The 2000 revision of the Declaration of Helsinki: a step forward or more confusion?

doi:10.1016/S0140-6736(01)06534-5

The Lancet

Volume 358, Issue 9291, 27 October 2001, Pages 1449-1453

https://doi.org/10.1016/S0140-6736(01)06534-5 Get rights and content

Summary

At a time when there was great attention and intense public controversy surrounding clinical (especially multinational) research, the 52nd general assembly of the World Medical Association (WMA) adopted the 5th revision of the Declaration of Helsinki (in October, 2000)—available at www.wma.net. These revisions are the most substantial adaptations since those adopted by the 29th WMA assembly in October, 1975. The commitment to revision of the declaration acknowledged that deficiencies and disagreements in interpretation needed to be corrected and that ethical standards evolve. Nevertheless, this revision process resulted in a controversial version of the declaration. Reports on the revisions have focused mainly on clinical trials that use placebos;1, 2 but because of the role of the Declaration of Helsinki in the ethics of research, a more thorough examination is needed. Here, we analyse the process of revision and the major changes made to the declaration.

Section snippets

Process of revision

Since 1997, much debate on the ethics of trials, especially trials in the developing world of regimens to prevent vertical transmission of HIV, has taken place. Most commentators agreed that changes to the declaration were needed, especially clarification of the placebo control issue.2, 3 Several drafts were considered, including one that was rejected at the WMA meeting in April, 1999.⁴ Afterwards, a new four-member committee began work on another version. The committee was composed of

Changes to declaration

In major alterations to the declaration's tone, the WMA asserts a change in its status and authority. Previously, the WMA called the declaration “recommendations” to physicians that “should be kept under review … [as] a guide” and stated that “Physicians are not relieved from criminal, civil, and ethical responsibilities under the laws of their own countries” (Panel 1). The revision states that the declaration no longer contains “recommendations” but rather is “a statement of ethical

Modification of structure

Previous versions of the declaration had four parts: introduction; basic principles; medical research and professional care; and non-therapeutic biomedical research with human beings. In the 2000 declaration, the non-therapeutic research category was eliminated. Although such categorisation had been severely criticised as inaccurate, illogical, and ignoring the possibility of some types of research, it did accentuate the widely accepted fact that research without the prospect of direct benefit

Improvements

Several of the revisions are clear improvements on previous versions. First, the document was updated to provide new guidance on ethical obligations for monitoring and oversight of clinical research. In addition to independent review of research protocols, committees (institutional review boards or regional ethics committees) are afforded the “right to monitor ongoing trials”. Also, investigators have an “obligation to provide monitoring information, especially any serious adverse events”

Concerns

One drawback in the new revision relates to vulnerable populations—groups in need of additional safeguards because they cannot protect their own interests through valid informed consent.⁸ Examples of populations traditionally regarded as vulnerable include people with mental impairments that affect their capacity to make decisions, people in institutions, and children. Although the previous version stated that “particular caution” should be used with patients in a dependent relationship with

Placebo controls

The debate about the appropriate standard of care in research, and especially use of placebo controls when effective therapy exists, was the impetus for the current revision. Substantial debate centered on provision II. 3 in the 1996 version, which required that in every medical study all participants “be assured the best proven diagnostic and therapeutic method”2, 5, 25 (Panel 1). Criticised as being imprecise and logically inconsistent with randomised trials, the main controversy focused on

Implementation of the declaration

The Declaration of Helsinki is an influential source of guidance that assists researchers in the design and implementation of ethical research in human beings. It is encouraging that the declaration is not seen as a timeless pronouncement of ethical ideals but rather as an ongoing document that can be reviewed and regularly revised. The incorporation of current thought, circumstances, and changing ethical ideals is valuable. Although laudable in many respects, the most recent revision of the

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Department of EthicsThe 2000 revision of the Declaration of Helsinki: a step forward or more confusion?

Summary

Section snippets

Process of revision

Changes to declaration

Modification of structure

Improvements

Concerns

Placebo controls

Implementation of the declaration

Placebo trials deemed unethical

Nat Med

Helsinki Discord? A controversial declaration

JAMA

Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries

N Engl J Med

Proposed revision of the Declaration of Helsinki

Bull Med Ethics

Proposed revisions to the Declaration of Helsinki—will they weaken the ethical principles underlying human research?

N Engl J Med

A fifth amendment for the Declaration of Helsinki

Lancet

The ethics of international biomedical research

BMJ

World Medical Association website newsletter

Helsinki's new clinical rules: fewer placebos, more disclosure

Science

International ethical guidelines for biomedical research involving human subjects