The Rhetoric and Regulatory Objective of Protection and Promotion

The impetus behind the sIRB rule for cooperative research projects can be situated within an emerging, international, two-pronged regulatory objective in human subjects research. This objective commands regulators to regulate research with a view towards ensuring both participant protection and research promotion. This objective reflects a significant change in the system design of human subjects research. For years, and indeed since the formal creation of the ethics review oversight system in the 1960s, the regulation of human subjects research has been designed to position research participant protection as the primary role of regulators, including the IRB's role as a local “satellite regulator” of research (at least on the ethical components of the proposed research). Under this system, local IRBs have been tasked with engaging in a precautionary evaluation (or a “regulatory event-licensing” assessment) of the ethics of a research proposal, with a primary view towards protecting the health, welfare, and dignity of research participants. The IRB accomplishes this task by issuing a single, independent opinion on the ethical acceptability of a research proposal, set within a regulatory framework that governs their operating procedures and the overall acceptability of research (including its scientific merit and legality). Protection of research participants may have been IRBs' primary role, but crucially, IRBs have also always performed secondary roles. One such role is a variation of the public interest aim of regulators of human subjects research generally: IRBs have an obligation to society, who are often the ultimate beneficiaries of research, to provide stewardship for the promotion of ethical and socially valuable research.

What we have seen in various countries in the past decade or so, however, is a flattening of this role hierarchy in regulatory strategy. A hierarchical role of “protection first and promotion second” has become a two-pronged regulatory objective positioned on equal plane. The introductory summary paragraph of the Final Rule reflects this (re)positioning well: “This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.”¹⁹ Likewise, in the executive summary, DHHS paints a dichotomous picture of research evolution (a “paradigm shift”²⁰ in how research is conducted) and regulatory stasis: “Since the Common Rule was promulgated [in 1991], the volume and landscape of research involving human subjects have changed considerably. […] Yet these developments have not been accompanied by major change in the human subjects research oversight system, which has remained largely unaltered over the past two decades.”²¹ In consequence, the regulations for human subjects research were proposed to be “modernized and revised to be more effective.”²² The sIRB rule — reflected in both the NIH Single IRB Policy and in the Common Rule — thus instantiates this desire for “more effective” regulation that evolves in parallel with advances in the science it seeks to govern; it is, in other words, seen as fulfilling the two-pronged regulatory objective of participant protection and research promotion. Indeed, the oft-expressed criticism of delay and duplication of multiple IRB review was seen as indicative of a regulatory strategy that emphasized participant protection at the expense of research promotion: the regulatory design for ethics review, as crafted in the mid-20th century, may well have been protecting participants, but it came at too great a cost to research promotion. And one may well argue that a multi-site research study that is subjected to multiple IRB review is not being sufficiently promoted (if at all). What this means is that the “next generation,” 21st century regulatory framework for ethics review commands regulators of human subjects research — including IRBs — to perform their tasks in a way that both protects participants and promotes research. Eliminating or curtailing multiple IRB review for collaborative research is a significant step towards achieving this regulatory objective.

As stated above, the Common Rule rhetoric of protection and promotion tracks rhetoric recently instantiated in statutory regulation elsewhere in the world. We see this foremost in the UK. The Research Ethics Services in the UK are responsible for managing RECs involved in the National Health Services of the UK's four nations (each nation has its own NHS).²³ NHS RECs, also known more formally as “RECs within the UK Health Departments' Research Ethics Service,” are more or less region-based committees, which is to say that they are not bound to any institution in the US sense (e.g. a university or academic medical center). Officially overseeing a local health area within the NHS systems, in practice they operate within a centrally administered, national system that enables them to review research applications and provide an ethics opinion on health-related research involving human participants that takes place anywhere in the UK.²⁴

The rhetoric of protection and promotion is reflected in the UK's health and social care reforming Care Act 2014 — and operationalized in the mandates of the Health Research Authority (HRA), the regulatory authority for health research in England, and its Research Ethics Service (RES) branch, as well as the mandates of RES offices in the three other nations of Scotland, Wales, and Northern Ireland. The main objective of the HRA in exercising its functions, including the management of National Health Service (NHS) RECs in England (and indirectly across the whole UK), is stated in the Care Act 2014 as two-fold:

• (a) to protect participants and potential participants in health or social care research and the general public by encouraging research that is safe and ethical, and

• (b) to promote the interests of those participants and potential participants and the general public by facilitating the conduct of research that is safe and ethical (including by promoting transparency in research).²⁵

The Care Act 2014 also charges the HRA with “ensur[ing] that research ethics committees it recognises or establishes […] provide an efficient and effective means of assessing the ethics of health and social care research.”²⁶ Other UK examples of the two-pronged regulatory objective of protection and promotion are seen in HRA guidance for potential members of NHS RECs, which states: “The key duty of a REC is to protect the interests of research participants whilst at the same time facilitating ethical research.”²⁷ The RES in Scotland also states this dual role, without specifying a role hierarchy: “The Research Ethics Service in Scotland is a part of the UK-wide national service aimed at facilitating research, whilst simultaneously protecting the rights, safety, dignity and well-being of people participating in research in the NHS.”²⁸ Likewise, the RES in Northern Ireland states its mission as: “To protect the rights, safety, dignity and well-being of research participants; and to facilitate and promote ethical research that is of potential benefit to participants, science and society.”²⁹

While the UK has recently instantiated the rhetoric of protection and promotion at the level of statutory law through the Care Act 2014, in practice it has been reflected in regulatory design for a number of years. In this sense, the UK can be seen as a pioneer in positioning protection and promotion on an equal plane, including through its efforts to reduce multiple REC review for multi-site research projects occurring across the country.

One can trace the modernization of UK research ethics review to 2004, the year the country nationally transposed the EU's Clinical Trials Directive 2001,³⁰ which mandated under Article 6 that EU Member States establish and operate RECs, and charged RECs with the responsibility of giving an ethics opinion, before a clinical trial commences, on any issue requested. Under Article 7, for multi-site clinical trials limited to the territory of a single Member State, Member States had to establish a procedure providing, notwithstanding the number of RECs in its territory, for the adoption of a single ethics opinion for that Member State. In the case of multi-site clinical trials carried out in more than one Member State simultaneously, a single opinion would be required for each Member State concerned by the clinical trial.³¹ This meant that no more than one ethics committee would play a part in assessing the ethics of the clinical trial proposal, no matter the location or number of the site(s) in the country. When the Clinical Trials Directive 2001 was nationally transposed in the UK in the form of the Clinical Trials Regulations 2004,³² the UK decided to make it formal policy that a single REC opinion would hold across the entire UK for any type of research application made to an NHS REC, and not only for clinical trials: “The policy of the [UK] Department of Health and the devolved administrations is that the requirement for a single ethical opinion should apply generally to all multi-site research within the UK.”³³ The rationale behind this policy decision was that to streamline the regulatory approvals process for all types of health research would greatly reduce the burden and delay for investigators, which by the 1990s and early 2000s was seen by many to be especially pronounced and causing harm to patients and the economy alike.^{Reference Alberti34}

Thus, we see that the sIRB rule now positions the US much more closely to the UK and much of Europe, not to mention more similarly constituted federal countries such as Australia and Canada, which have been making concerted efforts to reduce multiple ethics committee review across their states and provinces. This said, as noted in this article's introduction, one must be careful to distinguish both the regulatory contexts and ethics committee contexts of different jurisdictions. NHS RECs, which currently number 85 in total across the UK,³⁵ differ in many ways from the thousands of public and private IRBs across the US, including the mandated scope of review (e.g. only certain areas of health research and research within the NHS), disconnection from any one institution, and their public body nature. The UK, as a Member State of the EU, was mandated under the EU's Clinical Trials Directive 2001 to legislate by 2004 for a single REC opinion for clinical trials conducted in the country; that the UK then extended that mandate by policy to cover all types research reviewed by NHS RECs was possible because of several factors. Foremost, it was possible because NHS RECs are public entities, managed by the four health departments in the UK and subject ultimately to judicial review. The US, by dint of constitutional design, is unable to legislate in a way that comprehensively covers the research ethics oversight of all types of health research for all IRBs. So, the shift towards centralized ethics review, and away from multi-REC/IRB review, is undoubtedly significantly easier to effect in a country like the UK, which is heavily centralized (even with political devolution to three of the four nations) and operates government-managed ethics committees, than in a federal country such as the US or Canada, where ethics committees are institution-based (and therefore as likely to be private as they are public) and states (or provinces) may hold as much (or more) power than the federal government.

Nonetheless, the larger point still holds: the sIRB rule is but the American manifestation of an international health research regulatory objective that has been gestating for at least the past decade. This objective seeks to create a regulatory environment that protects the rights, interests, and welfare of participants in a proportionate manner; that is to say, a manner that seeks to make conducting research easier and less bureaucratic — and thereby more promoted — than regulatory approaches have previously allowed. The sIRB rule fits within the emerging paradigm of protection and promotion. In so doing, it enacts a modification to a long-standing governance structure and cultural practice of research ethics review — namely full, localized IRB review situated in each and every institution involved in a cooperative research project.

It also represents, however — as I have highlighted elsewhere with colleagues — a “modification that carries with it a good deal of uncertainty in its innovation. […] We are in state of policy equipoise regarding the superiority of the proposed sIRB over the existing system as several performance measures would need to be demonstrated.”^{Reference Rahimzadeh, Dove and Knoppers36} And indeed, DHHS recognizes this in the text accompanying the revised Common Rule: “We note that the NPRM discussed the fact that data about IRB effectiveness and how IRBs function operationally is generally unavailable.”³⁷ In this sense, then, several of the concerns raised by stakeholders are sound, including concerns regarding operational issues and a lack of evidence of IRB effectiveness (i.e. an assessment of “what works”). As I will discuss below, the sIRB rule does not completely eliminate multiple IRB review, which dampens gains in efficiency. At the same time, we should be mindful of how this “next generation” regulatory approach might be interpreted by regulators at the macro-managing level (i.e. OHRP and the HRA), the meso-managing level (i.e. the UK's Research Ethics Services and local health boards, and IRB's institutions), and at the satellite level (i.e. RECs/IRBs themselves). Might the “next generation” balance in approach tilt too far in favor of research promotion? And how would we know when this is the case? Moreover, it is unknown what the long-term impact this two-pronged regulatory objective might have on participants, researchers, and society.

There may not be a need for too much alarm. Findings from empirical research I conducted in the UK suggest that modifications to the health research regulatory space at the levels of statutory law and central regulatory authorities have not so much “trickled down” to affect the day-to-day practices of RECs, as these day-to-day practices have existed for a long time and have only recently been enacted in law.^{Reference Dove38} Ethics committees, managing regulators, and researchers share a common goal of promoting research that is safe and of high quality. There is also a shared commitment to the promotion of research that is ethical and of value to society. Thus, these actors carry similar interests and shared responsibilities, including the achievement of regulatory objectives and working through major moments of transition in the research lifecycle. This said, we should remain vigilant about changing regulatory practices to ensure that ethics committees and managing regulators do not promote research projects at the expense of participants' fundamental rights and interests. In my view, the sIRB rule does not get this balance wrong, and the evidence indicates that the single REC review policy in the UK has been a success since its enactment in 2004.

In sum, the sIRB rule is a recent example of a general international regulatory trend towards making national and regional ethics review oversight systems built for 21st century science, information communication systems, and ways of collaborating. The sIRB rule follows this trend — it certainly does not buck it — and there are grounds for welcoming it. Having now placed this rule within the larger principles-based regulatory objective of the revised Common Rule, which itself is part of an emerging international movement in health research regulation, the second part of my argument engages more directly with some the main criticisms of the sIRB rule. The first that I address in the following section is that centralized ethics review as envisioned in the sIRB rule, with its hub-and-spoke type of model of a “reviewing IRB” and “relying” institutions/IRBs, wrongfully effaces or otherwise unduly limits local ethics review, which some see as crucial in providing context and knowledge of local research practices. As I suggest through findings of empirical research conducted by myself and others, this may be an exaggerated or misplaced concern.

The Red Herring Argument of Local Context and Local Knowledge: Insights from Empirical Research

There is an oft-expressed concern with the sIRB rule (and other attempts at ethics review reform) that is both overstated and misplaced in my view: the concern that it effaces important, if not necessary, local IRB review in cooperative research projects.³⁹ The argument goes that local IRBs reflect, or have more knowledge of, local contexts within geographic areas and/or institutions and/or specific research areas and therefore they are best (or better) placed to opine on the ethics of a research proposal. Undoubtedly, the sIRB rule effects the biggest change to local IRB review in US regulatory history, and fundamentally shifts the argument away from maintaining local review. The case for this shift is expressed in the Federal Register as follows:

The sIRB rule does not (and indeed cannot) eliminate local IRBs, and it does not address any extra-territorial issues regarding ethics reviews:

The argument in favor of local IRB review is longstanding and should not be taken lightly. Since the creation of the IRB system in the 1960s, some policymakers have argued that norms or values do not transcend borders, including institutional borders. In many ways, the IRB system in the US is the most decentralized regulatory system ever devised. In 1967, Surgeon General William Stewart explained that:

This argument and belief persisted into the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the late 1970s:

And the argument in favor of local IRB review continues to be expressed in the writings of many scholars today, such as Brian Gladue of the Office for the Protection of Human Subjects at the University of North Texas Health Science Center, who writes:

Yet the case for local IRB review rests more on the force of its rhetoric than on the force of its logic. Appeal is often made to the close connection between an ethics committee and an abstract “local community,” but evidence of whether such a rapport or connection actually exists, whether local IRBs have any “greater familiarity with the actual conditions surrounding the conduct of research”⁴⁵ — and whether this adds any value to an ethics review — has not been forthcoming. More broadly, it is unclear why ethics reviews are seen as engaging exclusively local or even national concerns, particularly in present-day biomedical research that is colored by inter-institutional, inter-regional, and international collaboration. Compared to science review, ethics review is an exercise in localized assessment ad infinitum and ad absurdum. Peer review bodies for science are often conducted at one site, such as the location of the funder or sponsor, wherever they might be in the world. This is because there is general acceptance that a universal language of science exists, grounded foremost in methodology and consideration of the proposed research's relationship to similar previous studies and their findings.

Does ethics review lack a similar universal language? Ethical issues undoubtedly vary, depending on the research in question, and indeed to some extent on the location of the research site(s), but the ethical framework that committee members bring to bear on a project should not depend in itself on their institutional and geographic position. The question arises as to what exactly constitutes ethical values and commitments particular to a local context, and how such values and commitments are divined through the collective ethical reasoning of an IRB. Ethical reasoning may be conducted at various levels of systemization: from the highest level of abstraction — theories — and from there to principles (e.g. respect for persons, beneficence, non-maleficence, justice), to rules or norms (e.g. good research design, competent investigator, favorable balance of harm and benefit, informed consent), which in turn yield ethics judgments. In theory, each IRB member, and the IRB's collective opinion, may appeal to and apply a spectrum of theories, such as principlism, casuistry, deontology, or utilitarianism, not to mention pragmatism, each of which may consist of a systematic corpus of principles and rules. This is why it is not uncommon for IRBs (and members within them) to reach different opinions on the same research proposal — just as with courts of law, there can be a range of reasonable opinions. Within this spectrum of theories, different outcomes may emerge. None, some, or all may speak to issues regarding a specific geographic or institutional context.

The language of ethics and the ethical imaginary should enable IRB members individually, and the IRB in aggregate, to reach an “opinion” and justify that opinion by referencing, explicitly or implicitly, wider, socially-accepted norms or values. More often than not, though, those norms or values transcend borders, as seen in the CIOMS International Ethical Guidelines for Health-Related Research Involving Humans⁴⁶ and the WHO Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.⁴⁷ For example, the value of autonomy and the principle of respect for persons is reflected in the general requirement for informed consent in most forms of biomedical research. A local IRB at a university department will not (or should not) disregard the importance of informed consent as compared to its neighboring IRB at the academic medical center across town. I accept that some norms and values may be more emphasized than others, depending on cultural contexts. It may be the case, for example, that the trope of the liberal individualist ethos in the US that is reflected in, among other things, a strong demand for individual and written informed consent, carries less credence within certain communities in certain parts of the country. Some scholars may argue that informed consent may not fulfil the same important role in some contexts, as the concept is grounded in an individualistic ideal of personal autonomy. But it does not necessarily follow that local IRBs would know this “local context” information, would know this information better than another IRB, that this information necessitates or should necessitate a change in research design, that this information should modulate the ethical viewpoint of the IRB members, or that in the case of a cooperative research project such information cannot otherwise be obtained and considered by the sIRB. The rationale for preserving ethics committee review in each institution (and within each institutional department) is no more justified than it is for preserving ethics committee review in a region. Values and commitments in research ethics need not be bound to, nor defined by, a geographic border or institutional walls.

Preservation of institutional sovereignty for local review of multi-site studies carries heightened risk of several regulatory drawbacks, including inconsistent, sometimes overly risk-averse, and unjustified local interpretations, and confusion about the standards for compliance that apply to different types of research. On this point, much of the literature on the ethics review system, especially in the US, has been critical of the heterogeneous culture and decision-making practices in each ethics committee. “Inexplicable variation is a persistent pattern” among IRBs; they are “consistently inconsistent,” Carl Schneider writes in his book criticizing the “misregulation” of human subjects research.⁴⁸ Not only can individual IRBs and IRBs within one institution vary in their decisions, but multi-site studies also run an increased risk of having “inconsistencies” between IRB decisions, which may contradict each other.

I do not refute the evidence that has accumulated for years that inconsistency is a real issue in both IRB practices and outcomes, and that the concern for most focuses on the latter.^{Reference Green49} Nor do I deny that “local context” will probably wither to some degree under the sIRB model — that is partly the point of the regulatory change. But there is also evidence from the UK and elsewhere that confounds this received wisdom of the value of local context: rather than local review unpinning diverse ethical viewpoints, values, and commitments in research ethics can be remarkably similar across a vast geographic distance. I want to suggest that this alternative finding is linked to structural regulatory conditions underpinning REC/IRB meta-oversight, particularly an overarching regulatory structure that works to improve procedural and substantive consistency across ethics committees.

Over the course of 2016, I conducted a socio-legal investigation into the roles and practices of NHS RECs in light of recently implemented health research regulation in the UK that explicitly seeks to promote health research in the country, in part by streamlining regulation itself — for example, by instituting “proportionate” ethics review for some types of research to accelerate the review times and overall time that a research study could get underway. It was unclear how these recent regulatory changes, stressing efficiency and maximization of UK competitiveness for health research and maximization of return from investment in the UK, might affect the procedural and substantive workings of NHS RECs. It was also unknown whether the modification of research regulation at the level of legal architecture to promote research “trickled down” to the day-to-day practices of RECs, which the HRA is responsible for managing directly in England and partially across the UK.

Given the common finding of inconsistency within and between ethics committees, I expected a similar finding in my naturalistic observations of REC meetings. To the contrary, I found that a common behavior existed across the five RECs I observed for one year, and such behavior did not seem to impact on the resultant ethics opinions. As in the US, relative to each other, RECs are “black boxes”: committee members note they have little interaction with other RECs and have few common opportunities to engage with other RECs — and nor do they have much desire to do so. They do not really know what other committees do, whether they have undertaken ethics reviews in a similar manner, and whether their ethics opinions are similar to their own. Yet, despite these black boxes existing between each other, there exists a surprising degree of group homogeneity in terms of approach and rituals.

In the UK, one of the key rituals is the meeting and agenda structure for RECs. Established by the HRA in a template form, the meeting agenda was consistent across all five RECs I observed, namely in the order of: 1) Apologies for Absence; 2) Minutes of the Meeting Last Held; 3) Matters Arising; 4) Items for Information and Discussion; 5) REC Manager's Report; 6) Declarations of Interest; 7) New Applications for Ethical Review led by the Lead Reviewer and then Second Reviewer; 8) Any Other Business; and 9) Date of Next Meeting.

Within this structure, the timing was consistent, too. Items 1-6 rarely extended beyond five minutes discussion in total. The vast majority of each meeting was dedicated to Item 7: New Applications for Ethical Review. Following the presentation by the nominated “Lead Reviewer” (which typically ranged from seven to fifteen minutes), the nominated “Second Reviewer” would then add a few comments (which typically ranged from three to seven minutes) in a gap-filling manner, raising further queries to be posed to the chief investigator or areas of concern within an application. Then, the REC Chair would invite other REC members to comment on the application. Following this open discussion, the REC Chair would write down the “main issues” to discuss with the chief investigator or his or her representative, assuming the chief investigator or representative was attending in-person. (REC Managers were always taking minutes of the meetings, portions of which were then transformed into opinion letters that would be sent to the chief investigator and his or her research team.) Once the list of questions was formulated to all members' satisfaction, the REC Chair or Manager would retrieve the chief investigator waiting outside, invite him or her inside, and ask questions regarding the application. Following this back-and-forth dialogue, the chief investigator would leave, and the REC Chair would invite members to deliberate further on the application, culminating in a decision. More often than not, the outcome would be a “provisional opinion,” whereby the REC would request further information from the research team before reaching a final decision (which would almost always be a favorable opinion).

With an array of rituals, individual member and committee idiosyncrasies (e.g. the seating pattern, organization of papers, ways of communicating), and moral intuitions, even if ethics is “situated” — constrained by the limits of the committee structure, the communicative and epistemological dominance of the medical and scientific expert members, or the desire for group consensus and efficiency — any given ethics committee's output, as with the input, is somewhat uncertain. But only somewhat. For example, certain cues in the course of an ethics review (e.g. the type of research under review, a REC's trust in the researcher, the quality of the submitted application) can help make an outcome more predictable, though not certain. There is always an element of uncertainty in the outcome of an application following an ethics review. As regards precedent, intra-REC precedent (i.e. comparing current applications to past applications and decisions) occasionally was invoked in the deliberations I observed to serve as a reference and maintain consistency, but this was not done systematically. One member told me he could only recall two instances in over 20 years of serving on a REC where precedent was invoked. The norm was that each application was reviewed on its own merits. Group experience, or a “memory within the group” as one person told me, predominated the aiding of a decision at a higher thought level. As one REC Chair phrased it, “group moral maxims that we all generally share” helped determine if the past opinions were relevant to the current application so as to apply like a generally accepted ethical principle. Collective memory and experience, along with these “group moral maxims,” maintained order and propelled the REC towards a decision that they believed would be consistent within their REC and, ideally, across others, too.

What drove this homogenous REC group culture across the five I observed may be in large part be due to HRA standards driving consistency across the UK. Though the 300-page REC SOPs that the HRA publishes place a good deal of procedural standardization on RECs, they nonetheless permit them a wide latitude in which to roam substantively on ethics. And this wide latitude can result in potentially differing outcomes. For example, Samantha Trace and Simon Kolstoe conducted an analysis of the outcomes of several “Shared Ethical Debate” (ShED) exercises undertaken by some NHS RECs in England, with the resulting minutes from each REC compared along with the final decisions made by each REC on the project under consideration. They found that, “[b]roadly speaking, NHS RECs have been getting more consistent over time in terms of their decision-making, but the reasons for the final decisions as described in the committee minutes continue to vary widely.”^{Reference Trace and Kolstoe50} They suggest that qualitative research needs to be done “to understand why different committees can have such different discussions in relation to exactly the same research project and yet come to essentially the same conclusion.”⁵¹

I would attribute this similarity in outcome (i.e. conclusion) and variation in discussion (at least as reflected in the minutes, which must be taken with some caution) to the wide latitude given to RECs to roam on substantive ethical discussion. Even so, in my observations, on the whole RECs appear to roam in similar ways and in similar spaces. None exhibited practices and outcomes that could be seen as falling outside a range of reasonableness. More intriguingly, elements of REC culture — interpretive flexibility, self-policing behavior, and sensitivities with regard to relationships with researchers — would ordinarily suggest heterogeneity and militate against homogeneity. And yet, a strong degree of group cultural and regulatory homogeneity exists. Importantly, an “ethics of space” existed for each REC I observed that also constituted a connected regulatory space of RECs across the UK where homogeneity reigned. In other words, a researcher in the UK can submit an application in the south of England or the north of Scotland and experience a startlingly similar ethics review. RECs themselves may not be aware of how similar they are, procedurally and substantively. More than once REC members asked me how their REC “compared” to the others I was observing, and whether I found any differences. As I responded to them, at least based on the five I observed, the procedural and substantive differences are few and far between. Despite, or perhaps because of this homogeneity, there is a strong desire by RECs, including REC Managers, to preserve the sanctity of their black box and ethics of space. The evidence from the UK suggests, then, that it is possible to achieve procedural and substantive consistency across ethics committees without a concomitant withering of local concerns — provided, however, the right system and structure is in place and trust across committees is sustained.

Other empirical research carried out in 2015 and 2016 also reinforces this finding, albeit from a different angle, namely an international angle that focused on concerns regarding multi-jurisdictional data-intensive research projects.⁵² Here, I conducted interviews with 25 international experts in research ethics on the topic of ethics review “mutual recognition.” The aim was to explore the issues associated with ethics committee review of international data-intensive research projects, identifying current problems, real-life experiences, and potential solutions that are both bottom-up (via researchers, participants and publics) and top-down (via statutory regulation), as well as challenges in achieving both.

The most significant challenge identified by the participants was the pervasive notion of “locality,” specifically the sticking point of the desire by many in the system to protect local context and sensitivities. How, I wondered, could we address this ongoing concern that ethics is somehow necessarily “local,” and must remain local — nationally and institutionally — even though evidence suggests that a) ethics review processes and ethical reasoning is (or can be) similar across walls and borders, and b) with the right regulatory structure(s) in place, multiple reviews can be eliminated without prejudicing the rights and interests of research participants?

Some interviewees emphasized that existing and engrained procedural difference is often invoked as a rationale for local review, but felt it was “[not] defensible to maintain procedural differences because it's just that you do things slightly differently. [It's] just a nonsense to say that that should stand in the way of a more efficient review.”⁵³ Rather than accept local context as a valid justification to avoid reforming the ethics oversight system, participants suggested that existing initiatives in several jurisdictions demonstrate that it is possible to have a model similar to the sIRB rule, even without a centralizing authority such the UK's HRA that can drive procedural consistency through mandated SOPs and other regulatory devices. For example, Canada, like the US, has institution-based ethics committees, known as Research Ethics Boards (REBs). Multi-jurisdictional ethics review reform has been slow-going in the country. Yet several interviewees in Canada noted that Clinical Trials Ontario (CTO) provides an example of how ethics review can be rationalized in a sound way. CTO provides a single Ontario-wide ethics review for multi-site clinical trials in the province. The CTO Streamlined Research Ethics Review System (SRERS) supports any single “CTO Qualified” REB in Ontario to provide ethics review and oversight for multiple research sites participating in the same clinical trial. The aim is to scale up the initiative to other provinces.

In sum, what both the UK and international empirical research indicates is that the emphasis on the importance of local review and local context may be misplaced or exaggerated. It is unclear what “local context,” “local knowledge,” and sensitivities entail from an ethics perspective (as opposed to, say, from a governance or operations perspective), and it is doubtful whether IRBs can ever be comprised in a way that involves or represents local communities in ethics review processes in a meaningful way, much less that IRBs can adequately represent context and sensitivities through the voices of its (generally very few) community members. Perhaps what really is at stake here in this criticism of the sIRB rule is the desire to maintain local institutional control (and on this point, Gladue's connection between local politics and local ethics is apposite), and the rhetoric of local context is the hook on which to place this desire. Local control, however, is not a sufficient justification to ossify the regulatory system. The shakiness of the local context argument is one of the principal reasons in my view that the sIRB rule ultimately prevailed.

Though the local context criticism is in the end more of a red herring, there are two real weaknesses that exist in the sIRB rule that demand attention.

Residual Weaknesses in the sIRB Rule

Though I argue in support of the sIRB rule, two residual weaknesses remain in the regulatory structure for research ethics review that the Common Rule reform does not address:

• the hub-and-spoke model of a “reviewing IRB” with “relying” institutions/IRBs dampens the gains in efficiency the Common Rule claims to achieve with the sIRB rule (Weakness 1); and

• IRBs act as administrative regulatory bodies, so principles of natural justice (in other words, key elements of due process) should apply, and yet they are not fully built into the regulatory structure (Weakness 2). This weakness is expressed most prominently in the ongoing need for an IRB appeals system, which is all the more important with the implementation of the sIRB rule.

I suggest that these two weaknesses are not fatal to the sIRB rule or the revised Common Rule, and as such in the following sections and conclusion I suggest ways in which they might be addressed in future regulatory reforms.