The development and evolution of ethics review boards – Israel as a case study

A short history of ERBs in the social sciences

The regulation and administration of formal bodies that control and supervise the ethics of biomedical experiments and research are considered a relatively recent and modern development (Baker et al., 1999; Hedgecoe, 2009; Jonsen, 2000; Rubin, 2011; Rubin and Koren, 2003; Stark, 2007, 2010). Moreover, the extension of these institutional regulatory norms to research in the Social-Behavior Sciences (e.g. social work, sociology, law, economics, etc., referred to hereinafter as SBS) ¹ has occurred only in the last few decades.

ERBs were not mandated for reviewing SBS research until many years after they first appeared. This is not surprising, as in many cases, the potential risk inherent in SBS research is relatively low compared to its clinical counterpart: SBS studies do not commonly employ dangerous substances and any harm possibly resulting from studies—usually emotional distress—is usually minor or reversible. Moreover, the type of risks common to SBS research can be understood and assessed more easily by the research participants themselves (Dingwall, 2008), thus diminishing the problematic power relationship between researcher and participant and the need for external protection of participants’ wellbeing.

In effect, ERB regulation of SBS research dates to 1975 when the US Department of Health and Human Services (HHS) began requiring IRB ² approval of research proposals as a precondition for the release of HHS funds. Later, other US federal agencies, institutions, and foundations followed suit (Ceci et al., 1985), and in 1991, the Code of Federal Regulations’ “Common Rule” (Title 45, Part 46, Subpart A) was legislated, which most federal agencies, including those that fund SBS research, now follow (Israel and Hay, 2006).

The need to perform collaborative research with US-based academics and to receive US federal funding gave rise to a growing demand for the facilitation of ERB procedures in academic SBS settings in other countries as well, such as Canada (Haggerty, 2004) and the UK (Hedgecoe, 2009; Shaw et al., 2005; Slowther et al., 2006), which also adopted systematic regulation of SBS research review. In other countries, academic institutions began to voluntarily establish their own ERBs, independent of a guiding central authority; in most cases, their review processes copied the US model or adapted it to specific scientific journal requirements or research proposals calls.

The regulation of research ethics review in Israel

Israel has developed its research ethics review process in a unique manner. The formal institutional supervision and regulation to ensure ethical medical human experimentation began only in 1980 through the Israeli Public Health Regulations (clinical trials on humans). The regulations were drown in response to the 1975 addition to the Helsinki Declaration, of the requirement that all experimental protocols “should be transmitted to a specially appointed independent committee for consideration, comment and guidance.” In accordance, the regulations stipulated that all human research performed in clinical settings in Israel must be approved by an institutional ERB, named “the Helsinki Committee” (Landau, 2008; Landau and Shefler, 2007; Rubin, 2010, 2011; Rubin and Koren, 2003). The regulations also detailed the committee’s structure and membership ³ and adopted the 1975 version of the Helsinki Declaration as a guideline for the committee’s review.

It is important to note, that the regulations were drown by the Minister of Health, based on his authority, set out in article 33 of the Public Health Act of 1940, “to establish regulations regarding the opening, registration, management and supervision of hospitals and clinics.” Thus, both the regulations and their pursuing Ministry of Health’s (here by: MoH) director’s guidelines were, and still are to this day, legally relevant only to hospital settings and required only hospitals to establish a local ERB. Israeli health funds (HMOs) have later voluntarily adopted this regulatory scheme into their settings, established their own ERBs and see themselves as bound by both its procedural and substantial requirements.

In 2006, the MoH’s director’s guidelines clearly stipulated that the approval of a Helsinki Committee is a pre-requisite for performing not only clinical research, “involving physiological, chemical, biological, pharmacological, or radiological intervention,” but also SBS research, performed in medical settings. This was incentivized by the expansion of SBS research in hospitals in the early 2000s, especially by social work based and nursing-based researchers. The guidelines also established a specific Helsinki sub-committee for SBS research proposals.

ERBs in the academia in Israel

Due to the lack of legal requirements for research ethics review outside of the health sphere, most Israeli universities and academic institutions originally did not establish any formal process for ethical review or approval for their studies (Rubin, 2011). Consequently, most academic research has not been ethically reviewed well into the 2000s. The exception to this were classic clinical research projects, performed in academic settings, that in the absence of academic-set ERBs were submitted for review, under different pretenses, ⁴ to hospital Helsinki committees, and in some cases kept on being submitted there even after an ERB was established in the relevant academic institution.

The grass root need for ethical approval, regardless of a lack of regulatory requirement, rose out of the unique context of the Israeli academia. Israel is a small country, with few researchers and few academic journals. In order to flourish, Israeli science cannot exist in a bubble, and is very much based on international collaborations. The personal promotion of academic researchers in Israel encourages, and sometimes requires, the performance of a post-doctorate abroad and the publication of articles in journals with a high impact factor—most of them foreign, usually in English. Similarly, many of the evaluators for academic promotion purposes come from abroad. For example, in the social sciences—the common expectation at Israeli universities is that two-thirds of the evaluators (a total of six) will be from abroad. Many of the journals as well as research and evaluation partners are American, due to the Israeli preference for the English language.

The incentive and institutional reward model of the Council for Higher Education in Israel is also based on the same indicators, and therefore Israeli researchers largely adapt themselves to international and especially American expectations and standards—ethical review standards included.

As will be depicted later in this paper, academia set ERBs were only established in recent years, and the review of SBS research and experiments, performed in and by institutions outside clinical settings, has slowly set root and expended with it. For example, the University of Haifa’s Faculty of Social Welfare and Health Sciences voluntarily established its own ERB, and faculty members were encouraged—but not mandated—to submit their as well as their students’ research proposals for approval. This initiative was formally adopted in 2010 by the university’s senate (Haifa, 2011).

Most other Israeli universities have also formed their own ERBs since then, resulting in a “cultural” shift. Yet, both the establishment of ERBs and the review of SBS research in the academia are still not required by any formal or statutory code, and are performed on a voluntarily, non-regulated basis, with their structure, procedures, and requirements varying between institutions.

It is important to note that the Israeli Ministry of Health made several attempts over the years to coherently regulate research ethics, in a manner that disregarded the research’s setting—whether medical, academic, or other. This started with a 1997 first draft that after 8 years evolved into the Medical Experiments on Humans’ Draft Law (2005) (State Comptroller's Report 55B, 2004). It did not mature into law, yet was re-animated once every few years (either as a ministerial or a private bill). None of these attempts ever came to fruition. This was mainly due to severe criticism—amongst other things, over its non-disciplinary-adaptable and medically centered perspective. This type of criticism intensified over the years, correlating with the increasingly central role of empirical research in the SBS.

Our research was initiated at the end of 2012, on the backdrop of one of the more assertive of those regulatory attempts and its correlative spike in academic backlash. With its empirical components eventually executed in 2015–2016, our research both documented a turning point in the development of research ethics review in the Israeli academia and, as will be described at the end of our paper, served as an engine for change and progress into the current last stage in its development.

As academia-set ERBs were constructed with no central guiding hand, little is known of their reception, performance, and effectiveness (Koren, 2003; Rubin, 2011). Moreover, unlike ERBs in the USA or the UK, there has been almost no empirical research of their acceptance and institutional role.

The debate concerning ERBs in the social sciences

Over the years, the scientific literature has seen various critiques of ERBs in the SBS (Bosk and De Vries, 2004; DuBois and James, 2004; Ferraro et al., 1999; Hayes et al., 1995; Kancelbaum, 2002; Lincoln and Tierney, 2004; Malouff and Schutte, 2005; Pritchard, 2002; Silberner, 1998), including accusations that ERBs may be guilty of any one or more of the following: (a) favoring the protocols of selected colleagues; (b) concealing conflicts of interest; (c) making unreasonable requests to changing protocols; (d) imposing excessive bureaucratic requirements; (e) staffing reviewers who lack training in qualitative methods; or (f) being incompetent.

Cohen (1998), at a summit meeting titled “ERBs: All Checks and No Balances,” cited specific concerns: censorship of research topics, inconsistent decision-making, harassment, lack of accountability, biases, ineffective communication with investigators, lack of knowledge about research, unrealistic assessment of risks, lack of appeal mechanisms, wide variations in the interpretation of the federal regulations, and a focus on participants’ rights—leading to neglect of scientific merit. Adding to this list, other scholars noted excessive time to assess protocols, rudeness, justifying idiosyncratic rulings with the pretext that “local standards” overrode standard evaluation criteria, and being overly conservative and protective of the institution and the research participants (Bell and Wynn, 2023; Edwards et al., 2004; Keith-Spiegel and Koocher, 2005; Wainwright and Saunders, 2004).

The critics of ERBs also point out the inappropriateness of importing biomedical ethics into SBS, which, it is claimed, has resulted in perverse consequences (American Association of University Professors [AAUP], 2006; Caeymaex et al., 2023; Dingwall, 2008). In medical research ethics, continue the critics, a knowledge gap favoring researchers is assumed, and with it the need to predetermine hypotheses and procedures prior to the research, an interventional purpose for every study, and a weighty ethical duty to do no harm. SBS research, on the other hand, shares determinately different characteristics: Much of SBS research starts with no particular hypotheses or procedures in mind; many participants, rather than the researchers, actually enjoy the upper hand in the information imbalance; much of SBS research is observational and not interventional; and last, but not least, not all SBS codes of conduct place the same weight on the duty to do no harm. Much more weight is placed instead on the duty to seek and communicate the truth (Lincoln and Tierney, 2004; Peled-Raz et al., 2021; Schrag, 2010).

Finally, critics of the ERBs in SBS argue that falsely attributing biomedical research characteristics is a type of censorship, which infringes on the basic human right of free speech (Hamburger, 2004). From this perspective, ERBs practice a form of speech licensing, which in effect, is the censorship of ideas. Moreover, the critics further argue, the social costs of such scientific censorship are far greater and more harmful than the benefits; it interferes with legitimate scientific research, which can result in the unnecessary loss of lives (see, e.g. Dingwall, 2008).

Despite the wealth of criticism, most has not been based on empirical evidence, but rather on anecdotal or personal experience (De Vries et al., 2004). It is also interesting to note that the qualitative studies have shown that there is a dynamic and historical context to the ERBs way of work. As pointed out by Hedgecoe (2008, 2012) and Stark (2013), ERBs attitudes and perceptions are not static but dynamic. For example, their approach toward qualitative research (as opposed to quantitative ones) has changed throughout the years as both the membership and the expertise changed. Their work has also been marked by local and individual experiences of personal trust and first-hand/face-to-face knowledge of the researchers they regulate and assess. These findings emphasize the significance of the specific historic, contextual, and local framework of the ERBs operations for understanding their outcomes and actual impact.

Since Israeli ERBs in SBS are still evolving and being constructed, they are uniquely suitable for studying the social and interactional processes by which ethics regulations are defined, implemented, negotiated, and established; in this sense, ERB members and researchers serve as primary stakeholders in the ERB process.

Sampling and participants

The study focused on ERB members, researchers, and Deans of Research at Israeli research universities and academic colleges. ⁵ A purposeful sample of 46 participants was selected, comprising ERB current or past members and SBS researchers, who each interacted extensively with ERB’s evaluation processes. The participants came from all eight research universities of Israel, as well as seven large public and private academic colleges.

Procedure and Instrument

All participants were directly approached (via phone or email) by the research team. After receiving full information regarding the study, and once an informed consent was given, a meeting was set up for the interview, according to the time and place convenient to the participant. The interviews were conducted, during the period of 2015–2016, in various locations (e.g. university offices, libraries, cafes, private homes), and commonly took between 60 and 120 minutes. All interviews were audio recorded and transcribed into text.

All interviews were conducted based on an open, semi-structured interview guide. The interview guide focused on the participants’ perceptions of ethical conduct of research, the need (or lack there-of) for ethical regulation of research, the ERB procedures in their institution, the guidelines they use to evaluate proposals, and their perceptions of the interaction between ERB and researchers.

Qualitative analysis

The analysis of interviews was based on grounded theory principles (Charmaz, 2006; Strauss and Corbin, 1998), using Charmaz’s (2006) clear guidelines for separating, sorting, and synthesizing data with qualitative coding. The process may be described as consisting of three stages: open coding, axial coding, and integration (Strauss and Corbin, 1998). Open coding refers to the initial reading of raw data, during which the researcher marks comments and questions in the text. In the axial coding stage, the researcher connects emergent categories, while trying to find relationships between these and the points expressed by the participants and to identify subcategories. In the final stage, integration, connections are made between various themes across the different data sources and general categorizations are formulated, leading to the findings that will be presented below.

Limitations

Our dataset was collected between the end of 2015 to mid-2016. As such, it did not document the last of the phases in the development of ERBs in the Israeli academia.

Nevertheless, given that this paper analyzes historical processes and typologies of institutional interaction, the data remains valuable for illustrating core stages in the evolution of academic ERBs, offering insights worthy of exploration and learning.

Ethics, trustworthiness, and credibility

The research team consisted of five members; three males and two females; three were themselves ERB members (one of them—Chair of an ERB); all had extensive previous personal experience with submitting research proposals to ERBs; and three had ethical-legal background. The study received the ethical approval of the ERB at the University of Haifa. From a risk perspective, this study did not include any specific risk. However, looking at potential conflict of interests and biases, this research was more demanding, as three out of the five investigators, are members of ERBs themselves. Self-reflection was therefore crucial for the research team. The team conducted regular reflection meetings discussing both administrative and personal aspects of the research.

Qualitative research is focused on achieving trustworthiness and credibility about the study subject, without making claims to finding an absolute truth (Hammersley, 1995), as opposed to quantitative research, in which validity means truth (Angen, 2000). In this study, the use of extensive quoted interview excerpts in the analysis aimed to enable the readers to evaluate whether different aspects of the data that were collected create consistently rich and thick descriptions (Lieblich et al., 1998; Lincoln and Guba, 1985; Padgett, 1998). In addition, our qualitative research did not attempt to generalize; since the variables of each study are uniquely derived from the context and the data collected from the interviewees, there is no expectation to replicate identical findings (Schofield, 1993).

Institutional development of ERBs

Typology of participation in ERB Processes

So far, we have described the stages of establishing ERBs in Israeli Academia. The second theme that emerged from our study was the versatile typology of participation and reactions to the processes of constructing and implementing ethical reviews. It should be noted that those types of reactions are not separate from the processes, but rather were inherent to them and one could not be understood without the other as contextual background.

The following behavioral patterns characteristic to both researchers and committee members, were classified into a typology that was inspired by Merton's (1957) strain theory, although not identical. Whereas strain theory was developed within criminological context and may raise questions of relevance when applied to “normative” researchers and members of ERBs, the analogy is easily followed. In developing strain theory, Merton posited that society presents its members with goals that are considered to be normative, and with normative means to achieve those goals. By relating to the demands thus set up by society, its members are put under regulatory strain. Thus, they must either accept the goals set up by society, work to achieve them, and do it by the “approved” means; or they may reject the goals, or the means, or both, in order to relieve the strain. Accordingly, the resulting typology Merton presented related to the various ways by which ordinary persons either accept or reject such goals and means. Similarly, from our perspective, the construction of ERBs and the regulation of research behavior, has put new regulatory strains on researchers and ERB members, defining the normative ways by which researchers should conduct their research behavior. The choices reported by our interviewees regarding their acceptance or rejection of the new definitions of either the goals of ERBs, or the means by which those ERBs operate, gave rise to the following typology. Our final typology included conformists, ritualists, believers, centralists, and insurgents.

Understanding the emerging typology of process

Figure 1 presents the types of behaviors and actions enfolding in regard to the development of ethical review in Israel. We can discern between those driven by an ideology, and those who are driven by other concerns. The ideologists include both the original entrepreneurs who initiated the process of constructing ethical review systems, who believe and accept the need for ethical review and serve out of acceptance of the need for balance; the other ideological group, the prompters, is composed of those who see research ethics as part of wider ideological or moral system and use the ethical review process to advance or dictate their ideological belief system.

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Figure 1.

Typology mapping.

Other processes relating to the ethical review, as emerging from our findings, were driven by non-ideological concerns. As presented in Figure 1, Those may be sub-divided according to their trust in the system and in others within the specific context. Thus, the “centralists” may be described as ones who have little trust in the system or in other persons, therefore insisting on tightly controlling the review process and micro-managing it. “Let not the cat guard the cream.” The ritualists, like good bureaucrats, on the other hand, have high trust in the system, and low trust in other researchers, thus insisting on keeping every nuance of the process as tightly according to the existing dictates of the system, without allowing for any degrees of freedom nor the fitting of process to specific contexts. The conformists trust both system and others. They follow the system, and perceive others as reliable, thus act as good and functional community members. Finally, the insurgents tend to trust themselves and other researchers, while less trusting the system.

The paradigmatic shift of ethical review of research in social sciences

The developmental process described above can be seen as a very typical or “normal” process of incremental organizational change. Lewin (1951) described three stages of change in organizations or social systems in general. First, a “defrosting” of old patterns of behavior, attitudes, and values. Second, a transformation stage, at which new patterns of behavior values and attitudes as well as institutional arrangements emerge and are being reorganized and modified. Third, the Frosting stage, of establishing the new order, with changes then being aligned and settled.

Yet, the typology of reactions to the process, indicates that the type of change researchers had to live with, was of a different order. An experience of misalignment emerged between the process and the magnitude of change demanded of individual researchers. While the process was incremental, the level of change was radical, of second order, affecting the very nature of researchers’ work. Although the structural change was of minor magnitude, just another committee of many already existing in any academic institute; still, from the perspective of the “workers” (researchers), the nature of the change was dramatic, and called for redefinition of their work habitus.

ERBs in Israel evolved from an initiation stage (that started in the 1990s) through a stage of persuasion and search for legitimacy, to an institutionally regulated and mandated stage.

In most of the institutions we examined, the initiation stage involved a firm push by an “ethics entrepreneur.” The entrepreneurship of ERB formation in Israel could be a result of two trends that characterize higher education in Israel. The first is the “Americanization” of Israeli Academy. The constant gap between the number of PhD graduates and academic positions in Israel created a very competitive academic job market. To prevail, many researchers use a postdoctoral period of research abroad, mostly in the United States, to gain an advantage amongst their peers. This common stage in the academic development of researchers in Israel brought with it new research practices, such as the need for ethical review for non-medical studies. Upon their return and assimilation in the Israeli academy, these faculty members initiated similar practices in their institutions.

The second trend evolved from the first one. The lack of protocols for ethical review of non-medical research led these entrepreneurs to “import” practices from the one that already existed—the medical research ethics framework, and the medical ERBs (“Helsinki committees” in Israel) protocol. Despite the incompatibility of this Biomedical-ethical framework, it was the only one that was known and perceived as well grounded at the time. The entrepreneurs used the Medical ERB protocol as basis for the newly developed non-medical ERBs, causing much resistance. Many of our study’s participants referred to this trend as the “medicalization” of their study and expressed disapproval and resentment to it.

The persuasion stage often involved working through much resistance, due to the need to break away from traditional norms, that did not recognize the need for ethical review of social science research. It also required the formation of a new disciplinary-specific SBS research ethics framework. This allowed for the transition from the recognition of the general goal behind the ERB requirement, and the identification with its means of achieving better fitted SBS goals.

It wasn’t until the final consolidation and acceptance stage that ERBs became an integral part of the new norm of research, a stage that in many Israeli institutions is still in process.

This process is akin to the paradigmatic shifts described by Kuhn (1962), in which an established thinking paradigm, including basic assumptions, practices, and scientific language, is encountering difficulties and contradictions, yet is not discarded until a new paradigm, with different assumptions, practices and scientific language arises to replace it. Such replacement is never smooth nor taken for granted, rather it always encounters resistance by the “old guard” who find it hard to adapt to those new ways of approaching their substance and discipline. As attributed to Kuhn, an old paradigm is not discarded; rather it dies away with the last of its believers. This has been true for both the general integration of ERBs, as well as for the move from a biomedical ethics governing framework, to a SBS uniquely fitted one.