Protecting Human Subjects Guide
1. The IRB
at the University of Minnesota
Protecting human subjects involved in research is a collaborative
effort that demands the vigilance of University faculty, staff,
and students in partnership with the local community and federal
agencies. This guide through the peer review process is intended
to help researchers meet their responsibilities.
1.1 The Institutional Review Board's charge
The charge of the University of Minnesota's Institutional Review Board (IRB)
is:
- to protect human subjects involved in research at the University from
inappropriate risk and
- to ensure that human subjects consent to their research participation..
The Institutional Review Board (IRB) was formally established at the University
of Minnesota in the early 1970s as the "Committee on the Use of Human
Subjects in Research". The Regents' most recent policy statement, Research
Involving Human Subjects, was adopted by the Board of Regents on July
8, 1994.
The basis for the Regents' policy and the IRB charge is found in the Code
of Federal Regulations (CFR). Although protection of research subjects
is a concern of all federal agencies that sponsor research, leadership is
vested in the Office for Human Research
Protection (OHRP) and the Food and Drug
Administration (FDA). The OHRP has general responsibility for the protection
of humans as subjects in research, and the FDA regulates the use of drugs
and medical devices in experiments.
The OHRP's primary method of regulating compliance of institutions is through
"assurances." FederalWide Assurance (FWA)is an agreement with OHRP approved for three-year
intervals. The University's assurance identifies our responsibilities and
explains the steps that we will take to meet the federal regulations for
research on human subjects. Under certain conditions, additional assurance
documents must be filed.
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1.2 Membership and structure of the IRB
The IRB is composed of more than 60 members representing University faculty,
staff, students, and the local community. The committee strives for a balance
of men and women and representation from minority populations. Representatives
from the University of Minnesota campuses at Duluth and Morris also serve
on the IRB.
The members bring diversity in experience and expertise, which enables
the IRB to evaluate a wide range of research. The professional preparation
of IRB members includes:
- expertise in a range of research areas,
- familiarity with applicable laws and regulations with relevant standards
of professional conduct and practice, and
- knowledge of vulnerable or special populations such as children, prisoners,
pregnant women, and disabled persons.
The IRB is divided into six panels. Four panels review research in the health
and biological sciences, one reviews research in the social and behavioral
sciences, and the sixth is an executive committee that addresses policy issues
and provides guidance to the other five panels. Members are assigned to panels
on the basis of the panels' needs and the members' interests and expertise.
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1.3 Authorities of the IRB
To carry out its charge of protecting human subjects as required under federal regulations and Regents Policy, the IRB has the following responsibilities and authorities:
- The IRB reviews and has authority to approve, require modifications of, or disapprove all University research involving human subjects. No other University official may approve human subjects research if it has not been approved by the IRB.
- The IRB monitors and conducts continuing review of approved research at intervals of at least once per year. As part of this responsibility, the IRB has authority to observe or have a third party observe the consent process and the research.
- The IRB has authority to inspect research facilities and obtain records and other relevant information relating to the use of human subjects in research.
- The IRB takes such actions that are necessary in its judgment to comply with federal regulations or other applicable laws, including action to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
- The IRB reports to appropriate University and federal government officials:
- any unanticipated problems involving risks to subjects or serious or continuing noncompliance with IRB requirements; and
- any suspension or termination of IRB approval of research.
Contents
Next
Section: 2. What Is Subject to Review
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