Exempt and Minimal Risk Research
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Overview
Federal regulations designate certain types of research involving Human Subjects as being exempt
from further IRB oversight. A designation of ‘exempt’ means the project IS human research, but it is
very low risk and not subject to further requirements in the federal regulations.
Determination of whether a project is exempt from further IRB oversight requires a determination
by a designated IRB member. Investigators cannot make determinations whether Human Research
projects meet the regulatory criteria for exemption.
Limited IRB Review
Under the 2018 rules, certain exemptions require a limited IRB review. Limited IRB review requires
either a data/security review OR review and verification that broad consent was obtained. See the
guidance on Limited IRB Review for more information. The limited IRB review will occur at the same
time the project is reviewed for a determination of exemption.
Submission Requirements
Submission of a IRB Protocol for Human Subjects Research is required to make a determination of
exemption. The Human Subjects Protection Program and designated IRB members will review the
request for exemption. The investigator will receive a formal letter of determination of exemption.
Informed Consent
Obtaining informed consent from participants fulfills the ethical requirements of Respect for
Persons discussed in the Belmont Report. Exempt projects are still required to obtain informed
consent from subjects and consent should be provided in a language that subjects understand.
Exempt projects, however, have much more flexibility in what and how participants are informed
about the project. It is not necessary to obtain written consent for exempt studies, so long as
participants are informed.
The information contained in the informed consent does not have to meet the regulatory
requirements found in 46 CFR 46.116; however, potential subjects should have all the information
regarding the study (e.g., purpose, procedures, risks and benefits, and contact information), prior to
agreeing to participate in the study.
Modifications
Studies that are exempt need to submit Modifications in eIRB for IRB review and approval as
identified below. IRB records in eIRB are source documents for what the IRB has approved. If your
project does not require a Modification but you wish to make changes to your documents, you will
need to keep your documents updated in your own regulatory files. Submit a Modification in eIRB
with the requested change. Modifications are required when:
• Changes in PI/Co-PIs;
• Addition or removal of PI Proxies;
• Changes in the scope of previously approved research topic (such as an addition of a new
survey addressing a slightly different topic)
Exempt and Minimal Risk Research
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• Change in the data storage and protection of identifiable private information or
biospecimens that impact limited IRB review;
• Research involving prisoners that more than incidentally collects information on prisoners;
• New knowledge that increases the risk level;
• Removal or addition of funding;
• Addition of Banner as a research site;
• Addition of a single IRB or multi-site research project;
• Survey or interview procedures that involve children (i.e., individuals under the age of 18)
that do not fall under exempt category 1 which describes research in commonly accepted
educational settings;
• Observational research of children that involves participation by the researcher;
• Research subject to GDPR regulations;
• The use of any methods described in the Expedited review categories that do not meet the
exempt criteria (e.g., blood draws). For information about Expedited review categories,
please refer to this link: http://www.hhs.gov/ohrp/policy/expedited98.html
.
• Change in the way identifiers are recorded (directly or indirectly) from existing data,
documents, records, pathological specimens, or diagnostic specimens so that subjects can
be identified;
• Records review that involve prospective collection of data;
• Addition of an instrument, survey, etc. from which information obtained is recorded in such
a manner that (i) human subjects can be identified, directly or through identifiers linked to
the subjects; and (ii) any disclosure of the human subjects' responses outside the research
could reasonably place the subjects at risk of criminal or civil liability or be damaging to the
subjects' financial standing, employability, or reputation;
• Addition of vulnerable populations and research activities that may pose more than minimal
risk to the participant.
• Any additional amendments the Investigator wishes to have IRB approval.
Minor changes to exempt research do not need to be reviewed by the IRB. Minor changes include
simple revisions to already approved language (e.g., rewording survey language to make a
statement clearer, adding new survey questions in line with the already approved purpose and
questions, or updating recruitment materials to reflect new contact information). For odifications
that do not require IRB review, download the relevant approved documents within eIRB, make the
necessary changes, and save them separately in a regulatory folder within your protected
departmental drive. All modifications not reviewed by the IRB should be documented in a
systematic way to maintain an accurate record of all study activities to date.
Continuing Reviews
Human Research projects that are deemed exempt or minimal risk do not have a Continuing Review
requirement except as noted in the Continuing Review of Human Research guidance. This includes
exempt research that received a limited IRB review. The University of Arizona has chosen to require
Continuing Review on certain types of exempt research. Refer to Continuing Review of Human
Research guidance.
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Concluding Exempt Research
Investigators should submit a Continuing Review in eIRB when the exempt project is complete, so
that HSPP can update the University’s records.
Conflict of Interest
If a person is added to a project who meets the definition of a COI Investigator
, that investigator
must manually add the project to their COI disclosure. Instructions for this are found on the COI
webpage.
Under the University's COI policy, an Investigator is any person who shares the responsibility of
Conducting Research. This includes, but is not limited to, the Principal Investigator (PI), Co-PI, Co-
Investigator, Project Director (PD), Co-PD, Senior/Key Personnel, and any other person, regardless
of title or position, who is responsible for Conducting Research performed by or under the auspices
of the University. Conducting Research includes the design, development, testing, evaluation,
conduct, reporting, review, and oversight of a program of scientific inquiry. For questions, please
contact the COI Office at (520) 626-6406.
Investigator Responsibilities
• Maintain a regulatory file to support IRB determination, at minimum, the finalized protocol,
the IRB application, and the approval letter regarding the exempt determination.
• Ensure that research staff are appropriately trained, have completed all institutional COI
requirements, and are
qualified to conduct the tasks assigned.
• Oversee the conduct of all research activities. Investigators may delegate responsibilities,
but documentation of delegation is required and the PI must maintain oversight of all
research activities.
• Conduct research in compliance with the finalized protocol.
• Maintain research record (including signed consents if obtained) for six years past
completion of the study. See HSPP guidance, Data Security and Records Retention, for more
information.
• Ensure the subjects’ questions, concerns, and complaints are properly addressed and
resolutions are documented and retained in the study record.
• Report local information per HSPP requirements for Reporting of Local Information.
