Informed consent respects the patient’s right to self-determination and plays a crucial role in the decision-making process in healthcare. This article explains informed consent in detail.
What is the meaning of informed consent?
Informed consent is a critical concept in healthcare, meaning that patients freely and clearly consent to significant decisions about their health based on adequate information. Specifically, it involves healthcare providers offering comprehensive information about the purpose, methods, expected effects, potential risks and side effects, and alternative treatments. Patients, understanding this information, decide whether to undergo the treatment.
Informed consent is one of the fundamental principles to provide patient-centered healthcare, respecting the patient’s right to self-determination. This process allows patients to play an active role in their treatment, contributing to the establishment of trust between healthcare providers and patients. Legally, performing treatments without fully informed consent may be seen as violating patient rights.
In short, the process involves patients and their families fully understanding their condition and treatment, and healthcare professionals sharing information and agreeing with the patient, their family, MSW (medical social workers), and care managers.
How to explain informed consent simply?
Simply put, informed consent means “consent given after obtaining (being provided with) sufficient information.” This implies that healthcare providers thoroughly explain the purpose, methods, risks, and alternatives of the treatment to the patient, who then consents after understanding this information.
The Importance of Informed Consent
Here, we explain the importance of informed consent from the perspectives of…
- Respecting the patient’s right to self-determination
- Building trust
- Legal protection
Respecting the patient’s right to self-determination
Respecting the patient’s right to self-determination is one of the most crucial aspects of informed consent. When patients actively engage in decisions about their treatment, their understanding and acceptance of the treatment deepen. This proactive involvement can foster a positive attitude toward treatment, potentially enhancing its effectiveness. Respecting self-determination allows patients to choose treatments that align with their values and lifestyle, fostering satisfaction with the treatment process and outcomes.
Thus, respecting the right to self-determination encourages patients to actively participate in managing their health, enhancing the overall quality of care.
Building trust
Informed consent is vital for building a strong trust relationship between healthcare providers and patients. By transparently providing information to patients, healthcare providers can deepen patients’ trust in their sincerity and expertise. Trust facilitates patients’ comfort and cooperation during treatment, making communication smoother. This allows for addressing and alleviating any questions or concerns regarding treatment plans and processes, enhancing patients’ cooperation with their treatment.
Trust is the foundation upon which patients follow healthcare providers’ guidance, contributing to treatment success.
Legal protection
Properly obtaining informed consent is a critical means for healthcare providers to reduce legal risks. By proving that patients consented to treatment after receiving adequate information, providers can avoid potential legal disputes. For instance, if patients face unexpected side effects or risks post-treatment, documented evidence of prior explanation and patient understanding reduces the providers’ liability risk. Informed consent can serve as crucial evidence in medical lawsuits, fulfilling providers’ duty to explain while bolstering their legal protection.
Thus, informed consent is indispensable from a legal perspective for protecting healthcare providers.
Informed Consent and the Helsinki Declaration
Informed consent and the Helsinki Declaration share the common goal of protecting the rights of patients and research participants but are applied in different contexts. Informed consent primarily refers to the process where individual patients, before receiving medical procedures, are provided with sufficient information about the purpose, benefits, risks, etc., and then voluntarily consent. This is vital in daily medical practice.
On the other hand, the Helsinki Declaration sets ethical principles for medical research, especially human subject research, providing ethical norms. Within this declaration, informed consent is positioned as a crucial principle requiring research participants to be fully informed about the study and to freely and clearly consent to participation.
The connection between informed consent and the Helsinki Declaration lies in emphasizing the importance of individual self-determination and informed consent. However, while informed consent protects patient rights in the context of individual treatment, the Helsinki Declaration aims to protect the rights of research participants by providing an ethical framework and guidelines for medical research involving humans.
Informed Consent and the Law
The legal basis for informed consent includes Article 1-4, Paragraph 2 of the Medical Law. This article states:
The relationship between informed consent and the law occupies an important position within the framework of patient rights and medical ethics.
The legal aspect of informed consent focuses on guaranteeing the patient’s right to freely consent to health-related decisions based on sufficient information. This process is essential for building trust between patients and healthcare providers, grounded in the principle of respecting the patient’s right to self-determination.
Here, we delve into…
- Legal background
- Legal responsibilities and implications
Legal background
In many countries, informed consent is legally required. This ensures that before undergoing medical procedures, patients fully understand the purpose, benefits, potential risks, and side effects, as well as alternative treatments, and consent based on this understanding. For valid consent, healthcare providers must provide adequate and appropriate information.
Legal responsibilities and implications
Violations of informed consent can result in legal liability. If patients consent without adequate information and receive unwanted medical procedures or encounter unforeseen side effects or complications, healthcare providers may face negligence or battery (illegal physical contact) lawsuits. Therefore, it is legally crucial for healthcare providers to offer comprehensive information about all aspects of treatment and document patient consent.
Informed consent plays a crucial role within the legal framework for protecting patient rights and upholding medical ethics. Healthcare providers must strive to provide adequate information and secure patient consent, respecting patients’ right to make informed decisions. This respect enhances healthcare quality and reduces the risk of medical litigation.
Three Key Concepts of Informed Consent
Three key concepts constitute informed consent:
- Explanation
- Understanding
- Agreement
Below is a detailed explanation of each.
Explanation
Explanation is the first step in the informed consent process, where healthcare providers offer detailed information about the treatment’s purpose, methods, expected benefits, potential risks and side effects, and alternative treatments. The goal is to ensure patients have all the necessary information for making informed decisions about their health. Explanations should avoid technical terms and be in language easily understood by the patient.
This process forms the foundation of trust between healthcare providers and patients, encouraging active patient participation in their treatment.
Understanding
Understanding involves patients accurately grasping the provided information and recognizing its significance and impact on treatment decisions. Healthcare providers should encourage questions and address any concerns to ensure understanding. To confirm understanding, providers may have patients repeat the information, assessing their comprehension.
If adequate understanding is not achieved, explanations must be repeated to solidify the patient’s decision-making foundation.Glossary
Agreement
Agreement in informed consent typically means mutual consensus.
Agreement is the process where patients, understanding the information, decide to accept or refuse the treatment. This stage involves patients signing a written consent form, formally indicating their acceptance of the treatment plan. Agreement must be voluntary, and patients have the right to refuse any treatment. They can also withdraw consent at any time after treatment has started.
The agreement process emphasizes respecting patient self-determination, ensuring their treatment choices align with their values and preferences.
Main Contents of Informed Consent
What exactly is explained during informed consent? While it varies by condition and situation, typical contents include:
- Current diagnosis and condition
- Planned tests
- Planned treatment methods
- Medications administered
- Surgical procedures
- Whether transfusion is required
- Life-sustaining measures
- Expected progress and complications
Below is an explanation of each.
Current diagnosis and condition
Here, the patient is given detailed information about their current illness and symptoms. Healthcare providers clarify the patient’s condition, including the nature and progression of the disease.
This includes information on how the disease affects the body, long-term outlook, and potential complications.
Planned tests
Explanation of planned tests, including the type, purpose, schedule, expected results, and potential risks or side effects.
Preparation methods and post-test care instructions are also provided.
Planned treatment methods
Healthcare providers explain proposed treatment methods, including the purpose, expected effects, side effects or risks, duration, and the patient’s role and responsibilities during treatment.
Treatment options and alternatives are presented, allowing patients to make decisions based on self-determination.
Medications administered
Explanation of medications being administered or potentially administered, including name, use, administration method, effects, side effects, and interactions.
Instructions on proper medication use and points of caution during use are also provided.
Surgical procedures
If surgery is required, its necessity, type, associated risks and complications, and the postoperative recovery process are explained. Details on surgical procedures, anesthesia used, duration, and the medical team involved are provided.
Expected results and risks if surgery is not performed are also explained.
Whether transfusion is required
If transfusion is necessary, reasons, expected effects, associated risks and complications, type, required amount, procedure, and post-transfusion monitoring and care are explained.
Life-sustaining measures
Explanation of the necessity, type, duration, purpose, expected effects, risks, and complications of life-sustaining measures. Discussions include the implications of receiving such measures and the impact of refusing them.
Support is provided for patients and families making decisions about life-sustaining measures.
Exemptions from the Requirements of Informed Consent
There are cases where patients or families cannot fully understand the information provided by healthcare providers or respect their rights, leading to medical care being provided without full consent. These situations are called “exemptions from the requirements of informed consent,” often occurring in the following three circumstances:
- Emergency situations
- Therapeutic privilege
- Preventing harm to others
Each of these is explained below.
Emergency situations
In emergency situations, where there is an unforeseen change in the patient’s condition requiring prompt action to save their life or maintain health, medical care can be provided without fulfilling the requirements. It is necessary that the patient would have likely consented if there had been time. If there is no time for detailed explanations but possible to obtain provisional consent, the explanation requirement is exempted. When the patient is unconscious, family cannot be contacted, and urgent medical action is necessary, both the explanation and consent requirements are exempted.
Therapeutic privilege
Examples include avoiding precise explanations of diagnoses and prognosis for cancer patients. If accurate explanations hinder the patient’s judgment or cause significant harm to their mental or physical health, informed consent requirements may be exempted. However, this exemption must be carefully considered as it conflicts with the protection of the patient’s self-determination rights.
Preventing harm to others
Examples include “involuntary admission” in psychiatric care. If a patient poses a danger to others, necessary medical care can be provided without the patient’s consent to prevent harm, even if the patient has decision-making capacity. This aligns with the premise of informed consent that it does not apply to actions that harm others or society.
Is Informed Consent Important for Elderly Rehabilitation?
Obtaining informed consent is particularly important in elderly rehabilitation due to the physical and cognitive vulnerabilities of the elderly and the high risks associated with rehabilitation. Compared to younger individuals, the elderly are more likely to have chronic diseases such as heart disease, cerebrovascular disease, and diabetes, which can cause complications during rehabilitation. For example, exercise-induced heart strain can trigger arrhythmias or angina attacks, and decreased muscle strength and balance can lead to falls and fractures.
Therefore, before starting rehabilitation, healthcare providers must thoroughly explain the planned rehabilitation content, goals, expected benefits, and potential risks and side effects to the elderly patient and their family. This explanation should include positive aspects such as the potential to improve the elderly’s quality of life and aim for functional recovery for independent daily living, as well as honest communication about risks like seizures, breathing difficulties, arrhythmias, and falls.
Written consent from the patient and family is essential for ensuring transparency in the rehabilitation process and respecting the patient’s right to self-determination. Through informed consent, patients and families can actively participate
in decision-making related to rehabilitation, enabling patient-centered care. Understanding the risks and preparing for possible scenarios can maximize rehabilitation outcomes and maintain trust between healthcare providers and the patient’s family.
Informed Consent and Ethical Issues
Ethical issues related to informed consent often arise in medical practice. In emergencies or when exemptions apply, healthcare providers must act swiftly to save lives, sometimes making it challenging to obtain adequate informed consent. Balancing securing patient and family understanding and consent with protecting the patient’s life and health poses significant ethical dilemmas.
Here, we discuss…
- The need for immediate response in emergencies
- The quality of information understanding and consent
- Communication with family or representatives
The need for immediate response in emergencies
In emergencies, immediate medical action is required to save the patient’s life, often leaving insufficient time for thorough explanations and consent. Such situations demand significant ethical judgment from healthcare providers on balancing patient rights and safety.
The quality of information understanding and consent
Particularly for elderly or dementia patients with limited understanding, obtaining valid consent can be challenging. Respecting and protecting the patient’s right to self-determination becomes a critical issue.
Communication with family or representatives
When patients cannot express their wishes, family or legal representatives are involved in decision-making. Healthcare providers face challenging decisions when patient wishes differ from family opinions, ensuring the patient’s best interests are protected.
Countermeasures and Points to Consider
What countermeasures address ethical issues in informed consent? Here, we discuss…
- Respect for advance directives
- Continuous communication
- Utilizing ethics committees
Respect for advance directives
Respecting living wills or advance directives created by patients ensures medical care aligns with the patient’s wishes.
Continuous communication
Building trust through continuous communication with patients and families is essential. Even in emergencies, providing detailed explanations afterward and addressing concerns is required.
Utilizing ethics committees
Using ethics committees or consultation services in medical institutions offers diverse perspectives and advice on complex ethical dilemmas.
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