The review procedure is based on the category of your research. Review the following guidelines to determine the correct category for your proposal. The researcher--and if appropriate, the faculty advisor--makes the initial category determination. The IRB makes the final decision.
The IRB may require full review of any research submitted under either of the first two categories, as well as full review of any research previously approved under expedited review if you seek approval beyond the initial 12 month approval period.
The researcher can always request a higher level of review than what is required.
Exempt Review (Formerly designated "Category 1"): Research presents minimal risk to subjects, including:
- anonymous surveys on innocuous topics, both on paper and online
- anonymous, non-interactive non-participating observations of public behavior
- secondary analyses of existing data
- some research involving quality assurance or program evaluation
- 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
- research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) for all subjects, including minors
- research involving surveys or interviews for subjects over 18 only
- minor modifications in previously approved research
- continuing reviews of previously approved exempt or expedited research with no more than minor changes in procedures
See CFR 46.101 on the OHRP website for more detailed information.
Expedited Review (Formerly designated "Category 2"): Research presents minimal risk to subjects, including:
- some research involving surveys, interviews, focus groups, program evaluation, or quality assurance methodologies, including for subjects under 18 (e.g., minors); please note that some research in this category may be considered exempt
- research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior), including minors
- collection of data from voice, video, digital, or image recordings made for research purposes
- collection of data through non-invasive procedures
- most non-curricular, interactive research in schools
- continuing review of research previously approved by the convened IRB as follows:
- (i) the research is permanently closed to the enrollment of new subjects;
- (ii) all subjects have completed all research-related interventions; and
- (iii) the research remains active only for long-term follow-up of subjects or
- where no new subjects have been enrolled and no additional risks have been identified or
- where the remaining research activities are limited to data analysis
- continuing review of research where the convened IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified
See OHRP Categories of Research for more detailed information.
Full Review (Formerly designated "Category 3"): Research has the potential for harming participants, violates their rights, or requires special protections for participants. The IRB must convene a quorum and discuss proposals in this category, including:
- research which might put participants at risk of criminal or civil liability or be damaging to the subject
- research involving psychological or physiological intervention that involves more than minimal risk
- interviews or surveys on sensitive topics that may pose more than minimal risk (e.g., sexual activity, alcohol or drug use, illegal behavior)
- some research involving deception
- research with special populations (e.g., prisoners, adults with mental health issues or developmental delays) whether or not the research is covered by another assurance
- research involving deception
The following flowcharts may also help you determine which category best fits your research:
Chart 1: Is an Activity Research Involving Human Subjects?
Chart 2: Is the Human Subjects Research Eligible for Exemption?
Chart 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) Apply?
Chart 4: Does exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply?
Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply?
Chart 8: May the IRB Review Be Done by Expedited Procedures?
Last Updated 8/18/15