Editorials
Ethics
Volume 172 - Issue 6

The Declaration of Helsinki : revising ethical research guidelines for the 21st century

Author:  Kate Stockhausen

Med J Aust 2000; 172 (6): 252-253.
Published online: 20 March 2000
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A recent draft proposal for revising the Declaration has provoked heated controversy

The World Medical Association (WMA) Declaration of Helsinki1 is regarded internationally as the pillar of ethical standards for biomedical research involving humans. In 1997, the American Medical Association presented a draft proposal to the WMA to update the Declaration to bring it more into line with contemporary ethical thinking,2-4 whereupon the WMA began the current process of revising the Declaration.

Since 1964, the Declaration has evolved from a relatively broad set of ethical principles to a more defined, prescriptive set of guidelines, but it is extremely difficult to obtain global consensus on the Declaration because perceptions and ethical standards are not universal.

... we must determine just how the Declaration can remain relevant in the current biomedical research environment...
Ethical standards are a product of cultural, linguistic, moral, religious, and social considerations; hence, many nations develop their own ethical guidelines for biomedical research -- for example, the National statement on ethical conduct in research involving humans,5 released recently by Australia's National Health and Medical Research Council.

In June 1999, the WMA circulated a draft Proposed Revision of the Declaration of Helsinki6 to all National Medical Associations (NMAs). An international outcry ensued over the proposed amendments to issues such as informed consent, access to healthcare, placebo use, and publications (see Box).8-10 Some argued that the Proposed Revision established a model for human biomedical research ethics that encouraged utility and efficiency at the expense of patient autonomy and wellbeing.9 Those who defended the amendments said they were more in line with contemporary ethical thinking and did not impose unnecessarily stringent standards of practice.11 In this issue of the Journal, Loff and Black discuss some of the complexities associated with this debate and raise further questions.13

As a result of the lack of consensus between NMAs on the Proposed Revision, the WMA decided, at its General Assembly in October 1999, to develop a new draft revised Declaration in consultation with the public and WMA members.14

The difficulties imposed by the Declaration's prescriptive model are exemplified in the proposed amendments to placebo use (see Box). Robert Levine, Professor of Internal Medicine at Yale University School of Medicine, argues that the current Declaration's restrictions on placebo use, if taken literally, not only rule out the development of all new treatments other than for those diseases without a proven therapeutic treatment, but also forbid the use of a placebo when a standard therapy exists.11 Levine asserts that the current Declaration incorporates overly stringent ethical standards that needlessly impede biomedical research.

However, a literal interpretation of the Proposed Revision's approach to placebo use gives cause for alarm. It proposed to change the standard from not allowing placebo use where a proven therapy exists to freely allowing placebo use as long as participants do not die or become disabled as a result.8 In so doing, it failed to recognise other adverse health effects that could arise from placebo use, such as pain, discomfort, or psychological stress, which might constitute unacceptable risks of the treatment. Indeed, even the perception of an "acceptable risk" in biomedical research finds little uniformity.8,15

The WMA should take heart from the fact that the Declaration of Helsinki can still provoke such strong passion and emotion almost 40 years after its adoption. The recent controversy is a true testament to just how important the Declaration is to those with a vested interest in biomedical research. As we head into the new century, we must determine just how the Declaration can remain relevant in the current biomedical research environment while not diminishing the fundamental ethical principles surrounding patient autonomy and wellbeing.

Alternatives do exist to following the prescriptive model. A recent workshop on revising the Declaration of Helsinki, held by the Royal Society of Medicine, London,16,17 presented a reasonable alternative to pursuing the prescriptive approach:

  • The Declaration should not be rewritten;

  • The Declaration should remain a slim set of principles, not regulations, that could remain unchanged for a long time; and

  • Guidance on such issues as informed consent could be addressed in accompanying commentaries which could easily be revised while leaving the Declaration intact.17

By using this or a similar alternative, the Declaration of Helsinki will not be further denigrated in the way it has been over the past year, and will continue to prevail as the definitive statement of ethical principles in human biomedical research.

Kate Stockhausen
Senior Research Officer, Health Services
Australian Medical Association Federal Secretariat
Canberra, ACT

  1. World Medical Association Declaration of Helsinki as adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964.
  2. American Medical Association. Proposed Revision of the World Medical Association Declaration of Helsinki. Ferney-Voltaire, France: World Medical Association, 1997. (WMA document 17.CRev/97/A).
  3. American Medical Association. Background comments and text comparison aid for the proposed draft of the World Medical Association Declaration of Helsinki - recommendations guiding physicians and other investigators in biomedical research involving human subjects. Ferney-Voltaire, France: World Medical Association, 1997. (WMA document 17.CRev/97/B).
  4. Crawley F, Hoet J. Ethics and law: the Declaration of Helsinki under discussion. Bull Med Ethics Aug 1999: 9-12.
  5. National Health and Medical Research Council. National statement on ethical conduct in research involving humans. Canberra: Commonwealth of Australia, 1999. (Available from AusInfo government bookshops.)
  6. Medical Ethics Committee of the World Medical Association. Proposed Revision of the World Medical Association Declaration of Helsinki. Ferney-Voltaire, France: World Medical Association, 1999. (WMA document 17.C/Rev1/99).
  7. World Medical Association Declaration of Helsinki as amended by the 48th General Assembly, Somerset West, Republic of South Africa, October 1996.
  8. Australian Medical Association. AMA submission on the Proposed Revision of the World Medical Association Declaration of Helsinki (WMA document 17.C/Rev1/99). Canberra: Australian Medical Association, 1999. (Available from AMA, PO Box E115, Kingston, ACT 2604.)
  9. Brennan TA. Proposed revisions to the Declaration of Helsinki - will they weaken the ethical principles underlying human research? N Engl J Med 1999; 341: 527-531.
  10. Lurie P, Wolfe SM. Letter to Dr Delon Human, World Medical Association, on Helsinki Principles. Distributed by Public Citizen, Washington DC, March 1999.
  11. Levine RJ. The need to revise the Declaration of Helsinki. N Engl J Med 1999; 341: 531-534.
  12. Stockhausen K. Ethical hazards in new Declaration of Helsinki. Aust Med Aug 1999; 11: 10-11.
  13. Loff B, Black J. The Declaration of Helsinki and research in vulnerable populations. Med J Aust 2000; 172: 292-295.
  14. Summary minutes of the 51st WMA General Assembly, Tel Aviv, Israel, October 1999.
  15. Woodward B. Challenges to human subject protections in US medical research. JAMA 1999; 282: 1947-1952.
  16. Bulletin of Medical Ethics, European Forum for Good Clinical Practice. The 150th issue devoted to a workshop on revising the Declaration of Helsinki: a fresh start. Bull Med Ethics Aug 1999; 150.
  17. Report of a Workshop held at the Royal Society of Medicine, London. Revising the Declaration of Helsinki: a fresh start. Bull Med Ethics Oct 1999; 151: 13-17.

Some controversial issues raised by the draft Proposed Revision of the Declaration of Helsinki (17.C/Rev1/99)6
Documentation of informed consent
Article I.9 of the current Declaration states that a physician should "obtain a patient's freely-given informed consent, preferably in writing".7

Article 24 of the Proposed Revision introduces a waiver of written consent "when the research involves only slight risk or when the procedures to be used are customarily used in the practice of medicine without documentation of consent".6

Benefit of the amendment
The amendment could reduce the time and effort needed to obtain written documentation of consent from every research participant.

Objection to the amendment
It allows a great deal of leeway to waive written consent based on subjective standards such as risk.8-10 It also fails to recognise that research is inherently different from clinical practice and research participants require specific protection that may not be required in clinical practice.10

Access to health care
Article II.3 of the current Declaration states that "every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method".7

Article 18 of the Proposed Revision states that "every patient should be assured of the best proven diagnostic, prophylactic or therapeutic method that would otherwise be available to him or her" (emphasis added).6

Benefit of the amendment
It may be economically and logistically unfeasible for a researcher to provide the same standard of health care found in an industrialised nation to participants in a developing nation (as required by the current Declaration). The amendment would allow research sponsors in industrialised countries to help developing countries establish affordable treatments and preventive interventions for debilitating diseases, eg HIV/AIDS. 11

Objection to the amendment
It diminishes the researcher's moral and ethical commitment to protecting the patient's well-being.8-10 For economically disadvantaged individuals, the local standard of health care may be nothing; thus, providing an economic incentive to conduct biomedical research in economically disadvantaged areas and exploiting particular groups of research participants for commercial benefit.8-10,12

Placebo use and risk
Article II.3 of the current Declaration states that "in any medical study, every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists."7

Article 19 of the Proposed Revision states that "when the outcome measures are neither death nor disability, placebo or other no-treatment controls may be justified on the basis of their efficiency".6

Benefit of the amendment
In certain circumstances, it permits placebo use even when a standard therapy already exists. This allows researchers to trial new and improved treatments in a more efficient, cost-effective manner.11

Objection to the amendment
In freely allowing placebo use as long as participants do not die or become disabled, it fails to recognise other adverse health effects that could arise from placebo use, such as pain, discomfort or psychological stress.8

Author

  • Kate Stockhausen

References

  1. World Medical Association Declaration of Helsinki as adopted bythe 18th World Medical Assembly, Helsinki, Finland, June 1964.
  2. American Medical Association. Proposed Revision of theWorld Medical Association Declaration of Helsinki.Ferney-Voltaire, France: World Medical Association, 1997. (WMAdocument 17.CRev/97/A).
  3. American Medical Association. Background comments andtext comparison aid for the proposed draft of the World MedicalAssociation Declaration of Helsinki - recommendations guidingphysicians and other investigators in biomedical researchinvolving human subjects. Ferney-Voltaire, France: World MedicalAssociation, 1997. (WMA document 17.CRev/97/B).
  4. Aug 1999: 9-12. refbody4
  5. National Health and Medical Research Council. National statementon ethical conduct in research involving humans.Canberra: Commonwealth of Australia, 1999. (Availablefrom AusInfo government bookshops.)
  6. Medical Ethics Committee of the World Medical Association.Proposed Revision of the World Medical Association Declaration ofHelsinki. Ferney-Voltaire, France: World Medical Association,1999. (WMA document 17.C/Rev1/99).
  7. World Medical Association Declaration of Helsinki as amended bythe 48th General Assembly, Somerset West, Republic of South Africa,October 1996.
  8. Australian Medical Association. AMA submission on the ProposedRevision of the World Medical Association Declaration of Helsinki(WMA document 17.C/Rev1/99). Canberra: Australian MedicalAssociation, 1999. (Available from AMA, PO Box E115, Kingston, ACT2604.)
  9. Brennan TA. Proposed revisions to the Declaration of Helsinki -will they weaken the ethical principles underlying human research?N Engl J Med 1999; 341: 527-531.
  10. Lurie P, Wolfe SM. Letter to Dr Delon Human, World MedicalAssociation, on Helsinki Principles. Distributed by PublicCitizen, Washington DC, March 1999.
  11. Levine RJ. The need to revise the Declaration of Helsinki. NEngl J Med 1999; 341: 531-534.
  12. Stockhausen K. Ethical hazards in new Declaration of Helsinki.Aust Med Aug 1999; 11: 10-11.
  13. Loff B, Black J. The Declaration of Helsinki and research invulnerable populations. Med J Aust 2000; 172: 292-295.
  14. Summary minutes of the 51st WMA General Assembly, Tel Aviv,Israel, October 1999.
  15. Woodward B. Challenges to human subject protections in US medicalresearch. JAMA 1999; 282: 1947-1952.
  16. Bulletin of Medical Ethics, European Forum for Good ClinicalPractice. The 150th issue devoted to a workshop on revising theDeclaration of Helsinki: a fresh start. Bull Med Ethics Aug1999; 150.
  17. Report of a Workshop held at the Royal Society of Medicine, London.Revising the Declaration of Helsinki: a fresh start. Bull MedEthics Oct 1999; 151: 13-17.