications to the findings. The report and the supporting documentation will be included in the Principal Investigator’s profile for future reference. A copy of the report is available on request by the Principal Investigator. An additional copy of the report may be sent to the Department Chair at the discretion of the IRB Executive Chair, Chief/Executive Director of the HSPP, and/or Institutional Official.
5th Floor, Room 507 / Stanley S. Bergen Building
Newark, NJ 07101