What Research Must Be Reviewed
All research at the University of Minnesota that involves humans,
human tissue, or records gathered on human subjects requires IRB review.
This is true regardless of its funding source or area of research.
Research that requires IRB review includes any research on human
In addition, the following circumstances will require IRB review.
- is conducted by University faculty, staff, or students;
- involves University patients, students, staff, or faculty as
- is performed on the premises of the University;
- is performed with, or involves the use of, facilities or equipment
belonging to the University;
- satisfies a requirement imposed by the University for the award of
a degree or for the completion of a course of study; or
- is certified by a dean or department head to satisfy an obligation
of a faculty appointment at the University, including clinical or adjunct
Affiliated faculty research
Research conducted by "affiliated faculty" (including
who hold clinical or adjunct appointments) is also subject to IRB review.
Research conducted at another institution
Research projects conducted at other sites should be reviewed by the University of Minnesota IRB as well as by the other institution's IRB.
Research that is part of multicenter clinical trials
Approval of a document at the national level is not sufficient to bypass approval at the local level. Therefore, documents must also be submitted for IRB review.
Research in foreign countries
Research conducted by University researchers in foreign countries
falls under University guidelines. Although they cannot be imposed on
other cultures, the standards for ethical conduct cannot be lowered.
Human subjects in foreign countries deserve the same level of protection
as subjects in the United States.
Research conducted in courses
Courses in research methods and class assignments involving research with human subjects require IRB approval.
Faculty-supervised student research
Faculty must take an active role in ensuring that research projects are conducted in accordance with the IRB's requirements.
Research at a pilot or feasibility stage
Pilot and feasibility studies, even those with only one human subject, require the same review as full-scale research projects. Applications to the IRB for pilot studies should be identified as such, and subjects must be told during
the consent process that the study is a pilot.
Research involving secondary use of data
Projects that use data on human subjects gathered in earlier projects and in which individual identifiers are present require IRB review.
If, however, the data is gathered by someone who has legitimate access to
the records and who gives the investigator only "blinded" data (meaning
the investigator is unable to identify the subjects), the research project
may qualify for an exemption from full review.
Research using "waste" and "extra" material
Research conducted on "waste" or "extra" human
tissue or fluids must be submitted for review.
If the original consent for the clinical procedure contains permission
for the use of "waste" material for research, the IRB may not
require another consent form. Collection and use of "extra"
material will need IRB review.
- "Waste" material is defined as material that is collected
originally for clinical or diagnostic purposes but is no longer needed.
- "Extra" material is defined as material that is collected
above and beyond what is needed for a clinical or diagnostic procedure but
for investigational purposes.
Research projects in which the researcher is a
under contract with the University
IRB review is not required if the researcher has a strict consulting relationship in which:
All three of these criteria must be met, or the IRB will need to
review the project.
- the researcher is hired on his or her own time,
- the researcher holds no rights in the work, and
- neither the researcher nor the University retains any data.