Dr Clare Craig

February 2026

Introduction

The Declaration of Helsinki, first adopted by the World Medical Association  in 1964, has served for sixty years as the foundational document of research ethics. Its central moral commitment—that the rights and interests of the individual research participant must never be subordinated to the goals of science or society—was forged in the shadow of Nuremberg and has anchored every subsequent revision. That commitment is still formally present in the most recent text. But the ethical architecture surrounding it has changed so fundamentally that its practical meaning may no longer be what it was.

The WMA, responsible for the Declaration of Helsinki is a global association of each country’s medical association, representing their doctors and separate from the WHO.

This essay traces a single, consequential shift across three versions of the Declaration: the 1975 Tokyo revision, the 2013 Fortaleza revision, and the 2024 Helsinki revision. The shift is from an ethical framework in which the individual is the absolute moral priority—protected against the claims of science, society, and the state—to one in which the individual’s rights are balanced against an explicitly stated public health mission, embedded within a language of collective responsibility, community engagement, structural equity, and emergency responsiveness.

The argument is textual, not speculative. At each stage, the Declaration’s own words reveal what has changed.

1975: The Individual as Absolute Priority

The 1975 Tokyo revision established the ethical framework that would govern medical research for nearly four decades. Its moral structure is unambiguous: the individual comes first, and no competing interest may override that priority.

The purpose of biomedical research is defined in strictly epistemic and clinical terms: to improve diagnostic, therapeutic, and prophylactic procedures and to understand the aetiology and pathogenesis of disease. There is no mention of public health as a goal of research. There is no population-level mission.

The protective principle is stated with a clarity that admits no qualification:

“Concern for the interests of the subject must always prevail over the interests of science and society.”

— Declaration of Helsinki, 1975, Basic Principles, §5

The same principle is restated in the section governing non-therapeutic research:

“In research on man, the interest of science and society should never take precedence over considerations related to the wellbeing of the subject.”

— Declaration of Helsinki, 1975, Section III, §4

This is a simple moral hierarchy. The individual sits at the top. Science and society are explicitly named as competing interests and explicitly subordinated. There is no trade-off.

The 1975 Declaration is paternalistic in form: it vests authority, and therefore responsibility, in the physician, with the research subject as the object of protection. That paternalism is not autonomy-driven but protection-driven. The physician may decide what is best for the subject, but the subject’s interests are the only interests that ultimately count.

There is no special treatment of emergencies. 

2013: Expanded Protections, Individual Focus Intact

There were several revisions in 1983, 1989, 1996, 2000, 2002, 2004 and 2008 before the 2013 revision which was in place in 2020 and 2021. By the 2013 Fortaleza revision the scope and detail of the Declaration had been dramatically expanded. The 1975 tripartite distinction between therapeutic and non-therapeutic research had been abandoned and dedicated sections on vulnerable groups, research ethics committees, informed consent, placebo use, post-trial provisions, and research registration, and for the first time the institutional and commercial pressures that shape research design were  introduced. It was a far more sophisticated document than its predecessor.

Yet on the central question—the moral primacy of the individual—the 2013 Declaration is unequivocal. However, the point on prioritising the individual over the needs of science and society was gone. The purpose of research is defined in paragraph 6 as understanding disease and improving interventions: an epistemic and clinical framing. The protective clause follows in paragraph 8:

“While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.”

— Declaration of Helsinki, 2013, §8

The competing interest had been redefined—the generation of new knowledge—but it still explicitly subordinated this to individual rights. There is no mention of public health as a purpose of research. Knowledge is the only countervailing good, and knowledge loses.

The 2013 Declaration marks a decisive shift from protection by professional judgment to protection through individual autonomy. It places informed consent at the centre of the ethical framework and specifies in detail what potential subjects must be told, including aims, methods, funding sources, conflicts of interest, anticipated benefits and risks, and post-study provisions. It further states that subjects have the right to refuse participation or to withdraw consent at any time without reprisal. Unlike the 1975 text, which permitted the physician to bypass consent when deemed essential, the 2013 Declaration contains no such paternalistic escape clause. Ethical protection is no longer secured primarily by the physician’s judgment, but by the subject’s informed and continuing choice.

Crucially, the 2013 Declaration contains no special framing for public health emergencies. The same principles apply in all circumstances. There is no language of structural inequity, no requirement for community engagement, and no discussion of environmental sustainability.

The 2013 Declaration marks not a culmination but the beginning of a dilution of the individual-centred tradition. While it preserved the language of individual primacy inherited from 1975, it simultaneously embedded that principle within an expanding architecture of institutional processes and committees. In doing so, it began to displace the clinician’s personal moral responsibility with procedural governance. The physician was no longer the sole ethical agent, and although the individual was still described as the priority, that priority was now mediated, managed, and increasingly contingent rather than absolute.

This narrowing is not merely a change in wording; it is a change in the scope of what the individual is being protected against. In the 1975 Declaration, the individual is explicitly shielded against “science and society”—two vast and politically potent forces, named and subordinated in the text itself. By 2013, that formulation has disappeared. The only competing good now named is “new knowledge,” an epistemic abstraction rather than a social or political power. The individual is no longer explicitly protected against the claims of society, the state, or collective purpose, but only against the internal aims of research itself. The protective horizon has already contracted: from a defence against science and society to a defence against knowledge production alone. This change matters, because it quietly removes from the Declaration’s ethical field the very category of collective purpose as a named source of moral pressure on the individual.

2024: The Collective Turn

The 2024 Helsinki revision, adopted at the 75th WMA General Assembly—returning to Helsinki sixty years after the original Declaration—makes changes that are not merely additive but structural. The moral centre of gravity shifts from the individual to a balance between individual rights and collective goals. This shift is accomplished through four interlocking moves.

The Purpose Clause: Public Health Enters the Core

The most consequential change is to the purpose of research itself. In 2013, paragraph 6 defined the purpose as understanding disease and improving interventions. In 2024, paragraph 7 redefines it:

“The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, development and effects of diseases; improve preventive, diagnostic and therapeutic interventions; and ultimately to advance individual and public health.”

— Declaration of Helsinki, 2024, §7

The individual-priority clause follows immediately within the same paragraph:

“These purposes can never take precedence over the rights and interests of individual research participants.”

— Declaration of Helsinki, 2024, §7

The protective sentence is formally retained. But it is now protecting the individual against a different and more powerful set of competing interests than it was in 2013. In 2013, the competing good was the generation of new knowledge—an epistemic goal with limited political force. In 2024, the competing good now explicitly includes the advancement of public health—a collectivist goal that goes against foundational medical ethics which protect the individual and that carries political authority, institutional weight, and emergency-justifying power. Governments act in the name of public health. Regulatory agencies invoke it. Emergency powers are exercised under its banner. Populations are mobilised for it.

This is not a semantic change. It is a change in the kind of power that now sits on the other side of the scale from individual rights. Knowledge is an aspiration. Public health is a mandate. The moral hierarchy of 1975 and 2013—in which individual rights were protected against the relatively modest claim of scientific advancement—has been replaced by a framework in which individual rights must hold against a far more formidable counterweight: the health of populations, backed by the authority of states.

Emergency Framing: Constitutionalising the Exception

The 2013 Declaration contains no special provision for public health emergencies. This silence was itself a moral position: the same ethical principles apply regardless of circumstances. There is no crisis so urgent that it alters the fundamental obligations of researchers toward individual participants.

The 2024 Declaration breaks this silence:

“While new knowledge and interventions may be urgently needed during public health emergencies, it remains essential to uphold the ethical principles in this Declaration during such emergencies.”

— Declaration of Helsinki, 2024, §8

Read in isolation, this appears to be a reassertion of existing principles. But it is doing something the 2013 text refused to do: it names emergencies as a distinct ethical category within the Declaration itself. The very act of stating that principles must be upheld during emergencies concedes that there are circumstances in which upholding them is difficult, contested, or requires special emphasis. To name the exception, even while denying it, is to constitutionalise it—to give it a formal place within the ethical architecture.

This matters because every major historical erosion of individual protection in medical research has occurred under emergency justification. Wartime, epidemic, national security, public health crisis—these are the conditions under which informed consent has been suspended, experimental interventions deployed without adequate trial data, and vulnerable populations enrolled in research they did not fully understand. The 2013 Declaration’s silence on emergencies offered no guidance for such situations, but it also offered no vocabulary for justifying departure from its principles. The 2024 text fills the gap. In doing so, it introduces into the Declaration’s framework the very concept—crisis as a special moral context—that has historically been the mechanism by which individual protections are overridden.

The moment you constitutionalise “emergency” as a special ethical context within a document of fundamental principles, you have changed the structure of the rule, even if you keep the words. A principle that applies “even during emergencies” is a different kind of principle from one that simply applies. The former acknowledges a class of situations in which its own authority is under pressure. The latter does not.

The Language of Systems, Communities, and Structures

The 2024 Declaration introduces a vocabulary that has no precedent in either the 1975 or 2013 texts:

“Since medical research takes place in the context of various structural inequities, researchers should carefully consider how the benefits, risks, and burdens are distributed.”

— Declaration of Helsinki, 2024, §6

The same paragraph requires:

“Meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following medical research. Researchers should enable potential and enrolled participants and their communities to share their priorities and values; to participate in research design, implementation, and other relevant activities; and to engage in understanding and disseminating results.”

— Declaration of Helsinki, 2024, §6

Paragraph 11 introduces environmental sustainability as an ethical principle. Paragraph 12 adds a prohibition on research misconduct at the organisational level. Taken together, they represent a fundamental reorientation to collectivism. The 1975 and 2013 Declarations conceived of research ethics in terms of the relationship between individual researcher and individual participant. The 2024 Declaration embeds research ethics within a framework of collective responsibility, population-level goals, and institutional responsibility. 

Vulnerability Inverted: From Protection by Exclusion to Inclusion as Justice

The 2013 Declaration treats vulnerability, such as childhood or pregnancy, as a fixed characteristic of certain groups and responds with a protective logic: vulnerable groups should receive specifically considered protection, and research with them is only justified under restrictive conditions (§19–20). The default is exclusion. The burden of justification falls on inclusion.

The 2024 Declaration reverses this presumption:

“When such individuals, groups, and communities have distinctive health needs, their exclusion from medical research can potentially perpetuate or exacerbate their disparities. Therefore, the harms of exclusion must be considered and weighed against the harms of inclusion.”

— Declaration of Helsinki, 2024, §19

This is a profound shift. In the 2013 framework, exposure to research risk was a harm from which vulnerable populations needed protection, and exclusion was the default safeguard. Inclusion of vulnerable groups was justified only under restrictive conditions tied to responsiveness to their needs and likely benefit to the group, with exclusion remaining the default safeguard. In the 2024 framework, by contrast, the moral focus expands from the vulnerable group to the surrounding community and population, and exclusion itself is reframed as a potential harm that must be weighed against inclusion. The moral presumption has flipped: the burden of justification now falls not only on inclusion but equally on exclusion.

The implications are far-reaching. If excluding a vulnerable population from research can constitute a harm, then including them—exposing them to research risk—can be reframed as a matter of justice rather than a compromise of protection. This is a population ethics argument, not an individual-protection argument. It asks not “is this individual adequately protected?” but “is this group fairly represented in the research enterprise?” The unit of ethical analysis has shifted from the person to the population.

The 2024 text also reframes vulnerability itself. Where the 2013 Declaration treated vulnerability as an inherent attribute (“some groups and individuals are particularly vulnerable”), the 2024 text instead speaks of individuals, groups, and communities being “in a situation of more vulnerability” due to factors that “may be fixed or contextual and dynamic.” Vulnerability is thus no longer presented as a property of persons but as a condition produced by social and structural circumstances. Once vulnerability is framed this way, the ethical response naturally shifts away from protecting particular individuals from exposure to risk and toward managing systems, correcting structures, and redistributing participation. In other words, the focus moves from shielding the vulnerable person to intervening in the system that produces vulnerability—a move that privileges policy and population-level solutions over the direct, fiduciary protection of the individual.

Hierarchy and Balance: Two Kinds of Ethical System

The difference between the 1975/2013 framework and the 2024 framework is not a difference of emphasis within the same ethical system. It is a difference between two kinds of ethical system.

A hierarchical system establishes a fixed ranking of values. When values conflict, the ranking determines the outcome in advance of any particular case. The 1975 Declaration is hierarchical: concern for the individual must always prevail over the interests of science and society. The 2013 Declaration preserves this hierarchy within a more elaborate institutional structure. In both texts, you know before any specific dilemma arises whose interests will prevail. That is the point of a hierarchy. It removes the hardest cases from discretionary judgement.

A balancing system establishes multiple values as legitimate and requires that they be weighed against each other in context. The 2024 Declaration is a balancing system. It retains the language of individual primacy but surrounds it with co-equal ethical commitments to public health, community engagement, structural equity, environmental sustainability, and the fair distribution of research burdens and benefits. In any real-world conflict between individual rights and collective goals, the 2024 text provides vocabulary and justification for both sides. The 2013 text provided vocabulary only for the individual.

Balancing systems are inherently less protective of whichever value previously sat at the top of the hierarchy. A bright-line rule—the individual always prevails—is blunt but clear. A balancing test—individual rights must be weighed against public health, equity, community benefit, and emergency necessity—is nuanced but contestable. The question is what is lost when the ethical framework that was designed to protect individuals against collective power becomes a framework for negotiating between them.

What Is Lost

The practical consequences of this shift may be significant. When a government invokes public health to justify expedited research with reduced consent requirements during an emergency, the 2013 Declaration offered a simple answer: the same principles apply, and the individual’s rights can never be overridden. The 2024 Declaration offers a more complex answer: the principles apply, but research serves public health, emergencies are a recognised special context, structural inequities must be considered, communities should be engaged, and excluding vulnerable populations from research may itself cause harm. Each of these qualifications is reasonable in itself. Together, they create a framework in which the bright-line protection of the individual is refracted through multiple lenses of collective interest.

Consider a public health intervention delivered not through individual clinical encounters but through the environment itself—for example, the aerosolised dissemination of a vaccine or the atmospheric release of sulphur dioxide to reduce solar radiation—justified by urgency and population-level benefit. In such a case, individual consent is not merely difficult to obtain; it is structurally bypassed. Such proposals are not merely speculative. Public health organisations already recognise that environmental media and ecosystem conditions are integral to human health—for example, WHO’s One Health framework emphasises that the health of humans, animals, and ecosystems are closely interlinked, and WHO has convened high-level work on air pollution and health, underscoring that environmental factors are a legitimate concern of public health ethics and governance.

Under the ethical logic embodied in the 2013 Declaration, the analysis is straightforward. Medical intervention remains anchored in the moral status of the individual person. Participation must be voluntary, informed, and withdrawable. An intervention that cannot, by its nature, respect these conditions is ethically impermissible, regardless of the scale of the projected public benefit. The absence of consent is not a factor to be balanced; it is a decisive prohibition.

The 2024 Declaration does not authorise such measures. But it does something more subtle and more important: it redefines the ethical framework within which they would be assessed. Research and intervention are now explicitly oriented toward advancing public health; emergencies are named as a special context; and population-level benefit is treated as an ethical good in its own right. In that framework, the ethical question is no longer whether individual consent may be bypassed in principle, but whether the reasons for doing so are sufficiently weighty.

That is the structural change. A system in which the individual holds a veto has been replaced by a system in which the individual holds a weight. What is lost is not the language of rights, but their function as a stopping rule. With this drift, we must ask, what happens in the next edition?

Conclusion

The trajectory from 1975 to 2024 is not simply a story of expanding protections or advancing rights. It is a story of a changing answer to the most fundamental question in research ethics: when the interests of the individual and the interests of the collective conflict, whose interests prevail?

In 1975, the answer was unequivocal: the individual’s interests must always prevail over the interests of science and society. In 2013, the answer was the same, reinforced by a comprehensive institutional apparatus: the individual’s rights could never be overridden by the pursuit of knowledge. In 2024, the answer is formally unchanged but structurally transformed. The individual’s rights still cannot be overridden—but the purposes against which they are balanced now include public health, the competing interests are framed in the language of collective justice and emergency responsiveness, and the ethical universe of the Declaration has expanded from the protection of the individual against science to the balancing of individual rights against a complex web of societal goods.

The Declaration of Helsinki began as a shield for the individual against the claims of science and society. Over sixty years, it has become a framework for negotiating between them. The shield of autonomy remains in place and the individual still holds the veto — but the 2024 revision now identifies two potential adversaries against which that shield must stand firm: public health and health emergencies.