To Be or Not to IRB

A SoTL Researcher’s Roadmap Through the IRB Process

Darren Iwamoto, EdD and Jace Hargis, PhD - 2019

Abstract

The increase in Scholarship of Teaching and Learning (SoTL) over the past several decades have been substantial, thereby causing more questions about its value, significance and its barriers. As SoTL research grew and reached across multiple disciplines within institutions and between institutions this new paradigm of scholarship found itself needing to fit into the traditional model of scholarship. Institutional Review Boards (IRB) have historically focused on biomedical or social-science research. IRBs have found it challenging to adopt their process to research focused on pedagogical efficacy, for example. This is why many SoTL researchers have found navigating the components of human subjects research protections to be a challenge. SoTL research does not have to be a significant time commitment nor does the completion of an IRB approval request. This paper provides a simplified roadmap through the IRB process in hopes of making the process a less intimidating and cumbersome one.

Keywords: Code of Federal Regulation (CFR), Institutional Review Board (IRB), Scholarship of Teaching and Learning (SoTL)

Introduction

The impetus of this paper is in the substantial number of questions received from faculty to Centers of Teaching on whether they need an Institutional Review Board (IRB) approval to conduct research on their teaching, mostly in their own classrooms. The short answer is, it depends. We hope to provide a more extensive answer through this paper. The bottom line is that addressing the SoTL does not have to be a significant time commitment nor does the completion of an IRB approval request. The amount of time and effort will depend on the instructor’s research question, background and what decisions they plan to make from the findings. In short, even if an instructor does not wish to spend any time on experimental design, collecting/analyzing data, etc., simply viewing teaching in a scholarly way can be beneficial to instruction and subsequently learning.

Literature Review

The SoTL was initially discussed in Ernest Boyer’s (1990) landmark book entitled, “Scholarship Reconsidered.” In this text, he redefined scholarship in four categories: Discover; Application; Integration; and Teaching and Learning. The increase in SoTL over the past several decades have been substantial, thereby causing more questions about its value, significance and its barriers. There have been several broad definitions of SoTL, which include the investigation of teaching and learning practice (Huber & Hutchings, 2005; Menges & Weimer, 1996); using a systematic and intentional method for examining teaching (Cambridge, 1999; Kreber, 2001); research, which results in publicly disseminated scholarly product (Richlin, 2001; Savory, Burnett & Goodburn, 2007); and it is built upon by colleagues (Shulman, 1999).

As SoTL research grew and reached across multiple disciplines within institutions and between institutions this new paradigm of scholarship found itself needing to fit into the traditional model of scholarship. There are similarities between the two paradigms. Both seek answers to questions, generalizable, and made public. Where it begins to differ lies within the underlying motivation of SoTL research, which is to publish research that contributes to the excellence of teaching and learning (Halpern, et al., 1998).

One very important fact is that IRBs were not designed with SoTL research in mind (Martin, 2013). IRBs have historically focused on biomedical or traditional social-science research. IRBs have found it challenging to adopt their process to research focused on pedagogical efficacy, for example. This is why many SoTL researchers have found navigating the components of human subjects research protections to be a challenging step with their research agenda (Linder, et al., 2014).

To gain a better understanding of why obtaining IRB approval is a necessary step in SoTL research we need to familiarize ourselves with the history of human subjects research. In 1974 the federal government began regulation of human subject research with the passage of the National Research Act of 1974. This act came to be after a public outcry over human experimentation that did not take into account ethical considerations. Examples were the abuses of human subjects during World War II (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979), Tuskegee syphilis study (Schuman, et. al., 1955), and the study of obedience (Milgram, 1963). In 1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report. This report identified three basic ethical principles for the conduct of human subjects research: respect for persons, justice and beneficence. In 1984, using the Belmont Report as the foundation, federally appointed agencies that were responsible for the oversight of human subjects research promulgated the Common Rule. The Common Rule articulated the requirements of informed consent, how IRBs are created, their function, and the criteria used to review and approve human subjects research. The Common Rule was updated in January 2017 and introduced new steps in the protection of human subjects (U.S. Department of Health and Human Services, 2017).

The Common Rule defines research as “a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge” (U.S. Department of Health and Human Services, 2009, 45 CFR § 46.102(d)). Because SoTL research typically involves interventions or interactions with students such as manipulating pedagogy and/or a classroom environment, these types of SoTL projects fall under the definition of human subjects and must obtain IRB approval (or exemption). Here is where the problem lies. IRBs, which are governed by the Common Rule, were written with biomedical and social/behavioral research as the focus. A SoTL study that otherwise does not fall under traditional biomedical, psychological, or sociological human behavioral research may still necessitate an IRB inquiry that will most likely review the study through the lens of a biomedical, psychological, or sociological perspective (Martin, 2013; Linder, et. al., 2014).

Institutional Review Board (IRB)

A frequently asked question amongst SoTL researchers is if they have to obtain IRB approval. If you are doing research with human subjects then yes, you must submit an IRB request and receive approval or an exemption (Martin, 2013). The only entity that can define what is and what is not human subjects research is a university IRB. Because of this, it is important to familiarize oneself with your institution’s IRB committee members and its protocols.

The majority of SoTL researchers would classify their research as low risk. However, SoTL research could have potential risks that would need to be addressed. SoTL research could compromise certain aspects of the student-instructor relationship, coercion, not feeling able to decline participation, and fear of their grade being affected by not participating, are examples of potential harm/risks that students could experience during a SoTL study (Martin, 2013). This is where the IRB can be an important partner. The IRB is tasked with protecting the research participants (a.k.a., human subjects, HS) in all studies at their respective institution.

Let us take a closer look at the IRB review process. When reviewing a SoTL project, an IRB typically asks “Does this meet the regulatory definition of research?” They then apply a definition with a focus on “systematic” and “designed to contribute to generalizable knowledge.” They further ask, what is the intended purpose of the investigation? And Does this meet the definition of HS?” Human Subjects are defined as “a living individual about whom an investigator conducting research obtains (1) data through intervention or (2) identifiable private information” (U.S. Department of Health and Human Services, 2009, 45 CFR § 46.102(f)). If the answer to both questions is NO, then the project will most likely not require further review. If the answer to either question is YES, then the HS definition is met.

There are three major categories of IRB review, Exempt, Expedited and Full Board Review. Exempt is initially reviewed by an IRB committee member to determine/confirm exempt status. Research may qualify for Exempt status if it involves very minimal or no risk. Projects will not be given Exempt status if they involve more than minimal risk to participants, involve sensitive information, or include protected classes or vulnerable populations. There are 6 exemption categories. Typically, exemption category 3 (the human subjects are elected or appointed public officials or candidates for public office), exemption category 5 (research involving the public benefit of service programs), and exemption category 6 (Taste and food quality evaluation and consumer acceptance studies) are not as common in SoTL projects (U.S. Department of Health and Human Services, 2009, 45 CFR § 46.101(b)). The exemptions categories that are typically found in SoTL research are:

• Researching involving normal educational practices (Exempt Category 1);

• Use of tests, surveys, observing behavior (Exempt Category 2);

• Use of existing data (Exempt Category 4); and

• Conducted by the department for evaluation (U.S. Department of Health and Human Services, 2009, 45 CFR § 46.101(b)).

One of the critical questions that is asked about SoTL Exempt Research is if the project involves human subjects as defined as interaction with living subjects or collection of identifiable information (U.S. Department of Health and Human Services, 2009, 45 CFR § 46.102(f)). While students are human, they may not be "human subjects" until they are subjected to a research protocol. This can only be determined by your institution’s IRB committee.

The second class, Expedited, is the next level of IRB review. Expedited does not necessarily mean the review will happen in less time. This category is for studies that do not meet the criteria for Exempt, but do not require the review from the full IRB committee. For a study to be categorized as Expedited, the research must be categorized as no more than minimal risk. “Minimal risk is defined by federal regulations as more risk than the probability and magnitude of physical or psychological harm that is normally encountered daily living” (Martin, 2013, p. 65). Typical Expedited reviews are conducted by one or two IRB committee members in close communication with the IRB Chair. It should be noted that all IRB committee members would have access to the study and may comment on the review and approval process, if they choose too. Areas of improvement and stipulations can be made by the IRB reviewer(s), which the primary investigator must respond to prior to awarding full approval.

Full Board Review is applied when the threshold of minimal risk is exceeded or with vulnerable populations (e.g., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons) (U.S. Department of Health and Human Services, 2009, 45 CFR § 46.111(a)). “For instance, some IRBs consider the following to increase risk above minimal: inclusion of participants who are minors, videotaping or audiotaping participants, asking embarrassing or compromising questions, and providing some participants with benefits not available to others” (Martin, 2013). A Full Board Review involves the entire IRB committee and not just the IRB Chair and/or a designee, unlike Exempt and Expedited reviews. Regulations do not define what research must be reviewed, but outline criteria for determining types that qualify. Instances of Full Review for SoTL are rare.

Discussion

The Scholarship of Teaching and Learning (SoTL) is an important component of adding new knowledge to classroom practices. SoTL can increase teaching effectiveness through inquiry and discovery, rigorous research, reflection and evidence-based research methods, vetted through peer reviewed, and it is publicly disseminated. This can all lead to a greater awareness, with a subsequent focus on continual assessment that can be part of a promotion and tenure dossier by providing evidence of methods and components of a teaching portfolio.

The most common questions from instructors about SoTL IRB revolves around having to submit and receive an IRB approval for their research (prior to beginning the research). We would like to suggest that the IRB process does not have to be problematic for SoTL research and by actually going through the IRB process the feedback can be helpful to the researcher as well as validate the SoTL genre, research questions and design.

There are typically a number of resources on campus that can assist faculty with the IRB application process. One such resource is the IRB office and the IRB committee members themselves. In addition, many Centers for Teaching can assist and generally have staff who have been through the IRB process many times, so they can help instructors minimize their mistakes as well as become an important sounding board for future pedagogical inquiries.

We highly encourage researchers/instructors not to try and circumvent the process, as it puts the college or university at risk, the research in jeopardy, and could minimize the rigor of SoTL research as a whole. In addition, some groups try to reduce their efforts by applying for a “blanket” IRB, which is also highly discouraged. When we try to group all teaching research into an umbrella approval, we both minimize the potential impact of teaching research and we reduce the complexity of the art and science of teaching to the common misconception that teaching is one static concept. Taking a relatively small amount of time to create an individualized IRB form for each of your research projects will allow you to pursue and even modify (with submitting a quick addendum to your IRB) so that you are able to collect the data that supports your research and ultimately allows you to create actionable findings for you and perhaps others across your discipline and beyond.

Lastly, each institution determines the level of review required for each research project (e.g., Exempt, Expedited, or Full Board Review). Not all research must be reviewed by the IRB, but only your institution's IRB committee can make that determination (Swenson & McCarthy, 2012). The bottom line is that “research involving human subjects should be carefully evaluated, both in terms of legal requirements and ethical guidelines, to ensure that people are protected when they participate in research (Swenson & McCarthy, 2012, p. 28). The IRB committee is not a necessary evil, but rather an entity that is designed to protect the college, protect the researcher(s), and also to protect the participants.

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