Informed Consent

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Informed consent is a cornerstone of medicine, ensuring ethical treatment decisions and patient-centered care. Patients have the right to make informed and voluntary treatment decisions. Informed consent is more than merely a signature on a document; it is a communication process between the clinician and the patient. This process ensures that the patient is fully informed about the nature of the procedure or intervention, the potential risks and benefits, and the alternative treatments available. The patient can refuse or withdraw consent at any time during treatment. Informed consent respects patient autonomy, promotes trust in the patient-provider relationship, and safeguards against unethical practices. Medical care and medical research have become increasingly complex. Therefore, the role of informed consent continues to become more complicated as new medical challenges arise. Technological advances, diverse patient populations, and a growing emphasis on shared decision-making have made the topic of informed consent more open to discussion than ever before. 

This activity focuses on the critical aspects of informed consent and common challenges in obtaining informed consent. Participants explore the ethical, legal, and practical dimensions of informed consent. The emphasis is on enhancing patient communication and assuring informed and voluntary consent. This activity discusses the role of the interdisciplinary team in overcoming challenges and barriers to obtaining informed consent, thus ensuring that the patient's autonomy and rights are respected in every clinical interaction.

Objectives:

  • Identify the key elements required for the documentation of informed consent.

  • Screen patients for factors that may affect their ability to understand and provide informed consent, such as language barriers, cognitive impairments, or emotional distress.

  • Select the most suitable methods to enhance patient understanding and engagement during the informed consent process.

  • Apply interdisciplinary team strategies to implement shared decision-making and effective informed consent processes for all patients regardless of physical, mental, or societal limitations.

Introduction

Informed consent is a process in which a healthcare professional educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The history of informed consent in medicine is rooted in a broader evolution of ethical practices and legal standards surrounding patient autonomy. In the early 20th century, medical practice was largely paternalistic, with clinicians making decisions on behalf of patients without necessarily informing them of the details. The concept of informed consent began to emerge in response to several landmark legal cases, such as the 1914 case of Schloendorff v. Society of New York Hospital, where the court ruled that every human being of adult years and sound mind has a right to determine what shall be done with his own body. This ruling established the principle that patients must agree to medical procedures.

In the mid-20th century, unethical medical experiments, including the Tuskegee Study of Untreated Syphilis in the Negro Male and the Nazi human experiments during World War II, further underscored the need for stringent consent standards.[1] These events, along with the establishment of the Nuremberg Code and the Declaration of Helsinki, cemented informed consent as a fundamental ethical standard in research and clinical practice. [2][3] Informed consent has evolved from simply obtaining a patient's signature to a process centered on clear communication. This approach ensures that patients understand the risks, benefits, and alternatives of medical interventions, establishing it as a cornerstone of patient-centered care and medical ethics.[4][5] 

The patient must be competent to make a voluntary decision regarding whether to undergo a procedure or intervention. Providing informed consent requires assessing the patient's understanding, making a clear recommendation with supporting reasoning, and documenting the process. Healthcare professionals must emphasize the patient's active participation in decision-making and avoid creating any sense of coercion to agree with the clinician's recommendation.[6][7][8][9]

Function

The function of informed consent in health care is to ensure that patients are fully informed about the medical procedures or treatments they may undergo, enabling them to make autonomous decisions about their care. The informed consent process serves ethical and legal purposes by safeguarding patient rights, fostering transparency, and promoting trust between healthcare professionals and patients. Informed consent ensures that patients understand the risks, benefits, alternatives, and potential consequences of medical interventions, allowing them to weigh their options and participate actively in their treatment plans. This process is critical for respecting patient autonomy and allowing individuals to make decisions aligned with their values, beliefs, and preferences. In addition, informed consent protects clinicians by documenting that patients were adequately informed, reducing legal liability in case of adverse outcomes. Ultimately, informed consent is a tool to enhance patient-centered care and strengthen the clinician-patient relationship through open, honest communication.

The Joint Commission requires documentation of all the elements of informed consent in a form, progress notes, or elsewhere in the record. The elements needed for the documentation of the informed consent discussion include: 

  • The nature of the procedure or intervention
  • The risks and benefits of the procedure or intervention
  • Reasonable alternatives
  • The risks and benefits of alternatives
  • An assessment of the patient's understanding of these elements [10][11]

Smolenski recently redefined the functional meaning of informed consent to include the cross-section of 2 groups of values—autonomy and nondomination, followed by self-ownership and personal integrity. Smolenski suggests that informed consent is the protection of self-sovereignty over one's own body.[12][13][14][15][16]

Issues of Concern

Although informed consent is fundamental to ethical and legal medical practice, several issues of concern can compromise its effectiveness and the quality of patient care. These issues highlight the importance of improving communication, patient education, cultural competency, and ethical practices within the informed consent process to ensure it is intended to protect patient autonomy and promote trust in the healthcare system.[17]

Lack of Patient Comprehension

Complex medical jargon and varying levels of health literacy often result in patients agreeing to procedures or treatments without fully understanding the risks, benefits, or alternatives. Even when information is provided, it may not be communicated in a way that matches the patient's cognitive needs. This mismatch can lead to situations where consent is not truly informed, undermining patient autonomy and trust. Using everyday language instead of medical jargon is essential when communicating with patients or their proxies.

Recently, Zhang et al found an inadequacy in personal functional health literacy of hospitalized patients in Chinese teaching hospitals, resulting in compromised informed consent. The same study also identified impaired organizational health literacy. Recommendations were made to enhance the quality of informed consent forms and implement institutionally mandated, outcome-focused training on the subject for all clinicians.[18] A study by Miller et al highlighted that implementing a health literacy-based consent form and process improved patient-provider communication, increased patient comfort in asking questions, and encouraged the use of the teach-back technique in the perioperative setting.[19][20] 

Tools such as the teach-back method or test/feedback method can be used to assess whether patients comprehend the risks, benefits, and alternatives of their treatment. The teach-back method can help both patients and clinicians concentrate on the essential aspects of the information. To encourage active patient participation, engagement techniques and open-ended questions may be used to gather insights into patients' needs and preferences. Patients should be encouraged to ask questions to foster a more interactive dialogue. Interactive media and graphical tools can improve shared decision-making and effectively assess and present risks. Future research should continue to explore interactive interventions, given that these methods appear superior in improving patient comprehension.[20][21][20]

Language Barriers

Language barriers and the inadequate use of interpreters further complicate the informed consent process, especially in diverse populations where patients may not be fluent in the healthcare provider's language. Health literacy screening tools and medical interpreter services must be used for patients with limited proficiency in the particular spoken language.[22][23] American Sign Language (ASL) medical interpreters should also be available for hearing-impaired patients, ensuring clear and accurate communication.[21]

Cultural Differences

Ensuring cultural sensitivity is crucial in the informed consent process. In certain cultures, decisions are made collectively by a group rather than by individual signatures, and written consent may be perceived as a sign of mistrust. In addition, undocumented immigrants might hesitate to sign consent forms due to fears of deportation. In some cultures, the consent process involves consulting a family patriarch or a male representative designated by the family.[24][25][26][27]

Power Dynamics and Perceived Authority

Patients may feel pressured to consent to treatment due to the unequal power relationship between themselves and their clinicians, making it difficult for them to assert their preferences or ask necessary questions. This issue is especially problematic in vulnerable populations, such as older individuals, those with disabilities, or those facing acute medical conditions, who may feel even more dependent on their clinician's decision. Incarcerated individuals represent a particularly vulnerable population, requiring special consideration due to the limitations on their choices. Ensuring informed consent in this group demands meticulous attention to detail to uphold their autonomy and rights during treatment decisions.[28]

Time Pressures

Time pressures in medical settings often result in rushed consent processes, where healthcare professionals might not dedicate adequate time to thoroughly discuss all aspects of the decision-making process. Patients may be left feeling uninformed or uncertain but still obligated to proceed. Ideally, the decision-making process should allow patients a period of reflection.[29]

In his article, Rethinking Informed Consent, Lenze advocates for a more patient-centered approach to informed consent, emphasizing the need for a structured, two-way dialogue rather than a one-directional explanation from the healthcare provider. He proposes that informed consent should take place in a clinic or office setting, allowing patients sufficient time to ask questions and process their emotions. Lenze highlights examples of improper methods for obtaining consent, such as discussing the procedure shortly before it occurs, obtaining consent in the preoperative holding area, and securing consent when the patient is medicated or when the patient is on the verge of falling asleep.[30]

Changing Medical Circumstances

Evolving medical conditions, such as the COVID-19 pandemic, can necessitate updates to consent forms to reflect new risks, treatment protocols, and uncertainties related to the condition. For example, consent forms may need to include specific information about infection risks, changes in hospital procedures, or the potential impact of the virus on treatment outcomes. Keeping consent forms current ensures that patients are fully informed about the latest developments and can make well-informed decisions in light of changing health circumstances.[31]

Incomplete Disclosure

Ethical concerns arise when information is incompletely disclosed, either intentionally or unintentionally, such as downplaying certain risks or not presenting all available treatment options, including non-treatment. These occurrences can sometimes be driven by provider bias, where clinicians may assume what is best for the patient without fully engaging them in decision-making.

The particular state determines the required standard for adequate informed consent. The 3 acceptable legal approaches to adequate informed consent are as follows:

  • Subjective standard: What does this patient need to know and understand to make an informed decision? 
  • Reasonable patient standard: What does the average patient need to know to be an informed participant in the decision? 
  • Reasonable clinician standard: What does a typical clinician say about this procedure?

Many states use the reasonable patient standard because it focuses on what a typical patient needs to know to understand the decision at hand. However, it is the sole obligation of the clinician to determine which approach is appropriate for a given situation.[32][33][34]

Inadequate Documentation 

Inadequate documentation of the informed consent process can leave healthcare professionals vulnerable to legal action if patients later claim they were not fully informed. A study by Bottrell et al found that 4 required elements of informed consent—nature of the procedure, risks, benefits, and alternatives—were documented on consent forms only 26.4% of the time.[35]

Mohamed et al conducted a retrospective cross-sectional study examining consent forms for patients undergoing femur fracture operations. Study results revealed inadequate documentation of orthopedic-specific risks. The omissions were believed to be secondary to insufficient orthopedic training for the resident clinicians who most often were tasked with obtaining consent. Corrective measures included training sessions to enhance understanding of standard consent procedures and associated risks.[36][37][36]

Electronic Consent

Electronic informed consent, also called eConsent, offers several benefits, including enhanced accessibility, the ability to integrate multimedia tools for better patient understanding, and streamlined documentation processes. eConsent can improve patient engagement by allowing individuals to review information at their own pace and revisit materials when needed. However, challenges remain, such as ensuring equitable access for patients with limited technological proficiency or resources, addressing data privacy and security concerns, and navigating the regulatory complexities of implementing electronic informed consent systems across diverse healthcare settings. Despite these hurdles, electronic consent can significantly improve the informed consent process.

Obaidi et al conducted a review exploring patients' electronic consents in various healthcare settings and compared them to paper-based consents. The findings indicated that electronic consent is linked to key factors such as providing adequate information, ensuring accuracy, improving shared decision-making, and increasing efficiency.[38]

Patients with Impaired Decision-Making Capacity

Mental capacity is defined by the patient's ability to understand and retain information, evaluate options, and effectively communicate a decision. Informed consent can be challenging in specific situations, such as with patients who have impaired decision-making capacity due to cognitive impairments, mental health conditions, or severe illness. In these cases, assessing the patient's ability to provide informed consent may become complex, requiring involvement from surrogates or legal guardians, which can further complicate the process.[39] Cognitive impairment, mental illness, and severe medical conditions alone do not revoke an individual's right to provide informed consent as long as they can understand, evaluate, and communicate their decisions.[39]

Children

Children, typically younger than 18, cannot provide informed consent. Instead, parents or legal guardians must permit treatments or interventions. In this case, the process is termed informed permission, not informed consent. An exception to this rule is a legally emancipated child who may provide informed consent for herself. Some, but not all, examples of emancipated minors include minors who are younger than 18 and married, those serving in the military, those able to prove financial independence, and mothers of children (married or not). Legislation regarding minors and informed consent varies by state, so it is crucial to be aware of specific state laws.

Exceptions to Informed Consent

Several exceptions to the requirement for informed consent include:

  • When the patient is incapacitated
  • In life-threatening emergencies where there is not enough time to obtain consent
  • When consent is voluntarily waived

If the patient's decision-making ability is questioned or unclear, a psychiatrist may be requested to evaluate the patient to determine competency. A situation may arise in which a patient cannot make decisions independently but has not designated a decision-maker. In this instance, the hierarchy of decision-makers, determined by each state's laws, must be sought to determine the subsequent legal surrogate decision-maker. If this is unsuccessful, a legal guardian may need to be appointed by the court. .[40]

Clinical Significance

The concept of shared decision-making has evolved from the foundational idea of informed consent, expanding the focus from simply obtaining patient permission to actively involving patients in the decision-making process and ensuring their values and preferences guide care choices. Shared decision-making in medicine, increasingly recognized as essential to patient-centered care, is a collaborative process where healthcare professionals and patients work together to make informed decisions. This approach recognizes the clinician's expertise in understanding medical evidence and treatment options while equally valuing the patient's preferences, values, and unique circumstances. Through open dialogue, both parties share information—the clinician explains the risks, benefits, and uncertainties of various options, whereas the patient expresses their goals, concerns, and priorities. This partnership leads to decisions that are more aligned with the patient's values. This shared decision-making improves satisfaction, adherence to treatment plans, and overall health outcomes. In addition, shared decision-making fosters a patient-centered approach to care, which empowers patients to take an active role in their health and ensures that medical decisions are made with a holistic understanding of the patient's needs.[41]

Informed consent is required for various aspects of health care, including the following: 

  • Treatment
  • Dissemination of patient information
  • Discussion of the Health Insurance Portability and Accountability Act (HIPAA) rules
  • Specific procedures
  • Surgery
  • Blood and medication infusions
  • Anesthesia [6][42][43]

Obtaining informed consent in medicine is a process that should include describing the proposed intervention, emphasizing the patient's role in decision-making, discussing alternatives to the proposed intervention, discussing the risks and benefits of the proposed intervention, and eliciting the patient's preference, often confirmed by their signature. Effective informed consent requires a thorough discussion of all relevant risks, which typically encompasses general risks, risks specific to the procedure, risks of no treatment, and treatment alternatives. In addition, many consent forms express no guarantees that the proposed method can resolve the problem being addressed.

Patient safety is a primary focus in health care, and adequate informed consent is considered a patient safety issue. The Joint Commission recently addressed the challenges to ensuring effective informed consent. The emphasis on a patient signature as an indication of understanding is being called into question. The informed consent process is shifting to focus more on communication and less on signatures.

Studies of informed consent have found many barriers to obtaining effective informed consent. One significant issue is that some consent forms are written at a reading level that is too high for many patients to comprehend. In a search of relevant databases, Pietrsykowski et al found that patients' comprehension of fundamental informed consent components was low. This outcome is concerning, as it raises doubts about the extent to which patients can fully and authentically participate in the shared medical decision-making process.[44] The use of visual and digital communication tools is encouraged to improve the efficiency of obtaining consent. Actively engaging patients can enhance communication and ensure their safety and understanding.[45][46]

Informed consent may be waived in emergencies when there is no time to obtain consent or when the patient cannot communicate, and no surrogate decision-maker is available. If concerns or uncertainties exist about a patient's decision-making capacity, a psychiatrist may be consulted to evaluate their competency. A situation may arise in which a patient cannot make decisions independently but has not designated a decision-maker. In this instance, the hierarchy of decision-makers, determined by each state's laws, must be sought to determine the next legal surrogate decision-maker. [47]

Other Issues

Human Clinical Studies

Informed consent is mandatory for all clinical trials involving human beings. The consent process must respect the patient's decision-making ability and adhere to the individual hospital rules for clinical studies. Adherence to ethical standards in study design and execution is typically monitored by an Institutional Review Board (IRB). The IRB was established in the United States in 1974 under the National Research Act, which introduced regulations for human research in response to unethical practices, such as those observed in the Tuskegee syphilis experiments. Ethical and safe research standards have been an area of federal and presidential interest since then, with the development of many organizations and task forces since 1974 dedicated to this topic alone. Receiving special attention is the ability or inability of the inmate population to give truly voluntary informed consent to participate in research studies. [48]

Valid informed consent for research must include 3 major elements as follows:

  • Disclosure of information
  • Competency of the patient (or surrogate) to make a decision
  • The voluntary nature of the decision

United States federal regulations require a thorough and detailed explanation of the study and its potential risks. An IRB may waive the requirement for informed consent under specific conditions. Paramount to this is the minimal risk to the research participants. An example of minimal risk research is the assessment of interventions that generally occur in emergency situations, such as studying medications used for intubation in the emergency department or conducting a retrospective chart review.

Emmanuel and Boyle outlined the need to reconsider the consent process within the clinical research realm. Potential improvements may involve shifting the focus toward the dialogue aspect of the consent process and reducing reliance on the consent form itself. Greater use of multimedia and technology can enhance understanding, along with more structured, formalized scripts for consent discussions. In addition, requiring mandatory documentation to confirm participants' comprehension and exploring regulatory reforms can further strengthen the process.[49]

Enhancing Healthcare Team Outcomes

Informed consent is a crucial process in healthcare that requires an interprofessional team approach to ensure it is conducted ethically, effectively, and in a manner that genuinely respects patient autonomy. Clinicians bear the primary responsibility for ensuring that informed consent is obtained in a legally and ethically sound manner. Clinicians must be able to clearly explain complex medical information, including risks, benefits, and alternatives to treatments or procedures. Clinicians need strong interpersonal skills to gauge patient understanding and address concerns empathetically. Advanced practitioners and nurses play a critical role in reinforcing and clarifying the information provided by clinicians. Their expertise in patient education and emotional support is essential for ensuring that patients feel comfortable asking questions and making informed decisions. Social workers, patient advocates, and care coordinators should be skilled in providing additional support, especially in complex cases involving vulnerable populations or challenging decision-making scenarios. Informed consent should be approached as a collaborative effort, with each professional's expertise contributing to the patient's comprehensive understanding. Members of the team may also serve as witnesses to the consent.

A well-coordinated strategy involves regular communication among the care team members to ensure everyone is aligned with the information being presented to the patient. This approach prevents conflicting messages and ensures that all aspects of care are covered. Strategies should include tailoring the consent process to the individual needs of the patient, considering factors such as literacy level, cultural background, and emotional state. Using visual aids, simplified language, or interpreters as needed can enhance understanding. Accurate and thorough documentation of the informed consent process is essential. Strategies should also include follow-up conversations to address any ongoing questions or concerns the patient might have.

Healthcare professionals must collaborate to ensure that the informed consent process fulfills legal and ethical obligations, empowers patients, enhances their care experience, and improves clinical outcomes. When handled effectively, informed consent builds patient confidence, promoting adherence to treatment plans and improving health outcomes. Fully informed patients are less likely to encounter adverse outcomes due to misunderstandings or inadequate information. This process also minimizes the risk of errors, bolstering patient safety. Furthermore, a well-executed and ethically sound informed consent process enhances team performance, fostering a culture of trust, respect, and shared responsibility among healthcare professionals and patients.

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Parth Shah

Author

Imani Thornton

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Nancy L. Kopitnik

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John E. Hipskind

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