Investigators & Research Staff
Investigators and research staff have the responsibility to:
- Follow the HRPP requirements described in the Investigator Manual (HRP-103).
- Comply with all determinations and additional requirements of the IRB, the IRB chair, and the institutional official.
- Strengthen competencies in the conduct of clinical research.
Evaluating investigator performance of research serves an important function in the protection of human subjects by ensuring investigator compliance with IRB requirements, regulatory requirements and institutional policy.
Evaluation of investigator performance is best accomplished in a program that includes these activities:
- Quality Assurance (QA): defined as “all those planned and systematic actions that are established to ensure that the trial is performed and data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s)” [ICH1.46]
- Monitoring: defined as “the act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s)” [ICH 1.38]
- Auditing: defined as “a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s)” [ICH 1.6].
At the University of Minnesota, there are two primary mechanisms for conducting evaluation of investigator performance in the conduct of human subjects research:
- The Post-Approval Review (PAR) quality assurance function that reports to the HRPP and Office of the Vice President for Research (OVPR)
- The Clinical Trial Monitoring Service that reports to the Clinical and Translational Science Institute (CTSI) and the Academic Health Center (AHC).
Institutional Biosafety Committee (IBC)
The Institutional Biosafety Committee reviews research and teaching activities involving recombinant or synthetic nucleic acid molecules, infectious agents, biologically derived toxins, or other potentially hazardous biological agents.
The guiding principle of the IBC is to assist faculty, staff and students using potentially hazardous biological agents in performing those activities in ways that eliminate or reduce potential exposure to personnel, students, animals, and the environment.
Institutional Review Board (IRB)
The list of IRBs designated by the Institutional Official to be the IRBs relied upon by the HRPP and the scope of review of these IRBs is listed in the IRB rosters available from the IRB Office. Go to the IRB website.
Reliance on an external IRB requires an IRB Reliance Agreement and a local review for compliance with local policies of the University.
The IRBs relied upon by this University have the authority to:
- Approve, require modifications to secure approval, and disapprove all human research overseen and conducted by the University. All human research must be approved by one of the IRBs designated by the institutional official. Officials of this University may not approve human research that has not been approved by one of the University’s IRBs.
- Suspend or terminate approval of human research not being conducted in accordance with an IRB’s requirements or that has been associated with unexpected serious harm to subjects
- Observe, or have a third party observe, the consent process and the conduct of the human research
- Determine whether an activity is human research
- Evaluate financial interests of investigators and research staff and have the final authority to decide whether the financial interest and management plan, if any, allow the human research to be approved
Clinical & Translational Science Institute
The Clinical and Translational Science Institute (CTSI) helps ensure the protection of human research participants in University of Minnesota research studies by:
- training researchers and the research professional workforce and providing tools, resources, support, and funding to help maintain and expand their research knowledge
- monitoring studies to ensure research is conducted properly with the subject's safety in mind
- providing opportunities for researchers and patients to come together to design studies that include patient-centered recruitment strategies
- encouraging a team science approach to U of M research involving human subjects
The Office of Technology Commercialization works to get the revolutionary technologies that result from University research into the hands of the public.
Radiation Protection Committee
The All University Radiation Protection Committee (AURPC), composed of the membership of the Permit Review Subcommittee and the Human Use Subcommittee, advises, reviews, and approves radiation protection policies governing the use of ionizing radiation throughout the University. The chairperson of this committee or its subcommittees shall not be a major user of sources of ionizing radiation at the University. Members of the committees are appointed by the University president. No member is allowed to vote on any committee action directly relating to the approval of his or her application for use of sources of ionizing radiation.
Magnetic Resonance Research Safety
Center for Magnetic Resonance Research Safety Committee
The Center for Magnetic Resonance Research (CMRR), funded as a Biotechnology Research Center (BTRC) by the National Center for Research Resources (NCRR) until 2012 and by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) since then, focuses on development of unique magnetic resonance imaging and spectroscopy methodologies and instrumentation for the acquisition of structural, functional, and biochemical information noninvasively in humans, and utilizing this capability to investigate organ function in health and disease.