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Open Access 01-06-2020 | Scientific Contribution

Paternal consent in prenatal research: ethical aspects

Authors: Mats Johansson, Göran Hermerén, Nils-Eric Sahlin

Published in: Medicine, Health Care and Philosophy | Issue 2/2020

Abstract

The role of mothers in prenatal research has been discussed extensively. Significantly less work has been done on the father’s role. In this article, focusing on ethical issues, we seek to redress this imbalance. Examining the father’s position in research conducted on pregnant women, we ask whether or not paternal consent ought to be required in addition to that of the pregnant woman. Having distinguished between different concepts of father and mother, we proceed by giving an overview of the reasons for requiring consent of the woman who is carrying the child. We then examine which of these reasons apply to the biological father, and show that some of them are relevant to the father. The case, roughly speaking, revolves around privacy issues, the father’s future legal responsibilities, and the likelihood that he will care about the health and wellbeing of his future child. These factors in the decision problem should all be recognized, as should the fact that they can in principle be trumped by other considerations.

See, for example, the conditions set out in Article 13 of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (CETS 195).

Depending on age and level of maturity, the child can be given a right to veto participation. When the participant is adolescent his or her consent is occasionally required. Also, ‘assent’ (informed permission) can be required: see (AAP Committee on Bioethics 1995).

See https://www.boostb4.eu. The BOOSTB4 trial raises ethical issues beyond those considered in this paper: see (Götherström et al. 2017).

The BOOSTB4 proposal states that the primary outcome of the trial is safety, and that secondary outcomes relate to efficacy (fracture frequency, growth, bone mineral density, clinical status of OI and biochemical bone turnover).

We have conducted literature searches on ‘paternal consent’ and ‘parental consent’ on PubMed and Google Scholar. The published studies identified differed in many ways from this paper, which focuses on the conditions under which the informed consent of the biological, legal and social father should be required in prenatal research on unproven but promising stem cell therapies. A recent, but rare, exception is a general study of women's views on a paternal consent requirement for biomedical research in pregnancy (Sullivan et al. 2018).

https://www.bbc.co.uk/news/entertainment-arts-12084650 (accessed 26 November, 2018).

Here it is assumed that the woman is autonomous, and hence is capable to decide. Had this not been the case, due to an accident or illness for example, the father might (depending on circumstances) be allowed or even required to act as a surrogate decision maker. In those cases, he is expected to protect the interests of the woman. We are here not commenting that kind of situation.

In strictly clinical contexts, there are cases where pregnant women have been subjected to coercive measures (Mathieu 1991). This is very problematic to say the least, but it is a problem that falls outside of the scope of this article.

According to the current Swedish Ethical Review Act (2003:460), for example, this follows.

Even so, it must be noted that allowing her to pursue her autonomous interests might in some situations threaten the interests of the foetus; where abortion is being contemplated, there is typically a conflict of interest between the foetus and the pregnant woman.

Notice that we are not interested here in the foetus as a stakeholder—not because this is not interesting or important, but simply because if falls outside the scope of the present article.

Obviously, this point applies to fathers, too. The information may even indicate, for example, that the social or legal father is not the biological father, and this may have significant (and unwanted) consequences.

A very much more morally questionable and problematic reason would be to frustrate the wishes of the mother, or even punish her, in response to a real or imagined harm inflicted on him by her.

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Research involving children. 1977.

Needless to say, the father has no right to force the mother to participate, and nothing we have said so far implies that this is the case.

We have not been able to identify any alternative that is without problems. For example, it may be proposed that ethical nudge by including the possibility of parental consultation (including both parents) in the consent form while not granting veto for the father would have been a possibility and a better solution. But this proposed solution is not taking the father´s moral interests seriously. We are not suggesting that they trump all other considerations, only that they deserve to be discussed; and the aim of this paper is to call attention to this issue by comparing the interests of various categories of fathers and mothers.

The discussion of the paper takes as a starting point situations where a pregnant woman has a male partner who is the biological, social and legal father of the child, and no one else is involved in the pregnancy. We recognize that variants of this scenario, involving among other things same-sex relationships, multiple partners and surrogacy, raise further questions about collective consent, and we are grateful to Paul, Liz and Louis Robinson for pointing out how difficult it is to generalise about consent requirements beyond those applying to the biological mother.

AAP Committee on Bioethics. 1995. Informed Consent, Parental Permission, and Assent in Pediatric Practice. Committee on Bioethics, American Academy of Pediatrics. Pediatrics 95 (2): 314–317.

Götherström, C., et al. 2017. Stem Cells and Fetal Therapy: Is it a Reality? Gynaecology and Reproductive Medicine 27 (5): 166–167.CrossRef

Sullivan, K.A., et al. 2018. Women’s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy. Journal of Empirical Research on Human Research Ethics 13 (4): 349–362.CrossRef

Kim, J.H., and A.R. Scialli. 2011. Thalidomide: The Tragedy of Birth Defects and the Effective Treatment of Disease. Toxicological Sciences 122 (1): 1–6.CrossRef

Denny, C., and C. Grady. 2008. Research Involving Women. In The Oxford Textbook of Clinical Research Ethics, ed. E.J. Emanuel, 827. Oxford: Oxford University Press.

CIOMS/WHO. 2016. International Ethical Guidelines for Health-Related Research Involving Humans. Geneva: CIOMS/WHO.

Mathieu, D. 1991. Preventing Prenatal Harm: Should the State Intervene? Clinical Medical Ethics. Dordrecht: Kluwer Academic Publishers.CrossRef

Title: Paternal consent in prenatal research: ethical aspects
Authors: Mats Johansson
Göran Hermerén
Nils-Eric Sahlin
Publication date: 01-06-2020
Publisher: Springer Netherlands
Published in: Medicine, Health Care and Philosophy / Issue 2/2020
Print ISSN: 1386-7423
Electronic ISSN: 1572-8633
DOI: https://doi.org/10.1007/s11019-019-09919-1

At a glance: The STEP trials

Springer Medicine

Paternal consent in prenatal research: ethical aspects

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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