NUTRITION RESEARCH
Irene Cetin1, and Robin Gill2,
1University of Milano, Italy,2University of Kent, UK
Abstract: This paper examines three ethical areas arising from perinatal nutrition research: the first is concerned with properly informed consent in a context of interventionist research; the second with the role of research ethics committees and the third with the relationship between research and public policy
Key words: ethics; Perinatal; research
1. INTRODUCTION
In the last decades, developments in ultrasound technologies have taught us a great deal about perinatal development and growth. Although this progress has led to great improvements in diagnosis of fetal diseases, it has not been followed by improvements in therapeutic strategies during intrauterine life, so that time of delivery is often still the only route available to reduce perinatal morbidity and mortality (Pardi, 2003).
Very recently, research has developed around perinatal nutrition, both during intrauterine life and in the immediate neonatal period. This research is focused on two aspects:
1) understanding how the fetus/neonate “eats” and grows
2) developing interventionist therapeutical strategies for improving the rate of growth.
A number of studies point to long term risks related to alterations of the growth rate in the perinatal period and to the short and long term consequences for the health of children born small for gestational age (Lucas, 1991). Moreover, these children seem at higher risk when the restriction of growth in utero is not followed by catch up growth during the neonatal period (Eriksson, 1999). However, it is difficult to distinguish between risks related to genetic potential and those related to
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changes in supply of nutrients. Both clinicians and scientists should not forget that alterations in fetal nutrition and growth represent a complex disease that requires multidisciplinary care to maximize the benefits provided to the parents and their baby.
2. PROPERLY INFORMED CONSENT IN A
CONTEXT OF INTERVENTIONIST RESEARCH
2.1 What is informed consent?
Properly informed patient consent is now considered to be an essential feature of modern bioethics. If medical paternalism in the past allowed doctors and medical scientists to conduct forms of therapy or research without ‘burdening’ patients with information about their function or possible consequences, today this is no longer considered acceptable from either an ethical or a legal perspective. Even if such information is indeed a ‘burden’, it is now generally accepted that all competent patients do have a right to be properly informed. Some bioethicists even take the view that all patients must be given full and accessible information about medical interventions upon them whether they wish to have this information or not. Some argue that if it is patients’ right to have such information, then it is the duty of the doctor/medical scientist to provide and their duty, in turn, to receive it.
We do not take this view ourselves. But we do take the view that all patients and subjects of medical research should be offered clear and accessible information about its function, consequences and possible risks. This will enable them to make a properly informed choice about whether or not to participate and even to withdraw from research if they have subsequent misgivings. For us, properly informed consent involves the provision of sufficient and understandable information and space for a patient who has the capacity to make a stable choice about medical interventions or research on herself, to do so responsibly in a manner considerate to others (see Stirrat and Gill, 2005).
2.2 Who should give consent?
The specific context of interventionist perinatal nutrition research does raise some very serious ethical issues. Clearly babies are not competent to give such consent themselves. But should it be just the mother or both the mother and the father who gives this consent? There are likely to be very different answers given here within the various nationalities and cultures that comprise the European Union. Surrogate consent, when there may be unknown risks involved, is always problematic. Increasingly perinatal nutrition research today involves genetic screening. Surrogate consent is particularly contentious here. As yet genetic science is rather better at diagnosing genetic conditions thant in identifying a specific therapy for them. As a result, the genetic screening of babies now may, in the absence of any effective therapy, considerably disadvantage them in the future (for example, in terms of their future insurance or employment).
2.3 Risks and benefits
With or without genetic screening, interventionist perinatal nutrition research may well have no actual benefit for the baby involved. If, in addition, there is a risk (however unlikely) of serious harm to this baby, then it would normally be considered to be unethical. In bioethics it is usual to insist that benefits for that patient should outweigh any possibility of risk or burden. There are rare exceptions that are sometimes made to this principle – for example when an infant gives bone marrow to a sibling – but these are indeed rare, involve a minimal burden and arise from very specific medical crises. It would be difficult to justify such an exception in the context of perinatal nutrition research.
Insistence upon properly informed consent does place a duty upon doctors and scientists to provide clear and accessible information in a format that patients can really understand. This is especially difficult in technical scientific areas. There also needs to be careful consideration given to possible coercion, either because too much trust is given by some patients in their doctors (especially in pediatrics), or because doctors/medical scientists are too compromised by sponsoring bodies (such as the manufacturers of formula milk). Transparency is crucial at every level in perinatal nutrition research if properly informed consent is
to be achieved. It is also important for doctors/medical scientists to have some system of information feedback to research participants once thek results of that research have been established.
3 ROLE OF RESEARCH ETHICS COMMITTEES
The role of ethics committees is often viewed as troublesome by medical scientists and researchers. The area of perinatal nutrition research is no exception. It is particularly confusing when different local ethics committees reach opposite conclusions about the ethical acceptability of particular research proposals. It can also be troublesome when such ethics committees lack specialist competence in obstetrics and/or paediatrics. Within the European Union as a whole, there are well known and sharp differences between nations on particular issues. For example, in the United Kingdom embryonic stem cell research is allowed (up to, but not beyond, fourteen days), whereas in Germany and a number of other European countries it is regarded as unethical and remains illegal (albeit not always for the same reasons). There is unlikely to be total consensus on such issues and this can be vexatious to the research community.
However, although consensus may not be achieved on everything, greater cross-European and international research co-operation and dialogue may reduce difficulties somewhat. For example, there is now a much greater consensus on the issue of properly informed consent and the parameters that we have already discussed are not specific to any one nation. They are shared widely and increasingly across Western countries and are also developing within the South as well. We believe that ethics committees do have an important role to play in many countries and that they have raised awareness of ethical issues involved in modern medicine and science. However, we also believe that their competence still needs to be enhanced and enriched through internationald co-operation and dialogue.
One area that deeply concerns many ethics committees is the research use of surplus human blood and tissue in research. Some bioethicists have argued that it is unethical to use any blood or tissue (whether identifiable or not) for anything other than the specific research for
which it was collected (and for which patient consent was explicitly given). Others have argued that such an approach would be very detrimental to research. Historical samples, for example, have been extremely important in developing knowledge about HIV/AIDS. There is no immediate way of resolving this difference. However, a number of governments are currently exploring either the possibility of generic consent when samples are taken or even presumed consent especially for discarded and unidentifiable tissue (leaving the onus upon those who object to their discarded tissue being used in research to do so).
4 THE TENSION BETWEEN RESEARCH AND PUBLIC POLICY
4.1 The MMR example
It is well known in bioethics that public health raises some very specific tensions between individual rights and the public good. For example, the recent triple-vaccination (MMR) controversy in the United Kingdom raised a serious dilemma for some parents. Reading national newspapers it seemed at the time (even though this was later discounted by the scientific community) that there was a connection between triple- vaccination and autism. While these parents could be assured that the high level of MMR vaccination in the UK insured that their babies were unlikely to be infected by these diseases, then it may have seemed that it was in their interests not to have their own babies vaccinated (or to have single vaccines spread over a longer period of time). Yet if every parent adopted this attitude, vaccination levels and thus ‘herd immunity’ would soon drop and unvaccinated (or single-vaccinated) children would then be at risk. On this understanding, the common good (herd immunity) requires all parents to have their babies MMR vaccinated, but a more individual consideration in a context of high herd immunity might suggest (at least to those who were not scientifically informed) that MMR vaccination should be avoided.
4.2 Perinatal nutrition research
Perinatal nutrition research may raise similar concerns. If the connection, say between formula milk early feeding and later obesity really is as established as researchers such as Lucas claim (see paper in this book), then public policy might adopt some very restrictive policies.
Instead of simply instructing health visitors to encourage young mothers to breast feed, they might forbid the sale of formula milk without a prescription, provide serious tax incentives for young mothers who do breast feed (and thus penalise young mothers who do not), or seek to stigmatise or even criminalize formula feeding for young babies. But, of course, such draconian measures would seriously conflict with the ethos of many liberal, democratic societies and endanger individual rights. In any case, some of the other papers here raise proper scientific questions about the reliability or statistical significance of this particular link within perinatal nutrition research. The force of von Kries’ paper, for example, is that such a link may be established but that it is more significant for populations than for individuals (since adults who know that they are slightly more at risk of obesity than their breast-fed peersk can, after all, choose to eat less than them).
This raises crucial questions about the level of scientific certainty that is required in perinatal nutrition research in its relation to public policy.
While a scientific area is still developing, is it reasonable to require politicians to act on the basis of knowledge that is still disputed? And, in any case, how coercive should public health policy actually be (a dilemma that is already strongly debated in many European countries about public smoking)? An answer to these questions necessarily involves some tension between individual rights and autonomy, on the one hand, and public good on the other. In the context of research conducted in the Third World/Global South this tension becomes even more vexed. It is very tempting for multi-national companies to conduct research in the Third World/Global South, because it can be less expensive and may meet less resistance in the populations there. But this raises very sharp ethical dilemmas that are receiving increasing attention from bioethicists. Many are seriously concerned about the risk of individual exploitation in contexts where local research ethics committees may be as yet ill-developed. Ethical vigilance is, we believe, very much needed in this area.
5 CONCLUSIONS
In itself, perinatal medicine is taking care of individuals that are not independent and able to make choices, and this implies particular consideration. The rapidly developing methods for prenatal diagnosis, and the potential for perinatal nutritional therapy represent a new ethical challenge. This possibility of early diagnosis, of foreseeing the future of these individuals and therefore trying to change their future, needs ethical approach, a discussion amongst scientists, clinicians and ethicists about what is accepted by society.
REFERENCES
Stirrat GM and Robin Gill, 'Autonomy in Medical Ethics after O'Neill', Journal of Medical Ethics, forthcoming 2005.
Pardi G, I. Cetin, A.M. Marconi, A. Lanfranchi, P. Bozzetti, E. Ferrazzi, Buscaglia M, F.C. Battaglia, 'Diagnostic value of blood sampling in fetuses with growth retardation', New England Journal of Medicine, 328: 692-696, 1993.
Lucas A 'Programming by early nutrition in man', Ciba Foundation Symposium 1991;156:38-50
Eriksson JG, T. Forsen, J.Tuomilehto, P.D.Winter, C.Osmond, D.J.Barker, 'Catch-up growth in childhood and death from coronary heart disease: longitudinal study', British Medical Journal, 1999;318:427-31.
