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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.

 

Limited Review

In order to be eligible for limited review, the research must meet both criteria in Part A and one of the criteria in Part B.

PART A (must meet both criteria)

  1. does not involve as subjects prisoners*, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.
  2. the procedures of the 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.)

Limited review focuses on the following aspects of a proposal: accuracy of informed consent, protection of subject privacy, confidentiality of subject data, and the protection of subject autonomy throught the research process. See the application form for a detailed list of eligibility criteria. These criteria are based on relevant federal guidelines and are, briefly, as follows (quotations come from the linked federal guidelines):

PART B (must meet one of the following criteria)

  1. Most pedagogy (or SoTL) research. This category covers educational practices, curricula, and classroom management. To qualify, projects must ensure that the project only “involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content…”
  2. “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:”
    1. participant identity could not be ascertained from the data; or
    2. discovery of participants' identities “would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation"; or
    3. "there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data." 
  3. “Benign behavioral interventions [which] are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.” Examples include “play[ing] an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.” The same caveats about participant identity from the previous category apply here. The use of deception automatically disqualifies a study from this exemption category “unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.” 

*Research that involves prisoners is only eligible if their status as prisoners is incedental to the research hypotheses (e.g., you create a public questionnaire and have no way of preventing incarcerated people from potentially participating of their own volition).

**Note that research with children is only eligible for review under Categories 1, 2a, and 2b above. 

Expedited Review

Expedited review is used for most projects that meet both Part A criteria for limited review but do not meet any of the Part B criteria. See the application form for additional detail.

SoTL Review

SoTL review is specifically for Scholarship of Teaching and Learning. SoTL research typically qualifies for limited review. Please see the dedicated SoTL review form which modifies the limited review application 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 (but see the note in the limited review section for an exception), fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults as subjects.
  2. 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.
  3. Any research which does not fall into any of the categories explicitly identified as qualifying for limited or expedited review.
  4. 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 limited or 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.”
    • Deception may be used in studies that qualify for limited review if the informed consent procedure includes an unambiguous statement that the parcipeant will be deceived. This information should be salient in the consent form. The IRB recommends the following language: "This study involves deception. This means that, at some point during the study, you will be lied to about some feature of the study, including but not limited to the goals of the study, the purpose of a given task, or the information being observed." Then, during the final statement by participants, include: "By signing below, I agree to being deceived or lied to at any point during this study."
      • Note: studies are not eligible for limited review if participants are deceived concerning whether or not their behavior is being observed as that violates subjects' rights to privacy.
    • 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. Eric Olofson, Professor of Psychology
Telephone: 765-361-6328, Email: olofsone@wabash.edu

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