Determining Research Category

Within Which Category Does Your Research Fall?

If you are still unsure as to which category your project might fall, ask yourself these questions. Please keep in mind that the answers that are provided are intended for general guidance only.  The IRB will provide the final determination of your project's status.

  1. Does your research involve prisoners, fetuses, pregnant women, the seriously ill, mentally or cognitively compromised adults, or children under the age of 18? If yes, your project qualifies for Full Review.

  2. Does your research involve the documentation of recoding of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation? If yes, is your research completely anonymous so participants cannot be identified directly or through identifiers linked to the subject? If no, your project qualifies for Full Review.

  3. Does your research involve the collection of information regarding sensitive aspects of the subjects' behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior)? If yes, is your research completely anonymous? If no, your project qualifies for Full Review.

  4. Do the procedures of your research involve more than minimal risk (see IRB: Glossary of Terms) to the subject? If yes, your project qualifies for Full Review.

  5. Are you able to disclose to your participants all information about the actual purpose of your research without potentially influencing their behavior during the task? Does your research involve deception (see IRB Glossary)? Your research may qualify for Expedited Review if your use of deception is sufficiently justified; otherwise, it would need Full Review.

  6. Are the procedures of your research generally free of foreseeable risk to the subject? If no, do the procedures present more than minimal risk? If yes, your project qualifies for Full Review.

  7.  Does your research involve existing identifiable data, documents, records, or biological specimens (including pathological or diagnostic specimens) where these materials, in their entirety, have been or will be collected solely for non-research purposes? If yes, are the data sources used in your research publicly available and, although confidentiality will be strictly maintained, will information be recorded anonymously (e.g., use will not be made of audio- or video-tapes or names will not be recorded, even if they are not directly associated with the data)? If no, your project qualifies for Expedited Review.

  8. Does your research involve the collection of data which, if disclosed, could potentially place the subject at risk of criminal or civil liability or could be damaging to the subject's financial standing, employability, or reputation? If yes, your project qualifies for Expedited Review.

  9. Is your research on individual or group characteristics or behavior (including but not limited to perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) and does your research employ surveys, interviews, focus groups, program evaluation, human factors evaluation, or quality assurance methodologies? If yes, your project qualifies for Expedited Review.

  10. Does your research involve the collection of data from voice, video, digital, or image recordings made for research purposes where identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability, be stigmatizing, or be damaging to the subjects' financial standing, employability, insurability, or reputation? If yes, your project qualifies for Expedited Review.

  11. Does your research involve collecting data through any of the following procedures: 
    non-invasive procedures routinely employed in clinical practice excluding procedures involving x-rays or microwaves; physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subjects or an invasion of the subjects' privacy; weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, echography, sonography, ultrasound, magnetic resonance imaging (MRI), diagnostic infrared imaging, doppler blood flow, and echocardiography; moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. If yes, your project qualifies for Expedited Review.

  12. Does your research involve the prospective collection for research purposes of biological specimens? Is your research on drugs or devices for which an investigational new drug exemption is not required? Does your research involve the collection of blood samples by finger stick or venipuncture? If yes to any, your research qualifies for Expedited Review.

  13. Will your research be conducted in established or commonly accepted educational settings and will it involve normal educational practices (e.g., research on regular and special education techniques, curricula, or classroom management methods)? If yes, your project qualifies as Exempt from Review.

  14. Will your research involve the use of survey procedures, interview procedures, observation of public behavior, or educational tests? If yes, your project is Exempt from Review.

  15. Will your research involve the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens (for example, census tract data or data previously collected for another purpose)? If yes, Are these existing data, documents, records, pathological specimens, or diagnostic specimens either publicly available or is it information that will be recorded anonymously? Yes to either, your project qualifies for Expedited Review.

  16. Will your research, including demonstration projects, be conducted by or subject to the approval of federal department or agency heads?  If yes, Is your research designed to study, evaluate or otherwise examine: Public benefit or service programs (e.g., social security, welfare, etc.) and/or Procedures for obtaining benefits or services under those programs and/or Possible changes in or alternatives to those programs or procedures and/or Possible changes in methods or levels of payment for benefits or services under those programs? If yes to any, your project is Exempt from Review.

  17. Does your research involve taste or food quality evaluations or consumer acceptance studies and are the tested products wholesome foods without additives or foods containing additives at or below levels found to be safe by the FDA or approved by the EPA of the Food Safety and Inspection Service of the US Department of Agriculture? If yes, your project is Exempt from Review.

  18. Are all of your research participants public officials or people who are legally required to provide information to the government AND does your research involve only survey, interview, or observational research? If yes to both, your project qualifies for Expedited Review. If no, your project qualifies for Full Review