1. Common Rule Update: Exempt categories UT IRB
January 2019
Common Rule Update:
Exempt categories
UT IRB
The University of Texas at Austin

2. Overview Expanded categories enabling more research to be exempt
Some clarifications that may restrict exemptions
Some categories require limited IRB review

3. Standard Exclusions for Exempt
Prisoners may not be engaged in exempt research unless incidentally as part of a larger population
FDA regulated research may not be exempt

4. Category 1: Research in educational settings
Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

5. Category 1 continued Category Limitations
Conducted only in established or commonly accepted educational settings
No adverse impact on students’ learning or assessment of educators who provide instruction

6. Category 2: Surveys, interviews & public observation
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

7. Category 2 continued At least 1 must be met:
Data has no identifiers or linked code;
If identifiers or code, any disclosure of the research data could not possibly be harmful to subjects; OR
If data are identified or coded, the IRB conducts a limited review to determine privacy & confidentiality protections are adequate

8. Category 2 continued Category Expansion
Allows collection of identifiable information that could potentially lead to criminal / civil liability or be damaging to financial standing, employability, educational advancement or reputation (with IRB approved privacy & confidentiality protections)
Category Limitations
Minors cannot participate in surveys or interviews
Minors can only be publicly observed if investigators do not participate in activities being observed
Research cannot include any other interventions beyond those specified
Limited IRB review required for (iii)

9. NEW Category 3 – Benign behavioral interventions
Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

10. Category 3 continued At least 1 must be met:
Data has no identifiers or linked code;
If data are identified or coded, any disclosure of the research data could not possibly be harmful to subjects; OR
If data are identified or coded, the IRB conducts a limited review to determine privacy & confidentiality protections are adequate

11. Category 3 continued
Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.
Examples:
playing online game
solving puzzles under various noise conditions
Deciding how to divide a nominal amount of received cash between themselves and others

12. Category 3 continued Category Allowance
Allows collection of identifiable information that could potentially lead to criminal / civil liability or be damaging to financial standing, employability, educational advancement or reputation (with IRB approved privacy & confidentiality protections)
Category Limitations
Minors are excluded
Subjects must prospectively agree to participate
Cannot involve deception unless participants prospectively agree to be unaware of or misled about the nature or purposes of the research.
Limited IRB review required for option C

13. Category 4 – Secondary research for which consent is not required
Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

14. Category 4 continued The data or specimens are publicly available;
Information is recorded without identifiers or linked code AND the investigator does not contact the subjects nor re-identify subjects

15. Category 4 continued
The secondary use research is covered by a HIPAA waiver of authorization or is being done for healthcare operations (45 CFR ) or public health activities (45 CFR (b))

16. Category 4 continued
The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information……

17. Category 4 continued Category Expansion
Data no longer has to be existing at the start of the study; data may be prospectively collected
New: Allows for collection and use of identifiable health information if the information is regulated by HIPAA privacy laws
New: Allows for collection and use of identifiable information if collected by, or on behalf of, a Federal agency using govt-generated or govt-collected information

18. Category 5 – Federally conducted or supported research
Research and demonstration projects that are conducted or supported by a Federal department or agency… and that are designed to study, evaluate, improve or otherwise examine public benefit or service programs…
Must be published on publicly available Federal website prior to beginning

19. Category 6 – Taste & food quality
Taste and food quality evaluation and consumer acceptance studies:
If wholesome foods without additives are consumed, or
If a food is consumed that contains a food ingredient, 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 USDA

20. Categories 7 & 8 – Research registry with broad consent
UT does not implement categories 7 & 8 at this time

21. UT Specifics All exempt research requires prior ORSC approval
ORSC IRB analysts will make exempt determination
Studies requiring limited IRB review will be reviewed by an ORSC IRB analyst who is an IRB member
Amendments only required if:
Change in PI
Research changes may no longer qualify the research as exempt
Study status update required every 3 years
Any expedited research now qualifying for exemption will be reclassified at time of continuing review or amendment