Oversight

Quality Assurance Program

The Quality Assurance (QA) program evaluates investigator and Institutional Review Board (IRB) compliance with organizational policies, procedures, and applicable laws and regulations for human research activities conducted or overseen by the University of Minnesota.

The QA program includes the following functions:

• Evaluating Investigator Performance
• Evaluating IRB Performance
• Responding to Complaints, Concerns, and Questions
• Reporting on the Work of the HRPP through Metrics

Clinical Trial Monitoring Service

The Clinical Trial Monitoring Service (under the auspices of the Academic Health Center) performs clinical trial monitoring—defined in E6 GCP Consolidated Guidance as the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirements. In contrast to the “moment in time” QA reviews, clinical trial monitoring is an ongoing assessment through the life of the study.

Currently, the CTSI maintains a regulatory group in its Research Services division that provides monitoring services over the life of the study where monitoring is required by the FDA or NIH, or is requested by the study sponsor-investigator. Consistent with 5.18.1 of E6 GCP Consolidated Guidance, the main purpose of monitoring activities performed by the Clinical Trial Monitoring Service is to ensure:

• The rights and well-being of human subjects are protected
• Reported trial data are accurate, complete, and verifiable from source documents
• The conduct of the trial is in compliance with the currently approved protocol as well as with GCP and other applicable regulatory requirements

The CTSI monitoring group, as resources allow, will initiate a process where every non-industry sponsored biomedical study in the School of Medicine that is identified as greater than minimal risk is included in the monitoring program, as described above.

Biomedical studies sponsored by industry are not included, since the industry sponsor already provides this service directly. However, a small number of industry-sponsored studies conducted through the School of Medicine will be locally reviewed annually to provide awareness and understanding of the industry-monitored studies.

Health Information Privacy & Compliance

The Health Information Privacy and Compliance Office (HIPCO) is responsible for ensuring that individually identifiable health information is handled appropriately across the entire University.

Department of Audits

The Department of Audits provides a wide array of services to the University, primarily through the conduct of financial, operational, compliance, and information system audits. The types of work performed extend to human research conducted by the University, and include:

• Risk-based college and departmental audits
• Risk-based University process audits
• Risk-based information technology audits
• Investigations of financial or operational misconduct
• Special projects requested by University management
• Consulting on new systems, processes, or others areas of risk

Office of Institutional Compliance

The Office of Institutional Compliance (OIC) is responsible for four institutional program areas that have an impact on human research: compliance, conflicts of interest, policies, and the University president’s delegations of authority.

Risk Intelligence and Compliance Team

The Risk Intelligence and Compliance Team (RIACT) supports the research community by investigating research compliance concerns, overseeing research ethics and compliance education, and managing compliance programs across the University related to financial controls and the protection of humans and animals involved in research.

Office of the General Counsel

Legal counsel has the responsibility to:

• Provide advice upon request to the institutional official, IRB, and other individuals involved with the HRPP.
• Determine whether someone is acting as an agent of the University
• Determine who meets the definition of “legally authorized representative” and “children” when human research is conducted in jurisdictions not covered by policies and procedures
• Resolve conflicts among applicable laws