We would like to hear your views on the draft recommendations presented in the guideline, and any comments you may have on the rationale and impact sections in the guideline and the evidence presented in the evidence reviews documents. We would also welcome views on the Equality Impact Assessment.

In addition to your comments below on our guideline documents, we would like to hear your views on these questions:

1. Which areas will have the biggest impact on practice and be challenging to implement? Please say for whom and why.
2. Would implementation of any of the draft recommendations have significant cost implications?
3. What would help users overcome any challenges? (For example, existing practical resources or national initiatives, or examples of good practice.)

In this submission, we address additional questions (1) and (2) with a focus on the concept “shared decision making” in the context of maternity health services. We express our concern with the legal, human rights and practical implications of substituting the practice of obtaining “informed consent” with the legally fluid concept of “shared decision making”.

By way of summary, it is our submission that “shared decision making should not be used to replace the well-established, legally required and essential practice of obtaining informed consent, particularly in relation to women in childbirth. To do so would be to dilute a gold standard in medical practice developed over decades and endorsed by the WHO, International Confederation of Midwives and the International Federation of Gynaecologists and Obstetricians. It would also interfere with the contractual and consumer rights of patients entitled to relief at law.

The better proposition would be to strengthen the national laws around “informed consent” and, more importantly, to impose administrative and enforcement strategies that require evidence of meaningful and practical applications of this human right at the institutional level in relation to maternity heath care.

Informed Consent

A key legal concept enshrined in human rights law and codified in some national laws is the right to informed consent. It is founded on the right to bodily autonomy and the right to health [Committee on Economic, Social and Cultural Rights, General Comment No. 14, The Right to the Highest Attainable Standard of Health, UN Doc. E/C.12/2000/4 (2000), para. 8].

International instruments and caselaw make it clear that the failure to afford informed consent during pregnancy and childbirth is a violation of a woman’s fundamental human rights. Examples are set out below.

In its General Recommendation No. 24 on the core obligations of States parties under article 12 of the Convention (women and health), the Committee on the Elimination of Discrimination Against Women stated:

“States parties should also report on measures taken to ensure access to quality health-care services, for example, by making them acceptable to women. Acceptable services are those that are delivered in a way that ensures that a woman gives her fully informed consent, respects her dignity, guarantees her confidentiality and is sensitive to her needs and perspectives.” (para 22)

In I. V. v. Bolivia [Report No. 72/14, Merits, Inter-American Commission on Human Rights, Case 12.655 (August 15, 2014), para. 186], the Inter-American court stated, in relation to the sterilisation of a pregnant refugee without consent:

 “the informed consent of the patient is a sine qua non condition for the medical intervention, which is based on respect for the patient’s personal autonomy and freedom to choose her life plans without interference.”

Article 5 of the European Convention on Human Rights and Biomedicine 1997 provides:

“An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. 

This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. 

The person concerned may freely withdraw consent at any time.”

Informed consent rests upon an assumption that, despite the esoteric nature of medical knowledge, ordinary people are more than capable of assessing their medical needs and making a decision in their best interests —including a decision not to follow a doctors’ advice.

HRiC is concerned that this assumption is often overlooked in the training of, and practice by, maternity healthcare personnel, whether they are nurses, midwives or doctors, as evidenced by the recent landmark UK Supreme Court decision in “Montgomery v Lanarkshire” (hereinafter Montgomery’s case).

The answer to this problem is not to dilute or deviate from the legal obligation to obtain informed consent. It is to train and oblige personnel to properly apply the requirement as a matter of good everyday practice and to administratively enforce the requirement to obtain informed consent.

The principles for satisfying the requirement to afford informed consent are simple enough; two integrally linked, reciprocal requirements must be met before treatment can commence: (1) the duty to inform and (2) the right to consent. It acts as a contractual agreement between the parties for each recommended medical treatment: the offer (based on full disclosure of “terms and conditions”) and the acceptance or rejection of that offer.

On the right to consent or refuse medical treatment, while Montgomery’s case is often hailed as new law, there is ample, established precedent in UK medico-legal caselaw on this question:

“A mentally competent patient has an absolute right to refuse to consent to medical treatment for any reason, rational or irrational, or for no reason at all, even where that decision may lead to his or her own death.” (MB, Re [1997] EWCA Civ 3093)

Despite these early judicial interventions to preserve the rights to bodily autonomy, health and the privacy of pregnant women as persons equal before the law, the recent Montgomery’s case is evidence that “consent”, as a legal concept, remains a heavily contested issue in the everyday practice of maternity health services at the institutional level, where the boundaries between a practitioner’s duty to inform and the woman’s right to consent are constantly being shifted in favour of the practitioner.

Montgomery’s case does, however, judicially affirm the specific obligations of careproviders when seeking consent for a treatment. By law, careproviders are now required to do much more than engage in the usual practice of securing a signature on a standard consent form. They must offer timely information that will enable a pregnant woman to either consent to or refuse treatment, which includes an assessment of the material risks and benefits and the discussion of reasonable alternatives to the proposed treatment.

Rhetoric vs Reality

In most high-income countries like the United Kingdom, comprehensive judicial precedent, policies and guidelines together establish resources for obtaining informed consent. Unfortunately, these materials appear to have limited impact on the practical realities faced by the people who consume maternity health services.

In our work today, the fact pattern in Montgomery’s case of dismissing women’s concerns and requests for information and the failure to obtain informed consent prior to initiating treatment (or even, in some cases, over objections to that treatment) remains the norm. In some countries, including middle to high income countries, disrespect and mistreatment is so common that women speak of themselves as being “lucky” if they survived the childbirth experience unscathed.

In 2015, the extent of the mistreatment in both high and low income countries prompted the World Health Organisation to publish a statement on the extent and impact of abuse and disrespect of women in facility based childbirth. The abuse and disrespect are documented as a violation of women’s human and reproductive rights, and a subset of gender-based violence against women. This was followed by the 2018 WHO recommendations on intrapartum care advocating for a holistic, human rights-based approach to the provision of maternity health services.

In practice, the broad majority of health facilities have become impervious to a birthing woman’s human rights. Focussing only on hastening the delivery of the infant, maintaining hospital process lines and gender based stereotypes about women and motherhood, many personnel simply do not “see” the rights violations and gender-based violence being perpetrated in their presence. As a result, careproviders are dismissive, angered or genuinely confused by complaints about violations of rights, especially the failure to afford informed consent.

For example, in Montgomery’s case, the plaintiff gave evidence, in relation to a birth that took place in 1999, that she was pleading with her care providers to answer her questions and to respond to her repeated questions about needing a Caesarean Section. Her careprovider admitted that she did not attempt to understand, let alone meet, the plaintiff’s needs because, in her view, the doctor knew better. Despite the obvious violation of her human rights, it took the plaintiff nearly two decades and lengthy, repeat court battles to receive judicial acknowledgement that a failure to afford informed consent had caused harm to her and her infant.

In addition, the ongoing response to Montgomery’s case has raised questions about continued careprovider confusion around the concept and application of informed consent. Human rights lawyers saw the UK Supreme Court’s determination as a nod to the inviolable yet poorly enforced principles of informed consent in the provision of maternity care in the UK. By contrast, the UK’s Royal College of Obstetricians & Gynaecologists considered implementing processes to warn women about the risks of having a vaginal birth – a spontaneous bodily function which, in and of itself, is clearly not a medical intervention and therefore should not require any consent.

Special Rapporteur on Violence Against Women

On the human rights front, little has changed since Mrs Montgomery gave birth. In 2019, the UN Special Rapporteur on violence against women, its causes and consequences on a human rights-based approach to mistreatment and violence against women in reproductive health services with a focus on childbirth and obstetric violence [UN Doc. A/74/137] expressed virtually identical concerns based on reports received globally. In that report, the Special Rapporteur cited a failure to afford informed consent based on harmful gender stereotypes about motherhood and women’s subordinate role in society, and the unequal power dynamic within provider-patient relationships as root causes of mistreatment and violence in childbirth.

Then there is the abuse of the doctrine of medical necessity. In Montgomery’s case, the plaintiff’s careprovider retrospectively sought to justify her actions by asserting the doctrine of medical necessity. Two decades later, the UN Special Rapporter reported an abuse of that same doctrine, citing examples of where it was used to justify a violation of women’s human rights, in particular the right to informed consent.

These difficult circumstances are exacerbated when already constrained health systems are caring for birthing persons from non-English speaking backgrounds, or who are refugees, immigrants, in domestic violence situations, differently abled or identify as LGBTIQ.

When in balance, informed consent will constitute an agreement between care provider and woman over what treatment option to take in each instance, how it will be performed and whether it can result in any side effects, well before contact is made with the woman’s body.

That balance, particularly in the provision of maternity health services, is fragile. Women in labour are already vulnerable, made more so if they are young or socio-economically disadvantaged. They are unfamiliar with hospital protocols and the time restrictions being imposed on them. They feel restrained, exposed and displaced by repeated interventions and interactions with multiple and everchanging care providers. They are intimidated by the professional strangers pushing them into medical interventions. Equally, careproviders weighed down by liability concerns, professional and employment obligations, and cost cutting measures will inevitably elevate practical or medical expedience and outcomes over unmeasurable concepts such as compassion and dignity.

Committee on the Elimination of Descrimination Against Women

When careproviders are supported by the authorities or administrative bodies also seeking to avoid liability, the resulting power imbalance between woman and careprovider cannot be overstated,. As the Committee for the Elimination of Discrimination against Women determined in S.F.M v Spain [CEDAW/C/75/D/138/2018] (reported in 2020):

“The Committee considers that stereotyping affects the right of women to be protected against gender-based violence, in this case obstetric violence, and that the authorities responsible for analysing responsibility for such acts should exercise particular caution in order not to reproduce stereotypes.

In the present case, the Committee observes that there was an alternative to the situation experienced by the author, given that her pregnancy had progressed normally and without complications and that there was no emergency when she arrived at the hospital but that, nevertheless, from the moment she was admitted, she was subjected to numerous interventions about which she received no explanation and was allowed to express no opinion.

Furthermore, the Committee observes that the administrative and judicial authorities of the State party applied stereotypical and thus discriminatory notions by assuming that it is for the doctor to decide whether or not to perform an episiotomy, stating without explanation that it was “perfectly understandable” that the father was not allowed to be present during the instrumental delivery and taking the view that the psychological harm suffered by the author was a matter of “mere perception”, but that they did show empathy towards the father when he stated that he had been deprived of sexual relations for two years.”

As shown above, without the oversight of legal and human rights principles protecting the right to informed consent, that power imbalance can quickly shift in favour of the careprovider, without appropriate accountability. As we discuss in the next section, shared decision cannot address this deficiency in practice. It will only provide further means for avoiding responsibility and accountability in relation to obtaining consent.

“Shared Decision Making”

The Committee has described shared decision making as a “collaborative process that involves a person and their healthcare professional working together to reach a joint decision about care”.

In contradistinction to what we have outlined in relation to informed consent above, this definition seeks to conflate the two distinct legal concepts of “practitioner obligation” vis-à-vis “woman’s right”, treating the final decision on the care received by the patient as involving a “joint decision”. In cases involving criminal assault and battery, both avenues being applicable (but uncommon) to medical practice, the question of consent is significant because evidence of consent is either a complete defence or can, at the very least, establish that the criminal standard for conviction, ie “beyond reasonable doubt”, has not been met. In medical negligence, such as with Montgomery’s case, informed consent is an essential component of the transactional agreement between provider and patient without which, the practitioner can be said to have breached their duty to inform of the material risks and to offer alternatives.

In this context, shared decision making as a practice raises several legal questions:

• If decisions on care are jointly made, does the patient also share in the obligation to provide medical information and knowledge?
• Who makes the final decision or has the right to decide what treatment options to adopt?
• Who is accountable for errors in medical practice if consent can be “jointly agreed” by both parties?
• In the event of a disagreement on a proposed care plan, what protections will be afforded to vulnerable patients who, by reason of a shortage in medical personnel (such as in rural or regional areas), cannot find an alternative careprovider?
• Can shared decision making constitute a blanket agreement that the patient has understood and therefore consented in advance to all aspects of medical intervention?
• In relation to allegations of assault and battery, does shared decision making vitiate access to legal redress for assault and battery, rendering nugatory any accountability for trespass to the person in the practice of medicine?
• Will shared decision making develop a new (and lower standard of) legal accountability in relation to consent for the medical industry?

Example: The Birth Plan

The best example of the practical difficulties associated with “shared decision making” is the attempt by women to use birth plans in the provision of maternity health care. Birth plans were introduced by childbirth educators to encourage birthing persons to have an open discussion with their careproviders about the type of care they would like to receive before admission to hospital for labour and delivery. It is aimed at eliciting conversations about hospital protocols and standardised services offered by maternity health care providers and the possibilities for deviating from that standard. It recognises that women are vulnerable while in labour and are not in a position at that time to contest hospital protocols, keep track of the number of interventions being proposed and/or protect their privacy or their supporters, often all at the same time. It leads to consumer understanding and forewarning about careprovider preferences, particularly in relation to medical interventions such as pain relief, episiotomies and continuous monitoring during labour. Put simply, the birth plan is the best evidence of what a woman is willing to consider and consent to in relation to treatment options during the birth. Any change proposed to those terms requires informed consent, that is, a provider that shares information which includes an assessment of the risks and benefits and an offer of alternatives, in exchange for either agreement or refusal. To do otherwise will constitute assault or battery.

In law, birth plans should carry the same weight as the stated preference of an adult Jehovah’s Witness who is refusing blood products. In reality in maternity health care practice, however, birth plans are derided by providers of maternity health care. The words of one provider could not have put it more succinctly than this:

“’A steady but growing trickle of strange ladies is infiltrating the system and arriving in labour wards up and down the country with a familiar shopping list of demands telling doctors and midwives what to do…. These patients tend to arrive, without warning, in the Labour Ward with their lethal shopping lists…. They are not entitled to tell doctors how to do their work. They are not entitled to ask us to lower professional standards and to jeopardise babies’ lives.’

It would be trite to state that this extraordinary statement is at odds with the law and in conflict with the human right to equality, freedom from discrimination, the right to the highest attainable level of health and the right to bodily autonomy and informed consent.

Negative provider reactions to birth plans remain the norm to this day. HRiC receives numerous complaints, on a weekly basis, from women residing in high income countries including the UK, who sought and failed to engage their careproviders with a birth plan. Most careproviders are either unwilling or afraid to disclose personal practice preferences or standard hospital protocols. Women report that their health service or private provider either scoffed at or dismissed the notion of a birth plan, refused to even look at the birth plan or, perhaps worst of all, accepted a copy of the birth plan and subsequently either ignored or claimed to have lost the copy. By the time the woman arrives in hospital in labour and realises that her birth plan has been set aside as self-entitled nonsense, she is too vulnerable to effectively contest or, like a consumer in any other circumstance, to vote with her feet. The provider is already very much in control during this exchange. When we add economic, social or cultural disadvantages to that control dynamic, women find themselves in the perfect storm – all while delivering a baby.

Conclusion

In summary, HRiC submits:

• “informed consent” is the gold standard in human rights and medical practice for protecting vulnerable patients which, in relation to the provision of maternity health services, is endorsed by the World Health Organisation, the International Congress of Midwives and the International Federation of Gynaecologists and Obstetricians;
• “informed consent” has been developed over decades under the scrutiny of both human rights law and the national laws of countries;
• “informed consent” takes into consideration the respective rights and responsibilities of the parties, and constitutes the best evidence of the agreement between provider and patient for the provision of medical services;
• shared decision making, as defined in the draft recommendations, is at odds with the principles enshrined in the human and legal right to informed consent;
• the concept of shared decision making fails to acknowledge or address the power imbalance already evidenced in the provider/patient relationship in the provision of maternity health care;
• shared decision making assumes a health literacy that the most vulnerable amongst us – those subjected to adverse and/or hostile social, cultural and economic circumstances – will simply be unable to meet and can result in resigned acquiescence;
• shared decision making, by its very definition, dilutes the clarity required to determine who will be ultimately held accountable for breach of the duty to inform, the right to consent, negligence and/or mistakes and, with few exceptions, assault/battery; and
• the implications for diluting the legal concept of ‘consent’ in the UK are potentially far reaching and should not be dismissed until fully examined through consultation with legal professionals.

Recommendation

“Shared decision making” cannot and should not be used to circumvent or avoid the obligation to protect the human right to informed consent.

The real problem is that the obligation to afford informed consent is poorly understood – a reflection of the education and training of, and practice by, maternity healthcare personnel.

The answer to this problem is to:

• train and educate maternity health personnel on the human rights elements of informed consent without a narrowing of the concepts or an interpretation based on provider preferences;
• develop administrative and enforceable expectations at the institutional level for applying the practice of obtaining informed consent in relation to all treatment options as a matter of good standard practice;
• develop new ways to record and document informed consent which does away with the practice of obtaining last-minute signatures on standardised consent forms.

This should be done not simply to protect from liability and/or loss of employment but, as a minimum, to impose sound professional medical practice developed through a human rights lens.

Human Rights in Childbirth (HRiC) is an international organisation that advocates for and defends the human and reproductive rights of women and babies in pregnancy and childbirth. We are especially focussed on advocating against mistreatment and abuse of women in pregnancy and childbirth, an all too pervasive subset of gender-based violence affecting women at their most vulnerable, that is, when giving birth. This advocacy includes the examination, through a legal and human rights lens, of the mechanisms that potentially lead to or lend themselves to such mistreatment and abuse.