Abstract
In January 2019, revisions to federal regulations that outline requirements for ethical oversight of human subjects research (The Revised Common Rule) went into effect. These revisions reflect major changes in thinking about risk and protection of research subjects. The Revised Common Rule (RCR) considerably curtails federal oversight of social and behavioral science, with most non-interventional research and “benign” behavioral interventions becoming exempt from mandated Institutional Review Board (IRB) approval, although determination of exemption remains with IRBs. As two qualitative health researchers serving on IRBs, we consider how this contraction of federal oversight dovetails with longstanding criticisms of IRB oversight of qualitative research. We explore the passage of the RCR as a point of potentially important change in procedure and principle in relation to ethical oversight of qualitative health research. We identify challenges and opportunities with these changes at the institutional, professional, and individual levels for ethical and impactful qualitative research.
Keywords
Introduction
Institutional Review Boards (IRBs) are a common source of researchers’ ire and frustration, including among qualitative health researchers. As social scientists (an anthropologist and a sociologist) trained in qualitative methods at the doctoral level, we have longstanding research careers conducting qualitative research in public health. Our work ranges from qualitative, ethnographic studies, to behavioral interventions with stigmatized populations in international settings, to randomized controlled trials that include qualitative elements. Through these projects, we have considerable experience submitting IRB research protocols and the processes of review, approval, and amending our studies. In addition to our experience as researchers, we also both have extensive experience serving on IRBs: Owczarzak has served on IRBs at two institutions, and Smith has served as a member for one IRB and now chairs another.
As qualitative researchers, we have experienced the challenges of IRB oversight, including the requirement for detailed protocol documentation that does not easily align with qualitative inductive approaches, consent processes that can seem to unnecessarily complicate research conduct, cumbersome requirements for approval of expected and benign changes in research design during study implementation, and frustrating delays that can result from IRB procedures. At the same time, having served on IRBs, we have reviewed and approved dozens of public health, social science, and medical studies involving qualitative methods that ranged from collecting data with participants recruited anonymously through Mechanical Turk to highly complex interventional studies with participants across multiple countries. In our IRB member roles, we have gained insight into the processes of IRB review. We have seen how federal regulations play out “on the ground” of research studies, navigated labyrinthine bureaucratic requirements, and appreciated the deep discussions between board members about the scientific merits and ethical quandaries presented by the studies we review.
For the qualitative studies we review, the IRB routinely considers issues related to consent, incentives, risk, and dissemination. Is it acceptable to pay participants with small gifts like soap (Biruk, 2017) or not pay them at all when asking them to spend a considerable amount of their time discussing a sensitive topic? How well does the consent process explain the rationale for an observational study to a community that does not fully appreciate the nature of the problem being investigated? Why does an interventional study on one issue ask highly sensitive questions on another as part of the evaluation? Why is a health issue that is experienced by many being explored within a particular population—and why do such patterns repeat across multiple studies? Is language in an interview guide developed by someone outside of a community potentially traumatizing or stigmatizing to someone in it? Are there risks involved in bringing community members together to discuss issues related to a transmittable or stigmatized condition? What follow-up can a community expect after data collection is complete?
These questions have both ethical and scientific salience, and we have come to appreciate IRBs’ considerable role in the production of good quality, ethical research that has the potential to improve the lives of individuals and communities. A well-functioning and experienced IRB has a greater breadth and depth of perspective on many ethical issues than we might ever reasonably expect from an individual researcher or even an entire study team, particularly for novice researchers or established investigators who are new to working on a particular population or topic. For example, IRBs review numerous studies over time and thus gain a perspective on the relative burden of research borne by specific communities that would not necessarily be available to any single principal investigator. Also, through review of problem event reports, IRBs see when and how problems manifest in research, insight that can help other researchers avoid similar missteps in subsequent studies.
In IRBs with a culture that empowers members to share their perspectives and experiences, discussion between scientists from diverse backgrounds and community members can produce perspectives that may otherwise be missing in the development of research protocols. We have also seen instances where review processes contribute to considerable delays that may not enhance the science, and to a lack of shared understanding of the role of the IRB in relation to the study design and implementation. It is from these contrasting perspectives that we consider the implications of recent changes to federal regulations regarding ethical oversight of human subjects research for qualitative health research.
The IRB is charged with ensuring that the benefits and risks of any study are balanced and that individual (and community) participation in a study is voluntary and informed by what it means to take part in the research and any risks that may be involved. Recent changes to federal regulations of IRBs—referred to as The Revised Common Rule (RCR)—expands the definition of studies that are considered “exempt” from IRB oversight. The RCR raises the possibility that a broad swath of non-interventional, behavioral, and qualitative studies will no longer be subject to a full ethical review. The RCR offers an opportunity to interrogate extant IRB oversight processes, consider the positive and negative ramifications of recent changes, and explore what principles and processes should exist to facilitate effective and ethical qualitative health research going forward.
To engage with these questions, first we provide historical context for the development of IRB oversight, outline the nature of recent changes, and place these changes in dialogue with the longstanding debate about the appropriateness of IRB review for qualitative public health research. Second, we explore the implications of the RCR for both researchers and institutions, including possible gaps in ethical oversight, capacity, and processes. Finally, we highlight domains that any revised processes for ethical oversight of qualitative research should consider.
Historical Background
The National Research Act (NRA) was signed in 1974 by the US federal government to establish ethical standards for federally funded research involving human subjects. The goal was to create a structure to prevent abuse of research participants such as occurred in the Tuskegee Study. The passage of the NRA was followed by the establishment of a Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which published The Belmont Report in 1979 (Department of Health, Education, 1979). The Belmont Report outlined the ethical principles and expectations for biomedical and behavioral research, namely, respect for persons, autonomy, beneficence, and justice (Advisory Committee on Human Radiation Experiments--Final Report, 1994; The Common Rule, n.d.).
In 1991, the Federal Policy for the Protection of Human Subjects was published by the Department of Health and Human Services and subsequently adopted and codified across numerous federal departments and agencies (The Common Rule, 2018). The so-called Common Rule created requirements for ethical oversight for federally funded research, centered on the establishment and maintenance of IRBs, processes for obtaining informed consent, and assurances of compliance for institutions conducting federally funded research. The Common Rule applied to all research involving human subjects funded by one of the signatory agencies, ranging from biomedical research to non-interventional social science research, including qualitative research. The IRB review and approval process included consideration by administrative staff who process research submissions, amendments and reporting, as well as deliberations and decisions related to ethical considerations that are undertaken by a board of scientists and community representatives who are intended to represent diverse perspectives and skillsets.
The Common Rule mandated that 1) study participants be informed that participation in research is voluntarily and why the research is being undertaken be explained; 2) participants’ data and identities be protected; 3) any potential harms or benefits to participants be considered; and 4) risks posed be proportional to benefit at societal and/or individual levels. It required that risks to participants be minimized and that changes to either study conditions or processes that alter the nature of the risks or the balance of risks and benefits be subject to further ethical review. The process for IRB approval requires submission of a detailed protocol; documentation for recruitment, consent, and data collection tools; and plans for analysis, data management and security, and dissemination of study outcomes. Once approved, study progress and compliance with approved protocols and procedures is regularly reviewed, usually annually. The Common Rule established three levels of IRB review: exempt, expedited, and full committee. Historically, there were limited circumstances where research was considered “exempt” from IRB review. Although the Common Rule only applied to research funded by the US government, the principles and structures that it established were widely adopted for non-federally funded work within the US and internationally. While (Dingwall 2007) frames this expansion as “extraterritorial claims of U.S. legal institutions” and cultural hegemony, others argue that a formalized ethical review framework and process can help clarify diverging interests, allow greater consideration of the rights of vulnerable groups, and adjudicate conflict (London, 2002). Increasingly, academic journals require IRB approval as a condition for publication, further establishing US norms for ethical review as standard scientific practice.
Overview of the Revised Common Rule
A revision to the Common Rule was published in January 2017 and went fully into effect in January 2019. The revision was intended to continue to protect human subjects in the context of the changing nature of some risks in research while also reducing researcher burden (U.S. Department of Health & Human Services, 2017). The RCR reflects a major reconceptualization of the nature of risks and processes for protection of human subjects in research. Under the RCR, federally mandated review concentrates more specifically on biomedical interventions and studies that involve biomarkers/genetics, while also providing a new regulatory pathway for consent for research with biospecimens. The RCR also expands the categories of exempt research to include most social and behavioral science research, thereby considerably curtailing the federally mandated scope of IRBs in social and behavioral science.
Under the RCR, both qualitative and quantitative non-interventional research and “benign” behavioral interventions involving adults (where no deception is involved) are now exempt from IRB oversight (Schrag, 2019). However, the RCR recommends that investigators not be given the authority to determine their own exempt status. As a result, investigators must still submit a research proposal that allows IRBs to evaluate the methods, risks, benefits, and other ethical concerns and determine a project’s status (exempt, expedited, or full review). Under the RCR, it is acceptable for non-interventional social and behavioral science research to receive only an abbreviated review to determine exempt status (rather than going before a board that includes scientific researchers and community members). After an exempt determination is made, further oversight becomes unnecessary. As a result of this curtailed review process, scrutiny of a study’s consent forms, data collection instruments, and procedures to protect data and participants typically associated with full or expedited IRB review may not happen.
Institutional Review Board Review and Resistance by Qualitative Researchers
In some ways, the RCR addresses longstanding debates about the appropriateness of federal oversight in relation to humanities and social sciences research, particularly non-interventional, qualitative research typical of anthropology and sociology. Critics have argued that the Common Rule, and the subsequent system of IRB review and approval, was developed for and by biomedical researchers and imposed on research fields with no representation in its development and for which it has limited applicability (Peled-Raz et al., 2020; Schrag, 2019). Arguments to limit or eliminate IRB oversight have centered on three key domains: the limited potential harms associated with such research (Dingwall, 2007, 2008), the challenges of IRB oversight given the nature of qualitative research (Hodge, 2013; Metro, 2014), and the barriers to research created by the bureaucratic nature of the IRB process (Katz, 2006; Lederman, 2006; Lincoln & Tierney, 2004; Shweder, 2006; Wax, 1995; Wynn & Israel, 2018).
Opponents have argued that IRB oversight of qualitative research is inappropriate given differences in the potential harms associated with social science research compared to biomedical research (Dingwall, 2008). Institutional Review Boards expect researchers to submit a clear and detailed research plan for approval before any data collection is undertaken IRB opponents also argue that the typically iterative and emergent nature of qualitative studies make them incompatible with IRB review processes. They assert that when undertaken appropriately, qualitative research is open-ended and exploratory: what is studied and who participates in the study evolves as more information is gathered and research questions are refined in the light of new information (Blee & Currier, 2011). Thus, there is some tension between the structure of ethical review and approval that requires specificity of plans at the outset and the promotion of qualitative rigor for which such specificity is an impediment (Morse, 2007).
Prior to the RCR, some critics of IRB oversight for qualitative research argued that the process of IRB review prioritizes administrative or mechanistic concerns and presents an undue burden on researchers, potentially to the detriment of initiatives that could have societal benefit. This framing of IRB review as a “chore” (Bosk, 2007, p. 196) focuses on the highly bureaucratic nature of IRB review and asserts that compliance with IRB standards distracts from deeper ethical considerations (Guillemin & Gillam, 2004; Metro, 2014; Ribeiro, 2006). Moreover, critics assert that this expectation for IRB review for all human subjects research studies indicates a lack of institutionalized trust in professional capacity and responsibility for such work (Peled-Raz et al., 2020).
Given these critiques, the RCR may seem like a welcome change, for example, by reducing bureaucratic burden for research determined to be exempt. Through the expansion of the exempt category, the RCR acknowledges the more limited nature of the risks involved in research such as most qualitative studies. However, because a full proposal is still required for an exempt determination to be made, the RCR does not address tensions between a fluid research design and mechanistic review processes (Silverio et al., 2021). Moreover, as Sabati (2019) argues, the expansion of categories of ‘exempt research’ to cover most social science research limits the notions of harm and risks that research can impose on individuals and communities associated with social and behavioral research for both individuals and communities. There are, however, key ethical considerations for qualitative research on health topics and in health-related settings that should not be minimized or overlooked (Morse, 2007). For example, the RCR does not acknowledge that for individuals, qualitative questions and probing may stir feelings or trauma, or that communities can be harmed when representations dehumanize or compound stereotype and stigma (Tolich, 2014). Qualitative research also has the potential disclosure of detailed information about the lives of individuals and communities to a broad audience (Richards, 2002). Furthermore, research that promises but does not deliver on change can also cause harm by deepening the mistrust of marginalized individuals and communities towards critical social institutions, such as universities or health systems (Hewitt, 2007; Hugman et al., 2011). An effective review process of ethical concerns centered on the nature of qualitative research would prioritize such considerations, rather than discount them entirely (Hammersley & Traianou, 2012). Absent the formalized structure of an IRB under the RCR, studies may not have opportunities to be reviewed by a range of dedicated scientific and community experts dedicated to the ethical conduct of research.
While ultimate responsibility for the ethical conduct of research always lies with the principal investigator (Shah, 2013), over the past 30 years IRBs have been an essential arbiter of what constitutes ethical research, the domains subject to ethical scrutiny, and what protections researchers must implement in their studies. Critics of IRB purview over qualitative research, such as (Dingwall 2007), conceded that for biomedical research “it is entirely proper that investigators should not be judge and jury in their own cause.” We maintain that although the risks are different, and perhaps not of the same magnitude, the same consideration applies for qualitative health research. Historically, IRBs have served as an important check on potential investigator bias in favor of their own research projects and methods of obtaining and analyzing data. The value of external review of all research studies, including qualitative proposals, for ethical considerations is not due to an assumption of nefarious intent of researchers, but because it is often difficult, if not impossible, to see all possible concerns with a research plan, particularly when one is invested in the process and possibly an intended outcome (Hewitt, 2007).
With the RCR, it is likely that over time, review processes will be significantly scaled back or even eliminated for much social and behavioral research, greatly reducing great meaningful external ethical consideration of the research. Changes to the review process raise questions about the extent to which the qualitative research community is comfortable with a shift away from formalized, external review; whether qualitative research will continue to meet the highest ethical standards without external oversight; and how review processes, both inside and outside of any IRB structure, can be improved to better serve qualitative research and promote research of the highest ethical standards.
Opportunities and Challenges of the RCR for Qualitative Research
The rollback of federal oversight that comes with the RCR does not reduce the need for careful consideration of ethical issues in the conduct of qualitative research. Rather, the removal of a federal requirement for formal ethical review creates a void in terms of process and principle: who is responsible for evaluating the ethical issues raised by qualitative research initiatives and what principles should be used to evaluate them? We see a need and opportunity for the qualitative research community and individual researchers to fully consider the risks for participants, develop protocols to minimize or eliminate them, and hold themselves accountable for the implementation of these protocols. Unethical research cannot be good research and ensuring ethical practices must always be at the center of any research endeavor. Below, we outline considerations for institutions (e.g., universities), academies (e.g., professional organizations that promote specific academic disciplines), and individual investigators in the context of the RCR.
Institutions
The absence of a federally mandated, formal review structure raises questions about how to create or modify a system to support and enhance the development and delivery of ethical research. Although the implementation of federal mandates varied by institution, the Common Rule established structures and processes through which researchers and communities would meaningfully participate in ethics reviews. Without this structure under the RCR, institutions face the challenge of developing new models that engage diverse stakeholders in the review process, absent the federal mandate to include both community and scientific expertise in the process. One proposed model emerged from a 2017 interdisciplinary workshop at the University of Haifa, based on The New Brunswick Declaration, 2013. The New Brunswick Declaration promoted the concept of ethical, socially embedded communities of practice, with ground-up structures of mentoring, nurturance, and experiential learning that build on professional standards of competence and integrity in research (The New Brunswick Declaration, 2013). The ethics review model proposed ongoing consultation and support, rather than a single somewhat adversarial review typical of existing IRB review process, with a goal of the effective execution of the protocol (Peled-Raz et al., 2020, p.6). Under this model, an ethics review board would engage with researchers to support the formation of an initial protocol and address ethical dilemmas as they arise during study implementation (Peled-Raz et al., 2020, p. 7). The authors of the Haifa model advocate for efficient, transparent, and flexible review process that includes built-in feedback and dialogue among all stakeholders.
This process is intended to be explicitly and intentionally collaborative, rather than entirely evaluative. Enactment of such a model would require major changes to how institutions conduct reviews, work with researchers through the life of a project, and engage with community members. While this model may address some criticisms of how IRBs have historically worked, it also has the potential to be enormously burdensome for both IRBs and researchers. Moreover, it raises questions whether principles for determining the ethical propriety of a given research project are unique to each research proposal and what the process for reaching agreement on ethical suitability should be. In the context of the RCR, institutions may seek develop strategies for including both community and scientific expertise to support and facilitate ethical excellence, rather than simply relegating ethical oversight entirely to the research community.
Academies
Through the formalized review process, IRBs impose a standardized ethical lens onto research from a range of disciplinary and methodological backgrounds. Within the social scientific community, as outlined above, many researchers resented this imposition and therefore rejected the premise of external ethical oversight and evaluation. Professional organizations and academic societies such as the American Anthropological Association, the American Psychological Association, the American Sociological Association, and the American Public Health Association countered this standardization through the creation of ethical guidelines that address both general principles of ethical research and discipline-specific theoretical and methodological issues (American Anthropological Association, 2012; American Psychological Association, 2017; American Public Health Association, 2007; American Sociological Association, 2019). Such efforts may create a shared disciplinary understanding of what constitutes ethical research, particularly as new researchers are trained within a specific discipline. Professional societies outlined principles for ethical consideration but did not develop any formal review processes that evaluate studies for potential ethical concerns. Rather, post-hoc assessments (such as recently surrounded the work of Alice Goffman or earlier Sudhir Venkatesh) did little to protect human subjects and were highly problematic from a professional perspective (Tolich, 2016; Tolich et al., 2017). If, in the absence of formal IRB oversight, one’s peers are the appropriate arbiters of ethical consideration of a study, processes by which this consideration can be effectively provided prior to a study’s start and during its implementation would need to be developed. However, in a research world that is increasingly inter- or transdisciplinary, notions of discipline-based ethical training and adjudication may no longer be appropriate or sufficient.
Individual Investigators
For the past four decades, IRBs have offered an ethical framework through which research ethics are evaluated. This formal institutional oversight served to communicate that social scientific research is not, in fact, “merely a neutral endeavor of inquiry” (Sabati, 2019 p. 1061). At the same time, the prominent existence of an external body that ensures ethical standards may have relieved researchers from truly engaging in a consideration of the ethical issues involved in a study (Peled-Raz et al., 2020; Shah, 2013), creating the potential for a level of “ethical complacency” (Shah, 2013) or “ethical deskilling” within the research team. Institutional Review Boards structures and processes may have resulted in limited true engagement with research ethics within individual research teams, such that ethical considerations have been centered on the process of getting through ethical review rather than any true embrace of “ethics in practice” (Blee & Currier, 2011; Dixon & Quirke, 2018). With the RCR, the weight of responsibility for ethical oversight can no longer be seen as resting with the IRB and as external to the research team. The call for a return to a less bureaucratic and more professional oversight of research ethics assumes a benevolent researcher with an “inherent moral sense” (Kjeldgaard, 2006). However, while potential harms of qualitative research may differ from biomedical research, these harms are real. Without IRBs, individual investigators will need to be prepared to take an active, ongoing, and self-reflective role in ethical oversight of their projects. While this obligation is appropriate, feasible and effective processes for this self-monitoring will need to be developed.
Under the RCR and the potential withdrawal of IRB oversight from much qualitative health research, ethical review and oversight will likely need to be multilayered and actively involve institutions, academies, and individual investigators. Institutions can revise their processes to be more explicitly collaborative and iterative, rather than a hierarchical, evaluative, and conflict-based structure. Academies can be more engaged in training, establishing and community guidelines and promoting discussion of research ethics in practice, rather than stepping in when projects fail to adhere to ethical principles. Finally, individual investigators will need to develop the capacity for self-regulation and honest consideration of the full range of ethical issues that their projects raise. Whether such perspective is possible is an open question.
Points of Consideration and Recommendations
Many qualitative researchers have come to fear and resent, rather than engage with or appreciate, the role that IRBs play in their research. From an optimistic perspective, the RCR is an opportunity to reimagine ethical oversight and anchor it in the perspectives of informed and diverse community and scientific stakeholders. This reimagined process can benefit the subjects of research and researchers who conduct qualitative studies. The RCR is also an opportunity to ensure that the principles that inform these processes align more explicitly with the epistemological foundations and the pragmatic realities of high-quality, ethical qualitive health research. We see value in working to create workable and effective processes for review of qualitative public health research centered around the following principle-driven questions: • • • • • •
These considerations should be contextualized within a review structure that focuses on true engagement with ethical issues rather than simply bureaucratic compliance. When done well, processes of ethical review can be a collaboration between researchers, their scientific peers, and community members. While some bureaucratic hurdles are inevitable, this opportunity for focused peer engagement and consideration of individual studies should improve research design and help investigators maximize the benefits of their studies for the communities with which they work. A review structure that is reduced to only administrative review has the potential to strip away deep engagement with important ethical considerations while maintaining the bureaucratic “chore” elements that are not necessarily well aligned with qualitative methodology.
Looking Forward
It is critical that ethical consideration of proposed research studies be both careful and efficient to facilitate the conduct of important and high-quality research. A review process for social science research could be significantly streamlined to focus only on ethics and not on regulations (as is needed for other types of research). The RCR presents an opportunity for the qualitative research community to actively engage in the development of common standards to recognize and address actual potential risks of the work that we undertake. The questions and recommendations raised here are intended to serve as a starting point for deeper conversations about how to enhance and promote the conduct of high-quality, ethically sound qualitative health research.
The development and implementation of structures for formal ethical review processes as reflected in the Common Rule were necessary, given the horrific abuses and harms that those undertaking biomedical and public health research imposed on individuals and communities. During the 30 years that the Common Rule has governed ethical oversight of research, qualitative methods became more mainstream and better understood within health research, and IRB processes have improved to better serve the needs of and challenges posed by qualitative research. The RCR provides an opportunity to reconsider ethical concerns in explicit alignment with qualitative principles and practices, rather than working to make qualitative research fit a biomedical, quantitative and positivistic mold. Ultimately, there will always be a need for a structure to promote ethical research, predict and prevent ethical problems, and enhance sound science to promote health and protect communities and individuals.
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
