Informed Consent

Informed Consent

Despite popular belief, informed consent is not a document but a process involving communication or the meaningful exchange of information between healthcare professionals, patients, study participants, and researchers. In this regard, informed consent can be said to be of two types-informed consent for medical research and informed consent for clinical treatment. Farmer & Lundy (2017) define informed consent for treatment as a process during which healthcare professionals present a patient or their surrogate with information about the client’s diagnosis, prognosis, health status, treatment options, and risks associated with every treatment choice to allow them to participate in clinical decision-making. On the other hand, informed consent for research purposes involves a process of information exchange between researchers and participants during which participants are informed of the study’s nature, risks, implications, and significance (Adams et al., 2017). In both cases, the decision must be written, signed, dated, and obtained independently and voluntarily from the client or participant.

For informed consent to be deemed meaningful, valid, and complete, it must satisfy four main standards. The first one is information disclosure which dictates that the patient should be given enough information in a manner that facilitates their reception, comprehension, and processing of such information to make decisions independently. This requirement is fulfilled by ensuring that subjective, reasonable patient and physician standards are observed during disclosure (Shah et al., 2021). The second principle of meaningful informed consent is competence, which states that the patient should have the capacity to make an informed clinical decision. In cases where the patient’s competence is questionable and a psychiatrist determines that they are incompetent, decision-making is delegated to a surrogate who may be the patient’s healthcare professional or a court-appointed legal guardian. The third requirement is comprehension, where the patient must understand the information presented to them, and the final criterion is voluntariness, meaning consent should not be coerced (Kadam, 2017).

The principle of informed consent has become particularly salient in recent times due to a shift from paternalistic care practices in which healthcare providers are viewed as experts in clinical decision-making to patient-centered care where the patient is perceived as an active participant and expert in their own health. This requires the patient to be involved and consulted when making healthcare-related decisions. In patient-centered care, the nurse is the patient’s advocate, with a responsibility to ensure that care is responsive and respectful of patient needs. According to Strini et al. (2021), nurses play an essential role in the informed consent process because they interact with patients and their families the most and are thus conversant with their beliefs, values, and desires. Therefore, they can ensure that client autonomy is respected during clinical decision-making.

However, implementing informed consent introduces a host of ethical and legal difficulties since patients’ decision-making capacity can be limited by numerous factors. These include time constraints, patient understanding of complex information, lengthy consent forms, fear and anxiety over new procedures, and cognitive and other deficits that may limit competence (Kadam, 2017). In such instances, nurses must respect the patient’s right to self-determination after providing them with all the necessary information, even if the patient refuses life-saving treatment. This presents an ethical dilemma due to conflicts between the principle of autonomy which requires nurses to respect patient decisions and the principles of beneficence and nonmaleficence which obligate nurses to act in the patient’s best interest and protect them from harm. In addition, while nurses may advocate for the patient’s autonomy to be respected, they work under the supervision of physicians who may override the patient’s wishes and order nurses to administer interventions despite the patient’s refusal. The complexity of decision-making surrounding informed consent makes the concept an important ethical dilemma within the nursing practice.

Ethical Principles Involved

The concept of informed consent is based on several ethical principles. One of these principles is autonomy. This principle denotes the supposition that every individual has an unconditional and intrinsic value which grants them the power to make rational choices and exercise their right to self-determination (Varkey, 2020). Informed consent seeks to protect this right by obligating healthcare providers to present patients with information regarding their condition, the available treatment options, and associated risks and respecting the patient’s decision if they are deemed competent to make the decision. Autonomy forbids healthcare professionals from imposing treatment on a competent patient who expressly and voluntarily declines such treatment after analyzing the information presented, conflicting with other ethical principles, including beneficence.

Another ethical principle related to informed consent is truth-telling. This principle states that an autonomous client should be informed of their diagnosis and prognosis and their right to decline disclosure. If a patient chooses to be informed of their condition, the healthcare professional should provide factual information sensitively and tactfully regardless of the severity of the client’s illness (Varkey, 2020). Healthcare providers may fear giving patients bad news for fear of causing them anxiety, making them lose hope or belief that the patient may not understand the information. However, truth-telling is essential as it allows patients with terminal illnesses or progressively degenerative conditions to plan their affairs, make amends if necessary, and obtain the support they need to manage their condition in the best way possible.

Another principle involved in informed consent is beneficence which obligates healthcare professionals to act in a patient’s best interests (Varkey, 2020). Under beneficence, nurses should save people in danger, remove any hazards that may result in patient harm, help people with disabilities, and protect patients from coming to harm. In this sense, nurses should promote patient welfare by providing adequate information about their health, available treatment options, and associated risks. Here, informed consent allows patients to choose a treatment option with full awareness of the dangers instead of selecting an intervention that may harm them without their knowledge. However, informed consent usually conflicts with beneficence in that a client may decide that the risks of a procedure are too high and thus decline treatment.

Informed consent is also concerned with the principle of nonmaleficence. Under this principle, nurses should not harm patients in any way. This principle also requires healthcare professionals to alleviate a patient’s suffering using appropriate medication (Varkey, 2020). However, informing patients that they need opioids to relieve their pain or sedation may lead to their refusal of drugs due to the fear of getting addicted if they have a family history of addiction or are trying to beat addiction. This conflicts between informed consent and nonmaleficence, especially if sedation or opioids are necessary for the patient’s treatment.

Case Study

Two female patients are admitted to the emergency department after neighbors complain of a smell. The patients are brought to the hospital in an ambulance but have refused treatment, although they are shaking and screaming throughout the journey to the hospital. Upon physical examination, the patients have no visible signs of injury but are clearly in pain with lesions on their skin. They keep screaming that their bodies are on fire but decline medical help when the doctor orders further examinations. In addition, healthcare professionals cannot check and monitor their vitals because they refuse treatment and remain quiet when asked what they have ingested. One of them tries to leave but cannot support her weight on her legs. The nurses try to help her up, but the patient shouts that she does not want to be touched. The refusal to be touched, coupled with pain at the slightest touch and the inability to stand, make the doctors conclude that they have hyperesthesia and lower extremity paresis. Therefore, the substance the patients have taken is attacking their nervous system.

Given the patients’ continued refusal to accept treatment, the physician asks for a psychiatric evaluation, during which the patients remain silent and keep refusing treatment. However, the psychiatrist determines they are responsive and cognizant and thus have the right to refuse treatment. By this time, the lesions on their skin are more visible and extensive. Unable to withstand the pain, one of the patients places a plastic bag over her head, committing suicide. This allows the doctors to run a toxicology screening on the deceased to determine what substance they are dealing with, upon which they discover that the patient had taken thallium, a highly toxic substance. The doctors then inform the other patient about this information and tell her that there is an antidote to counteract thallium’s effects and that refusing to take the treatment will lead to her death in a few hours.

The psychiatrist is present during this informed consent process and asks the patient whether she understands the information and is willing to take the medication. The patient admits that she understands and agrees to take medicine if the doctors leave her alone, after which a nurse is asked to administer the medication and monitor the patient. However, the patient starts getting worse, prompting the nurse to call the doctors into the room, upon which they discover that she has not taken the pills. She tells the healthcare professionals that she is ready to die if it will raise awareness about global warming and prompt the government to act. The nurse tells the patient that her death might not achieve much and that she will die in a few hours, but the patient is adamant in refusing treatment.

The doctor orders the nurse to restrain the patient and start a nasogastric tube to enable them to administer medication, but the nurse reminds the doctor that the patient has been found competent by a psychiatric evaluation. The patient is still refusing treatment, but the nurse is forced to obey the doctor’s orders, after which she informs the psychiatrist of the doctor’s decision. The psychiatrist orders the doctor to remove the tube because the patient has expressed her desire to refuse treatment. Now, all the healthcare professionals can do is wait for the patient to accept treatment or die, whichever happens first.

Analysis

The case study above describes an incident in which patients engage in self-harm and refuse treatment, even though they are in agony. Their refusal of treatment prevents healthcare professionals from examining them or administering any medication to alleviate their pain. A psychiatric evaluation reveals that they are competent to make healthcare-related decisions, preventing doctors from overriding their treatment refusal. After the doctors discover what the patients have taken after an autopsy, the surviving client refuses treatment even after being informed that there is an antidote. Consequently, the healthcare professionals can do nothing since the patient has been provided with relevant information but still declines treatment. The doctor forces the nurse to violate the patient’s autonomy by restraining her and forcefully administering the antidote. Here, the nurse is faced with a dilemma since, as a patient advocate, she should ensure that the patient’s autonomy is respected, but as a healthcare professional, she should administer interventions as proposed by her superiors. The nurse informs the psychiatrist of this violation, who tells the doctor that the patient’s right to self-determination after making an informed decision trounces the doctor’s obligations under beneficence.

Examples of How This is Addressed in Institutions

Typically, when healthcare professionals encounter patients who engage in self-harm and refuse treatment, the first step is determining the patient’s capacity to decline treatment. A patient’s ability to object constitutes their comprehension of the choice they are making and associated risks and benefits, a clear and consistent expression of said choice, and reasoning in that they can explain their refusal and appreciation of the information provided to them (Pirotte & Benson, 2021). After capacity has been established and the patient keeps refusing care, healthcare professionals share their advice, experience, and knowledge with the patient to ensure the patient’s choice is informed and to try to influence the client positively. Healthcare professionals must respect the patient’s autonomy if the patient remains adamant. This conflicts with the principle of beneficence, particularly when refusal is based on personal convictions or religious beliefs that lack scientific support and to which healthcare professionals are opposed. Although healthcare professionals must respect the patient’s decision in such cases, they are obligated to prevent further harm to themselves and others. Still, their hands are tied unless the patient is a continued danger to themselves and others.

Nursing Care Strategies

When dealing with a competent patient who refuses treatment, nurses should present their knowledge and advice to the patient in a respectful manner without coercion or judgment. They should then carefully listen to the patient’s objections and explore the reasons for the refusal as it may help them identify acceptable alternatives. If the patient remains adamant in their objection, nurses should accept the client’s decision and keep in mind that the patient is not an adversary (Pirotte & Benson, 2021). Since interacting with such patients can be difficult even for healthcare professionals, nurses who are unable to provide quality, non-judgmental care to patients refusing treatment should request reassignment.

Plans for Implementing Strategies to Address the Ethical Dilemma

The first step in ensuring that nurses adequately implement the above strategies for dealing with the refusal of treatment is incorporating ethics education into the nursing curriculum. According to Strini et al. (2021), there is limited evidence about nursing preparation in informed consent. Therefore, the nursing curriculum needs to cover ethics training to adequately prepare nurses to deal with ethical dilemmas involving this concept. In addition, informed consent should be left to nurses instead of physicians. Such is because nurses interact more with patients than physicians, and thus patients are more willing and comfortable admitting ignorance and asking nurses questions than physicians. In addition, nurses know the patient better and are therefore better placed to determine whether the patient has adequate information to make an informed decision (Wilkenfield & Campbell, 2020). Thus, educating nurses about ethical principles to enable them to better handle ethical dilemmas surrounding informed consent and delegating the responsibility of obtaining consent to nurses are critical measures in ensuring the meaningfulness and adequacy of informed consent.

References

Adams, P., Prakobtham, S., Limpattaracharoen, C., Suebtrakul, S., Vutikes, P., Khusmith, S., Wilairatana, P., Adams, P., & Kaewkungwal, J. (2017). Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: A retrospective document review. BMC Medical Ethics, 18(1). https://doi.org/10.1186/s12910-017-0210-0

Farmer, L., & Lundy, A. (2017). Informed consent: Ethical and legal considerations for advanced practice nurses. The Journal for Nurse Practitioners, 13(2), 124- https://doi.org/10.1016/j.nurpra.2016.08.011

Kadam, R. A. (2017). Informed consent process: A step further towards making it meaningful! Perspectives in clinical research, 8(3), 107– https://doi.org/10.4103/picr.PICR_147_16

Pirotte, B. D., & Benson, S. (2021). Refusal of Care. In StatPearls [Internet]. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK560886/

Shah, P., Thornton, I., Turrin, D., & Hipskind, J. E. (2021). Informed Consent. In StatPearls [Internet]. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK430827/

Strini, V., Schiavolin, R., & Prendin, A. (2021). The role of the nurse in informed consent to treatments: An observational-descriptive study in the Padua hospital. Clinics and Practice, 11(3), 472-483. https://doi.org/10.3390/clinpract11030063

Varkey, B. (2020). Principles of clinical ethics and their application to practice. Medical Principles and Practice, 30(1), 17-28. https://doi.org/10.1159/000509119

Wilkenfeld, D. A., & Campbell, G. (2020). Improving informed consent by enhancing the role of nurses. Nursing Ethics, 28(4), 575- https://doi.org/10.1177/0969733020956375

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Week 7

Discussion 1

Discuss the elements of informed consent. Provide a clinical example of what can happen when some elements are not adhered to.

Compose at least 2-3 paragraphs all in APA format with proper references.

Discussion 2

Describe an organizational environment that would facilitate the ethical practice of nurses caring for chronically ill patients. As you read about patients’ rights, describe one patient right that is often not fully implemented in the patient care environment. Identify specific strategies to help ensure that this right is supported within the patient care environment. Explain how the registered nurse can assist in protecting patient rights.

Compose at least 2-3 paragraphs all in APA format with proper references.

Week 8

Discussion 1

Describe a clinical situation in which a registered nurse may encounter moral distress. Answer the AACN’s Four A’s and further explain the situation and the possible mitigation strategies.

Compose at least 2-3 paragraphs all in APA format with proper references.

Discussion 2

Describe different ways that social media use can violate ethical nursing practices. How can ethical social media use be beneficial to healthcare professionals and their patients?

Compose at least 2-3 paragraphs all in APA format with proper references.