Emily K. Sullivan, PhD, BCBA-D
University of Rochester Medical Center, Rochester, New York, United States

ASAT's Science CornerInitially, hearing the title “Institutional Review Board” (IRB) may evoke imagery of a powerful and, perhaps even elusive, entity whose purpose is to review an institution’s inner workings and ongoing activities. Although the name alone may convey this impression, it is distinctly mismatched with the actual scope and purpose of an IRB. The board’s role is far more specific: providing oversight of research conducted with human participants within the institution or institutions it oversees. The IRB’s central responsibility is to uphold ethical standards and to ensure that research participants are protected from harm (i.e., physical, psychological, social, and privacy-related; Balon et al., 2019; Lynch et al., 2022). However, exploring the role of an IRB begins with first establishing what qualifies as human subject research. As it relates to individuals with autism spectrum disorder (ASD), this can be particularly challenging as there can be a great deal of overlap between prospective research, evidence-based clinical treatment evaluations, and quality improvement initiatives.

What is Considered Research?

Federal regulations define research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (U.S. Department of Health and Human Services, 2026). This definition is intentionally broad in scope and may encompass studies in which investigators directly collect information or medical samples from participants or manipulate them or their environment for research-specific purposes. Importantly, this definition encompasses activities that occur across settings, including research labs, classrooms, clinics, or homes, if they are intended to create or otherwise contribute to generalizable knowledge. As such, research is not defined by the methodology employed or by the location in which it is conducted, but rather by its function. In other words, activities become research when the investigator intends to disseminate the results to a broader scientific audience (i.e., to contribute to generalizable knowledge, including via outlets such as conference presentations or publications), even if the activities are completed as part of routine clinical or educational services. For example, in clinical service delivery settings, evidence-based practices are often incorporated in client assessment and treatment packages. In these cases, data may be used solely to inform clinical decision-making at the individual level (not research), at the institutional level (i.e., quality improvement, not research), or investigators may seek to include these data in conference presentations or publications to the larger scientific community (research).

What is an IRB?

Many professionals regularly engage in numerous activities that could meet the definition of research; the process of IRB review was developed to ensure that the pursuit of knowledge does not expose participants to unnecessary risk or exploitation (Gunderson & Frampton, 2026). An IRB review includes a careful assessment of the potential risks, anticipated benefits, informed consent procedures, confidentiality protections, conflicts of interest, and compliance with regulatory standards (LeBlanc et al., 2018; U.S. Department of Health and Human Services, 2026). In this sense, the IRB serves as both a gatekeeper and an educator, protecting participants while guiding investigators toward ethically sound research practices (Balon et al., 2019).

Federal regulations require that an IRB comprise at least five members with diverse expertise and experiences (U.S. Department of Health and Human Services, 2026). For example, researchers, scientists, and professionals across different fields, as well as representatives from the community the institution serves. Specifically, one member with scientific expertise, one member with expertise in a non-scientific area, and one member who is neither affiliated with the institution nor an immediate family member of someone who is (U.S. Department of Health and Human Services, 2026). Non-affiliated non-scientific members play a critical role given their reduced bias; however, these members may be difficult to recruit and retain on an IRB (LeBlanc et al., 2018). Prioritizing diversity within the IRB serves as a safeguard, ensuring that proposed research studies are evaluated through multiple lenses, including not only scientific merit but also ethical considerations and community impact.

Why IRB Oversight Matters

Those who provide informed consent to participate in research often cannot fully anticipate the potential risks associated with their participation. For participants, IRB oversight ensures that research has been independently evaluated to minimize potential risks, including unintentional ones, and that any risks a study poses are ethically justified (U.S. Department of Health and Human Services, 2026). For researchers, IRB approval serves as evidence that appropriate ethical standards were considered from the outset, and ongoing oversight ensures that these standards are followed throughout the study (Persons et al., 2021; Normand & Donohue, 2023). Many academic journals require documentation of IRB review or exemption before publishing research involving human participants (Persons et al., 2021). This expectation reflects a broader norm within behavior analysis and the scientific community at large: research must respect the rights and dignity of the individuals who make it possible.

For the public, IRB oversight helps maintain trust in scientific research. Historical abuse in human subjects’ research demonstrates the consequences of conducting studies without independent ethical review (for additional discussion, see Gunderson & Frampton, 2026). Modern research oversight systems, including the IRB, were created to ensure that such violations are not repeated (Mead et al., 2025).

What does an IRB do?

In practice, IRBs carry out several key activities, including reviewing research protocols before studies begin, evaluating whether study procedures pose more than minimal risk, and determining the appropriate level of review required. The National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research (1979) discussed the three ethical principles in the Belmont Report: respect for others, beneficence, and justice. These principles serve as the primary guidelines for protecting human subjects that the IRB is designed to uphold. LeBlanc et al. (2018) outlined six criteria that an IRB should determine that a research study application meets prior to its approval. Table 1 outlines the alignment between the six criteria described by LeBlanc et al. (2018) and the three ethical principles in the Belmont Report (National Commission for the Protection of Human Subjects in Biomedical & Behavioral Research, 1979).

Table 1

Criteria for Research Application Approval According to the Belmont Report Ethical Principles

Belmont Report Ethical Principles (1979) Criteria for Research Study Approval Described by LeBlanc et al. (2018)
Principle 1: Respect for Others

Individuals treated as autonomous agents

Individuals with diminished autonomy are entitled to protection

 Best practice procedures (e.g., the study’s purpose, the procedures involved, potential risks, and their right to withdraw at any time is sufficiently explained using language potential participants can understand) are used to obtain informed consent from all participants (or legal representatives), and with appropriate documentation

Inclusion of safeguards to protect participants from undue influence or coercion (e.g., dual relationships, lavish incentives)
Principle 2: Beneficence

Do no harm

Maximize potential benefits while minimizing potential harms

 Minimization of participant risks and use of best-practice interventions and procedures

Any risks are balanced with reasonably anticipated benefits of participation

If participants include vulnerable populations (e.g., children with disabilities), all requirements specific to vulnerable populations are met
Principle 3: Justice

Fair distribution of potential risks and benefits of research

 Unbiased participant selection procedures

Note. The six criteria described by LeBlanc et al. (2018) that a research study must meet to receive approval are organized by their alignment with the ethical principles outlined in the Belmont Report (National Commission for the Protection of Human Subjects in Biomedical & Behavioral Research, 1979).

Some studies undergo full board review, while others may qualify for expedited review or exemption from continued oversight. Importantly, the IRB determines whether a project qualifies for exemption, not the investigator. Certain categories of research, such as analyses of publicly available data or some research conducted in clinical service delivery settings involving typical educational practices (LeBlanc et al., 2018; U.S. Department of Health and Human Services, 2026), may pose minimal risk and, as such, may only require limited oversight from the board. However, “exempt” does not mean that a project does not require review. Exempt studies are those for which, after initial evaluation, the board determines that the study is sufficiently minimal risk. In these cases, ongoing monitoring is deemed unnecessary. The board also reviews informed consent documents and procedures to ensure that participants understand the study’s purpose, the procedures involved, potential risks, and their right to withdraw at any time (LeBlanc et al., 2018; U.S. Department of Health and Human Services, 2026). Confidentiality procedures are evaluated to ensure that private information is adequately protected (e.g., materials with identifying information are stored electronically on a password-protected computer server; Persons et al., 2021).

Following approval, IRBs monitor ongoing studies, review reports of adverse events (i.e., any anticipated or unanticipated event that may increase the risk of physical or psychological harm incurred as a result of research participation; U.S. Department of Health and Human Services, Office for Human Research Protections, 2016, such as confidentiality breaches or injuries), require modifications to study protocols when ethical concerns arise, and conduct continuing reviews of approved research protocols. Much like the peer review process (Frampton, 2025), IRB review is educational. It often requires investigators to clarify procedures, strengthen safeguards, and anticipate ethical issues that might otherwise be overlooked (Balon et al., 2019). Although this process can feel tedious for investigators, it frequently improves the overall quality and transparency of research. Most importantly, the process serves as a proactive measure to mitigate potential risks associated with participation in research.

When to Seek IRB Oversight

One of the most common questions clinicians, researchers, or related professionals ask is, “When is IRB approval required?” Although specifics vary across institutions, a useful consideration is the researcher’s purpose or intention in conducting the study. If an activity is designed to produce knowledge that will be generalized beyond the immediate context (i.e., the participant or individuals served by the institution), particularly if publication or dissemination is anticipated, this activity likely qualifies as human subject research and should be submitted to the IRB.

This issue is especially relevant for behavior analysts and related professionals for whom data collection is a routine activity within ongoing clinical service delivery. Program evaluations, treatment monitoring, and clinical decision-making often involve systematic data collection. These activities typically remain within the scope of ongoing clinical service delivery or quality improvement initiatives focused on generating data to inform improvement or refinement of institutional procedures or practices (Bass III & Maloy, 2020). However, when the goal shifts toward sharing findings with a broader scientific audience, the activities may fall within the regulatory definition of research. That is, when the same activities that typically fall within the scope of ongoing service delivery or quality improvement are, or at any point, become part of efforts to generate knowledge intended for dissemination, these activities may meet the definition of research under both federal regulations and the definition provided by the Behavior Analysis Certification Board (BACB, 2020). This distinction matters because the line between what may be described as a clinical innovation, a program evaluation, and research can be easily blurred. The moment the goal shifts toward dissemination, IRB review becomes necessary. Although it may be frustrating for investigators at times (Whitney et al., 2008), independent ethical review is not just red tape; it is a safeguard for both participants and investigators.

Importantly, the absence of an IRB within an organization does not eliminate an investigator’s ethical obligation to obtain review and oversight. Prospective investigators are advised to critically consider the limitations and ethical implications of proceeding with research activities without the input of an IRB (Osborne & Luoma, 2018). Increasingly, academic journals that serve as primary outlets for disseminating research procedures and findings are requiring documentation of IRB review or exemption before publication (Persons et al., 2021). This requirement reflects a broader societal expectation: research involving human beings must be independently evaluated. Public trust in science depends on it. As such, prospective investigators should consider partnering with a local university or a commercial fee-for-service IRB or advocating within their organizations to develop an IRB (see LeBlanc et al., 2018; Normand & Donohue, 2023; Valentino & Juanico, 2020; Valentino & Onofrio, 2023).

Final Considerations and Takeaways

The IRB is not an institutional regulator but a necessary safeguard for participants and investigators. It does not exist to impede research but exists to ensure that the allure of pursuing scientific advancement does not eclipse the human rights and dignity of the individuals who make that pursuit possible. Research moves forward. However, pauses and reflections prompted by the activities of the IRB enable it to move forward ethically and responsibly. This review ensures researchers articulate risks, justify procedures, and design safeguards before participants of a research study are exposed to potential harm. Through IRB review process, investigators can improve study design, clarify research goals, and strengthen confidence in the ethical conduct of research studies and the findings disseminated. Collectively, these factors help to ensure that when families are faced with decisions related to treatment for a loved one with ASD, the decision is based on the strongest, most reliable evidence.

 

References

Balon, R., Guerrero, A. P. S., Coverdale, J. H., Brenner, A. M., Louie, A. K., Beresin, E. V., & Roberts, L. W. (2019). Institutional review board approval as an educational tool. Academic Psychiatry, 43(3), 285-289. https://doi.org/10.1007/s40596-019-01027-9

Bass III, P. F., & Maloy, J. W. (2020). How to determine if a project is human subjects research, a quality improvement project, or both. Ochsner Journal, 20(1), 56-61. https://doi.org/10.31486/toj.19.0087

Behavior Analyst Certification Board. (2020). Ethics code for behavior analysts.

Gunderson, G., & Frampton, S. E. (2026). Science Corner: An introduction to research ethics. Science in Autism Treatment, 23(8).

Frampton, S. (2025). Rejected, revised, resilient: The ultimate path of a peer-reviewed paper. Science in Autism Treatment, 22(6).

LeBlanc, L. A., Nosik, M. R., & Petursdottir, A. (2018). Establishing consumer protections for research in human service agencies. Behavior Analysis in Practice, 11(4), 445-455. https://doi.org/10.1007/s40617-018-0206-3

Lynch, H. F., Eriksen, W., & Clapp, J. T. (2022). “We measure what we can measure”: Struggles in defining and evaluating institutional review board quality. Social Science & Medicine, 292, 114614. https://doi.org/10.1016/j.socscimed.2021.114614

Mead Jasperse, S. C., & Kelly, M. P. (2025). Contextualizing contemporary research ethics policies and practices in significant historical events. Behavior Analysis in Practice, 18(3), 631-649. https://doi.org/10.1007/s40617-023-00865-2

National Commission for the Protection of Human Subjects in Biomedical & Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

Normand, M. P., & Donohue, H. E. (2023). Research ethics for behavior analysts in practice. Behavior Analysis in Practice, 16(1), 13-22. https://doi.org/10.1007/s40617-022-00698-5

Osborne, T. L., & Luoma, J. B. (2018). Overcoming a primary barrier to practice-based research: Access to an institutional review board (IRB) for independent ethics review. Psychotherapy (Chicago, Ill.), 55(3), 255-262. https://doi.org/10.1037/pst0000166

U.S. Department of Health and Human Services, Office for Human Research Protections. (2016). Guidance on reviewing and reporting unanticipated problems involving risks to subjects or others and adverse events. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html

U.S. Department of Health and Human Services. (2026). Protection of human subjects, 45 C.F.R. § 46. https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46

Valentino, A. L., & Juanico, J. F. (2020). Overcoming barriers to applied research: a guide for practitioners. Behavior Analysis in Practice, 13(4), 894-904. https://doi.org/10.1007/s40617-020-00479-y

Valentino, A. L., & Onofrio, O. M. (2023). Obtaining resources to support research in applied clinical settings. In Research Ethics in Behavior Analysis (pp. 103-124). Elsevier. https://doi.org/10.1016/B978-0-323-90969-3.00009-8

Whitney, S. N., Alcser, K., Schneider, C. E., McCullough, L. B., McGuire, A. L., & Volk, R. J. (2008). Principal investigator views of the IRB system. International Journal of Medical Sciences, 5(2), 68-72. https://doi.org/10.7150/ijms.5.68

Reference for this Article:

Sullivan, E. K. (2026). Science corner: Exploring the role of an institutional review board. Science in Autism Treatment, 23(10).

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