Reflections on a Principal of Research Ethics: Tom Beauchamp, Moral Specification, and Waivers of Informed Consent

Abstract

Tom Beauchamp’s work is deeply woven into the field of bioethics. In this article, we honor Professor Beauchamp’s pioneering contributions to research ethics, focusing on his seminal work articulating the key ethical principles that have become central to our understanding of research ethics scholarship and practice. We then examine how Professor Beauchamp’s analytical framework of shared moral principles for research ethics can inform a contemporary ethics challenge: when can the requirements of informed consent permissibly be relaxed for research studies embedded into clinical care? We use this example both to illustrate how conceptual analysis and moral specification can inform the work of investigators, institutional review boards, and others charged with ensuring the ethical conduct of human subjects research, and to highlight where further conceptual work and practical guidance are needed.

Tom Beauchamp was an exceptionally prolific scholar who made foundational contributions to bioethics. In his role as the Staff Philosopher for the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission), he was primary drafter of the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. With James Childress, he co-authored the classic Principles of Biomedical Ethics, “the first major American bioethics textbook,”(Ravitsky and Fins 2025) which has aptly been described as having “shaped a field of study for decades, and … institutionalize[d] that field around the world.”(Beauchamp and Childress 2019) His other contributions to bioethics include The Human Use of Animals and the influential A History and Theory of Informed Consent (the latter of which he co-authored with his wife, Ruth Faden).

As this abbreviated list of accomplishments makes clear, Professor Beauchamp’s work is deeply woven into the field of bioethics. To expand on the metaphor, in weaving, the warp threads provide the foundation, through which the weft threads are interwoven to create the fabric. As a forerunner in bioethics, Professor Beauchamp’s pioneering work is the warp and those of us who have followed behind have necessarily interwoven our ideas, the weft, with his. In this article, we will pull on one thread of his influential scholarship: that which pertains to research ethics.

We begin by briefly summarizing Professor Beauchamp’s contributions to research ethics, focusing on his seminal work articulating key ethical principles in the Belmont Report and Principles of Biomedical Ethics. We will then examine how the analytical framework of shared moral principles for research ethics – the warp – can inform the practical question of when the requirements of informed consent might permissibly be relaxed for research studies embedded into clinical care – the weft. We use this example of a contemporary ethics challenge both to illustrate how conceptual analysis and moral specification can inform the work of investigators, institutional review boards (IRBs), and others charged with ensuring the ethical conduct of human subjects research, as well as to highlight where further such conceptual work is needed.

Background on the Belmont Report & Its Legacy

The National Commission was created by the 1974 National Research Act. Signed into law in the twilight of the Nixon Administration, the National Research Act had three main components: “(1) directing preparation of guidance documents on broad research ethics principles and various controversial issues by multidisciplinary experts appointed to a new federal commission, (2) adopting a model of institutional review boards, and (3) establishing federal research regulations applicable to researchers receiving federal funding” (Rothstein and Wolf 2024).

The National Research Act instructed that the Commission be composed of eleven members “distinguished in the fields of medicine, law, ethics, theology, the biological, physical, behavioral and social studies, philosophy, humanities, health administration, government, and public affairs” (National Research Act). The Commission was supported in this work by several staff members, including Professor Beauchamp, who joined the staff in late 1975. Initially hired to write a paper on justice, he was subsequently tasked with drafting the document that became the Belmont Report. When he received this assignment, Professor Beauchamp “thought it was because I was the new kid-on-the-block on the staff. And I was getting the dregs of the assignment. Because it was what nobody else wanted to do” (Beauchamp 2004). In September 1978, the National Commission published three reports. While Professor Beauchamp initially envisioned the Belmont Report as “background” for the Commission’s work (Beauchamp 2004), it is now regarded as its defining accomplishment.

The Belmont Report is divided into three sections. The first section distinguishes the boundaries between research and practice, defining “research” as “an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby develop or contribute to generalizable knowledge,” and “practice” as “interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success” (The Commission 1978). In later writings, Professor Beauchamp argued that this bifurcation of research and practice might need to be reconceived in order to best protect the interests of patients and subjects—particularly for activities such as quality improvement research and comparative effectiveness research, in which research activities are deliberately intertwined with the delivery of ongoing clinical care (Beauchamp 2011; Kass et al. 2013).

The report’s second section describes three basic ethical principles or “general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions.” These are: respect for persons, beneficence, and justice. Finally, the third section discusses the application of those principles. According to the Belmont Report, the intent of enumerating these principles was to “assist scientists, subjects, reviewers, and interested citizens to understand the ethical issues inherent in research involving human subjects,” and thereby to “provide an analytical framework that will guide the resolution of ethical problems arising from research with human subjects” (The Commission 1978).

Each of the three principles makes moral demands of researchers within a specific domain of research (Beauchamp 2020). Respect for persons -- assuming those persons are capable of self-determination -- requires protecting autonomy and personal dignity through voluntary, informed consent. Beneficence requires ensuring that research “be justified on the basis of a favorable risk/benefit assessment.” Meanwhile, justice requires “that there be fair procedures and outcomes in the selection of research subjects” at both the individual level and for classes of persons, as well as fair distribution of the benefits of research. By applying each principle to a zone of moral concern, the Belmont Report not only articulated abstract principles, but also, in Professor Beauchamp’s own words, “moved towards an applied, professional morality of research ethics” (Beauchamp 2010; 9).

Notably, the principles found in the Belmont Report differ somewhat from those Beauchamp and Childress proposed in their book, Principles of Biomedical Ethics (Beauchamp and Childress 1979). Specifically, Principles replaces “respect for persons” with “respect for autonomy”, and it bifurcates concern for well-being into two principles, “beneficence” and “non-maleficence.” This may reflect Professor Beauchamp’s feeling that “the first principle [in the Belmont Report]—the principle of respect for persons—was a kind of mishmash of considerations of beneficence and non-maleficence rolled into respect for persons …” (Beauchamp 2004). In an oral history, Professor Beauchamp described proposing to the National Commission’s members that the principles be restructured, but this proposal was ultimately rejected.

In 1978, it was “unimaginable” to Professor Beauchamp that the Belmont Report would be as widely read and referenced as it is today (Beauchamp 2004). Today, however, it would be difficult to overstate its influence. The principles and their corresponding practical applications became the “backbone of federal law” governing human subjects research in the United States, (Beauchamp 2010; 29) laying the conceptual foundation for the Federal Policy for the Protection of Human Subjects (Common Rule). Further, they have influenced decades of research ethics scholarship (Friesen et al. 2017).

This influence notwithstanding, the Belmont Report has not been immune to criticism. Thoughtful analyses have questioned the Report’s continued applicability to the contemporary landscape (Friesen et al. 2017; Miller and Kimmelman 2020). A point of substantial critique is the Report’s distinction between research and practice and the implications of this distinction for ethical oversight of research embedded into care. Below, we examine one particular implication – namely, informed consent requirements -- and how Beauchamp’s methodological approach might inform corresponding ethical and regulatory decision-making.

The “Work” of Moving from Theory to Practice

The articulation of basic principles provided within the Belmont Report fulfilled the National Commission’s stated goal of providing a framework for analyzing and resolving ethical problems (The Commission 1978). Yet an “analytic framework” is a far cry from a “plug and play” tool. While research ethics is often referred to as “applied ethics,” applying principles to a practical problem will not necessarily yield a clear resolution (Beauchamp 2010; 47). As Professor Beauchamp himself noted, the members and staff of the National Commission were “keenly aware” that the Belmont Report’s framework was “too indeterminant by itself to decide practice or policy to resolve moral conflicts” (Beauchamp 2010; 23). Thus, the “work” of research ethics is in “molding the general principles…so that they become sufficiently concrete…to give them increased action-guiding capacity” (Beauchamp 2010; 23).

One approach to this “work” is that of specification. Beauchamp described specification as the “progressive and substantive delineation of principles and rules that gives them a more specific and practical content. Because principles are at a lofty level of abstraction, little practical content can be drawn directly from them. More precision through specification is therefore essential for regulative and decision-making contexts” (Beauchamp 2010; 157).

Importantly for our purposes, Professor Beauchamp observed that this process of specification -- of molding, refining, and further developing principles to “make them more precise for purposes of policy” – is one that must be continuously undertaken as “new or unanticipated circumstances arise” (Beauchamp 2010; 158). Here, we will focus on a central challenge for contemporary research ethics, namely, the deliberate intertwining of research and clinical care – as occurs in pragmatic clinical trials, quality improvement research, and comparative effectiveness research – and the resulting question of when waivers of consent are ethically permissible. (While the regulatory criteria for granting both alterations and waivers of consent are identical, waivers and alterations are morally distinct (Kim and Miller 2016). For clarity, we will focus our analysis on the issue of waivers.)

Informed Consent – When Can Requirements Permissibly Be Relaxed?

The first section of the Belmont Report characterizes research and care as distinct activities. This bifurcated approach was informed by concern that ambiguity in what constituted “research” might create a loophole that would enable physician-investigators to bypass IRB review by presenting their activities as “therapy” rather than research (Beauchamp & Saghai 2012). The proposed solution was a “segregation model” in which research and practice were characterized as “conceptually exclusive, nonoverlapping sets of activities,” (Beauchamp & Saghai 2012) each conducted by specialized individuals, and governed by distinct systems of ethical oversight.

This approach appears to have been largely effective at protecting research participants. However, over the past two decades, scholars (including Professor Beauchamp) and practitioners have noted that this segregation model has had the practical effect of significantly reducing the social value of clinical research. This model has contributed to paradigm in which research studies, and their use of strict exclusion criteria, separate data systems, and highly controlled research settings, fail to generate evidence that is applicable for “real world” clinical practice (Kass et al. 2013; Califf and Sugarman 2015). To address this concern, more research is being embedded into clinical care. Examples include comparative effectiveness research studies that examine the benefits and harms of available (not new) interventions, and pragmatic clinical trials, which are “designed for the primary purpose of informing decision-makers regarding the comparative balance of benefits, burdens and risks of a biomedical or behavioral intervention” (Califf and Sugarman 2015). The rise in embedded research has fueled debate regarding the permissibility of forgoing study-specific informed consent for research activities that are embedded into ongoing clinical care.

Reflecting on these challenges in 2011, Professor Beauchamp observed:

Clinical research today is often closely in contact with clinical medicine. In this environment, the research-practice distinction, and our understanding of clinical ethics and research ethics, may need increased flexibility and modification…we may already be behind in our thinking about how to make the needed adjustments to best protect the interests of patients and subjects (Beauchamp 2011).

He argued that ethical and regulatory structures governing informed consent processes were among the areas meriting increased flexibility. Thus, while Professor Beauchamp is widely known for emphasizing the normative importance of respect for autonomy and consent, he recognized that these must be balanced against other interests:

…several circumstances are encountered in contemporary medicine and research that suggest a need to relax requirements of informed consent…In some cases of low-risk research, subjects of research need not be contacted at all, and occasionally disclosures and warnings may be substituted for obtaining explicit informed consents… it does not follow from the great social importance of the rules and practices of informed consent that institutional policies of informed consent must rank the protection of decision making above all other values. The preservation of autonomous choice is the first, but not the only, institutional commitment (Beauchamp 2010; 75).

Yet, how do we weigh institutional commitments to know what we must do in practice? With this challenge in mind, we turn now to evaluating how conceptual and moral analysis of the basic ethical principles can inform applications of the regulatory criteria for waivers of informed consent in the context of research studies that are deliberately embedded in clinical care. In doing so, we seek to show how the warp and the weft are interwoven, resulting in the fabric of research ethics.

As our focus is on research activities for which participants are exposed to a research intervention, such as in comparative effectiveness research, we will focus our analysis on the original four regulatory criteria for waivers or alterations of consent in the US federal regulations (Table 1) and will not consider the more recent criterion which applies to research with existing identifiable biospecimens or private health information.

Table 1.

Common Rule (45 CFR §46.116(f)(3)) Requirements for Waivers and Alterations (Pre-2018 Revisions)

In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:   (i) The research involves no more than minimal risk to the subjects;   (ii) The research could not practicably be carried out without the requested waiver or alteration;   (iii) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and   (iv) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

Before we analyze these criteria in detail, we note that the waiver criteria themselves illustrate how specification of higher-level principles, in Beauchamp’s sense, tends to proceed. On Beauchamp’s approach to ethical method, we start with more abstract or general principles—here, respect for persons—which Beauchamp describes as “the moral convictions that inspire the highest confidence ” (Beauchamp 2003). A principle like respect for persons must be given action-guiding content to inform its application to specific cases. For example, obtaining informed consent is typically how respect for persons is shown in research contexts. The resulting requirement for informed consent is thus a more concrete specification of respect for persons.

However, as we apply the requirement for informed consent itself to specific cases, we find projects for which it seems that obtaining consent may not always be required to show adequate respect. This in turn prompts us to spell out more concretely the situations and conditions under which informed consent may not be needed. The criteria for waiver found in the US regulations can be seen as an attempt at stating such conditions. As such, they are, ultimately, part of the specification of respect for persons. The waiver criteria themselves require interpretation and conceptual analysis, as emerges below. Further, and crucially, those criteria themselves must be applied to specific cases, opening the possibility for further refinement. This dance between principles and their application to particular cases is often described (following John Rawls) as a process of “reflective equilibrium” (Beauchamp 2003).

When is research “no more than minimal risk”?

The first criterion for a waiver or alteration of consent is that the research involve “no more than minimal risk.” The general moral relevance of assessing the risks of research and the appropriateness of its risk/benefit ratio derive primarily from the principle of beneficence. As described in Belmont, “beneficence…requires that we protect against risk of harm to subjects and also that we be concerned about the loss of the substantial benefits [to society] that might be gained from research” (The Commission 1978). In the context of consent waiver criteria (seen as a specification of informed consent and respect for persons), the requirement that research be no more than minimal risk to warrant a waiver reflects the idea that one main purpose of informed consent is to empower individuals to protect their own interests or well-being—which suggests that consent is less important and may even be unnecessary for some activities that pose little to no risk of harm. Writing with colleagues decades later, Professor Beauchamp recognized that some comparative effectiveness studies offer a way to collect socially valuable data without violating the principles of beneficence and non-maleficence, characterizing these trials as presenting “only minimal risks” for individual patient-subjects, yet offering “immense” potential benefits for future patient welfare (Faden, Beauchamp, and Kass 2014).

Federal regulations define research risks as ‘minimal’ when they do not exceed the risk of harm or discomfort “ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (US Department of Health and Human Services 2018). This standard is one of the primary means by which U.S. regulations protect participants, without blocking appropriate and valuable research. Yet, studies have found significant variation in IRB determinations of minimal risk in other contexts, including for pediatric research (Shah 2004) and research with pregnant women (White et al. 2021). While we are unaware of research formally assessing the application of the minimal risk standard to research evaluating commonly used existing therapies, anecdotal reports suggest considerable variation in this context as well.

When assessing the risks of trials comparing existing therapies, including whether or not those risks are “minimal,” several issues have proven controversial. We focus here on one such issue, namely, which risks should be considered as research risks?

Some have argued that IRBs should apply an “incremental” risk perspective (Gelinas, Wertheimer, and Miller 2016; Kass et al. 2024). From this perspective, “what matters is the risks and effects of the research, over and above whatever risks the patient incurs from the clinical care she receives” (Gelinas, Wertheimer, and Miller 2016). Thus, oversight bodies should base risk-level determinations on the “marginal or additional burdens of research participation, relative to those of ordinary clinical care” (Kass et al. 2024). Notably, these arguments propose that the incremental risk perspective should apply even in situations where individuals are randomized between different accepted therapies, and therefore at least some will receive a therapy different from that they would have received outside the research context. As long as the options being compared are not known to be prospectively worse (from each other and any other clinically available options), being randomized to a treatment that differs from what a participant would have received in clinical care does not pose added research risks.

These proposals notably diverge from draft guidance from the Office of Human Research Protections (OHRP). According to OHRP:

In standard of care studies, OHRP generally considers the risks of a specific standard of care being evaluated to be risks of research if (1) a standard of care that at least some of the individual subjects will be assigned to receive will be different from the standard of care that they would have received if they were not participating in the study, and (2) there might be different risks associated with those standards of care. Therefore, in such studies, the possible differences in risk being evaluated are considered risks of the research (“Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care” 2014).

In subsequent commentary, OHRP described their position as follows: “If the research changes the treatment that a person would have received if they were not in the research, then the treatment is a research intervention, and its risks need to be considered. This is the case even if the study involves assigning people to one or more versions of ‘usual’ or ‘standard care.’” (OHRP 2024). According to OHRP, in a study comparing two routinely used treatments for which it is not known whether one is better than the other, if some participants are given a treatment different from what they would have received outside the research study, then the risks of the given treatment become research risks. OHRP’s view has been criticized for preventing valuable research from taking place, as it would require many studies to be viewed as presenting more than minimal risk, thereby foreclosing the opportunity to meet the criteria for a consent waiver in contexts where full research consent would disrupt the goal of embedding research seamlessly into clinical care.

OHRP’s draft guidance shares features with an approach proposed by Scott Kim and Jonathan Kimmelman, which holds that randomization itself, to the extent it results in some participants receiving a different treatment than they would have received in clinical care, is a source of research risk because it results in participants “facing the potential risk of faring worse in the trial” than they would have had they not entered the trial (Kim and Kimmelman 2022).

This points to a critical debate in research ethics: does research raise concerns whenever individuals are treated differently than they would be treated outside of research? Or only when they are treated in ways prospectively known to be worse? (Remember that if the different treatment was known to be worse in advance of the study, the research would not be done.)

Debate over this question seems to reflect, at least in part, views about the moral relevance of personalized care. One argument for why research raises concerns whenever individuals are treated differently than they would be outside of research might be that patients have the right to a certain type of relationship with their physician, one in which the interests of patients, rather than those of science, drive decision-making. Yet arguments based in the moral relevance of personalized care often seem to reflect an assumption—sometimes implicit—that there is something about personalized care or physician judgment that is, if not a guarantee of a superior clinical outcome, at least protective of an inferior one.

Take, for example, Cory Goldstein and Charles Weijer, who argue that patients in trials comparing the effectiveness of usual care interventions are “deprived of the protection and the benefit of the individualized judgment of their physicians” (Goldstein and Weijer 2020). However, whether (and if so, when, where, and how much) individualized physician judgment is protective in the absence of data on the comparative safety and efficacy of two or more usual care interventions remains contested. How, for example, should we weigh one physician’s preference for intervention A over intervention B, if another, equally experienced clinician might have chosen intervention B for the same patient? Writing with colleagues, Jonathan Casey describes such cases as reflecting “arbitrary variation”—variability that reflects factors unrelated to patient characteristics, such as physician specialty, hospital formulary, geography, or industry marketing (Casey, Rice, and Semler 2023). A more ethical system of research and clinical care, he argues, is one that structures this variation through comparative clinical trials in order to “generate knowledge, reduce variation, and improve outcomes over time” (Casey, Rice, and Semler 2023). Under this view, excessive deference to individualized physician judgments represents a failure to, borrowing from the phrasing in Belmont, appropriately appreciate the “loss of the substantial benefits [to society] that might be gained from research” (The Commission 1978).

When can the research not “practicably” be carried out without the waiver?

By comparison to “minimal risk,” there has been far less inquiry into when research would be “impracticable” without an alteration or waiver of consent (Laurijssen et al. 2022). According to guidance from the U.S. Food and Drug Administration (FDA), “practicable” means:

1. That recruitment of consenting subjects does not bias the science and the science is no less rigorous as a result of restricting it to consenting subjects, or

2. That the research is not unduly delayed by restricting it to consenting subjects.

Further, the guidance notes, “the emphasis is on situations where it is impracticable to carry out the clinical investigation, as designed, without the waiver or alteration, rather than on situations where it is not feasible to obtain informed consent from subjects” (Food and Drug Administration 2023).

This guidance shares notable parallels with the analysis of practicability within the scholarly literature. A narrative review identified “practicability” as having been used to describe four different conditions: obtaining informed consent is overly demanding of researchers (in terms of time and resources), obtaining informed consent leads to invalid study outcomes, obtaining informed consent harms the participant (such as by delaying delivery of medical care for an emergent condition to obtain research consent), or obtaining informed consent is meaningless for the participant (such as might occur in cluster randomized trials for which individuals would not be able to opt out of the intervention) (Laurijssen et al. 2022).

Admittedly, what constitutes “undue delay” or “prohibitively” high time or resource costs are difficult issues requiring investigator and IRB judgment, as well as consideration of scientific validity, social value, and resource scarcity (Gelinas, Wertheimer, and Miller 2016). Nevertheless, looking across these definitions suggests some limits or guardrails on when the impracticability criterion might be met. First, the mere fact that the researcher is inconvenienced is not sufficient justification. Second, designs that might detract from practicability, such as the use of cluster randomization, must be justified independently; trial design should drive the request for waiver rather than a desire to waive consent driving trial design.

When does a waiver adversely affect rights and welfare?

Requirements of informed consent for research are justified by the principle of respect for autonomy. As Professor Beauchamp explained:

In moral philosophy, personal autonomy has come to refer to personal self-governance…To respect an autonomous agent is to recognize with due appreciation the person’s capacities and perspectives, including his or her right to hold certain views and to take certain actions based on personal valued and beliefs…[including] to authorize or refuse authorization of a medical or research intervention (Tom L. Beauchamp 2010; 65).

Yet respecting autonomy does not require ensuring individuals have “unfettered choice” in every aspect of their lives, nor does it require viewing all choices as equally worthy of respect (Kass et al. 2024). Under this view, the moral relevance of consent for research depends on the nature of the research in question. Moreover, there is no general right not to be included in research without consent.

This reasoning parallels that of an argument by one of us who, writing with colleagues, has argued that “the purpose of consent is to let a person waive her rights of control over some aspects of her life…[but] becoming part of a research study does not always seriously undermine one’s control” (Gelinas, Wertheimer, and Miller 2016). The primary function of informed consent in research for adults with capacity is to protect autonomy, including respecting the right of personal control over one’s own life and decisions, and “not interfering with decisions in an individual’s sphere of sovereignty” (Gelinas, Wertheimer, and Miller 2016). While some medical decisions are certainly properly understood as within that zone of sovereignty, others are more appropriately viewed as within the institutional sphere of practice and policy. Decisions about which soap clinicians use to disinfectant their hands, for example, are not decisions appropriately viewed as requiring patient consultation or consent. Hand soap might seem like a trivial example. To go further, patients are generally not consulted about which kind of standard laryngoscope their doctor will use to intubate their trachea. Consequently, assuming that there is no general right against being included in research, institutions should have the right to conduct research comparing different types of soap or different kinds of laryngoscopes—and to do so without patient consent.

Professor Faden, writing with colleagues, has similarly argued for distinguishing between decisions that are viewed as within the sphere of institutions versus those invoking “meaningful patient decisions” when assessing the permissibility of waivers or alterations of consent. (Kass et al. 2024). Assessing what constitutes a meaningful patient decision involves answering two questions. First, is patient input ordinarily sought for the intervention being studied? System-level interventions, such as nurse staffing ratios or the choice of antiseptic solutions in surgical units are not decisions about which patient input is normally solicited (even though they may have considerable implications for patient welfare). Second, does the research remove from patients the ability to make a decision that is relevant to their values, priorities, or other patient-specific logistical or practical considerations? (Kass et al. 2024) (Note that the standard here is not whether there is any chance that some patients might have relevant values or preferences. Instead, it is whether there is reasonable likelihood of this being the case.)

Of particular relevance to the latter question, community consultation may provide value when researchers anticipate seeking a waiver of informed consent (Largent et al. 2025). When consent is waived, consultation can serve some of the functions of informed consent and provides a tangible step to show respect for persons – thus fulfilling the obligations set forth in the principles. Consultation is not, of course, cost-free and there are open questions about how best to accomplish it; nevertheless, there is reason for researchers to consider whether community input would be valuable for their trial.

When is it appropriate to provide additional pertinent information about research participation?

The final criterion for waivers we’ll consider here is arguably the one that has received the least scholarly attention: when should individuals be provided additional information about research participation? This criterion has often been interpreted as being limited to debriefing participants following studies involving deception (O’Rourke et al. 2025). However, communicating information to participants about research into which they are being, or were, enrolled in without consent finds support from a range of ethical justifications. Communicating information to participants can promote one or more of six goals: demonstrating respect for persons; promoting participant understanding of the research; enabling participant understanding of their contributions; allowing participants to voice any concerns; promoting participant engagement; and building trust and trustworthiness (O’Rourke et al. 2025). Given the ethical importance of these goals, proactively notifying participants about research should be the default, and those who seek not to communicate any information about research should be required to justify not doing so (O’Rourke et al. 2025).

The argument that notification should be the default notably diverges from current practice, in which investigators often assume that, if they have met the regulatory criteria for a full waiver of consent and therefore need not obtain participants’ informed agreement to participate, then there is no reason to provide them any information about the research. Yet this view ignores the fact that providing information about research to individuals may be valuable for reasons beyond respecting their decisions regarding research participation (O’Rourke et al. 2025).

As previously noted, the Belmont Report’s formulation can be read as essentially equating respect for (autonomous) persons with respect for autonomy. On this view, respect for persons “capable of deliberation about personal goals and of acting under the direction of such deliberation” (The Commission) is limited to permitting them to direct the course of their own lives – an opportunity that is provided, according to Belmont, “when adequate standards for informed consent are satisfied” (The Commission 1978). If that is correct, there is no obvious reason, at least as far as respect for persons is concerned, to notify individuals about research when they are not being asked for consent. A broader understanding of respect for persons, however, reveals that there can be reasons to notify individuals about their research participation even when they are not being asked to consent to it. For example, it can be valuable to disclose that individuals are being enrolled in a study, thereby alerting them to research generally, and to the goals of the study specifically (O’Rourke et al. 2025).

While disclosing information about research to participants can have value, it also comes with costs and burdens. Furthermore, the relative value of disclosure may vary by study; for instance, it may be less important to know your anonymized medical records were used in a study of re-hospitalization than if your care was directly affected by an intervention. Investigators and IRBs should therefore consider on a case-by-case basis whether, how much, and how to disclose for any given study (O’Rourke et al. 2025).

Conclusion

The Belmont Report is one of Professor Beauchamp’s key contributions to research ethics. The Report strongly influenced the Common Rule, which allows for waivers of informed consent if certain conditions are met. Yet, as research is increasingly embedded into care, there are numerous unresolved ethical questions about when those conditions are, in fact, met – or even, more fundamentally, whether the conditions themselves are those best suited to calibrate the appropriate level of ethical oversight of and required protections within specific research activities.

These debates notwithstanding, this article’s exploration of waivers of consent showcases the extent to which the principles articulated by Professor Beauchamp remain relevant today. It also highlights something Professor Beauchamp himself fully recognized: that the process of specification is needed if the principles are to offer specific and practical answers to open ethical questions. Further, the process alone cannot resolve all practical problems and moral disagreements. There is still room for reasonable people to disagree, even when they do the “work” of specification. The appropriateness of waiving informed consent for embedded research is one area where such disagreement persists. To ensure consistency in practice and clarity in the application of federal research regulations, guidance (especially federal) is needed. This guidance should both be informed by deliberation among research ethics scholars, IRB representatives, investigators, and patients, and reflect the competing moral values and relevant trade-offs.

In developing such guidance, we’d do well to emulate Professor Beauchamp’s approach, described by his son Zach Beauchamp as “respect for custom coupled with a healthy dose of intellectual skepticism.” Among his students and colleagues, such skepticism was often reflected through his prolific use of the proverbial ‘red pen.’ A former student offered a compelling example: the student once received over 6,000 words of commentary from Professor Beauchamp on a 7,000 word paper. It is fitting then, that Professor Beauchamp’s body of work –and the ongoing process of specification – will inspire many people to put pen to paper well into the future. As this dialectic unspools, Professor Beauchamp’s legacy will continue to be woven into the fabric of bioethics.