Published 17 October 2008, doi:10.1136/bmj.a2128
Cite this as: BMJ 2008;337:a2128

Editorials

Fresh thinking about the Declaration of Helsinki

A comprehensive approach to ethical research

The Declaration of Helsinki is the cornerstone of research ethics.¹ Its periodic revision provides an opportunity for debate about its purpose and effectiveness.² The sixth revision, being considered by the World Medical Association (WMA; www.wma.net/e/ethicsunit/helsinki.htm) this October, follows extensive consultation.^{1 2} However, debate about the operational details often loses sight of the objectives and principles.² Much has changed in the nature of research and bioethical thinking since the declaration was conceived.^{1 2 3} Public confidence in research is at an all time low, and the current model and traditional ethical tools seem to be failing to meet their objectives. It is time for fresh thinking.

The declaration’s objectives were framed, in response to past abuses, to protect human subjects in research.² However, the framework put in place to protect subjects has been criticised as paternalistic and for failing to address the full scope of ethically responsible research.¹

We propose an alternative comprehensive framework in which basic ethical principles collectively inform, support, and direct all aspects of research—from the design of the research agenda and research questions, through the process of evaluation and execution, to the dissemination of results and distribution of benefits. This would broaden the scope of ethical research beyond that of the behaviour of the individual investigator to include the full range of stakeholders.

A robust approach to ethical research requires a rethinking of the concepts of autonomy, justice, vulnerability, and benefit. The conflicting values and duties inherent in research—for example, the duties to the individual versus society in the distribution of potential risks and benefits—also need to be dealt with.⁴

Historically, ethics dealt with how we treat other individuals and prioritised respect for autonomy (people’s right to make their own decisions about their lives)⁵ in a way that has not served us well.³ Autonomy is intimately linked to health outcomes and is best understood in relation to factors in society that shape identity and moral agency (the capacity to make choices).^{3 4}

Injustice derives from inequalities in power structures, resources, and knowledge, which are particularly acute in resource poor countries. Moving to a model in which the subjects of research are seen as partners would reduce these inequalities. Such a model would do more to increase autonomy^{1 3 6 7} and justice than an approach based merely on protection. Similar considerations apply to population groups, where inequalities can be reduced by engaging and empowering their members^{1 6 7} in participatory research, as shown in social science and community health research.⁴

Vulnerability should be considered as a state—resulting from these inequalities—and should not simply be identified with special groups such as prisoners, pregnant women, or children.^{8 9} The overprotection and subsequent exclusion of such groups offend justice, limit generalisability, and perpetuate inequality.¹

Although research is primarily directed towards individuals it has much wider implications for society. A system based solely on preventing harm ("negative" ethical obligations)²—in the context of exploiters and victims, and researchers versus ethics committees—is ill equipped to deal with the broader ("positive") obligation to benefit society.^{3 6}

The declaration must be reinterpreted in the social, cultural, political, and economic contexts in which research occurs.^{1 2} Considered "dead,"^{10 11} the declaration’s life was further threatened when the United States Food and Drug Administration removed the requirement for trials conducted outside of the USA to comply with it. Because the declaration sets international standards for research ethics it must reflect differences in local capacity for ethical oversight,¹ and cultural values attached to the meaning of research, uncertainty, and the individual.

With this background, can we expect dramatic advances in the objectives and philosophical considerations of the declaration after the consultation? The WMA has started to tackle several of these themes. Justice is addressed by strengthening the definition of vulnerability,⁹ by emphasising equity in access based on inclusion rather than exclusion, and by tackling barriers to access.

Transparency is addressed by requiring clinical trials to be registered and stipulating that people have the right to information about the research they are involved in.² The vision and scope of the declaration has expanded to include methodologies such as observational studies; however, the underlying principles should cover the whole reach of research on humans. To do less violates justice. It is now recognised that ethical obligations extend to communities and populations who may be either the direct object of research oraffected by it.

To create a culture of ethical responsibility, the declaration needs to speak to all stakeholders, not just researchers. Although WMA represents doctors, dental and nursing organisations participated in the consultation, and other researchers are now "invited" to adopt the document. The declaration must be a moral compass for the whole research agenda and be binding on all people. It should have the capacity to shape research at all levels.

Despite progress, controversies continue. The two related controversial articles (29 and 30)² are likely to remain, even if they are restructured. Article 29 recognises that researchers have a responsibility that extends beyond the duration of a study, including individuals’ and communities’ rights to access any benefits. Arguments about whose responsibility this is and the availability of resources do not diminish its importance. Article 30 is more controversial because it is perpetually misframed in terms of arguments about the ethical and scientific correctness of placebos rather than the principle that individuals should not knowingly be deprived of beneficial interventions.

Regulations are not an appropriate primary response to problems that are social in origin.^{4 12} Rather than being based on moral reasoning, ethical codes have largely been devised to shape policy.^{7 10} However, they are also only instruments and cannot achieve their objectives in isolation from an ethical social culture.

These broader perspectives pose new challenges to those charged with ethical review and oversight, too often within narrow conceptual frameworks.¹ The proposed changes to the declaration are improvements, but to remain the centrepiece for ethically responsible research it will need to show that it meets several criteria. It must be proactive,³ dynamic,² universal, transparent, responsive, and consultative.² Most importantly, it should inspire us all to approach research in an ethically responsible manner.

Cite this as: BMJ 2008;337:a2128

¹ Dalhousie University, Halifax, NS, Canada B3H 2Y9, ² Department of Philosophy, Center for Health Policy Research and Ethics, George Mason University, Fairfax, VA 22030, USA, ³ Biomedical Ethics Unit, McGill University, Montreal, QC, Canada H3A 1X1

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Competing interests: MG made submissions to the WMA and attended stakeholder workshops. LE and CE are members of the International Network of Feminist Approaches to Bioethics’ Committee on the Declaration of Helsinki, which made submissions to WMA.

Provenance and peer review: Commissioned; not externally peer reviewed.

References

1. Eckenwiler LA, Ells C, Feinholz D, Schonfeld T. Hopes for Helsinki: reconsidering "vulnerability." J Med Ethics 2008;34:765-6.[Free Full Text]
2. Goodyear MD, Krleza-Jeric K, Lemmens T. The Declaration of Helsinki. BMJ 2007;335:624-5.[Free Full Text]
3. Sherwin S. Whither bioethics? How feminism can help reorient bioethics. Int J Feminist Approaches Bioethics 2008;1:7-27.[CrossRef]
4. Buchanan DR. Autonomy, paternalism, and justice: ethical priorities in public health. Am J Public Health 2008;98:15-21.[Abstract/Free Full Text]
5. Rhodes R. Rethinking research ethics. Am J Bioethics 2005;5:7-28.[CrossRef]
6. Dowdy DW. Partnership as an ethical model for medical research in developing countries: the example of the "implementation trial." J Med Ethics 2006;32:357-60.[Abstract/Free Full Text]
7. Buchanan D, Sifunda S, Naidoo N, James S, Reddy P. Assuring adequate protections in international health research: a principled justification and practical recommendations for the role of community oversight. Public Health Ethics 2008 Epub June 14.
8. Finder SG. Vulnerability in human subject research: existential state, not category designation. Am J Bioethics 2004;4:68-70; discussion W32.[CrossRef]
9. Levine C, Faden R, Grady C, Hammerschmidt D, Eckenwiler L, Sugarman J. The limitations of "vulnerability" as a protection for human research participants. Am J Bioethics 2004;4:44-9.
10. Schuklenk U. The Declaration of Helsinki is dead [electronic response to Goodyear MD, et al. The Declaration of Helsinki. BMJ 2007;335:624-5]. BMJ October 8 2007, www.bmj.com/cgi/eletters/335/7621/624#177805.
11. Noble JH Jr. Declaration of Helsinki. Dead. BMJ. 2007;335:736.[Free Full Text]
12. London L. Ethical oversight of public health research: can rules and IRBs make a difference in developing countries? Am J Public Health 2002;92:1079-84.[Abstract/Free Full Text]

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