Top

Published in:

01-06-2011 | Original Article

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

Authors: Zuzana Deans, Ainsley J. Newson

Published in: Health Care Analysis | Issue 2/2011

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.

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.

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.

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.

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”.

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

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.

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

Benn, P. A., & Chapman, A. R. (2009). Practical and ethical considerations of noninvasive prenatal diagnosis. Journal of the American Medical Association, 301(20), 2154–2156.PubMedCrossRef

de Jong, A., Dondorp, W. J., de Die-Smulders, C. E. M., Frints, S. G, M. & de Wert, G. M. W. R. (2009) Non-invasive prenatal testing: Ethical issues explored. European Journal of Human Genetics advance online publication 2 December 2009; doi:10.1038/ejhg.2009.203.

Faden, R. R., & Beauchamp, T. L. (1986). A history and theory of informed consent. New York, Oxford: Oxford University Press.

García, E., Timmermans, D. R. M., & van Leeuwen, E. (2009). Reconsidering prenatal screening: An empirical-ethical approach to understand moral dilemmas as a question of personal preference. Journal of Medical Ethics, 35, 410–414.PubMedCrossRef

Getz, L., & Kirkengen, A. (2003). Ultrasound screening in pregnancy: Advancing technology, soft markers for fetal chromosomal aberrations, and unacknowledged ethical dilemmas. Social Science and Medicine, 56, 2045–2057.PubMedCrossRef

Hahn, S., & Chitty, L. S. (2008). Noninvasive prenatal diagnosis: Current practice and future perspectives. Current Opinion in Obstetrics and Gynecology, 20(2), 146–151.PubMedCrossRef

Marteau, T. M. (2009). Informed choice: A construct in search of a name. Edwards, A. & Elwyn, G. shared decision-making in health care: Achieving evidence-based patient choice. Oxford: Oxford University Press (Chap. 13).

Marteau, T. M., Dormandy, E., & Michie, S. (2001). A measure of informed choice. Health Expectations, 4(2), 99–108.PubMedCrossRef

National Institute for Health and Clinical Excellence. (2008) Antenatal Care: Routine Care for the Healthy Pregnant Woman Nice clinical guideline 62. Available at: http://www.nice.org.uk/nicemedia/pdf/CG062NICEguideline.pdf [Viewed 08/09/09].

10.

Newson, A. J. (2008). Ethical aspects arising from non-invasive fetal diagnosis. Seminars in Fetal Neonatal Medicine, 13(2), 103–108.PubMedCrossRef

11.

O’Neill, O. (2002). Autonomy and trust in bioethics. Cambridge: Cambridge University Press.CrossRef

12.

O’Neill, O. (2003). Some limits of informed consent. Journal of Medical Ethics, 29, 4–7.PubMedCrossRef

13.

Press, N., & Browner, C. H. (1995). Risk, autonomy, and responsibility: Informed consent for prenatal testing. Hastings Center Report, 25(3), S9–S12.CrossRef

14.

Royal College of Obstetricians and Gynaecologists. (2006). Amniocentesis: Consent Guide 6. Available at: http://www.rcog.org.uk/files/rcog-corp/uploaded-files/Consent6Amniocentesis2006.pdf [Viewed 08/09/09].

15.

Schmitz, D., Netzer, C., & Henn, W. (2009). An offer you can’t refuse? Ethical implications of non-invasive prenatal diagnosis. Nature Reviews Genetics, 10, 515.PubMedCrossRef

16.

Scully, J., Porz, R., & Rehmann-Sutter, C. (2007). You don’t make genetic test decisions from one day to the next—using time to preserve moral space. Bioethics, 2(14), 208–217.CrossRef

17.

van den Heuvel, A., et al. (2010). Will the introduction of non-invasive prenatal diagnostic testing erode informed choices? An Experimental Study of Health Care Professionals. Patient Education and Counseling, 78(1), 24–28.PubMedCrossRef

18.

Vassy, C. (2006). From a genetic innovation to mass health programmes: The diffusion of down’s syndrome prenatal screening and diagnostic techniques in France. Social Science and Medicine, 63, 2041–2051.PubMedCrossRef

19.

Wright, C. F., & Burton, H. (2009). The use of cell-free fetal nucleic acids in maternal blood for non-invasive prenatal diagnosis. Human Reproduction Update, 15(1), 139–151.PubMedCrossRef

20.

Wright, C. F., & Chitty, L. S. (2009). Cell-free fetal DNA and RNA in maternal blood: Implications for safer antenatal testing. British Medical Journal, 339, b2451.PubMedCrossRef

Title: Should Non-Invasiveness Change Informed Consent Procedures for Prenatal Diagnosis?
Authors: Zuzana Deans
Ainsley J. Newson
Publication date: 01-06-2011
Publisher: Springer US
Published in: Health Care Analysis / Issue 2/2011
Print ISSN: 1065-3058
Electronic ISSN: 1573-3394
DOI: https://doi.org/10.1007/s10728-010-0146-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 2/2011

On the Notion of (Medical) Invasiveness

Mental Health Consumer-Operated Services Organizations in the US: Citizenship as a Core Function and Strategy for Growth

Pandemic Ventilator Rationing and Appeals Processes

A Communitarian Approach to Public Health

Managing Health(-Care Systems) Using Information Health Technologies

Can Questions of the Privatization and Corporatization, and the Autonomy and Accountability of Public Hospitals, Ever be Resolved?