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Should Non-Invasiveness Change Informed Consent Procedures for Prenatal Diagnosis?

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Abstract

Empirical evidence suggests that some health professionals believe consent procedures for the emerging technology of non-invasive prenatal diagnosis (NIPD) should become less rigorous than those currently used for invasive prenatal testing. In this paper, we consider the importance of informed consent and informed choice procedures for protecting autonomy in those prenatal tests which will give rise to a definitive result. We consider whether there is anything special about NIPD that could sanction a change to consent procedures for prenatal diagnosis or otherwise render informed decision-making less important. We accept the claim that the absence of risk of miscarriage to some extent lessens the gravity of the decision to test compared with invasive methods of testing. However, we also claim that the definitive nature of the information received, and the fact that the information can lead to decisions of great significance, makes NIPD an important choice. This choice should only be made by means of a rigorous and appropriately supported decision-making process (assuming that this is what the pregnant woman wants). We conclude that, on balance, consent procedures for NIPD should mirror those for invasive testing, albeit without the need to emphasise procedure-related risk.

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Notes

  1. As ffDNA is derived from the placenta, there is a small chance that the genetic information in the maternal bloodstream may not be exactly representative of the fetus.

  2. We recognise that the ‘routinisation’ of screening and testing in pregnancy is ethically contentious and has been debated in the ethics literature [5]. However, a substantive consideration of the nuances of the debate over routinisation is beyond the central scope of this paper.

  3. For example, a measure of the thickness of the nuchal fold (the thickness on the back of the fetus’ neck) that lies on the 99th percentile of the normal distribution may have no clinical significance, but it may also indicate a risk of Down Syndrome.

  4. Policy on how NIPD is to be offered to pregnant women is not yet determined and is the subject of an ongoing UK national research programme (http://www.rapid.nhs.uk). NIPD could be offered to (1) replace antenatal screening programmes with a ‘one stop’ definitive indication of risk; (2) as an intermediary step between antenatal screening and invasive diagnosis; or (3) as a follow-up to antenatal screening instead of invasive prenatal diagnosis; in the same way that amniocentesis is offered now. Which of (1)–(3) is chosen will depend on the success rates for pilot studies of NIPD, financial implications and educational and counselling resources. A determination of the preferred model is therefore inappropriate at this stage and we do not adopt a preferred model in this paper, although we briefly discuss policy implications in section “Implications for Policy”.

  5. Further analysis and comparison of these terms has been undertaken elsewhere [7].

  6. Decision-making on the basis of probability, or uncertainty, can be problematic for different reasons. Making a decision on the basis of uncertain information involves a risk analysis. It is possible, for example, that a woman could terminate her pregnancy on the basis of the probability that the fetus carries a certain genetic condition, only to find that in fact the fetus did not have that condition. Indeed, avoidance of such problems of uncertainty forms part of the appeal of NIPD.

  7. This will, of course, depend on the clinical utility and validity of this test, and women’s acceptance of its reliability.

Abbreviations

NIPD:

Non-invasive prenatal diagnosis

CVS:

Chorionic villus sampling

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Acknowledgments

The contributions of the SAFE Research Team: Professor Theresa Marteau, Professor Lyn Chitty, Dr Elizabeth Dormandy and Ms Ananda van den Heuvel, whose work has made this paper possible, are acknowledged with thanks. The authors would also like to thank Dr James Wilson, Dr Samantha Leonard, Professor Angus Clarke for helpful discussions and comments during the drafting of this paper, and anonymous referees for helpful comments. The paper was written with support from the Special Non-Invasive Advances in Fetal and Neonatal Evaluation (SAFE) Network of Excellence (LSH-CT-2004-503241). The authors acknowledge the support from the European Commission who funded this network.

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  1. Centre for Ethics in Medicine, Department of Community Based Medicine, University of Bristol, 3rd Floor, Hampton House, Cotham Hill, Bristol, BS6 6AU, UK

    Zuzana Deans & Ainsley J. Newson

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  1. Zuzana Deans
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  2. Ainsley J. Newson
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Correspondence to Zuzana Deans.

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Deans, Z., Newson, A.J. Should Non-Invasiveness Change Informed Consent Procedures for Prenatal Diagnosis?. Health Care Anal 19, 122–132 (2011). https://doi.org/10.1007/s10728-010-0146-8

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