Basic principles
The fundamental principle is respect for the individual (Article 8), his right to self-determination and the right to make informed decisions (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. The investigator's duty is solely to the patient (Articles 2, 3 and 10) or volunteer (Articles 16, 18), and while there is always a need for research (Article 6), the subject's welfare must always take precedence over the interests of science and society (Article 5), and ethical considerations must always take precedence over laws and regulations (Article 9).
The recognition of the increased vulnerability of individuals and groups calls for special vigilance (Article 8). It is recognized that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor (Articles 23, 24), then allowance should be considered for surrogate consent by an individual acting in the subject's best interest, although his or her consent should still be obtained if at all possible (Article 25).
Operational principles
Research should be based on a thorough knowledge of the scientific background (Article 11), a careful assessment of risks and benefits (Articles 16, 17), have a reasonable likelihood of benefit to the population studied (Article 19) and be conducted by suitably trained investigators (Article 15) using approved protocols, subject to independent ethical review and oversight by a properly convened committee (Article 13). The protocol should address the ethical issues and indicate that it is in compliance with the Declaration (Article 14). Studies should be discontinued if the available information indicates that the original considerations are no longer satisfied (Article 17). Information regarding the study should be publicly available (Article 16). Ethical publications extend to publication of the results and consideration of any potential conflict of interest (Article 27). Experimental investigations should always be compared against the best methods, but under certain circumstances a placebo or no treatment group may be utilised (Article 29). The interests of the subject after the study is completed should be part of the overall ethical assessment, including assuring their access to the best proven care (Article 30). Wherever possible unproven methods should be tested in the context of research where there is reasonable belief of possible benefit (Article 32).
WHO: The Declaration of Helsinki and public healthAs public-health ethics develops, it needs to show a similar openness to the legitimate rights of individuals.
Such openness should be a characteristic of public-health research ethics, something that is sorely in need of development. The 2000 version of the DoH has been severely criticized by some public-health advocates for its restrictions on medical research,6 but at least some of this criticism seems to be based on a rejection of ethics (in favour of commerce) rather than an alternative public-health research ethics. There is enormous scope for the latter, in epidemiology, health systems research, disaster preparedness and relief, etc. but it needs to be consistent with, not dismissive of, traditional health-care ethics. Only then will it be able to achieve its goal of improving health care for all members of the public.
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