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Review Categories

Institutional Review Board

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Review Categories

All research, including that which the investigator believes falls into the exempt category, must be submitted to the departmental reviewer for confirmation of the relevant review category as defined by federal regulations. The criteria used to determine the categories of review are described below.

Expedited Review

For a research project to be eligible for expedited review, all items in Part A, AND at least one item in Part B MUST apply.

Part A (all items must apply)

  1. The research does not involve as subjects prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.
  2. The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability, be stigmatizing, or be damaging to the subject's financial standing, employability, insurability, or reputation.
  3. The research does not involve the collection of information regarding sensitive aspects of the subjects' behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
  4. The procedures of this research present no more than minimal risk to the subject. ("Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.) 

Part B (at least one item must apply)

  1. Research involving existing identifiable data, documents, records, or biological specimens (including pathological or diagnostic specimens), where these materials, in their entirety, have been collected or will be collected solely for non-research purposes. [NOTE: These sources are not publicly available and, although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or-video-tapes, names will be recorded, even if they are not directly associated with the data).]
  2. Collection of data through use of the following procedures: a) non-invasive procedures routinely employed in clinical practice excluding procedures involving x-rays or microwaves; b) 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 subject or an invasion of the subject's privacy; c) 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; d) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight and health of the individual.
  3. 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 or be damaging to the subjects' financial standing, employability, or reputation.
  4. Research on individual or group characteristics or behavior (including but not limited to research involving perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior, or research employing surveys, interviews, oral history, focus groups, program evaluation, human factors evaluation, or quality assurance methodologies).
  5. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior. [NOTE: Although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or videotapes, names will be recorded, even if they are not directly associated with the data).]
  6. Research that involves mild deception. [NOTE: Deception must be scientifically justified and de-briefing procedures must be outlined in detail. Based upon the judgment of the reviewers, some protocols involving deception may qualify for expedited review.  In other cases, the deception will be of sufficient consequence to require full IRB review. See description of Full IRB Review in Part C, below]
  7. Prospective collection for research purposes of biological specimens; research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required; collection of blood samples by finger stick or venipuncture.
  8. Research previously approved by the convened IRB as follows:
    (a) 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
    (b) where the research remains active only for the purposes of data analysis; or
    (c) where the IRB has determined that the research involves no greater than minimal risk and  no additional risks have been identified; or
    (d) where no new subjects have been enrolled and no additional risks have been identified.

SoTL Review

SoTL review is specifically for Scholarship of Teaching and Learning.  The review is similar to expedited, but with modifications in light of the work being conducted within the classroom (or laboratory/studio) setting.

Full IRB Review

Full IRB review is required if ANY of these apply to the proposed research:

  1. The research involves prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults as subjects.
  2. The research involves the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability, be stigmatizing, or be damaging to the subjects' financial standing, employability, insurability, or reputation.
  3. The research involves the collection of information regarding sensitive aspects of the subjects' behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
  4. The procedures of the research involve more than minimal risk to the subject.  The risk may be actual or perceived.  “More than minimal risk" means that the probability and magnitude of physical or psychological harm or discomfort likely to be experienced in the proposed research is greater than that that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
  5. Any research which does not fall into any of the categories explicitly identified as qualifying for exempt or expedited status.
  6. The research involves deception, and the nature of the deception is considered of sufficient consequence to require consideration by the full IRB. (Deception of lesser consequence may be eligible for expedited review (see below for a discussion of Deception). 

During each full IRB review, the committee members will consider whether the degree of risk to human subjects requires IRB review more frequently than once per year.

Deception

Deception involves withholding information from subjects that might affect their decision to participate in the study.  The IRB regards very seriously any use of deception, since withholding information violates the fundamental ethical principle of autonomy.  If we have respect for subjects as autonomous individuals, we also respect their right to a make a decision about their participation based on full information.  Nonetheless, there are certain types of research that would be impossible without deception (e.g., fields such as social psychology), and deception is acceptable under federal regulations as long as appropriate protections are provided.

Deception occurs in varying degrees of severity. In its most benign form – incomplete disclosure – subjects are told the truth but not the whole truth. The only information that is typically withheld is the experimental hypothesis to ensure that subjects provide unbiased responses.  Progressively more severe examples include (a) deceiving subjects about the purpose of the experiment, (b) deceiving them about the status of other individuals who they believe to be subjects (confederates), and (c) deceiving them about the status of individuals supposedly outside of the experiment (e.g., persons allegedly needing help in a study of helping behavior).  The most extreme form of deception occurs when participants are not even aware that they are subjects until after the experiment has concluded

The IRB endorses the following principles of best practice in studies involving deception:

  • Deception should never be employed if there is an alternate way of studying the research question without deception.
  • Incomplete disclosure (to protect the research hypothesis) is acceptable as long as the project follows the practices outlined below.
  • The Principal Investigator (PI) should consult first with the departmental representative and/or the chair of the IRB before developing protocols that involve deception that is more severe than incomplete disclosure.  (NOTE:  If the PI and the department’s IRB representative are the same person, the PI should consult with the department’s alternate representative, or with the IRB chair.)
  • Every experiment involving deception must include the following provisions: 
    • The consent form must advise subjects that they are not receiving all of the relevant information prior to the experiment, but they will be fully informed at its conclusion.  The IRB recommends the following language: “Details concerning the specific purposes and predictions of this research will be described at the conclusion [or change this to "now", if it is OK for the subject to know this at the beginning of the experiment] of the experiment. ”
    • Subjects must receive a thorough debriefing at the conclusion of the experiment, including a disclosure of the deception and an explanation of why it was necessary for the experiment.  A complete debriefing script should be approved in advance as part of the methodology of the study.
    • To restore subjects’ autonomy and control (that is, to restore the right to decide on participation based on full information), experimenters must, at the conclusion of the debriefing, offer subjects the opportunity to withhold the use of their data if they are unhappy with the deception. 

Questions? Contact the Wabash IRB Chair Dr. Karen L. Gunther, Professor of Psychology
Telephone: 765/361-6286, Email: guntherk@wabash.edu