Exempt Review

							 References:
45 CFR 46
Middle Tennessee State University IRB Policies and Procedures
IRB Management and Function; Amdur, R. and Bankert, E.; 2002 Jones and Bartlett Publishers, Inc.
Does my protocol qualify for Exempt Review?

You should be aware that exempt status does NOT mean the study is exempt from IRB review. Exempt is defined
as being exempt from further review and approval beyond the Compliance Officer or one of the two IRB Co-Chairs.
Research using data from living persons does not require IRB approval when the research does not involve human
subjects as defined in 45CFR46, i.e. obtaining research data through intervention or interaction with an individual or
with their identifiable private information; or the only involvement of human subjects is one of the below “exempt”
categories.

As stated in 45 CFR 46.101(b):

    •    45 CFR 46.101(b)(1): EVALUATION/COMPARISON OF INSTRUCTIONAL STRATEGIES/CURRICULA
         Research conducted in established or commonly accepted educational settings, involving normal
         educational practices, such as (i) research on regular and special education instructional strategies, or (ii)
         research on the effectiveness of or the comparison among instructional techniques, curricula, or
         classroom management methods.

        • 45 CFR 46.101(b)(2): EDUCATIONAL TESTS, SURVEYS, INTERVIEWS, OR OBSERVATIONS
         Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
         procedures, interview procedures or observation of public behavior, unless: (i) information obtained is
         recorded in such a manner that 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.

    •    45 CFR 46.101(b)(3): PUBLIC OFFICIALS OR CANDIDATES FOR PUBLIC OFFICE
         Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
         procedures, interview procedures or observation of public behavior that is not covered under the previous
         paragraph if: (i) the human subjects are elected or appointed public officials or candidates for public
         office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally
         identifiable information will be maintained throughout the research and thereafter. You will be asked in
         your application to describe how subjects may be identified or are at risk, or state the federal statute that
         allows the confidentiality of the subject to be maintained throughout the research and thereafter.

    •    45 CFR 46.101(b)(4): COLLECTION OR STUDY OF EXISTING DATA
         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 identified, directly or through identifiers linked to the
         subjects. Note: To qualify, the data, documents, records, or specimens must be in existence before the
         project begins. Additionally, an investigator (with proper authorization) may inspect identifiable records, but
         may only record information in a non-identifiable manner. For questions contact the MTSU IRB
    •    45 CFR 46.101(b)(5): RESEARCH AND DEMONSTRATION PROJECTS
         Research and demonstration projects which are conducted by or subject to approval of federal
         Departmental or Agency heads (such as the Secretary of Health and Human Service), and which are
         designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures
         for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those
         programs or procedures; (iv) possible cof payment for benefits or services under those programs.

Note: This applies to federally funded projects only and is most appropriately invoked with authorization or
concurrence from the funding agency. Additionally, specific criteria must be satisfied to invoke this. Also, this
category does not apply if there is a statutory requirement that this project be reviewed by an IRB or if the research
involves physical invasion or intrusion upon the privacy of subjects.

    •    45 CFR 46.101(b)(6): FOOD QUALITY EVALUATION AND CONSUMER ACCEPTANCE
         STUDIES
         Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome food, without
         additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level
         and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level
         found to be safe, by the FDA or approved by the EPA or the Food Safety and Inspection Service of the
         U.S. Department of Agriculture.



If you believe your research qualifies for Exempt Review
If you believe your research does not involve human subjects as defined in 45 CFR 46, i.e. obtaining research
data through intervention or interaction with an individual or with their identifiable private information; or the only
involvement of human subjects is one of the “exempt” categories set forth above in 45 CFR 46 101(b), you should
apply for Exempt Review. The form can be downloaded at the IRB website: download the current IRB Form

If you believe your research qualifies as no greater than minimal risk, does not involve vulnerable populations,
but does not fall under one of the above exempt categories, you should apply for Expedited Review. The form
can be downloaded at the IRB website: download the current IRB Form

If your research is greater than minimal risk or involves a vulnerable population, then you should apply for Full
Review. The form can be downloaded at the IRB website: download the current IRB Form

If you have any questions, need to report an adverse event, and/or seek further clarification, please do not
hesitate to call (615) 898-____ or e-mail compliance@mtsu.edu.

If you have any concerns regarding integrity and ethics in research and scholarship at MTSU, please do not
hesitate to call (615) 898-____ or e-mail compliance@mtsu.edu. The confidentiality of anyone who contacts the
office will be protected under the Whistleblower Protection Act
(http://thomas.loc.gov/cgi-bin/query/C?c101:./temp/~c101ln65SLD). Working together we will promote the highest
standard of integrity and ethics in research and scholarship.

Emily Born
Sam Ingram Building Rm 011B
Box 134
PH: 615-494-8918
FX: 615-898-5028
 Email: compliance@mtsu.edu