The Declaration of Helsinki

Abstract

Mosaic tablet, dynamic document, or dinosaur?

The Declaration of Helsinki is a respected institution and one of the most influential documents in research ethics,^1w1-w7 having withstood five revisions and two clarifications since its conception in 1964. Its guardian, the World Medical Association, recently invited submissions for further revision.²

The history of the declaration has been well documented.^{3 4 5} The Nuremberg Code (1947) was one of the first statements of the ethical principles involved in human experimentation.^w8 However, because of its association with Nazi war crimes it had relatively little effect on practice.^w9 The Declaration of Helsinki dealt with clinical research more directly, but was portrayed as a weakening of the stringent protections of Nuremberg. Nevertheless, for a quarter of a century only minor changes were made and it became engrained in the international culture of research ethics.

In 1996, the declaration added a reference to placebos in response to concerns about trials in perinatal HIV transmission in developing countries. Critics pointed out that continuing to use placebos when efficacy had been demonstrated implied a different ethical standard for developing countries than for developed ones. Having entered into the specifics of trial design the declaration was drawn into a debate on whether ethical principles are universal or are relative to the context in which they are applied⁶ and also into related principles of research in developing countries.

The World Medical Association was then pressured to make more radical reforms. An American proposal, seen by some as a further attempt to weaken the declaration, resulted in a vigorous debate, but despite lack of consensus and strong feelings by some that it should not be changed,⁷ a major revision was approved in 2000. This did little to improve acceptance.

Concerns were also expressed that the cumulative changes represented a shift towards protecting the efficiency of research at the expense of the protection of human subjects. A division between developed and developing countries also emerged with claims of American ethical imperialism,^{6 8w10} although new emphasis on social justice and a duty to benefit communities as well as individuals received praise. Complaints about clarity resulted in the addition of footnotes in 2002 and 2004, but this also failed to achieve global endorsement. The situation was further complicated by the appearance of other guidelines, including those from the Council for International Organizations of Medical Sciences,^w11 the Nuffield Council,^w12 and Unesco (United Nations Educational, Scientific, and Cultural Organisation),^w13 which were seen to be potentially conflicting. It was even suggested that the declaration was out of touch and irrelevant.⁹

The debate on the future of the declaration raises several fundamental questions about the essential purpose of the declaration, its structure (basic principles or procedural rules), its status (static or dynamic), the extent to which it can influence understanding and practice, and the nature and limits of universality in ethics.

The nature of the declaration has progressively changed from simply restating Nuremberg as an ethical code to being increasingly prescriptive.¹⁰ The more procedurally based it has become the more divergent opinion has become, with calls for reversion to the simplicity and conciseness of a Nuremberg-like document. Other guidelines by contrast provide detailed commentaries, and the declaration may fail by being neither code nor commentary. The arguments surrounding the declaration point to a failure to clearly separate related but distinct concepts—standard of care, ethical standards, ethical principles, and the operationalisation of principles.

Whether “ethical standards” are considered universal will depend on what exactly is meant by this term. They have been criticised as representing the North American context in which they were formulated.¹¹ The more that basic principles are elaborated, the more room there is for interpretation and dissent.

Among core ethical principles, respect for the individual's autonomy and their community have traditionally been considered the most important. The principle of autonomy has recently undergone much rethinking. Autonomy should not be thought of as always completely free of external influence, but to be relational, constrained by factors such as health, social relationships, sex, and power inequality.^w14 The debate has occurred within too narrow a formal framework, without sufficient attention to the inherent inequalities and vulnerability that characterise the relationship between subjects and researchers. It requires reframing by stating that respect for the individual needs to encompass both their individuality and the cultural and relationship factors that shape their decision making.

The World Medical Association needs to respond to criticisms that a lack of transparency in its revision process does not reflect the spirit of openness and disclosure in articles 11, 16, and 27 of the declaration. Similar considerations of transparency should apply to all aspects of the conduct and results of research itself, as described in the Ottawa Statement (ottawagroup.ohri.ca/index.html).

The declaration has only limited direct legal authority¹ but has gained considerable moral authority. As such it is more symbolic than instrumental. Symbolic function is evident by people's attitude towards it, and the frequency with which they use it to justify their opinions. Its instrumental role derives from direct reference in legal statutes, and indirectly through influence on legislators and courts.¹

It is difficult to estimate how effective the declaration is. Claims that it is violated daily raise questions as to how effective it can be in the absence of monitoring or enforcement. However, a complete understanding of the role of the declaration requires us to recognise that it represents an external imposed morality, not the researcher's own internal morality,^w15 which limits its ability to influence practice. Ethical research is a collective responsibility. Unless researchers incorporate the ethical principles outlined by codes such as Helsinki into their own and the collective morality¹² they will remain simply words. The Declaration of Helsinki is a brave venture and “the property of all humanity,”⁴ which has the potential to continue to promote high ethical standards and protect the vulnerable, but only if we embrace it. The declaration's strength lies in its core principles, which are a moral compass transcending procedural rules and revisions.