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. 2001 Aug 4;323(7307):283.

Revised Declaration of Helsinki

Ethics is not just for ethicists

Adnan A Hyder 1
PMCID: PMC1120893  PMID: 11505939

Editor—Singer and Benatar's editorial on revisions of the Declaration of Helsinki proposes “capacity development,” defined as an increased number of professionals trained in ethics.1 Although this is indeed a step that needs to be taken, I cannot agree that it alone will advance the cause of ethical research, especially with the plans that the authors propose.

The assumption that having more trained people will change the system satisfies a necessary but not sufficient criterion. The fact that there are more doctors in the developing world today than there were 20 years ago does not mean either that the practice of medicine is better or that health needs are addressed. It depends on what these people trained in ethics do, where they do it, how they sustain their efforts, and how they integrate their contributions within the overall health development of nations.

The numbers and budgets presented in the proposal are simply arbitrary—they are not defended and so are difficult to evaluate. If $100m is available, what are the alternative pathways for investment for the developing world? If one considers all the health and staffing needs then the need for ethics training may not be the most important: community health workers, trained birth attendants, and others may be higher on the list. Another major issue is where the money goes. Implicit in the editorial is that the money will have to go to training centres in the West. This means that 90% of the money is not going to the developing world—a feature of “aid” well known to those in the South.

The editorial severely underplays the role of other stakeholders. The importance of roles for professionals from a wide variety of disciplines, of decision makers, of community leaders, and of business leaders in shaping the practice of ethics in the South needs to be recognised. A “global alliance for health ethics” and the proposed influence on the World Bank and World Trade Organisation are only distant visions. Is this the most effective or most efficient way to achieve that vision? Activists, lobbyists, and social scientists will beg to differ.

As long as ethics is viewed as something that is only for ethicists, or for those who have only been trained, it will never have the profound influence we all hope that it will have in both the developing and developed world.

Footnotes

AAH is the recipient of one of the ethics training grants from the Fogarty International Center of the National Institutes of Health.

References

  • 1.Singer PA, Benatar SR. Beyond Helsinki: a vision for global health ethics. BMJ. 2001;322:747–748. doi: 10.1136/bmj.322.7289.747. . (31 March.) [DOI] [PMC free article] [PubMed] [Google Scholar]
BMJ. 2001 Aug 4;323(7307):283.

WMA will continue to revise policy as medicine and research changes

Delon Human 1,2,3, Francis Crawley 1,2,3, Carel IJsselmuiden 1,2,3

Editor—The BMJ has devoted considerable coverage to the revision of the World Medical Association's Declaration of Helsinki.1-1,1-2 The declaration and its revision have greatly increased the global research community's sensitivity to research ethics.

Although there can be little disagreement with the general sentiments expressed in Singer and Benatar's editorial on the declaration,1-3 some remarks are necessary to balance the arguments put forward. The authors state that “revisions . . . are unlikely to make research more ethical throughout the world.” The revision process of the Declaration of Helsinki contradicts this statement in the sense that increased awareness of ethical principles should improve ethical behaviour in research; the revision has already had an impact on clinical research.

The revision process, which entailed wide consultation and numerous intense debates among the different stakeholders in research, contributed much to a greater sensitivity to ethical behaviour in research. One example of its effectiveness was the increase in interest in the World Medical Association's policy. Visits to the association's website (www.wma.net), and specifically the section on the association's policy, had grown from seven a month in May 1998 to 220 000 visits a month by October 2000.

The revision has already had an impact on research, hopefully in a positive manner. The World Medical Organisation organised a conference on the ethical implications and implementation of the revised declaration in March this year in Pretoria, South Africa, which was attended by government regulators and some of the world's leading pharmaceutical companies, researchers, and ethicists. During this conference a representative of a large pharmaceutical company in Britain mentioned that since October 2000 up to eight new trials had been either disallowed or postponed because of the new guidelines in the declaration.1-4 All of these rulings were based on the article in the declaration concerning the ethical use of placebo controlled trials (article 29).

While congratulating the authors on their call for increased capacity, we would emphasise the importance of the revision of internationally accepted ethical codes, of which the Declaration of Helsinki is probably the most well known. The World Medical Association is committed to continue this process of revising policy as the medical and research environment changes, always using as its first consideration the best interests of patients.

References

  • 1-1.Rothman KJ, Michels KB, Baum M. For and against: Declaration of Helsinki should be strengthened. BMJ. 2000;321:442–445. [PMC free article] [PubMed] [Google Scholar]
  • 1-2.Christie B. Doctors revise Declaration of Helsinki. BMJ. 2000;321:913. doi: 10.1136/bmj.321.7266.913. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 1-3.Singer PA, Benatar SR. Beyond Helsinki: a vision for global health ethics. BMJ. 2001;322:747–748. doi: 10.1136/bmj.322.7289.747. . (31 March.) [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 1-4.Bmj.com news roundup: Ferriman A. WMA agrees to refine changes to Declaration of Helsinki. BMJ. 2001;322:1142. [Google Scholar]
BMJ. 2001 Aug 4;323(7307):283.

Authors' reply

Peter A Singer 1,2, Solomon R Benatar 1,2

Editor—Hyder seems to misunderstand our proposal. Of course advancing the cause of ethics depends not simply on training people but on what they are trained to do. This would include research, advocacy, and strengthening the capacity of others such as members of research ethics boards. A key factor for success is that the funds should primarily be used for direct support of ethics centres in developing countries. We referred to this in our editorial as “the crucial step, yet to be taken.”

There are indeed other capacity strengthening needs in global health, but to trade them off against each other is short sighted, and the other areas that Hyder mentions also have important ethics aspects that are addressed by our proposal. The figure of $100m does not come with a detailed budget justification in an editorial. It is a rough calculation intended to give a sense of scale—and of how relatively little it would cost to achieve such an important effect.

Our vision would need to be pursued in a multidisciplinary manner with multiple stakeholders and careful attention to governance. Ethics will have minimal effect if its intended audience is only ethicists. We don't envision that the trainees would be professional philosophers but rather that they would be an interdisciplinary group. They would all be opinion leaders who could use their ethics training to influence others. Our vision is an outward looking one in which ethics is a vehicle for improving social and economic policies beyond the direct healthcare setting—in relation to, for example, research, genomics and biotechnology, and end of life care in developing countries.

We also wish to comment on Human et al's letter. We are not calling for an abandonment of international codes of ethics, or for these codes never to be updated. Our main point is that incremental change, such as revising a code, is necessary but not sufficient. To make a dramatic leap forward in global ethics (in this case, research ethics) more fundamental change and innovation are needed.

Our proposal for fundamental change is a commitment to broadening and strengthening capacity in ethics in developing countries. The balance until recently in international research ethics was 100% codes, 0% capacity strengthening. We would like to see this balance tilt more towards capacity strengthening. The Fogarty Bioethics Research and Education Program is an important first step, and we outlined further steps in our editorial. But editorialising is not enough: it is time for action.

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