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.
 
 

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