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

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

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

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.

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

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:

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

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)

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:

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

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

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

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:

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

Category 4 continued The secondary use research is covered by a HIPAA waiver of authorization or is being done for healthcare operations (45 CFR 164.501) or public health activities (45 CFR 164.512(b))

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

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

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

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

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

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