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Brockport / IRB / Proposal Categories

Proposal Categories

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 researcher can always request a higher level of review than what is required.

Review Categories

Exempt Review (Formerly designated "Category 1") Human subjects research that is found to be exempt does not requre IRB review, but investigators still must comply with federal guidelines governing human subjects research. The IRB office will make the final determination of exempt status. 

Exempt research presents minimal risk to subjects, including, but not limited to:

  • anonymous surveys on innocuous topics, both on paper and online
  • anonymous, non-interactive non-participating observations of public behavior
  • secondary analyses of existing data if:
    • the data is publicly available, or
    • the information is recorded by the investigator in such a way that participants cannot be identified, directly or through identifiers linked to the participants
  • some research involving quality assurance or program evaluation
  • classroom-based research done by faculty or students at The College at Brockport as part of the college curriculum (see  Class projects  for more information)
  • research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
    • (i) research on regular and special education instructional strategies
    • (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 where no identifying information will be recorded that can link subjects to the data, and disclosure of the data could not reasonably place the subjects at risk of civil or criminal liability or be damaging to the subjects' financial standing, employability, or reputation

Click here for more specific guidelines about educational research, exempt proposals, and research that does not require IRB review.

See CFR 46.101 on the OHRP website for more detailed information.

Expedited Review (Formerly designated "Category 2")  The research presents no more than minimal risk to human subjects, AND the research involves only procedures listed below (Note: This applies to both initial and continuing IRB review).

Research presents no more than minimal risk to subjects, including, but not limited to:

  • 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 (Note: Some research in this category may be exempt from the DHHS regulations. This listing refers only to research that is not exempt.)
  • research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Some research in this category may be exempt from the DHHS regulations. This listing refers only to research that is not exempt.)
  • most non-curricular, interactive research in schools 
  • collection of data from voice, video, digital, or image recordings made for research purposes
  • collection of data through non-invasive procedures
  • continuing review of previously approved expedited research with no more than minor changes in procedures
  • continuing review of research previously approved by the convened IRB as follows:
    • Where (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 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

Note: The specific circumstances of the proposed research must be considered when determining whether an activity listed above involves minimal risk. The expedited review procedure may not be used for research where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are not greater than minimal.

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, but not limited to:

  • research which might put participants at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing,
  • 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)
  • studies involving deception, when withholding information or debriefing raises the risk level of the study beyond minimal
  • studies involving populations requiring additional protections because of cultural, economic, or educational vulnerability (e.g., prisoners, adults with mental health issues or developmental delays) whether or not the research is covered by another assurance
  • continuing review of research previously approved by the full board that does not meet the specifications for expedited continuing review
  • studies including information that may be disclosed requiring mandatory legal reporting (e.g., child/elder abuse, HIV infection, etc.)
  • studies performed in populations different from the one(s) in whom risks have been identified and the possibility of unknown or increased risk exists (e.g., studies in children involving drugs previously tested only in adults).

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 2/22/16