Introduction

The thought of having to submit a proposal to IRB for approval has been enough to turn away many students (and some practitioners) from engaging in qualitative research. IRB approval is generally required for any studies involving “human subjects.” It may seem easier to work with numbers rather than people. Although I share common frustrations with delays and bureaucratic hassles associated with IRBs, on the whole, seeking IRB approval for your study should not keep you from doing the kind of research you want to do or answering the questions that truly matter to you. This chapter will walk you through what you need to know to have a successful relationship with your institutional review board.

What are IRBs?

Any researcher whose research includes “human subjects” is required by federal guidelines to have their research protocol reviewed in advance by their institution’s ethical review panel.^[1] In the US, these panels are known as institutional review boards, or IRBs. The federal policy on human subjects research is often referred to simply as the Common Rule. First codified as such in 1974, the Common Rule was substantially revised in 2017, with those revisions being implemented in 2019. In the grand scheme of things, these rule changes are very new, so the first thing you must realize is that much of what has been written about IRBs and the Common Rule has since changed. As a new student to qualitative research, you will be operating under the new updated Common Rule, and this may differ from what your teacher or past researchers understood. That said, the changes were not quite as substantial as some had hoped (more on this below). More commonly, the shifting guidelines put a lot of burden on local IRBs to modify their reviewing practices. As this often included structural changes in personnel and software, resulting delays occurred in 2019–2021, just as the global pandemic hit. Your institution may still be working to adapt. These adaptations are really the first major change since the inception of the IRB system in the 1970s.

The Common Rule and the establishment of IRBs occurred on the heels of several well-publicized ethical breaches in research design and study of the mid-twentieth century. In the 1930s, there was the infamous Tuskegee experiment, in which African American men, roughly half of whom had syphilis, had treatment withheld. Horrendous and inhumane medical “experiments” by Nazi doctors during the 1940s came to light during the 1947 Nuremberg trials, leading to calls for the regulation and oversight of medical experiments and the eventual “Nuremberg Code.”

Despite this code, the Tuskegee experiment continued in the US (until 1972), as did several other unethical studies: the Willowbrook study of hepatitis transmission in a hospital for mentally impaired children, the Fernald School trials using radioactive minerals in impaired children, and the Jewish Chronic Disease Hospital case in which chronically ill patients were injected with cancer cells.

The National Research Act was passed in 1974, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission authored the Belmont Report, enunciating three ethical principles that form the basis of acceptable human subjects research. These principles are the following:

Respect for persons. Treat individuals as autonomous human beings, capable of making their own decisions and choices; do not use people as a means to an end. Respect for person requires (1) obtaining and documenting informed consent; (2) respect the privacy interests of research subjects; and (3) considering additional protection when conducting research on individuals with limited autonomy (e.g., children, prisoners and others under custodial supervision).

Beneficence. Minimize the risks of harm and maximize the potential benefits. Beneficence requires: (1) using procedures that present the least risk to subjects consistent with answering the research question(s); (2) gathering data from procedures or activities that are already being performed for non-research reasons; (3) ensuring that risks to subjects should be reasonable in relation to both the potential benefits to the subjects and the importance of the knowledge expected to result from the study; (4) maintaining promises of confidentiality; and (5) monitoring the data to ensure the safety of subjects.

Justice. Treat people fairly and design research so that its burden and benefits are shared equitably. Justice requires: (1) selecting subjects equitably (not excluding a group out of bias or mere convenience) and (2) avoiding exploitation of vulnerable populations or populations of convenience.

These principles should look familiar to you if you read chapter 7, as they are similar to the general ethical principles of qualitative research. You might notice, however, that the context of the Belmont Report and some of its language on principles are geared toward the kinds of biomedical research that had raised concerns (e.g., What does “monitoring the data to ensure the safety of subjects” mean in the context of interview-based research?). Indeed, the Common Rule that followed from the Belmont Report was really created with the image of human subjects in medical experiments in mind and so imperfectly aligned itself with codes of ethics that made sense for those who talked to people (rather than injecting them with a potential vaccine). This would become a big issue in the following decades and was the primary reason the Common Rule was revised in 2017.

The IRB review system was designed following the Belmont Report to provide an independent, objective review of research involving human subjects. Any institution that received federal funding was subject to the Common Rule. Rather than create a corps of federal agents reviewing research protocols, the Common Rule required each and every research institution (all colleges, hospitals, research foundations) to create its own review panel, known as its IRB. In accordance with federal regulations, an IRB has the authority to approve, require modifications in, or disapprove research. According to the regulations, the IRB must be composed of diverse members,^[2] including at least one person from the local community outside of the institution itself. In practice, most IRBs also include at least one attorney. For university IRBs, the majority of its members are drawn from different disciplines (e.g., there might be one biology faculty member and one sociologist). These are not full-time positions, which explains some of the delays and long processing times students confront (and complain about). Some applications will require “full-board review,” while others can be addressed by IRB representatives.

The Common Rule Since 2019

IRB jurisdiction is triggered whenever there is research involving human subjects. Part of the changes implemented in the Common Rule had to do with defining both “human subjects” and “research.” You may wonder why this was necessary, but consider the following: Is asking your grandmother questions about her childhood for a classroom project “research”? Does an IRB have to review your research design before you talk to her? What about the journalist who observes the Taliban taking over Kabul and then writes about this for the New York Times? What if she includes quotes from Afghanis? Or this: You collect information from blogs about cooking for a thesis on cultural transmission. Do you need IRB approval here? Or this: You code and analyze diaries of people who lived through the US Civil War for a dissertation in US history. Before the Common Rule clarifications, some IRBs were in fact claiming that all were human subjects research (see “Advanced: IRB Imperialism?” for more). This caused a great deal of frustration and confusion among researchers, journalists, librarians, historians, and students.

According to recent clarifications, a human subject is “a living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens” (45 CFR 46). I have added the italics to emphasize the aspect of this definition most applicable to qualitative research (we do not take biospecimens). Note that the individual must be living, so historical analyses of diaries or oral histories fall outside IRB jurisdiction. There are still ethics involved in doing this kind of research, but your IRB will not be weighing in on those. Note, too, that the information must be gained through some form of interaction. This would seem to suggest that preexisting data sets such as already collected oral histories or blogs, even of living persons, are also outside the IRB’s jurisdiction (although there are privacy concerns; see [2] of the definition).

Not everything involving human subjects is covered by IRBs. The interaction must be part of “research.” (This requirement excludes most journalism and classroom projects.) Research is designed as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (emphases added). If you are writing a research paper for a class and you are not expecting to publish that paper beyond the classroom, it does not count as “research” under this definition. Further, if you are collecting data from human subjects for the sake of the data itself and not to make any analyses based on that data, it is not research (think of the US Census or data gathered by public health officials). My own institution’s IRB (the Oregon State University Institutional Review Board) clarifies that “the intent or purpose of the systematic investigation is dissemination of findings (publication or presentation) outside of OSU” and is “intended to have an impact (theoretical or practical) on others within one’s discipline.”^[3] Activities that are specifically not deemed to be research include “scholarly and journalistic activities” such as oral histories, journalism, biographies, literary criticism, legal research, and most historical scholarship. Government functions with separately mandated protections (e.g., US Census) are not research.

Figure 8.1 displays the decision tree used at Oregon State University for determining IRB jurisdiction.

Applying the Belmont Principles to Human Subject Research

Now that we know what “human subjects research” is in IRB-land, we need to understand how the three Belmont principles are applied to research that is subject to review.

As part of the Respect for Persons principle, IRBs are looking to ensure that human subjects have consented to be part of the study. People cannot consent to something they do not understand, so IRBs look to ensure that potential participants have been duly informed about both the study itself and their rights regarding the study (e.g., the right to opt out at any time, something denied the men in the Tuskegee experiment). IRBs will carefully scrutinize consent forms and recruitment material. Most IRBs recognize informed consent as a process, not a single document. Information must be presented that will enable potential participants to voluntarily decide whether to enroll in the study and then also to stay in the study during its duration. Anything that could pressure participation (such as including one’s employee or student) will raise red flags. The procedures used in obtaining informed consent, including recruitment flyers, should be designed to educate potential study participants in terms that they can understand. IRBs will probably stop you from recruiting participants with a promise of money in bold letters. Your IRB may also ask you to include a translation of the document if you are recruiting persons whose primary language is not English.

There are some standard attributes to include on any consent form (figure 8.2). Your IRB office probably has a template it makes available to researchers. Download this, and adapt it to your study.

In general, deception is frowned upon, as it undercuts informed consent. As mentioned in the previous chapter, however, there are a few recognized exceptions. Deception may be permitted when all of the following obtains:

• The study must not involve more than minimal risk to the subjects.
• The use of deceptive methods must be justified by the study’s significant prospective scientific, educational, or applied value.
• The protocol must clearly address why deception or incomplete disclosure is necessary to ensure that the research is scientifically valid and feasible and that an alternative, nondeceptive methodology could not be used.
• Subjects should not be deceived about any aspect of the study that would affect their willingness to participate.

In addition, an immediate debriefing, when possible, is often required.

IRBs will also look to see that you have presented the study so that the risks of harm are minimized and the potential benefits (e.g., knowledge production, increased understanding) are maximized (Beneficence principle). They will want to know that you are conducting the study with as minimal intrusion as possible and that you have thought about the importance of the research and balanced this against the inconvenience or harm that could accrue to the people you are studying. Further, IRBs spend a lot of care ensuring that you are taking all available precautions against breaches of confidentiality and anonymity. At a minimum, they will want you to include descriptions of how you are safeguarding the data you collect, where you are warehousing it (e.g., a password-protected computer file), and how long you will store it after the completion of the study.

Finally, IRBs will review your application for adherence to the Justice principle. They will scrutinize your protocol to ensure that you have selected your subjects equitably (not excluding a group out of bias or mere convenience) and that you have avoided exploiting vulnerable populations or populations of convenience.

There are three levels of IRB review: full, expedited, and exempt. Full-board reviews are invoked when a preliminary review (sometimes by a single IRB representative) indicates that the research involves greater than minimal risk or is of minimal risk research but does not meet one or more of the expedited review categories. Full review is used whenever vulnerable populations are included in the protocol. Vulnerable populations have historically encompassed children, prisoners, and pregnant persons. There are separate guidelines listing when expedited review is possible (see your own IRB website for its list). Exempt review is a specific subset of research involving human subjects that does not require continuing IRB oversight. Studies that are deemed full or expedited require continuing review. Changes in the protocol can move a study from one category of review to another. If all of this sounds confusing, welcome to bureaucracy! There are good reasons for IRB to set its own guidelines for how the categorizations work, as each institution is a bit different in the kinds of research that are likely to be reviewed. You will have to work with your IRB for more clarity in this area.

Working with your IRB

Every institution has a unique IRB. It is helpful to find your IRB’s website and review the process described there. Although all adhere to the Common Rule, the actual process of review may differ. Some IRBs use software programs to help route applications between expedited, exempt, and full-board reviews. Smaller institutions are likely to have more personal review processes where you may end up talking to an actual person who manages the entire process. Given the substantial changes enacted in the Common Rule in 2017, it is likely that your IRB’s website has been recently updated and includes a wealth of helpful material.

Know that the process takes a lot of time and that the actual amount may depend on staffing at your institution. A fully functioning IRB may take two to three weeks to review your protocol. Another may take six to nine months. It is helpful to know in advance the time frame for your application process. Ask your IRB or colleagues at your institution who have recently submitted a study for review. Know what triggers “full-board review” (e.g., inclusion of “vulnerable” populations). Note, too, that many IRBs require some determination of whether a study is “exempt” from IRB review. In other words, even if you are pretty sure that what you are doing is not “human subjects research” (see above), you may still have to go through some form of review process.

Have all of your documents in shape for submitting your application, as any errors or missing documents will delay the review process. Although each IRB’s process is different, you can generally expect to include at least the following documents for a qualitative project:

1. Protocol (research design). This should include a full description of your sample and site selection, how participants will be recruited, how consent will be obtained, and how documents (e.g., transcripts, consent forms) will be safeguarded. The reviewers will also need to know about your research question and the importance of the study so they can balance the benefits and costs of the study.
2. Consent form. Your IRB will probably have its own template for this (see the website). If not, there are numerous models available online, and I have included a basic one here as well. You will want to make sure you include a decent description of the study targeted to your audience, that you include contact information for you (the principal investigator, or PI) and the IRB, and that you include the signature and date lines as well as separate initial lines if you are asking for consent to be recorded (audio and/or video).
3. Recruitment material. If you are using a poster/flyer or email to distribute, you will need to attach this to your protocol. The IRB will be looking for clarity and honesty in your recruitment materials.

Once you have submitted your materials, keep in touch with your IRB. If your IRB uses a software system, you may be able to monitor the process online and will be able to know if it gets held up somewhere. Otherwise, contact the IRB if things seem to be taking longer than one would expect (knowing what you know about how your IRB works)—it may be that there is a problem with your materials that you need to correct.

I cannot stress strongly enough that it pays to establish a good working relationship with your IRB office. Be polite in all correspondence with IRB officers, and when you have been assigned an IRB tracking number, use this number in the subject line of any correspondence. Reach out if you have questions. They really are there to help you.

Advanced Reading: IRB Imperialism?

Throughout its history, two major critiques have been leveled at IRBs by qualitative researchers. The first is that, designed to prevent unethical biomedical experiments and often composed of members who do those kinds of research, IRBs are ill-equipped to review most qualitative research. Second, and relatedly, “mission creep” of IRBs and federal regulations more broadly has occurred. Thus, IRBs were never very well suited to reviewing the kinds of work qualitative researchers do (interviewing and observing humans), and they have been increasingly intrusive over the decades. At the very least, “there is a culture clash in the bureaucratic gatekeeping demands of the IRB and the emergent ‘figure it out as you go along’ character” of qualitative research (Lareau 2021:39). But some critics have gone so far as to charge IRBs with silencing important research, or at least putting so many hurdles in the way that researchers opt out of more challenging (and potentially insightful) research designs. Recall that most IRBs have a lawyer or two on board. Lawyers are famously wary of litigation and tend to encourage boards to withhold permission to study those with power or who might otherwise cause conflict. Graduate students in particular are advised or compelled to seek less controversial subjects or to avoid human subjects entirely as being too much of a hassle. After all, there is no IRB that will stand in the way of quantitative analyses of already collected data sets. Pressure to change the Common Rule was relentless throughout the 1990s, 2000s, and 2010s, eventually resulting in the 2017 revision, which, to many, was “too little too late.” Although the jurisdiction of IRBs has been somewhat scaled back (see above), the larger critiques remain, and there is some reason to fear mission creep will reassert itself in the future.

Two books published during the fight to change the Common Rule speak eloquently to these issues. Schrag’s (2010) historical analysis of how qualitative research became included in the jurisdiction of the Common Rule in the first place and with what consequences is a fascinating read. Each field of research, Schrag argues, has, by necessity, its own ethical rules and guidelines. What works to protect human subjects against biomedical experimentation is not the same at all as what will protect a human subject against being exploited and used by an unethical ethnographer who leaves the field precipitously. How did the biomedical researchers manage to impose their own field’s rules so completely on another field? This “ethical imperialism” resulted in an ethics regime that is “contrary to the norms of freedom and scholarship that lie at the heart of American universities” (8). For the sake of simplicity, regulators “forced social science research into an ill-fitting biomedical model” (9). The regime was created largely in response to biomedical ethical violations (e.g., Tuskegee), with very little attention paid to social sciences and humanities. Questions over the meaning of “human subjects” and “research” were never properly answered. In speaking of the National Commission, “it was as if a national commission on the lime industry had completed its work without deciding whether it was regulating citrus fruit or calcium oxide” (76). Further, “IRB review of the social sciences and the humanities was founded on ignorance, haste, and disrespect. The more people understand the current system as a product of this history, the more they will see it as capable of change” (192).

Van den Hoonaard (2011), writing contemporaneously of research ethics boards (REBs) in Canada, whose establishment paralleled IRBs in the US, demonstrates how their reach has impaired and deformed qualitative research during this period. Researchers have tailored their approaches in response to technical demands imposed by REBs, leading social science disciplines to resemble one another more closely and to lose the richness of their research: “Many social scientists get lost in the moral tundra because the signage speaks to biomedical research, as opposed to social research” (4). By observing the work of REBs (a qualitative research in and of itself!), Van den Hoonaard uncovers the social relations and power tied up in this ethics regime. Rather than seeing research as a right, review boards act as if research is a privilege, retaining the power to themselves to grant or deny permission. Researchers then employ particular strategies of avoidance or partial or full compliance as they seek approval from ethics committees. Both researchers and individual members of the ethics review system recognize that something is not working here, but no one is able to change course. The current ethics regime offers an inappropriate model for social science research. It can sometimes appear to strangle legitimate research, curtail academic freedom, and throw up so much red tape that the actual pursuit of doing qualitative research ethically gets lost in the bureaucratic “normalization” of ethics (55).

The changes to the Common Rule have addressed some of the concerns of Schrag and Van den Hoonaard. Furthermore, the issues they speak of (mission creep, silencing and diverting studies away from the powerful) occurred variously depending on location. Some IRBs have been better managers of the delicate balance between protecting human subjects and advancing important research than others. I hope that however your IRB operates, you do understand that the ethics of your research should not be confined to or equated with IRB review. There are many other ethical issues raised by qualitative research that by and large go unexamined by IRBs and REBs (see chapter 7). It is helpful to understand the role and place of IRBs and how they particularly protect you and your university from incurring legal liability. Try not to get too frustrated with the bureaucracy. And most of all, remember that your role as an ethical researcher is ongoing, and securing IRB approval for a study is just one of many duties and responsibilities you bear.