But recent revisions to one of science’s underlying ethical declarations may open it up to criticism, according to a new paper by Annette Rid from the University of Zurich and Harald Schmidt from the London School of Economics (Journal of Law, Medicine & Ethics, Spring 2010, pp 143-148).
The 1964 signing of the Declaration of Helsinki followed the earlier Nuremburg Code (1947), before both of which ethical guidelines for research were few and far between: Scientists were governed more by their consciences and not so much by the written word.
The original declaration was a simple 11-point document, but numerous revisions over the years, with the most recent coming in 2000, have seen the Declaration evolve into “a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements,” stated Rid and Schmidt.
According to the World Medical Association, “although the Declaration is addressed primarily to physicians, the WMA encourages other participants in medical research involving human subjects to adopt these principles”.
And with the emphasis in health and wellness circles on getting science to support potential health claims, the focus on the ethics of how to conduct human studies becomes critical. Two areas in particular are causing ethicists headaches.
Placebos
The areas of weakness caused by the 2000 revision is in the use of placebos, and with the European Food Safety Authority (EFSA) and the US Food and Drug Administration (FDA) putting the emphasis on the value of randomised placebo-controlled trials (RCTs), what issues should researchers be aware of?
Rid and Schmidt note that placebo is “research involving deception”, since subjects think they are getting something when they are not. This has ethical implications, but such studies are acceptable when “the deception is necessary for scientific validity, if the research has important social value and involves no more than minimal risk to subjects, if subjects are debriefed about the study’s deceptive nature after its completion, and if subjects are given the opportunity to withdraw their data in the debriefing process”, they stated.
A different stance is taken by Karin Michels from Harvard School of Public Health and Kenneth Rothman from Boston University, who argued in Bioethics in 2003: “Despite the mandates of the Declaration of Helsinki and concern from ethicists and scientists, the US Food and Drug Administration (FDA) continues to demand and defend placebo-controlled evidence of efficacy and safety for the development of many new pharmaceuticals, even if effective therapy exists.
“We suggest that the FDA’s arguments defending their practice are insufficient to justify medical research that violates the Declaration of Helsinki.”
Vulnerable populations
Another area of interest to nutrition is the choice of subjects to participate. The ageing population is drawing attention on dietary approaches to improve brain health. Such is the interest that the world's largest food company, Nestlé, signalled its intention to get a head start on the competition with the signing of an agreement in November 2006 with the Swiss Federal Institute of Technology (EPFL) to investigate the role of nutrition in cognitive function.
But studies to examine the impact of a nutrient on cognitive function ask questions on how is research performed in people who may not be able to give their informed consent.
A recent article in Bioethics by Stefan Eriksson, associate professor of research ethics at Uppsala University in Sweden, considered this very issue. Current guidelines are “misguided”, said Eriksson.
The issue is that such people would fall outside the norm, and that new guidelines need to be drafted in order to provide legal obligations to compensate for any injuries suffered.
“But we also need to consider other issues, such as how surrogate decision-makes can be of use to these persons and how to find ways to estimate a dementia patient’s capacity for autonomy,” said Eriksoon. “We need to continue the debate and do more research on the ethics of research on persons with limited decision-making capacity.”