Exemption Approval Categories
Research activitivies seeking exemption must fit within one of the following list
of approval categories. If none of these apply, then the activity is either does
not require IRB oversight or must not qualify for exemption. In most occassions,
those studies that involve more than one of the following categories have to be submitted
as separate exemption processes even if they answer the same research question. However,
the IRB office will determine if multiple protocols are necessary or not once all
the information has been submitted to the IRB office. Most of MTSU exemption protocols
come under the categories of 1 or 2 from the following list.
1. Research conducted in established or commonly accepted educational settings
Research involving normal educational practices, such as,
(a) research on regular and special education instructional strategies; OR
(b) research on effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods.
2. Research involving the use of educational tests, survey procedures, interviews
or observation of public behavior
Research described in this category also includes cognitive diagnostic, aptitude and
achievement can be considered as "exempt" UNLESS:
(i) the information obtained from the participants is recorded in such a manner that
human subjects can be identified directly or through identifiers linked to the subjects;
AND/OR
(ii) any disclosure of the human subjects’ responses outside the research could reasonably
place the subjects at risk or criminal or civil liability or be damaging to the subjects’
financial standing, employability, or reputation.
3. Research involving appointed public officials or candidates for public office
Research as described in category 2 that could not be granted exemption unless 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.
4. Research Involving the Use of Existing Data
Research involving the collection or study of existing data, documents, records (pathological specimens or diagnostic specimens) if 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 or the data were collected
through a different protocol approved by an ethics committee such as the IRB.
5. Research Conducted by Agency Heads to Evaluate Effectiveness
Research and demonstration projects which are conducted by or subject to the approval
of department or agency heads, 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; OR
(iv) possible changes in methods or levels of payments for benefits or services under
those programs.
6. Taste and food quality evaluation and consumer acceptance studies:
(i) if wholesome foods 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 Food and Drug Administration (FDA) or
approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection
Services of the US Department of Agriculture.