Introduction

Informed consent is the process in which a health care 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 physicians 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. These events, alongside the development of the Nuremberg Code and the Declaration of Helsinki, solidified informed consent as a foundational ethical requirement in both research and clinical practice. Over time, informed consent evolved to not only involve a patient's signature but also the process of clear communication, ensuring that patients understand the risks, benefits, and alternatives to medical interventions, ultimately making it a cornerstone of patient-centered care and medical ethics.[1][2]

The patient must be competent to make a voluntary decision about whether to undergo a procedure or intervention. Implicit in providing informed consent is an assessment of the patient's understanding, rendering an actual recommendation, and documentation of the process. Health care professionals must make a recommendation and provide their reasoning for that recommendation. The clinician must make it clear that the patient is participating in the decision-making process and must avoid making the patient feel forced to agree with the clinician.[3][4][5]

This activity focuses on the critical aspects of informed consent and common challenges in obtaining informed consent. Participants will gain a deeper understanding of the ethical, legal, and practical dimensions of informed consent with an emphasis on enhancing patient communication and ensuring that consent is truly informed and voluntary. The activity also highlights the role of an interprofessional team in discussing complex medical information with patients, leading to better patient understanding and more meaningful consent.

Function

The function of informed consent in health care is to ensure that patients are fully informed about the medical procedures or treatments they are about to undergo, enabling them to make autonomous decisions about their care. It serves both ethical and legal purposes by safeguarding patient rights, fostering transparency, and promoting trust between health care 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. Additionally, informed consent protects clinicians by documenting that patients were adequately informed, reducing legal liability in case of adverse outcomes. Ultimately, informed consent functions as a tool to enhance patient-centered care and strengthen the physician-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 required elements for documentation of the informed consent discussion include the following:

1. Nature of the procedure
2. Risks and benefits of the procedure
3. Reasonable alternatives
4. Risks and benefits of alternatives
5. Assessment of the patient's understanding of elements 1 through 4

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. Informed consent, then she suggests, is the protection of self-sovereignty over one's own body.[6]

Issues of Concern

While 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 fulfills its intended purpose of protecting patient autonomy and promoting trust in the health care system.

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.[7] Results from a study by Miller et al emphasize how 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.[8][9] 

Tools like the teach-back method or test/feedback method can be employed to assess whether patients comprehend the risks, benefits, and alternatives of their treatment. Teach-back can help both patients and clinicians concentrate on the essential aspects of the information. To boost active patient participation, engagement techniques and open-ended questions may be utilized 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.[9]

Language Barriers

Language barriers and inadequate use of interpreters further exacerbate the informed consent challenge, especially in diverse populations where patients may not be fluent in the language spoken by the health care provider. Health literacy screening tools and medical interpreter services must be utilized for patients with limited proficiency in the particular spoken language.[10][11] American Sign Language (ASL) medical interpreters should be made available for deaf patients, ensuring clear and accurate communication.

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 might be seen as a sign of mistrust. Additionally, 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.[12][13][14][15]

Power Dynamics and Perceived Authority

Patients may feel pressured to consent to treatment due to the unequal power relationship between themselves and their physicians, making it difficult for them to assert their preferences and/or ask necessary questions. This issue is especially problematic in vulnerable populations, such as older individuals, those with disabilities, or individuals facing acute medical conditions, who may feel even more dependent on their clinician's judgment.

Time Pressures 

Time pressures in medical settings often result in rushed consent processes, where health care 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.[16]

In his article, "Rethinking Informed Consent, "Lenze suggests the need for a system change. Rather than clinicians consenting patients, which hints at a 1-directional pitch, informed consent should be obtained. The consent process should occur in a clinic or office setting where patients have ample time to ask questions and process their emotions, rather than 15 minutes before surgery in the preoperative holding area or as they are about to fall asleep.[17]

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.[18]

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 the decision-making process.

The required standard for adequate informed consent is determined by the state. The 3 acceptable legal approaches to adequate informed consent are as follows:

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

Many states use the "reasonable patient standard" because it focuses on what a typical patient would need 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.[19][20][21]

Inadequate Documentation 

Inadequate documentation of the informed consent process can leave health care professionals vulnerable to legal action if patients later claim they were not fully informed. A research study by Bottrell et al found that the 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.[22]

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 residents and physicians who most often obtained consent. Corrective measures included training sessions to enhance their understanding of standard consent procedures and associated risks.[23]

Electronic Consent

Electronic informed consent, also referred to as eConsent, offers several benefits, including enhanced accessibility, the ability to integrate multimedia tools for better patient understanding, and streamlined documentation processes. It 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 health care settings. Despite these hurdles, electronic consent holds significant potential to improve the informed consent process.

Obaidi et al conducted a review exploring patients' electronic consents in various health care 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.[24]

Patients with Impaired Decision-Making Capacity

Mental capacity is defined by the patient's ability to understand, retain information, evaluate options, and effectively communicate his 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.[25] Cognitive impairment, mental illness, and severe medical conditions alone do not revoke an individual's right to provide informed consent as long as they have the capacity to understand, evaluate, and communicate his decisions.

Children

Children (typically younger than age 18) cannot provide informed consent. As such, parents or legal guardians must permit treatments or interventions. In this case, it is not termed "informed consent" but "informed permission." 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 under 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 is state-based. It is essential to understand the specific state laws.

Exceptions to Informed Consent

Several exceptions to the requirement for informed consent include 1) the patient is incapacitated, 2) life-threatening emergencies with inadequate time to obtain consent, and 3) voluntary waived consent. 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 next legal surrogate decision-maker. If this is unsuccessful, a legal guardian may need to be appointed by the court.

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, ensuring their values and preferences guide their care choices. Shared decision-making in medicine, increasingly recognized as essential to patient-centered care, is a collaborative process where health care 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, while the patient expresses their goals, concerns, and priorities. This partnership leads to decisions more aligned with the patient's values and improves satisfaction, adherence to treatment plans, and overall health outcomes. Shared decision-making fosters a more patient-centered approach to care, empowering patients to take an active role in their health and ensuring that medical decisions are made with a holistic understanding of the patient's needs.[26]

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 transfusions
• Anesthesia [3][27][28]

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 (usually by signature). Discussion of all risks is paramount to informed consent in this context. Most consent includes general risks, risks specific to the procedure, risks of no treatment, and treatment alternatives. Additionally, many consent forms express no guarantees that the proposed procedure will cure 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 barrier is that some consent forms contain language that is at too high a reading level for many patients. In a search of relevant databases, Pietrsykowski et al discovered 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.[29] The use of visual and digital communication tools is being encouraged to address some of the inefficiencies in the process of obtaining consent. Patients should be actively engaged as a way to enhance communication and ensure patient safety and understanding. 

Informed consent may be waived in emergencies if there is no time to obtain consent or if the patient is unable to communicate and no surrogate decision-maker is available. Also, not every procedure requires explicit informed consent. For example, taking a patient's blood pressure is a part of many medical treatments. However, a discussion regarding the risks and benefits of using a sphygmomanometer typically is not required.

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 usually monitored by an Institutional Review Board (IRB). The IRB was established in the United States in 1974 by the National Research Act, which called for regulation in human research that was prompted by questionable research tactics used in the Tuskegee syphilis experiments and others. 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.

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

US federal regulations require a full, detailed explanation of the study and its potential risks. An IRB may waive informed consent if certain conditions are met. Paramount to this is the 'minimal risk' to the research participants. One example of minimal risk research is the assessment of interventions that generally occur in emergency situations. Examples include 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. Additionally, requiring mandatory documentation to confirm participants' comprehension and exploring regulatory reforms can further strengthen the process.[30]

Enhancing Healthcare Team Outcomes

Informed consent is a crucial process in health care that requires an interprofessional team approach to ensure it is conducted ethically, effectively, and in a manner that genuinely respects patient autonomy. Physicians bear the primary responsibility for ensuring that informed consent is obtained in a legally and ethically sound manner. Physicians must be able to clearly explain complex medical information, including risks, benefits, and alternatives to treatments or procedures. Physicians 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 physicians provide. Their skills in patient education and emotional support are 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 viewed as a team effort, where each professional’s expertise contributes to a comprehensive understanding for the patient. 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.

Health care professionals must work together to ensure that the informed consent process not only meets legal and ethical standards but also truly empowers patients, enhances their care experience, and improves clinical outcomes. When informed consent is handled effectively, patients are more likely to feel confident in their care, leading to better adherence to treatment plans and improved health outcomes. Properly informed patients are less likely to experience adverse outcomes due to misunderstandings or lack of information. Ensuring that patients are fully informed reduces the risk of errors and enhances overall patient safety. A well-coordinated and ethically sound informed consent process reflects positively on team performance, fostering a culture of trust, respect, and shared responsibility among health care professionals and patients.