UHSRC Exempt Review Procedures
Introduction
Not all human subject research is subject to Federal Regulation 45 CFR 46. If you are
not sure if your study meets Federal criteria for human subject research, please
consult this page [LINK TO: “Eastern Michigan University Human Subjects Review
Committee Process” document].
Research that falls into at least one of six categories can undergo Exempt review.
“Exempt” does not mean that you do not have to submit an application to the
UHSRC. Rather, Exempt means that the study does not meet criteria for review
according to Federal Regulation 45 CFR 46. Your study still must be submitted to the
UHSRC for review.
Exempt reviews also are conducted on an ongoing basis and not at monthly
meetings. As such, there is no submission deadline for Exempt review. Turn-around
time for Exempt research, from initial submission to approval letter generally takes
3 to 4 weeks.
Categories for Exempt Review
In order to qualify for Exempt review, all research activities must fit into one or
more of the six categories below:
1. Research conducted in established or commonly accepted educational
settings involving normal educational practices, such as research on regular
and special education instruction strategies, or research on the effectiveness
of or the comparison among instructional techniques, curricula, or classroom
management methods.
2. Research involving the use of educational tests, survey procedures, interview
procedures, or observation of public behavior, unless:
a. Information obtained is recorded in a directly or indirectly
identifiable manner; or
b. Any disclosure of the human subjects’ responses outside the research
could reasonably place subjects at risk of criminal or civil liability or
be damaging to the subjects’ financial standing, employability, or
reputation.
3. Research involving the use of educational tests, survey procedures, interview
procedures, or observation of public behavior that is not exempt under
Category 2 above, if:
a. The human subjects are elected or appointed public officials or
candidates for public office; or
b. Federal statutes require without exception that the confidentiality of
the personally identifiable information will be maintained throughout
the research and thereafter.
4. Research involving the collection or study of existing data, documents,
records, pathological specimens, or diagnostic specimens, if these sources are
publicly available or if the information is recorded by the investigator in such
a manner that subjects cannot be directly or indirectly identified.
5. Research and demonstration projects conducted by or subject to the
approval of department or agency heads, and which are designed to study,
evaluate, or otherwise examine public benefit or service programs;
procedures for obtaining benefits or services under those programs; possible
changes in or alternatives to those programs or procedures; or possible
changes in methods or levels of payment for benefits or services under those
programs.
6. Taste and food quality evaluation and consumer acceptance studies, if:
a. Wholesome foods without additives are consumed; or
b. Foods consumed contain food ingredients at or below the level and
for a use found to be safe, or agricultural chemicals or environmental
contaminants at or below the level found to be safe, by the Food and
Drug Administration or approved by the Environmental Protection
agency or the Food Safety and Inspection Service of the U.S.
Department of Agriculture.
Exempt Review Process
Exempt research is submitted to the Office of Research Compliance but reviewed at
the College level. Each College has its own Exempt Review Board that reviews all
Exempt research to ensure that the research is conducted in accordance with EMU
policies and procedures, and professional standards, regarding human subject
protection. Although Exempt research is not held to the standards of Federal
Regulation 45 CFR 46, human subjects must still be protected and the principles
outlined in the Belmont Report (respect for persons, benevolence, and justice) still
apply.
Exempt applications must provide a clear and coherent description of study
methods. Additionally, recruitment and consent must be free of coercion, and the
consent process must be clear and understandable to the subject population. As
such, recruitment documents and a consent form or script are required. See the
Consent section below for assistance in developing a consent form/script for
Exempt research.
Exempt Submission Processing
When submissions are received by the Office of Research Compliance, they are
reviewed for completeness and risk. If the application is incomplete or any
supplemental documents are missing, the Office of Research Compliance will contact
the Principal Investigator with the requirements for a complete application package.
Once the application package is complete, the research will be preliminarily
reviewed for risk. If the research is judged not greater than minimal risk, and all
research activities fall into one or more Exempt categories (see above), then the
Office of Research Compliance sends the application to the Chair of the appropriate
College Review Committee. The College Review Committee Chair assigns the study
to one or two College Level reviewers who have 2 weeks to complete their reviews.
The College Review Committee Chair then conducts their own review, compiles all
reviews, and sends correspondence to the Principal Investigator. The
correspondence may contain revisions that are required before the Principal
Investigator can start their research. The Principal Investigator must respond to all
revisions and submit their response via IRBNet. The response to the revision
request letter will be processed by the College Level Committee Chair within 2 to 4
days upon receipt. The College Level Committee Chair will then send an Exempt
Determination Letter (similar to an approval letter) indicating that human subject
research activities can begin.
Consent for Exempt Research
Although Exempt research is not subject to Federal Regulations regarding informed
consent, EMU policy still requires that an informed consent process be used in all
human subject research, including Exempt research. However, the consent process
for Exempt research may be less formal and does not require that the subject sign a
consent form. For Exempt research, the consent form/script must contain the
following elements:
1. A statement that you are a researcher conducting a research study.
2. A description of the study procedures
3. A description of the risks
4. An explanation of how you will keep data confidential, how data will be
stored (and for how long), and how data will be disseminated. If you would
like to identify the subject in publication or presentation, you must include
this information and provide the subject with the option of not being
identified.
5. A statement that participation is voluntary and that the subject can
discontinue participation at any time.
6. Your contact information, your advisor’s contact information if you are a
student, and the following statement: “For information about your rights as a
participant in research, you can contact the EMU Human Subjects Review
Committee at human.subjects@emich.edu or 734-487-3090.”
Post-Approval
Once you receive your Exempt Determination letter, you are all set to begin your
research. Unlike Expedited and Full-Board reviewed research, your study does not
have an expiration date. You do not need to submit for annual review, however, the
UHSRC requests that you submit a study closure form when your research is
completed.
Changes to Approved Research: If you plan to make any changes to your study
during the course of your approval period, you must submit a Modification Request
Form and all relevant supplemental materials detailing these changes and obtain
UHSRC approval prior to implementation. Any changes made to already-approved
documents must be highlighted or tracked using Track Changes mode in Word.
Exempt Modification Requests are reviewed to ensure that the study still qualifies
for Exempt review with the requested changes. Exempt Modification Requests are
typically approved within one week from the submission date.
If you have any questions about Exempt review, contact the Office of Research
Compliance at research.compliance@emich.edu or 734-487-3090.