Version May 2024
INTRODUCTION — Clinicians have a legal and ethical responsibility to provide patients with adequate information that they can process and use to make appropriate decisions about their clinical care. During pregnancy, informed consent can be described as the process of decision-making between a patient and the health care provider regarding the clinical management of the pregnancy. The goals of the informed consent process are to empower the patient with information about benefits and risks that are needed for an informed choice about authorizing specific clinical management and is typically required for clinical circumstances of increased clinical risk (eg, cesarean birth, chorionic villus sampling) and to support the patient to make voluntary decisions [1,2].
This topic will discuss general issues related to informed consent during pregnancy. Informed consent in other settings is reviewed separately:
●(See "Cesarean birth on patient request", section on 'Ethical issues'.)
●(See "Informed procedural consent".)
●(See "Consent in adolescent health care".)
●(See "Ethics in the intensive care unit: Informed consent".)
TERMINOLOGY
●Beneficence – An ethical principle that creates the clinician's ethical obligation to provide clinical management that in evidence-based clinical judgment is reliably predicted to result in net clinical benefit for the patient.
●Conflict of interest in clinical judgment – Conflicts of interest in clinical judgment occur when the decision-making process is influenced by the clinician's self-interest, resulting in biased clinical judgment.
●Directive counseling – Directive counseling involves making recommendations to the patient. It is acceptable when there is only one medically reasonable alternative or when one among two or more medically reasonable alternatives is superior in evidence-based clinical judgment.
●Nondirective counseling – Nondirective counseling involves offering all forms of clinical management that are medically reasonable when none is clinically superior in evidence-based clinical judgment. No recommendation is made.
Shared decision making is another name for nondirective counseling and, therefore, not a universal model of informed consent.
●Medically reasonable alternative – A medically reasonable alternative is a clinical management approach that is technically possible and supported in beneficence-based clinical judgment.
●Preventive ethics – The use of the informed consent process to anticipate and prevent ethical conflict.
●Respect for autonomy – An ethical principle that creates the clinician's obligation to empower the patient with information about the medically reasonable alternatives for clinical management and to make voluntary decisions.
●Assisted decision making – Assisted decision making in the professional ethics of obstetrics refers to utilizing others (eg, family, other caregivers or clinicians) to assist patients in exercising their capacity to make decisions for themselves when impairments of their decision-making capacity are potentially reversible with such assistance.
●Best interest standard of surrogate decision making – The best interest standard means that the surrogate decision maker should make decisions for the patient based on a comprehensive assessment of the patient's biopsychosocial interests.
●Substituted judgment standard of surrogate decision making – The substituted judgment standard means that the surrogate decision maker should make a good-faith effort to make decisions based on an understanding of the patient's values and beliefs when these are reliably known.
STEPS IN INFORMED CONSENT
Adult pregnant patients — In the professional ethics of obstetrics and in health law, adult pregnant patients are presumed to have the capacity to participate in the informed consent process [3]; exceptions are discussed below (see 'Patients with impaired mental capacity' below). To empower a pregnant patient to participate in the informed consent process, the clinician should lead the patient through the following steps [4,5]:
●Identify the medically reasonable alternatives for the management of the patient's condition. A form of clinical management is medically reasonable when both of two criteria are satisfied: the clinical management is technically feasible and there is an evidence base for prediction of net clinical benefit (an excess of clinical benefits over harms). This is known as a beneficence-based clinical judgment. When a form of clinical management is technically feasible but not reliably predicted to result in outcomes with net clinical benefit, it is not medically reasonable and should not be offered. The belief that it is ethically permissible to offer clinical management whenever it is technically feasible is false.
●Present the medically reasonable alternatives to the pregnant patient with a description of essential clinical components, clinical benefits, and clinical risks. Risks include those commonly observed, such as postoperative pain, discomfort, and prolonged recovery after cesarean. Risks also include rare events that have serious, far-reaching, and irreversible consequences, such as death from general anesthesia.
The language used should be appropriate to the patient's educational attainment, and the pace should be based on the clinician's sense of the patient's informational needs. Literature or other teaching tools (videos, websites) can improve communication and patient understanding. The patient should be encouraged to ask questions, and answers should be professional, evidence-based, and respectful. When patients have adequate mastery of information about the medically reasonable alternatives, they have achieved what is known as cognitive understanding in the professional ethics of obstetrics [6].
●Ensure that the patient understands that the consequences of medically reasonable alternatives could happen. This is known as appreciation in the professional ethics of obstetrics [6]. Patients should be supported as needed (eg, in cases of denial) to achieve appreciation.
●Assist the patient to evaluate the medically reasonable alternatives. Asking patients what is important to them for their pregnancy and its outcomes assists in bringing their values to mind and using these values to assess the benefits and risks that have been described in the previous steps. For example, a patient may express a high priority on a vaginal rather than cesarean birth. The goal is for the patient to achieve what is known as evaluative understanding in the professional ethics of obstetrics [6].
●When there is only one medically reasonable alternative, and when among two or more such alternatives one is superior in evidence-based clinical judgment, the clinician should recommend it. This information is usually valued by patients and can help to achieve evaluative understanding. Making recommendations is known as directive counseling in the professional ethics of obstetrics [7]. For example, the obstetrician should strongly recommend cesarean birth for well-documented, intrapartum complete placenta previa as the only medically reasonable alternative.
●When there is no clinically superior medically reasonable alternative, all should be offered and none recommended. This is known as nondirective counseling or shared decision making in the professional ethics of obstetrics. Because of their narrow scope, neither nondirective counseling nor shared decision making should be considered a universal model for decision making with pregnant patients [2,7]. For example, when a pregnant patient has had a single previous cesarean with a low transverse incision, the obstetrician should offer both trial of labor after cesarean (TOLAC) and planned cesarean birth.
●Assess comprehension. The clinician should make a reasonable effort to ensure that the patient understands the information that was provided. A useful technique to assess understanding is to ask the patient to summarize the information that has been conveyed and to clarify any misunderstandings.
●Elicit the patient's voluntary authorization. The clinician should be alert to and seek to mitigate sources of internal influence (such as extreme anxiety) or external influence (well-meaning but intrusive family members) that appear to be controlling the patient's decision-making process.
A condition for valid informed consent is that the patient makes decisions voluntarily (ie, free from coercion or manipulation). Coercion occurs when intentional threats or other actions substantially constrain the patient's ability to choose freely. For example, a clinician might attempt to coerce a patient by stating that the clinician will terminate the clinical relationship unless the patient undergoes a particular procedure. Manipulation involves attempts to influence the patient's choices through behaviors such as withholding information or lying.
●Ask the patient to sign required organizational forms to document the process, content, and authorization of consent. This step is not identical to the seven preceding steps, which underscores the dictum that a signed consent form, while it documents the authorization component of the informed consent process, is never equivalent to that process [3,8]. Appropriate documentation is described separately. (See "Informed procedural consent", section on 'Documentation'.)
Special populations and settings
Pediatric patients — The law in every state makes provisions for the roles of pediatric patients in obstetric decision making. These provisions may differ in their detail (eg, some states hold that pregnancy emancipates a minor and others do not), but all agree that the informed consent process for adult patients should be followed. The clinician should adjust the above steps to the developmental stage and its limitations of the patient (see 'Adult pregnant patients' above). For example, younger pregnant adolescents or adolescents with an unwanted pregnancy or a pregnancy resulting from sexual assault may need increased psychosocial support to achieve cognitive understanding, appreciation, and evaluative understanding. Adolescent patients may also need protection from controlling influences, including family members or older male partners (the wider the age gap, the greater the vulnerability of the adolescent patient to control by the partner).
The clinician should be aware of legal limits placed on the decision-making authority of pregnant adolescents in the applicable jurisdiction. Some states place no restrictions, but others do (eg, states with parental notification laws that govern decision making about termination of pregnancy). Organizational policy should be based on applicable law and strictly followed. Consultation with appropriate legal counsel should be sought when there are questions about the nature and applicability of these legal limits on the scope of decision-making authority of adolescent patients.
Consent in adolescent health care, including different categories of minor status (eg, emancipated minor, medically emancipated minor, mature minor); consent for specific medical/obstetric services; refusal to consent; and liability for payment are reviewed in detail separately. (See "Consent in adolescent health care".)
Patients with potential language barriers — When a patient does not speak the local language, informed consent should be obtained in the patient's native language using an interpreter, preferably one who is familiar with medical terminology. This is necessary to ensure that both the patient and clinician understand the information being conveyed. Translation services through interpreters, including by telephonic communication, are required for accreditation by the Joint Commission.
Family members should not be used to interpret information because they may filter or inaccurately translate the information, which may impede the patient's ability to make an informed judgment. The patient may also be uncomfortable asking some questions or giving truthful answers when a family member is the interpreter.
Urgent situations — An exception to the requirement for informed consent is a medical emergency, which exists when an urgent, lifesaving procedure is required (eg, endotracheal intubation in the setting of acute respiratory failure) and delaying the procedure in order to obtain informed consent would pose a risk of serious, imminent harm (eg, death or severe disability). In such emergencies, the courts have recognized a doctrine of implied consent; the clinician may assume the patient would consent based on the assumption that no reasonable person would refuse the procedure in these circumstances. For example, a pregnant patient brought to the emergency department after an automobile accident with suspected abdominal bleeding can be taken immediately to the operating room for laparoscopic exploration and repair of potential bleeding sites. However, a patient with a terminal condition may have an advance directive expressing refusal of live-lengthening intervention.
The emergency exception should not be used when it is possible to obtain informed consent. Moreover, it should not be used to override a patient's clearly articulated treatment preferences (eg, a patient who refuses blood transfusions on religious grounds). Finally, even if a complete informed consent conversation is not possible, it is often possible in emergency settings to have an abbreviated discussion about the treatment in question. The goal should be simple consent (ie, the patient says "yes" after a brief explanation of what needs to be done). After clinical intervention is completed and the patient is stable, the patient should be informed about what happened and participate in informed decision making about subsequent clinical management.
Patients with impaired mental capacity — Capacity refers to the ability to utilize information about the patient's condition and proposed treatment options to make a choice that is congruent with the patient's values and preferences. The law and ethics have settled on four decision-making abilities that constitute capacity: understanding, expressing a choice, appreciation, and reasoning. When patients exhibit difficulty in any of these decision-making abilities, assessment of decision-making capacity should be undertaken [6]. For patients whose impairments may be reversible, assisted decision making should be used. For patients whose impairments are severe enough that they are judged to irreversibly lack the capacity to make a decision, surrogate decision making should be used. (See "Assessment of decision-making capacity in adults".)
●Assisted decision making – Mental illnesses and disorders have an impact on the patient's ability to participate in the informed consent process, with the adversity of impact a direct function of the severity of the mental illness or disorder [6,9]. This impact may be reversible. In response, the clinician should work with the patient to determine whether the patient can complete the steps of the informed consent process. If the patient struggles to do so, the clinician should involve a mental health professional with the goal of supporting the patient to complete the steps. Others, especially family members, should be enlisted in this process (eg, to help patients express what is important to them and to achieve a stable evaluative understanding). The goal is to support patients in exercising their capacity to make decisions for themselves. This is known as assisted decision making in the professional ethics of obstetrics [6,9].
●Surrogate decision making – In some cases, the process of assisted decision making does not succeed in enabling patients to make decisions for themselves. Others need to decide for the patient, which is known as surrogate decision making [8]. Who should serve as the surrogate decision maker is addressed in applicable law and should be reflected in organizational policy based on applicable law.
Surrogate decision making should first attempt to meet the substituted judgment standard, according to which the surrogate should make a good-faith effort to make decisions on the basis of the patient's values and beliefs when these are reliably known. In some jurisdictions, values and beliefs are "reliably known" under the preponderance of evidence rule (more likely than not to be true [ie, accept the surrogate's judgment unless there is evidence that the surrogate is not acting in good faith]). In other jurisdictions, values and beliefs are "reliably known" under the clear and convincing rule (75 percent probability of being true, a more demanding standard).
When substituted judgment cannot be achieved, the best interest standard should guide the surrogate. Judgments should be based on a comprehensive assessment of the patient's biopsychosocial interests.
In the professional ethics of obstetrics, the surrogate decision maker can make any decision that the patient would make, including decisions to continue or to terminate a pregnancy. However, some jurisdictions restrict the legal scope of obstetric decision making (eg, they do not recognize the authority of an advance directive or surrogate decision maker to authorize termination of pregnancy or withdrawal of life-sustaining therapies [10]. They may require continuation of life-sustaining therapy in the interest of fetal survival).
Surrogate decision making plays a major role when the pregnant patient's condition requires critical care management that has temporarily reduced the patient's decision-making capacity. (See "Ethics in the intensive care unit: Informed consent".)
ADDITIONAL MEDICOLEGAL ISSUES — Additional medicolegal dimensions of informed consent (eg, the duty to inform, consequences of failure to obtain informed consent, withdrawal of consent) are presented elsewhere. (See "Informed procedural consent".)
PREVENTIVE ETHICS — Making reliable decisions with patients during the intrapartum period can be put at risk by distraction and time constraints. These limitations can hinder the decision-making process with patients, increasing the risk for miscommunication and subsequent disagreement between the patient and clinician about the care plan. Obstetrics has the distinct advantage, when a patient is receiving prenatal care, to initiate the informed consent process in advance of the time at which decisions have to be made and thus prevent miscommunication and disagreement. This is known in the professional ethics of obstetrics as preventive ethics [11]. For example:
●All pregnant patients should be informed that 2 to 3 percent of all pregnancies are affected by fetal anomalies [12]. If an anomaly occurs, it is almost certainly not the fault of the pregnant patient or clinician. The clinician should explore with the patient options for risk assessment, diagnosis, and management of fetal anomalies.
●All pregnant patients should be informed that a normal, low-risk pregnancy can suddenly and without warning become a high-risk pregnancy, for which cesarean birth may be necessary and therefore strongly recommended for either the patient's health or the fetus's and future child's health [11]. If patients have strong reservations about cesarean birth, this approach allows them to surface these reservations well before the intrapartum period, making it feasible to address and resolve them.
●The clinician, in conjunction with the oncologist, should provide information to a pregnant patient with newly diagnosed cancer about how cancer treatment might affect the pregnancy and the medically reasonable alternatives that may need to be subsequently considered.
●The clinician should inform pregnant patients with preexisting disease that might be worsened by pregnancy about the signs and symptoms for which patients should self-monitor and contact the clinician when they occur.
RESPONDING TO REQUESTS FOR INAPPROPRIATE CLINICAL MANAGEMENT — Inappropriate requests, by definition, are requests for types of clinical management that are not medically reasonable because they are incompatible with evidence-based clinical judgment (eg, requesting vaginal birth in the setting of placenta previa or a persistent category III fetal tracing). A trial of the patient's preference is therefore ethically inappropriate. Instead, the clinician's goal should be to transform such requests into informed requests by implementing the steps of informed decision making described above. (See 'Adult pregnant patients' above.)
This process should include a clear description of the clinical reality that cesarean birth may be necessary to protect both the mother and fetus. Almost always, this empowerment of the patient's autonomy will result in the withdrawal of inappropriate requests. If necessary, the clinician should explain that professional integrity prohibits implementing clinically inappropriate care plans [8]. The informed consent process should not be based on such self-interest. The clinician, therefore, bears the responsibility of preventing bias of the informed consent process originating in self-interest. This goal can be routinely accomplished by following the steps of the informed consent process described above. (See 'Steps in informed consent' above.)
RESPONDING TO PREGNANT PATIENTS WHO DECLINE BLOOD TRANSFUSION — Pregnant patients can legally refuse transfusion. However, when a mother's life will likely be lost unless transfused, leaving behind a healthy newborn, the father or a designated guardian should be available to care for the child. If no parent or guardian will be available to care for the newborn after the mother's death, the question has been raised as to whether the transfusion should be given in order to save the life of the infant's sole caregiver. This controversial possibility must be weighed carefully by the hospital ethics committee and in the court system. Hospital policy should guide decision making about these controversies and documenting the patient's decision.
The case of a pregnant patient carrying a fetus that needs transfusion before birth to save its life is also legally and ethically controversial and should be approached similarly. The law and professional ethics in pediatrics are clear that, when necessary to prevent the death of a neonatal patient, transfusion and other lifesaving procedures should be performed even if the parents refuse.
The ethical, legal, and practical clinical issues of declining blood transfusion are discussed in detail separately. (See "Approach to the patient who declines blood transfusion".)
PREVENTING BIAS OF THE INFORMED CONSENT PROCESS ORIGINATING IN CONFLICTS OF INTEREST — Conflicts of interest occur in decision making when the process is influenced by the clinician's self-interest [8]. The informed consent process should not be based on such self-interest. The clinician, therefore, bears the responsibility of preventing bias of the informed consent process originating in self-interest.
A powerful form of self-interest, and therefore a source of bias, is personal convenience. Performing a cesarean birth may allow the physician to spend less time in the hospital with a laboring patient. Fetal tracings and labor curves are known to be variable in their interpretation and therefore at risk for being slanted to justify a cesarean of convenience, as the clinician can tell the patient that such findings are concerning. This results in prohibited bias of the informed consent process. Clinicians have the responsibility to protect their professional integrity by practicing heightened self-awareness and critical appraisal of their own clinical judgment to prevent such bias and the unnecessary procedures that can result.
RESOURCES — The American College of Obstetricians and Gynecologists provides resources on informed consent for its members and others, including:
●Committee Opinion Number 819: Informed Consent and Shared Decision Making in Obstetrics and Gynecology [13]
●Informed consent forms and documenting informed consent (members only)
●Informed consent versus shared decision making (members only)
●Informed consent for surgical procedures (members only)
SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: General prenatal care" and "Society guideline links: Labor".)
SUMMARY AND RECOMMENDATIONS
●Adult pregnant patients – Clinicians and their patients should utilize the informed consent process for obstetric management in a stepwise process that implements the ethical principles of beneficence and respect for autonomy. A condition for valid informed consent is that the patient has the capacity to make informed and voluntary (free from coercion or manipulation) decisions. (See 'Adult pregnant patients' above.)
●Special populations and settings
•Pediatric patients – Pregnant pediatric patients are treated by the law in some jurisdictions as adults. (See 'Pediatric patients' above.)
•Patients with potential language barriers – When a patient does not speak the local language, informed consent should be obtained in the patient's native language using an interpreter, preferably one who is familiar with medical terminology, to ensure that the patient understands the information being conveyed by the clinician and is able to ask questions. (See 'Patients with potential language barriers' above.)
•Urgent situations – The emergency exception to the requirement for informed consent exists when an urgent, lifesaving procedure is required and delaying the procedure to obtain informed consent would pose a risk of serious, imminent harm. In such emergencies, the clinician may assume the patient would consent based on the assumption that no reasonable person would refuse the procedure in these circumstances, unless there is a valid advance directive refusing such clinical intervention. (See 'Urgent situations' above.)
•Patients who cannot complete the informed consent process – For patients who have not been able to complete the steps of the informed consent process, the clinician should attempt assisted decision making to reverse impairments of decision making. For patients for whom assisted decision making fails (ie, the patient has irreversibly lost the capacity to complete the steps of the informed consent process), the clinician should complete the steps of the informed consent process with the legally designated surrogate decision maker, implementing, in priority order, the substituted judgment standard and then the best interest standard. (See 'Patients with impaired mental capacity' above.)
●Inappropriate requests – The clinician should respond to clinically inappropriate requests of patients by utilizing the steps of the informed consent process with the goal of transforming the patient's request into an informed request. (See 'Responding to requests for inappropriate clinical management' above.)
●Preventing bias – Clinicians have the professional responsibility to practice heightened self-awareness and critical appraisal of their own clinical judgment to prevent bias originating in conflicts of interest and the unnecessary procedures that can result. (See 'Preventing bias of the informed consent process originating in conflicts of interest' above.)
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