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Autonomy as Corporeal, Not Just Cognitive

Megan S. Wright, Resuscitating Consent, 63 Bos. Coll. L. Rev. 887 (2022).

Contemporary discussions of the law and ethics of informed consent to medical treatment tend to focus on the process of information communication, including the scope of the disclosures physicians are required to make, and the ability of patients to truly understand those disclosures and integrate them into their medical decision-making. Without dismissing the importance of communication and understanding in securing consent to treatment, Prof. Megan Wright’s article, Resuscitating Consent, directs the reader’s attention to a fundamental concept that seems to have been overlooked as the law and practice of informed consent have developed. Namely, that the principle of patient autonomy upon which informed consent doctrine is based has a corporeal – not just cognitive – component.

Prof. Wright wisely reminds readers that respect for bodily integrity was a foundational principle in the development of autonomy-based legal protections for patients. However, evidence suggests that health care providers in acute care hospitals are willing to violate this principle by imposing medical treatment against contemporaneous patient objections. Prof. Wright argues that all patients – not just those deemed to have decision-making capacity – have an absolute right to refuse treatment as a matter of bodily autonomy. “[P]atients,” according to Prof. Wright, “continue to have bodily integrity interests that should be respected even if they acquire decisional impairments and are deemed incapable of autonomy understood as capacity for rationality.” Contemporary U.S. law, however, fails to adequately protect these interests, and this article offers several compelling recommendations for addressing this issue.

By re-centering bodily integrity at the core of consent to treatment, Prof. Wright challenges the idea that the corollary to “informed consent” must be “informed refusal.” She supports her argument by discussing the theoretical basis for autonomy as a foundational principle of medical ethics; the historical development of informed consent doctrine; the negative impact that treatment over objection has on patients, providers, and the rule of law; and contemporary legal developments in the field of supportive decision-making for patients with cognitive impairments. While recognizing and reinforcing the importance of information and cognition to decisions to proceed with treatment, Prof. Wright argues that the right to maintain one’s bodily integrity by refusing treatment is not conditional on cognitive capacity or understanding. Thus, physicians who require formal or informal competency assessments when patients refuse care are improperly acting as gatekeepers to a right that should be unconditional.

Prof. Wright’s primary recommendation in this article is that any gatekeeping role be left to the judiciary, rather than to individual health care providers. As a model, she points to the New York Family Health Care Decisions Act, which establishes “absolute legal capacity to refuse medical treatment” that can only be overridden if “a court judges the patient to be incompetent.” She also proposes that surrogate decision-makers and agents acting pursuant to health care powers of attorney have similarly limited authority to override a contemporaneous treatment refusal. To provide additional protections for patients, she recommends that health care providers who question a refusing patient’s decisional capacity first prioritize restoring decisional capacity if the patient is amenable, providing assistive communication technology, and inviting family members to engage in persuasive discussion with the patient. However, if these attempts fail, the patient refusal must be respected unless the health care team seeks and secures court approval. Failure to do so, under the model Prof. Wright proposes, would lead to tort liability.

Prof. Wright acknowledges and aptly addresses several challenges to this proposed approach, including arguments about the prioritization of health at all costs, concerns about provider autonomy, potential harms to third parties, and the value of existing exceptions to consent requirements. The one counterargument I believe deserves further discussion is about patient refusals in the context of medical emergencies and time-sensitive decisions. Prof. Wright recognizes the importance of the emergency exception to informed consent in cases where there is no time to secure consent, but argues that in the case of “treatment over objection, it would be perverse to allow providers to lawfully rely on the emergency exception to override their patient’s prior treatment refusal” (as in cases like Werth v. Taylor (Mich. App. 1991), where a pregnant woman’s consistent refusals to accept blood products for religious reasons was overridden when a medical emergency arose). Prof. Wright argues for making the emergency exception “stricter,” but it would be helpful to further explore the practical implications of such a proposal. For example, Prof. Wright advocates for a clearer path for emergency court petitions, a suggestion that would be bolstered by exploration of the timeliness and efficacy of emergency petitions in other contexts, like guardianship.

The issue of tort liability is an essential piece of this puzzle, and Prof. Wright offers valuable insights into how policymakers could best take advantage of tort law’s deterrent effect in these situations. As Prof. Wright acknowledges, it is only recently that courts have started to consistently recognize that unwanted treatment that improves a patient’s condition or extends their life qualifies as a legally cognizable harm. Prof. Wright’s proposal for tort liability when physicians override contemporaneous treatment refusals without a court order is consistent with this developing trend. Notably, she also acknowledges the ongoing challenges of bringing civil actions in such cases, including the difficulty in finding an attorney to take a dignitary harm case on a contingency fee basis. She suggests several ways in which legislation could address this problem, such as by allowing for statutory damages, attorney’s fees, and punitive damages.

Overall, the article reminds us of the importance of bodily integrity as an element of autonomy-based doctrines like informed consent, at a time when much academic discussion focuses primarily on disclosure and understanding. In doing so, Prof. Wright brings informed consent doctrine back to its roots, so to speak, and asks important questions about how it has developed in the context of treatment refusals.

Cite as: Nadia Sawicki, Autonomy as Corporeal, Not Just Cognitive, JOTWELL (May 11, 2022) (reviewing Megan S. Wright, Resuscitating Consent, 63 Bos. Coll. L. Rev. 887 (2022)), https://health.jotwell.com/autonomy-as-corporeal-not-just-cognitive/.

Laurie’s Legacy

Edward Dove and Niamh Nic Shuibhne (Eds), Law and Legacy in Medical Jurisprudence: Essays in Honour of Graeme Laurie (2021).

Law and Legacy in Medical Jurisprudence: Essays in Honour of Graeme Laurie, edited by Edward Dove and Niamh Nic Shuibhne, includes 18 essays that explore legacy in its various forms, and in various contexts, drawing on the many impacts and innovations to date of medical jurisprudence pioneer, Graeme Laurie.

The volume does three things particularly well. Firstly, it serves as a Festschrift honouring a great scholar. Laurie recently stepped down from the Chair of Medical Jurisprudence at the University of Edinburgh to pursue other projects. His intellectual legacy is profound, and whilst he has written on almost every medical law issue he is particularly well known for his work on liminality, human tissue, genetic privacy and information governance, and his co-authored text book on medical law. His contribution to the next generation of scholars is equally impressive, and fortunately is set to continue in his role of Professorial Fellow.

Secondly, the volume offers insightful commentary on wide-ranging medico-legal issues. The chapters focus on medical research, biobanking, tissue, ectogenesis, surrogacy, assisted suicide and other substantive issues. This is evidence of the breadth of Laurie’s engagement, and the impressive list of contributors, each renowned in their field, is testament to how well Laurie is respected and admired. The insights are original and far ranging and they are insightfully assimilated by the editors in the Introduction.

Thirdly, the book offers a conceptual analysis of the many dimensions of legacy and uses this as an analytical lens on the evolution of medical jurisprudence. Health law and medical law programmes are flourishing around the world, but their scope and nomenclature is often debated. Laurie championed the importance of interdisciplinarity through engagement with ethics, medicine, humanities and the social sciences, as well as with social, political and economic contexts. The book also sets out some of the limits of medical law, wherein the jurisprudential issue at play is almost always part of a bigger picture. In an Afterword to the book, Lawrence Gostin says:

The field of ‘medical jurisprudence’, to use the University of Edinburgh parlance, has come a long way. It is not just about medicine and what happens in the clinic; it also explores health systems, including public health systems. It is not just about health systems, but also upstream social and commercial determinants of health. And it is not just all-of-government, but also all-of-society.

The volume charts an expansion of medical jurisprudence from a focus on doctors to a focus on health systems, driven in part by an increasingly interdisciplinary focus but also by events such as medical scandals and the COVID-19 pandemic. The volume notes that negative jurisprudential legacies can flow from incremental legal decision-making or event-focused reforms. These, in turn, can encumber medical jurisprudence, preventing its development in line with changing societal values.

Laurie’s work on liminality challenges the regulations that keep the boundaries in place. Where a regulatory provision is no longer fit for purpose, recognition of liminal spaces allows the landscape to be reimagined, the spaces between boundaries explored ,and boundaries to be broken down. A good example is found in laws governing 16–18-year-olds. Recasting them in a shared ‘liminal’ space between adulthood and childhood can help to explain laws that allow them to consent but not necessarily to refuse life-sustaining medical treatment.

Legacy is collective as well as individual; negative as well as positive. The reader is left with an appreciation of Laurie’s individual legacy and his contribution to the collective legacy of medical jurisprudence. Particularly importantly for me, the collection of essays provides valuable insight into how that legacy might be positively developed through Laurie’s example of interdisciplinarity, innovation, collaboration, and boldness.

Cite as: Emma Cave, Laurie’s Legacy, JOTWELL (April 26, 2022) (reviewing Edward Dove and Niamh Nic Shuibhne (Eds), Law and Legacy in Medical Jurisprudence: Essays in Honour of Graeme Laurie (2021)), https://health.jotwell.com/lauries-legacy/.

An Unapologetically Inconsistent Enforcement Regime

Jacob Elberg, Health Care Fraud Means Never Having to Say You’re Sorry, 96 Wash. L. Rev. 371 (2021).

Fraud is a major problem in American health care. It costs American taxpayers and patients from about $70 to $234 billion annually, which accounts for between three and ten percent of total health spending in the United States. It is an area that would be benefited by serious legal scholarly focus and inquiry, and well served by well-supported and implementable policy suggestions based on empirical data. Professor Jacob Elberg, through his serious and important work in this space, has provided just that in his most recently-published piece Health Care Fraud Means Never Having to Say You’re Sorry. Here, Elberg again shows why he is a leading voice in health care fraud and abuse scholarship.

The piece focuses on the civil federal False Claims Act (FCA), a major tool for the federal government that imposes major civil penalties against health care fraud defendants. As has been argued before, use of the FCA and its draconian penalties overwhelmingly leads to settlement, which—without courts’ review of the government’s theory of liability—can stunt the development of the FCA itself. In addition to the lack of meaningful judicial review in these matters, defendants often deny any wrongdoing as they settle FCA allegations, leaving the public and other defendants in the dark about whether the allegations had merit or drew a settlement simply because of expediency or the risk or cost of litigation. As Professor Elberg says, this has “fueled a cost-of-doing-business narrative in which health care entities are required periodically to pay inconsequential settlements to the government regardless of their conduct.”

The basis of Professor Elberg’s article is a review of 195 settlements that resolve FCA allegations between early 2018 and the spring of 2020, and he examines them specifically for whether the FCA defendants publicly admitted responsibility for the government’s loss. Professor Elberg finds that 92 percent of settlements did not include defendants’ acceptance of responsibility, and that 37 percent of defendants actively denied responsibility. Relatedly, he powerfully asks why the Department of Justice (DOJ) does not require defendants to admit responsibility as part of a health care settlement, especially because it requires admissions in virtually all cases in which it settles criminal claims.

In addition to noting the inconsistency in the DOJ’s current practice between civil and criminal resolutions, Professor Elberg also observes (1) recent changes to the DOJ’s FCA policy that seem to indicate that it will reward an acceptance of responsibility, (2) the history and development of the Security and Exchange Commission’s (SEC)’s admission standard (which requires admissions in some cases), and (3) other enforcement goals that seem to be undermined by the DOJ’s failure to require an admission of responsibility. In so doing, Professor Elberg shines a light—through his collection and presentation of hard data—on an area of legal enforcement that suffers from glaring inconsistencies.

Most importantly, Professor Elberg is concerned about kind of behavior the enforcement regime is incentivizing. Indeed, he argues that not requiring an admission of wrongdoing could hamper the DOJ’s main goals, like deterring bad behavior, incentivizing cooperation, and rewarding a culture of compliance in the industry. Given the lack of credit they receive for an admission of responsibility, this could prompt even more health care industry defendants to refuse to cooperate with investigations or to invest in compliance programs altogether, as Elberg observes.

Professor Elberg powerfully identifies some barriers to the DOJ in requiring the admission of responsibility, from a concern over resources to increased litigation risk, and also makes a persuasive case for how the DOJ may want to take a nuanced or targeted approach to requiring settlement admissions. Indeed, one may wonder if, from a fairness perspective, it makes sense to require settling defendants to admit responsibility absent proof at trial, but that question does not detract from Professor Elberg’s main goal, which is injecting some order and consistency into a mysterious enforcement regime that seems to currently lack it.

Ultimately, Professor Elberg is concerned that the DOJ’s enforcement regime may be at risk of losing legitimacy because of how the settlement-dependent mechanism is deployed and how its cases are settled. His findings seem to suggest, as he argues, that the “DOJ pursues, illegitimately, weak cases it cannot prove at trial” and it “lends credence to the widespread belief that civil health care fraud settlements simply do not signal wrongdoing.” Given the scourge of health care fraud and abuse on this country’s health care system, that is a powerful and damning concern, and raises even deeper questions about faith in a fair enforcement mechanism and the rule of law itself.

Cite as: Zack Buck, An Unapologetically Inconsistent Enforcement Regime, JOTWELL (March 24, 2022) (reviewing Jacob Elberg, Health Care Fraud Means Never Having to Say You’re Sorry, 96 Wash. L. Rev. 371 (2021)), https://health.jotwell.com/an-unapologetically-inconsistent-enforcement-regime/.

The Hidden Public Health Consequences of “Putting Patients First”

Richard S. Saver, Physicians' Elusive Public Health Duties, 99 N.C. L. Rev. 923 (2021).

Both legal and ethical frameworks governing the practice of medicine typically emphasize the importance of “putting patients first.” In a thoughtful new article, Richard Saver shows how this often-unquestioned maxim has allowed the medical profession to “too easily discount community health considerations.” (P. 926.) After identifying a variety of ways in which physicians’ patient-centered ethos has led to the “externalization of health risks to the general public” (P. 928), he offers suggestions for “making community physicians’ public health duties more cognizable and influential.” (P. 929.)

As Saver demonstrates, physicians sometimes use the mantra of putting patients first as a justification for actions that threaten community welfare. For example, when the COVID-19 pandemic worsened in March 2020, some physicians continued to perform elective surgical procedures, citing their duties to patients as a justification for ignoring public health advice to conserve hospital resources. Similarly, physicians have appealed to patient interests as a justification for ignoring public health guidance to limit the prescription of broad-spectrum antibiotics and, until recently, for prescribing large amounts of opioids despite the foreseeable risk that leftover pills would be diverted to non-patients. Physicians’ patient-centered orientation has also led them to resist calls to use medical encounters as an opportunity to promote public health messages. For example, while many medical groups have urged physicians to play a greater role in combatting gun violence, most physicians rarely talk to patients about firearms, perceiving such discussions “as beyond their professional scope of practice” and potentially damaging to the physician-patient relationship. (P. 964.)

Saver attributes these attitudes to both legal influences and the culture and ethics of the medical profession. On the legal side, he notes that physicians’ duties to patients are typically not triggered absent the formation of a treatment relationship with an individual patient, and once triggered, these duties are often characterized in fiduciary terms. While some courts have recognized circumstances in which physicians have duties to non-patients, those duties have been carefully circumscribed. For example, courts that have recognized a duty to warn third parties at risk of contracting an infectious disease from a patient have limited the duty to household members or other specific persons with a very close nexus to the patient. In addition to judicial reluctance to recognize public health duties, most licensing statutes focus exclusively on physicians’ patient care obligations. While a few statutes mention physicians’ duties to comply with disease reporting obligations, and a handful even incorporate more open-ended duties to avoid “harm to the public,” Saver notes that these broader public health obligations are rarely enforced.

The law’s conception of physicians’ duties largely mirrors the medical profession’s understanding of its own responsibilities. Even though the American Medical Association (AMA) revised its Code of Ethics in 2016 to emphasize that physicians have certain public health obligations, Saver argues that “much of this guidance pays mere lip service to physicians’ public health role.” (P. 944.) For example, while the AMA recognizes physicians’ obligation to participate in routine universal patient screening for HIV, it advises physicians that their “primary ethical obligation is to their individual patients.” In light of this obligation, the AMA cautions, screening programs must include a mechanism for patients to opt out of being tested. Saver points out that no AMA ethics opinion provides “any indication when physicians’ public health duties will ever eclipse and outweigh their obligations to individual patients.” (P. 945.)

The profession’s “seeming enfeeblement of [public health] duties by obfuscation” should not be surprising, Saver argues, as appeals to public health conflict with medical ethics’ “strong concern with individual autonomy and patient beneficence.” (P. 945.) He also suggests that a focus on public health could also be seen as a threat to physicians’ autonomy and potentially their economic welfare. For example, when physicians refused to postpone elective surgeries in the early months of the COVID-19 pandemic, “the ‘patients first’ rationale was so broad and seemingly beyond reproach that it could obscure financial incentives and other questionable reasons at odds with community health protection.” (P. 952.)

Saver cogently explains the costs of viewing physicians’ responsibilities primarily in terms of individual patients. The public health system, he argues, “cannot effectively operate without broad, engaged participation of private physicians.” (P. 972.) For example, physicians are the first to observe warning signs of community health threats and are often in the best position to act on those threats in a timely manner. Similarly, physicians’ role as gatekeepers to health care products and services “makes them uniquely positioned to direct the use of limited societal resources for safeguarding the health of the community.” (P. 974.) Because physicians are trusted community members, they also can play an important role in communicating public health messages, both to their own patients and members of the community.

Saver recognizes that efforts to reconceptualize physicians’ duties to incorporate public health interests are likely to face resistance. In addition to challenging the dominant patient-first attitude, a legal duty to promote public health could be seen as conflicting with the common law’s reluctance to impose affirmative duties. It could also raise fears about exposing physicians to potentially unlimited liability or undermining physicians’ fiduciary duty of loyalty to patients. However, he convincingly argues that none of these potential objections raises insurmountable problems. Moreover, “from the ex ante perspective, before knowing what their particular circumstances will be, most individuals would likely prefer a regime where physicians have more robust public health duties that sometimes trump patient welfare concerns.” (P. 980.)

Saver concludes with recommendations for legal and policy reform. As a starting point, he urges stronger enforcement of the minimal public health obligations the law already imposes on physicians, such as statutes requiring physicians to report certain communicable diseases, and stepped-up enforcement of public health obligations by medical licensing boards. He also calls on lawmakers to consider adding financial incentives under Medicare and other government health care programs to encourage physicians to meet targeted public health goals, such as prescribing antibiotics according to public health guidelines or engaging in a particular number of gun-violence screenings with patients. Recognizing concerns about exposing physicians to unbounded liability, he suggests that enforcement of public health duties might be delegated to “intermediaries and proxies for the public, such as state attorneys general or state medical boards,” rather than expanding tort-law causes of action.

Saver’s analysis demonstrates that, while “putting patients first” is often an admirable attitude, physicians who focus exclusively on their individual patients can undermine community well-being. While the legal changes he recommends are relatively modest, they could lay the groundwork for an important shift in physicians’ self-conception of their professional responsibilities. The article is an important contribution that deserves the attention of anyone interested in health law, bioethics, and the medical profession.

Cite as: Carl Coleman, The Hidden Public Health Consequences of “Putting Patients First”, JOTWELL (February 14, 2022) (reviewing Richard S. Saver, Physicians' Elusive Public Health Duties, 99 N.C. L. Rev. 923 (2021)), https://health.jotwell.com/the-hidden-public-health-consequences-of-putting-patients-first/.

Charting a New Path for Health Care Reform

Lindsay F. Wiley, Elizabeth Y. McCuskey, Matthew B. Lawrence, and Erin C. Fuse Brown, Health Reform Reconstruction, __ U.C. Davis L. Rev. __ (forthcoming, 2022), available at SSRN.

Since the 1960s, debates over health reform in the United States have focused on expanding access to health care, improving its quality, and lowering its costs. In their forthcoming article, Health Reform Reconstruction, Professors Lindsay Wiley, Elizabeth McCuskey, Matthew Lawrence, and Erin Fuse Brown argue that this so-called “iron triangle” framework has led to an unjust health care system by marginalizing equity, solidarity, and public health concerns. Building on their prior work, the authors call for a new set of principles to guide health care reform that centers around health justice. The Article also identifies legally and logistically entrenched fixtures of the U.S. health system and shows how they have structurally constrained health reform and undermined social justice goals. This provocative Article is a must-read for those interested in health reform, and the authors’ reframing of the issues pushes stakeholders to ask whether reform proposals will reinforce these problematic fixtures or dismantle them (albeit partially), thereby moving us closer to a more just health care system.

The Article is organized around four lessons that the authors pull from the U.S. health care system’s deficient and inequitable response to the COVID-19 pandemic. Part I presents the first lesson ─ “that health care reform requires new principles rooted in solidarity, equity, and justice.” (P. 5.) The authors argue that the pandemic has revealed weaknesses in our health care system that have increased COVID-19’s public health and economic harms, such as failing to fairly allocate, adequately supply, and constrain prices for COVID testing, treatment, and vaccines. The pandemic’s disproportionate impact on low-income, Black and Brown communities also has made highly visible the health care system’s failure to reduce long-standing disparities in health. In addition, the pandemic highlighted our interdependence across racial and socio-economic lines. The authors argue that evaluations of future health reforms therefore should be guided by three core criteria ─ anti-subordination, equitable distribution, and community empowerment ─ criteria often overlooked or marginalized by the iron triangle framework. Specifically, they believe we should ask whether reforms (1) dismantle or reinforce structural racism, economic injustice, and other forces of social subordination; (2) ensure the just distribution of the burdens and benefits of public investments in health care and public health; and (3) allow for decision-making processes that give recognition to and empower subordinated groups that too often are excluded from collective self-determination.

Part II focuses on the second lesson the authors pull from the pandemic ─ that health reform has been structurally constrained by four fixtures of the U.S. health care system that impede solidarity and egalitarian justice ─ namely, individualism, fiscal fragmentation, federalism, and privatization. The authors provide a detailed discussion of how each of these fixtures is legally and logistically entrenched in our health care system and the ways in which they have undermined our COVID-19 public health response. For example, given the health care system’s orientation toward treating individual patients, coronavirus testing was used simply as a diagnostic tool in caring for individuals rather than also supporting disease surveillance programs. The authors also explain how fiscal fragmentation that spreads costs and benefits across patients, employers, public and private payors, and providers impeded the public health response by producing a mismatch between those who would benefit from public health interventions and those asked to pay for them.

The Article’s third lesson is that these four fixtures contribute to racial and socioeconomic disparities in the burden of disease. Part III describes the fixtures’ racists foundations and how they continue to perpetuate socioeconomic inequality. In linking key structural components of our health care system to racism and subordination, the authors remind us that health reforms that reinforce these fixtures further cement structural inequalities in health care. A key illustrative example discussed by the authors is the Affordable Care Act (ACA). While many have hailed the ACA for expanding access ─ a pillar of the iron triangle ─ the authors explain how Medicaid expansion further entrenched the country’s two-tiered health care system, with reduced access to care for Medicaid’s disproportionately minority and low-income beneficiaries given the program’s lower payment rates to providers.

In Part IV, the authors discuss their final lesson ─ that health reforms needs “a reconstruction in ethos, centered on health justice criteria.” (P. 56.) The authors believe a single-payer health care system would advance health justice and population health by disassembling the four fixtures. However, they rightly recognize that these fixtures are structural impediments to far-reaching reforms. In deference to this reality, they argue for confrontational incrementalism, or incremental reforms that lay the groundwork for future transformation of the health care system by displacing the fixtures. Accordingly, evaluations of proposed reforms would not simply consider their impact on cost, quality, and access, but would primarily focus on whether they further health justice by confronting the entrenched fixtures. Policymakers and scholars committed to a more just health care system should consider adopting confrontational incrementalism as a method for achieving this goal.

Cite as: Jessica Lind Mantel, Charting a New Path for Health Care Reform, JOTWELL (January 14, 2022) (reviewing Lindsay F. Wiley, Elizabeth Y. McCuskey, Matthew B. Lawrence, and Erin C. Fuse Brown, Health Reform Reconstruction, __ U.C. Davis L. Rev. __ (forthcoming, 2022), available at SSRN), https://health.jotwell.com/charting-a-new-path-for-health-care-reform/.

Medical Necessity, Then and Now

Amy B. Monahan and Daniel Schwarcz, Rules of Medical Necessity, 107 Iowa L. Rev. ­­___ (forthcoming, 2022), available at SSRN.

In a must-read article, Amy Monahan and Daniel Schwarcz have teamed up to undertake, in their own words, an “exhaustive review of caselaw and publicly filed health insurance policies,” and report back on what health insurers have been doing with their contract terms to try to control their claims spend-out. The results are riveting. Monahan & Schwarcz document a shift twenty years in the making. The nature of what they see is a switch from insurers defining the scope of coverage using the broad standard-like term of “medically necessity” within each benefit category, to the use of highly particularized rules embodied in clinical policies or guidelines that are directly or indirectly fixed by reference in the insurance policy terms.

Their piece is a reply of sorts in a conversation across the decades with another colossus of an article, Mark A. Hall & Gerard F. Anderson, Health Insurers’ Assessment of Medical Necessity, 140 U. Pa. L. Rev. 1637 (1992). Each article, Monahan & Schwarcz’s and Hall & Anderson’s, stands and grapples with the fundamental and enduring crosswinds of the health coverage conundrum and renders them into a coherent historical narrative of sweeping momentum.

If you wanted to understand private health insurance coverage and its discontents over the last half century, you could do a lot worse than simply reading these two articles. A more conventional history would survey the political epiphenomena of the underlying forces that Monahan and Schwarcz document—phenomena such as the impact of ERISA and the fraying employer-based system of coverage, the managed care revolution and its expression as the prevailing ethos of the Jackson Hole Group and Clinton Health reform era, the subsequent managed care backlash and Patients’ Bill of Rights campaigns followed by the evidence-based medicine movement, and then the passage of the ACA. But Monahan and Schwarcz follow a rarer model of scholarship that peels back the surface events to reveal the corresponding hydraulics beneath, and we as readers are all the wiser for it.

I found the rules versus standards framework to be a handy organizing tool in their endeavor, one that clicks satisfyingly into place. It lends a conceptual handle and plausibility to the story they tell of change over time, specifically of ever greater “rulification” in the way coverage decisions get made. The framework goes on to deliver a pay-off in the form of a prediction that bears out: that courts will be ever more disempowered in health insurance decisions. But the rules versus standards frame stops short of answering the question of who should be empowered instead. The inherent limitation of this theoretical frame shows a bit toward the end of the article, which fractures into an array of different proposals about which I will say more in a moment.

Meanwhile, Monahan & Schwarcz add an interesting twist in the application of the frame. They argue that the rulification not only diminishes judges’ role; it also disrupts a delicate balance of other forces keeping insurers in check, such as administratively-required internal and external review as well as legislatively mandated benefits, all of whose mechanisms assume a standard-based regime.

While Monahan & Schwarcz and Hall & Anderson may disagree on whether the U.S. health system at the time of their respective articles suffered from a state of excessive rulification (the former’s view) or excessively discretionary standards (the latter’s), I think that their posture of disagreement is otherwise overstated. It is notable that neither pair thinks that the answer lies in judges deciding what gets covered. Nor does it lie with doctors or insurers deciding, never mind legislators. True, Monahan & Schwarcz chafe more at the notion of judges being pinned down by rulification, even if they wouldn’t vest judges with the substantive decisions either. And Hall & Anderson trust a utilization review entity more than Monahan & Schwarcz do. Indeed, I wonder if that is the main axis of distinction between the positions that these articles stake out. Monahan & Schwarcz’s account is suffused with doubt over whether the evidence will ever be sufficient for the technocrats to definitively and legitimately decide what life-saving care is warranted. The decision of what care is appropriate will always push the ever-elusive frontier of knowledge, will always harbor residual unknowns, particular to the individual. To me, their hard-earned caution may represent as great a sea-change over the decades as the rulification they document; it speaks to an epochal chastening of our (or at least my) optimism about evidence-based medicine and its close corollary, value-based payment. To imprison the judgments about appropriate care too tightly in a matrix of decision rules now feels procrustean. Monahan & Schwarcz insist upon an institutionalized release valve—and here is where they offer a smorgasbord of answers.

Some I feel are no-goes, like their third option, proposing to mandate that plans use a particular set of medical necessity determinations such as Medicare’s. The authors themselves also voice doubts about the political viability of the second proposal, which would involve legislating strong substantive standards for utilization review into ERISA with a private cause of action. But I particularly liked the first proposal, whereby state and federal insurance regulation, following Minnesota’s lead, would prohibit plan reliance on rules of medical necessity after internal appeals, ensuring that external appeals and any ensuing litigation remain open fora for challenging an insurer’s rules of medical necessity for substantive error as applied to a specific patients’ circumstances. And their final proposal of greater transparency is a no-brainer. Every one of us should call our Congressional delegations to press for this as soon as possible, pausing only to read what I whole-heartedly recommend as a most thought-provoking contribution on the core problems defining our field.

Cite as: Christina S. Ho, Medical Necessity, Then and Now, JOTWELL (December 8, 2021) (reviewing Amy B. Monahan and Daniel Schwarcz, Rules of Medical Necessity, 107 Iowa L. Rev. ­­___ (forthcoming, 2022), available at SSRN), https://health.jotwell.com/medical-necessity-then-and-now/.

Compounding Vulnerability: Hospital Emergency Rooms as Sites Of Race- And Class-Based Police Surveillance

Ji Seon Song, Policing the Emergency Room, 134 Harv. L. Rev. 2646 (2021).

At the time of this writing, there is widespread public consciousness of both racial health disparities, owing to the COVID-19 pandemic, and the problems of racialized policing in the United States, owing to a wave of protests of police killings of Black people. In a timely new article, Professor Ji Seon Song masterfully explores the relationship between inequitable access to health care and policing by analyzing whether and how criminal procedure doctrine protects patients in hospital emergency rooms (ERs) from harmful police practices.

Professor Song’s primary field of interest is criminal law, not health law—but that, I suggest, is one of the reasons why health law scholars and others interested in health policy should give it a read. This, an article primarily analyzing a criminal law issue, provides new and valuable insights about primary interests and status relationships in health care. Though debates about the coherency and scope of health law as a field are ongoing, most health law scholars are concerned with a fairly discrete set of primary interests and status relationships. Among these are the unique vulnerability of patients during a therapeutic transition, the duty of care that medical professionals owe to vulnerable patients, and the persistence of inequities in access to health care by race and class. Professor Song touches on each of these interests in her analysis of the criminal procedure doctrine governing police investigations. As someone who seeks to provide valuable insights about the intersection of health and immigration laws to the community of health law scholars, this type of scholarship is of particular interest to me, and I appreciated the opportunity to review this piece and provide feedback to Professor Song before it was published.

In the article, Professor Song explains how the current doctrine of criminal procedure does not account for the medical vulnerability of patients in the ER; rather, it views ERs as “an extension of the street.” She also explores the ways in which medical professionals become enlisted in policing-related tasks and explains how this involvement both enhances policing and may contradict medical professional norms and responsibilities. Finally, she describes how ERs serve as safety net providers for disproportionately poor and minority (not to mention, immigrant) populations. Therefore, policing the ER “can have a net-widening effect” on police surveillance of historically marginalized groups. Professor Song’s analysis of criminal procedure doctrine reveals that far from accounting for the multiple vulnerabilities of ER patients, the doctrine intensifies them. She outlines a new doctrinal approach rooted in the concept of immigration sanctuary, proposing a revision of the Fourth Amendment reasonable expectation of privacy standard based on medical privacy. She also proposes hospital-based institutional practices and local policies to safeguard ER patients’ privacy and dignity based on harm reduction principles.

The article’s major descriptive contribution is its analysis of how criminal procedure doctrine has failed to protect the privacy rights and dignity of patients in the ER, and how this relates to primary interests in health law such as ethical considerations of medical vulnerability, medical professional duties to patients, and the eradication of health care access inequities. Its normative contribution is its proposal to conceptualize ERs as patient sanctuaries through constitutional doctrine, local policymaking, and institutional practices.

As police reform proposals are actively debated, Professor Song offers valuable insight into their salience for health law and policy. Social and political pressure may soon reach a tipping point for doctrinal, legislative, and institutional shifts that would provide some measure of privacy and dignity to patients in the ER, restore patients’ trust in medical professionals in the ER, and eliminate a discrete barrier to health care access based in criminal law.

Cite as: Medha Makhlouf, Compounding Vulnerability: Hospital Emergency Rooms as Sites Of Race- And Class-Based Police Surveillance, JOTWELL (November 10, 2021) (reviewing Ji Seon Song, Policing the Emergency Room, 134 Harv. L. Rev. 2646 (2021)), https://health.jotwell.com/compounding-vulnerability-hospital-emergency-rooms-as-sites-of-race-and-class-based-police-surveillance/.

Coming Out of the Drug-Use Closet

Dr. Carl Hart’s Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear opens with a controversial admission. The Columbia University Ziff Professor of Psychology declares that he is “an unapologetic drug user” and, consequently, “a happier and better person.” Dr. Hart urges “responsible” adults to “come out of the closet” about their recreational drug use and its myriad beneficial impacts.

Two important contentions animate Drug Use for Grown-Ups. The first is the widely accepted notion among experts that America’s long-standing criminalization of certain drugs, grounded in their anti-scientific demonization and racialization, is the crux of our problem. Simply stated, our never-ending war on drugs, which has resulted in our country’s unenviable distinction as global mass incarcerator, is an expensive and racist failure. Dr. Hart aptly characterizes American drug policy as a “monstrous, incoherent mess.” Few drug policy experts would disagree.

In fact, critiques of the U.S. drug regime tend to revolve around this theme. Scholars often implore policymakers to end the racist drug war by pointing out that it exacerbates widespread and inequitable harms. They argue that individuals who suffer from problematic drug use deserve compassion and evidence-based treatment instead of stigmatization and incarceration. Drug Use for Grown-Ups, however, not only refuses to loiter in these basic premises, it rejects them as a viable entry points to a productive conversation about American drug prohibition.

As such, the book’s significant contribution to the drug reform canon is located in its dominant and more contentious claim. That is, that responsible, recreational adult drug use enhances pleasure and happiness and that the Declaration of Independence endows all Americans with the unalienable right to such pursuits. Dr. Hart is not a legal academic and, to his credit, he makes no effort to engage with scholarly debates about the founders’ meaning of the Declaration’s “pursuit of happiness” clause. Instead, he deploys the clause to point out that government prohibition undermines our fundamental right to use drugs to enhance happiness so long as that use does not inflict collateral, societal harms. In this connection, Congress enacted a federal right to try law in 2018, which permits individuals with life-threatening health care conditions to take investigational drugs that have not yet obtained Food and Drug Administration (FDA) approval so long as they satisfy enumerated, stringent criteria. The overwhelming majority of the states have also enacted their own right to try laws. The federal courts, on the other hand, have repeatedly rejected the claim that Americans have a fundamental, constitutional right to use illicit substances.

Drug Use for Grown-Ups’s straightforward proposition that adults who do not suffer from serious or terminal illness ought to be able to use drugs to live more empathetic, enjoyable, and meaningful lives has been met with predictably vigorous resistance. Such opposition, of course, has much to do with the power and pervasiveness of American anti-drug propaganda, which teaches that the use of illicit drugs to achieve an altered consciousness is a moral failing that will inevitably lead to problematic outcomes, such as bad parenting, unemployment, substance use disorder, and premature death. Our “what doesn’t kill you makes you stronger” culture is defined by anti-pleasure principles, such as the timeless notion that euphoria is the devil’s work.

American sprinter Sha’Carri Richardson’s recent disqualification from the 2021 Summer Olympic Games due to a positive marijuana test brilliantly illustrates the tension between our cultural anti-drug programming and science. It makes no sense that Richardson was forced out of the Olympics on such grounds because there is no support for the claim that marijuana improves athletic prowess. Banning Richardson from running in the Summer Games due to marijuana use is indistinguishable from—and just as ridiculous as—banning her for taking a Tylenol.

More telling was Richardson’s explanation for her marijuana use and the public’s reception to that rationale. Richardson reported that she had legally used marijuana to cope with the unexpected death of her mother and the public response was predominantly sympathetic and supportive. One wonders how the American public would have responded if Richardson—a Black American woman and athletic superstar—had simply used marijuana to experience pleasure and happiness.

There is, of course, nothing remarkable about Richardson’s drug use. Most Americans take drugs. Some use prescription drugs to mitigate or treat health care conditions; they do so even when such use runs the risk of serious side effects, such as heart attack, seizure, or paralysis. Others routinely use legal, over-the-counter drugs—such as caffeine and alcohol—to achieve a more desirable consciousness, such as heightened alertness or reduced anxiety. Dr. Hart challenges us to examine these phenomena against our otherwise deeply held belief that there is something sinister about using drugs responsibly to enhance our happiness and well-being.

This review is in no manner intended to undermine the seriousness of substance use disorder and other forms of addiction. As already noted, however, the criminalization of drugs enhances drug use-related harms; exacerbates poor public health outcomes; fuels unsafe, illicit underground drug markets; and disparately targets minority populations and other socially and economically disenfranchised groups. Our criminal legal system both ignores the root causes of substance use disorder and devours significant resources that could be devoted to addressing the social and structural determinants of health that drive drug overdose epidemics. The pervasive criminal surveillance of certain drugs, such as opioids, coupled with concerns about substance use disorder also has led to the undertreatment of individuals with chronic pain conditions who may benefit from opioid therapeutics.

Dr. Hart intentionally unmoors his argument that responsible adults have a fundamental right to use drugs to enhance happiness from conventional advocacy for substance use disorder prevention and treatment, on the theory that most recreational drug use is for pleasure and not problematic. He dedicates a chapter of Drug Use for Grown-Ups to critique the term “harm reduction” due to its negative connotations with drug use outcomes. That stated, the evidence strongly suggests that drug decriminalization or legalization would both permit drug use for pleasure and improve the public health outcomes associated with problematic drug use. In the throes of a significant heroin drug crisis two decades ago, Portugal decriminalized simple drug possession and replaced its criminal justice approach with evidence-based public health treatment interventions. Twenty years later, Portugal’s drug overdose rate is five times lower than the European Union average and one-fiftieth of that of the United States. Equally impressive is that fact that Portugal’s drug use rate has declined among 15-to-24-year-olds, which is the population most at risk of initiating drug use.

It is important to close by noting the significant risks that Dr. Hart undertook by coming out in Drug Use for Grown-Ups. Individuals who admit to illicit drug use in the United States face a panoply of potential punitive repercussions including arrest and imprisonment, loss of custody of a child, professional licensure discipline, and even research funding exclusion. As a prolific neuropsychopharmacology expert and tenured drug researcher at a prestigious Ivy League university, Dr. Hart may be viewed as imbued with the privilege necessary to withstand the professional and legal blowback he is likely to receive in response to his candor. Because Dr. Hart is a Black man with dreadlocks living in America, it strikes me as more appropriate under the circumstances that we characterize him as a profile in courage rather than one in privilege.

Cite as: Jennifer Oliva, Coming Out of the Drug-Use Closet, JOTWELL (October 12, 2021) (reviewing Carl L. Hart, Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear (2021)), https://health.jotwell.com/coming-out-of-the-drug-use-closet/.

How the Mantra of Informed Consent in the Canadian Assisted Dying Debate Obscures Somatic Oppression

Jonas-Sébastien Beaudry, Somatic Oppression and Relational Autonomy: Revisiting Medical Aid in Dying through a Feminist Lens, 52 U.B.C. L. Rev. 241 (2020), available at SSRN.

In 2015, Canada’s Supreme Court ruled that an absolute prohibition on physician assisted suicide and euthanasia violated the right to life, liberty and security of the person. It did not endorse a full-fledged constitutional right to what has since been termed in Canada ‘medical assistance in dying’ [hereafter MAID], explicitly limiting its ruling to the circumstances of the plaintiff, a person approaching her natural death due to a fatal neurological disease (Amyotrophic lateral sclerosis). It also suspended its declaration of invalidity for one year, inviting Canada’s parliament to develop a ‘stringent regulatory regime’ and made other statements that left room for lawmakers to design specific access criteria. Yet, the constitutional rights basis of its ruling and parameters it set out in its ratio dedicendi fuelled a seemingly irresistable rhetoric around the existence of a broad constitutional right to MAID.

This rhetoric found its culmination in a recent bill, which expanded MAID outside an already flexible end of life context. During parliamentary hearings on the new law, about all major disability rights organizations, and three United Nations Special Rapporteurs, warned that the new law, which creates, exclusively for people with disabilities, access to MAID outside the end-of-life context, was stigmatizing and discriminatory. Some academic commentators expressed dismay about how Canadian feminist scholars jumped on the bandwagon of atomistic autonomy-based rhetoric and failed to account for the complexity of end-of-life decision-making in the context of a seriously constrained health care and social support system. Daryl Pullman, invoking Carol Gilligan, argued for the need to hear from a “different voice of care”. McGill University’s professor Jonas Beaudry recently provided such a different voice in Canadian legal scholarship with a sophisticated analysis of the country’s MAID debate through a relational theory and disability rights focused lens.

In Somatic Oppression and Relational Autonomy, Beaudry puts forward that most Canadian arguments around Medical Assistance in Dying ignore how ableist, ageist and ‘diseasist’ attitudes can lead to an internalized form of oppression that undermines the autonomy of people with disabilities in their decision making with respect to requests for termination of their life. The paper follows an earlier MAID-focused publication in which Beaudry urged the Canadian Supreme Court, which has in recent years increasingly interpreted even socio-economic rights from a more individualistic angle, to embrace a concept of autonomy that takes stock of our embededness in a larger social, cultural and economic context.

With extensive references to relational, feminist, and disability theory, Beaudry puts forward a concept of autonomy that goes beyond the mantra of choice as expressed through “informed consent”; a mantra that dominates Canadian health law and bioethics discourse around MAID and has been strikingly present in Canadian case-law that undergirds the country’s legal expansion of MAID. He particularly builds on Diana Meyers’ procedural concept of autonomy to explore how factors of oppression can compromise the relational competency to construct one’s authentic self, and how that concretely plays out for people with disabilities in the context of MAID. Beaudry adds to Meyers’ key components of autonomy–the ability to self-discover, self-define, and self-direct–the notion that autonomy as relational competency requires a sufficient range of options.

After laying out this theoretical basis, the paper analyzes in detail how societal attitudes towards disability, ageing and struggling with illness concretely interfere with people’s ability to make autonomous decisions, and particularly so in the context of a seriously constrained health care context. Beaudry’s rich tapestry of how somatic oppression interferes with autonomy finds inspiration in disability literature, but he also discusses evidence of MAID practices in other liberal MAID regimes. Having followed closely the media reporting and having participated actively in Canadian parliamentary hearings on MAID legalization, I find his discussion of how internalizations of shame, disgust, and fear of becoming a dependent self and a burden to others, can contribute to somatic oppression and may fuel demand for MAID particularly compelling. During recent parliamentary hearings, for example, one parliamentarian called for a broadening of MAID with vivid descriptions of what she termed the ‘indignity’ of incontinency, loss of self-control and pain. Such declarations happened in sessions where other (disabled) Canadians were testifying about the stigmatizing, ableist nature of references to ‘loss of dignity’ in discourses about what for many is an inevitable component of their daily life. The first official report of Canada’s 5 year of MAID practice, which came out after Beaudry’s article was published, also confirms explicitly that many people who died by MAID in Canada experienced some of the factors he discusses, such as fear of being a burden to others, loneliness, and an inability to participate in meaningful activities, as key components of their ‘unbearable suffering.’ Beaudry’s analysis should inspire others to concretely document how these concerns are already playing out in practice.

Beaudry concludes his analysis with an agenda for further research and policy work, which should focus in his view on promoting ‘social aid in living’ and ‘dignity in life’ for persons with disability. He acknowledges that convincing courts, legislators, and legal scholars to embrace the complexity of how people make health care decisions in the face of oppression, cultural harms, and social inequality, will be an uphill battle. The bright line offered by an atomistic informed consent model, supposedly protected by procedural rituals of health care professionals, offers seemingly easy and pragmatic solutions, which policy makers find uniquely appealing and which dominates our legal discourse. But he puts forward that his approach, which calls for shifting from discourses about safeguards to developing substantive support measures to counter oppression, should be broadly acceptable as it “need not be interpreted as a justification for banning MAiD or directly negating individual preferences in a way that would raise a charge of paternalism.”

With this last point, Beaudry may in my view be looking too much for a reconciliation of a disability and feminist critique of MAID with the dogmatic embracing in Canada of open-ended life-termination by choice. Beaudry’s analysis should, so it seems to me, also inspire a questioning of the expressivist impact of a legislative endorsement of the medical profession’s role in actively ending the lives of people with disabilities who are otherwise not close to death, based on inherently complex concepts of autonomy and suffering. Canadian law now explicitly endorses in legislation the perception (a self-perception but one which clearly—as convincingly argued by Beaudry—is influenced by context and other-perception) that a life with disability is more likely unbearable, lacking in dignity, and without further purpose, than the lives of others.

Beaudry’s argument that ‘informed consent’ procedures and current safeguards in Canadian MAID law do not address the much more fundamental issue of somatic oppression and its impact on autonomy is spot on. But particularly those reading his insightful analysis from outside the Canadian context should ask whether the legalization of the practice of state-supported, medical profession organized ending of life of people with disabilities isn’t in and of itself a form of state-supported oppression which risks fundamentally undermining their autonomy, and above all, constitutes an immediate threat to their lives.

Cite as: Trudo Lemmens, How the Mantra of Informed Consent in the Canadian Assisted Dying Debate Obscures Somatic Oppression, JOTWELL (September 8, 2021) (reviewing Jonas-Sébastien Beaudry, Somatic Oppression and Relational Autonomy: Revisiting Medical Aid in Dying through a Feminist Lens, 52 U.B.C. L. Rev. 241 (2020), available at SSRN), https://health.jotwell.com/how-the-mantra-of-informed-consent-in-the-canadian-assisted-dying-debate-obscures-somatic-oppression/.

How Research Ethics Committees Act as a “Witness” to Research

Rachel Douglas-Jones, Committee as Witness, 39 Cambridge J. of Anth. 55 (2021), available at Berghahn Journals.

In her recently published article in the Cambridge Journal of Anthropology, Dr. Rachel Douglas-Jones, an Associate Professor at the IT University of Copenhagen, investigates how research ethics committees (RECs, or IRBs as they are known in the United States and some other countries) witness research that has yet to occur. For those of us in law, “to witness” holds particular meaning. According the free Legal Dictionary (to take a relatively trite form of research at my desk), a witness is one who, being sworn or affirmed, according to law, deposes as to their knowledge of facts in issue between the parties in a cause. For those who remember their law school lectures in civil and criminal procedure, there are a variety of rules and tests to determine competence to give evidence qua witness, and compellability of witnesses. To witness, and to be a witness, holds particular power in law.

But to witness also holds other forms of meaning, and can be a powerful concept in extra-legal circumstances, too. Douglas-Jones, as an anthropologist, is less interested in the legal meaning of “witness” (though, as an aside, it would make for an interesting area of investigation in legal anthropology). She is instead keen to better understand how RECs, particularly those in the Asia-Pacific region where she spent a number of years conducting research, rely on “visual cultures”–“spatial and temporal forms that underpin [their] capacity to speak”–to render a collective decision on the ethical acceptability of a research project even before the research itself happens. Her article is an excellent one that is deserving of a wide readership.

Applying this to regulatory studies, we would say that RECs provide a kind of “regulatory event license” to researchers. RECs all over the world, like other forms of administrative bodies (particularly those designed to review applications and then grant, or not, or revoke or suspend, licenses–think of “Gambling Control Boards” or “Alcoholic Beverage Control boards”), have taken more or less the same form since their creation in the 1960s and 1970s. Indeed, were we to relabel RECs/IRBs, we might be more inclined to label them Research Control Boards, as this more accurately captures the regulatory design. After all, their approach is similar to other control boards. Specifically, they comprise a body of experts (and sometimes “lay” community members) who receive applications from researchers, who in turn seek to conduct a project that involves human participants in some way. These research applicants ask the committee for an ethical “green light” to begin their project. Phrased another way, researchers apply to a REC and essentially request: “here is the project I propose to do, and all the ethical issues I think are associated with it, and how those issues have been adequately addressed; can you give me a permission to begin it?”

Legal scholars such as Professor Carl Schneider have been highly critical of this approach in the context of research ethics, arguing that the regulatory design of RECs is so fundamentally misconceived that it inevitably does more harm than good. Taking a blue skies approach, we can think of other ways in which research projects might be (better) assessed for ethical acceptability, and to ensure that researchers conduct themselves ethically. We could, for instance, establish a regulatory regime where research is only reviewed after the fact to see if any wrongs were committed (a kind of audit regime), and if so, sanction those researchers for their transgressions. We could rely solely on tort law as a kind of private ordering regime, enabling research participants to sue researchers and institutions for legal wrongs committed (e.g., battery, negligent conduct). Or, as another example, we could design a more trust-based system that instils in researchers values of virtuous conduct, whereby they promise to behave ethically and with integrity (adhering to a kind of honor code that would lead to institutional or professional sanction if breached).

In any event, countries, and institutions within them, around the globe continue to operate the regulatory design enacted more than 50 years ago for research involving human participants. In other words, the regulatory event-license regime continues to operate without having undergone any fundamental reform. Maybe that means the system is working, or maybe it is more a case of inertia and inability to consider alternative, better (read: more effective and more efficient) ways of assessing the ethics of research projects. The system remains: RECs receive documents, and as part of this may invite researchers to present their project at a committee meeting; they read, listen, and deliberate; and they render an opinion in the form of a regulatory event-license (the approval letter). In her article, Douglas-Jones focuses on the power behind this form of witnessing. She does not criticize this regulatory design per se; rather, she encourages us to consider how witnessing is not just a legal concept, but in fact, in this context, an “ethical moment” and a bureaucratic instantiation of ethics.

Through ethnographic examples of her fieldwork of RECs in Asia, Douglas-Jones’s article deftly points to instances in the process of ethics committee work where there is a “translation of ideals of vision into the bureaucracies of ethics committee practice,” such as the witnessing of the scientific validity of the protocols on their table (which is not bearing witness to the making of a fact but to what can be sought as knowledge) and the committee’s approval level as the (final) product of their assessment, and which can be seen as a form of attestation. More specifically, Douglas-Jones elucidates how a visual logic of seeing from “all sides” (the participants’, the researchers’, each REC member’s, the sides from society more generally, etc.) underpins the committee’s imagined vision, and thereby its legitimacy. And the visual is what predominates at the form of witnessing: neither individual REC members, nor the REC as a whole, are generally constituted to leave their conference table and go out into the “field” to actually witness in all senses how research is being performed, and how ethical a given research project is. Instead, they view documents, and as a possible addition, they may ask the applicant to present at the committee meeting and observe their responses to questions as a means of establishing rapport and gauging trustworthiness. The form of witnessing for a REC, then, is a witness to the attendant documents, the visual culture, that comprise committee work generally, and ethics committee work especially. So, to witness in this context is not merely to “see” the proposal and attendant documents; it is to see it in a certain way, and to produce – through the social technology of the committee – a document with a decision. And, as noted above, RECs “witness” research at the ex ante and ab initio stages: they not only “see” the proposal as a kind of (anticipatory) witness to it, but they also witness it in a certain way, and produce a document with a decision – all situated in a space of anticipation – and we might add, in a black boxed space where one cannot easily witness the witnessers in action.

Ultimately, Douglas-Jones invites us in her article to reflect on how REC members across the world participate in a “global regime of knowledge making” (a finding Prof. Laura Stark has also noted in her work on IRBs in the USA) through their ethical consideration of prospective research and approval of project designs, and that this is best understood through the lens of witnessing. The knowledge making “is anticipatory, it depends on ideals of disinterested yet motivated vision, and it has the power to generate a collective voice through which to speak.” It also depends on partial obscurity, of course, where individual REC members’ voices are obscured and reflected in “concealed expertise,” with the REC approval (or rejection) letter reflecting an ostensibly consensus view of the committee. Through their positioning the research lifecycle, that is, at the beginning stage, the REC’s approval letter enables the research project to move forward, onto the next stage – which is the implementation of the project (subject, of course, to any other regulatory approvals that might be needed). The concept of “witnessing”, as Douglas-Jones describes it, adds to our understanding of RECs because it helps us see how they fit within the longer traditions of scientific witnessing. Douglas-Jones urges us to take stock of the importance of this bureaucratic work, and how this work performs a kind of witnessing of what “good” science will be, both scientifically and ethically. As she writes, “research futures – as they pass over the tables of ethics committees – emerge through the ideal that committee work will indeed be witnessing work; that it will be ethical work, for ethical ends.”

For those of us in law, and with an interest in the regulatory design and performance of these committees, the question is: is that “ideal” actually being realized, and is this an appropriate ideal at all? And if not, how might the realization of ethical research be better accomplished? This is an area where anthropologists and lawyers can bring their work together fruitfully to consider how, if at all, the system of research ethics review might be done better.

Cite as: Edward Dove, How Research Ethics Committees Act as a “Witness” to Research, JOTWELL (August 13, 2021) (reviewing Rachel Douglas-Jones, Committee as Witness, 39 Cambridge J. of Anth. 55 (2021), available at Berghahn Journals), https://health.jotwell.com/how-research-ethics-committees-act-as-a-witness-to-research/.