- What Is It?
- 4 Principles
- The Right to Refuse Treatment
- Clinical Trials and Research
- Children and Consent
What Is Informed Consent?
- Doctors will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo a treatment or test. This process of understanding the risks and benefits of treatment is known as informed consent.
- Informed consent is based on the moral and legal premise of patient autonomy: You as the patient have the right to make decisions about your own health and medical conditions.
- You must give your voluntary, informed consent for treatment and for most medical tests and procedures. The legal term for failing to obtain informed consent before performing a test or procedure on a patient is called battery (a form of assault).
- For many types of interactions (for example, a physical exam with your doctor), implied consent is assumed.
- For more invasive tests or for those tests or treatments with significant risks or alternatives, you will be asked to give explicit (written) consent.
- Under certain circumstances, there are exceptions to the informed consent rule. The most common exceptions are these:
- An emergency in which medical care is needed immediately to prevent serious or irreversible harm
- Incompetence in which someone is unable to give permission (or to refuse permission) for testing or treatment
What Are the 4 Principles of Informed Consent?
There are 4 principles of informed consent:
- You must have the capacity (or ability) to make the decision.
- The medical provider must disclose information on the treatment, test, or procedure in question, including the expected benefits and risks, and the likelihood (or probability) that the benefits and risks will occur.
- You must comprehend the relevant information.
- You must voluntarily grant consent, without coercion or duress.
Decision-making capacity is often referred to by the legal term competency. It is one of the most important components of informed consent. Decision-making capacity is not black and white. You may have the capacity to make some decisions, but not others.
The components of decision-making capacity are as follows:
- The ability to understand the options
- The ability to understand the consequences of choosing each of the options
- The ability to evaluate the personal cost and benefit of each of the consequences and relate them to your own set of values and priorities
If you are not able to do all of the components, family members, court-appointed guardians, or others (as determined by state law) may act as "surrogate decision-makers" and make decisions for you.
To have decision-making capacity does not mean that you, as the patient, will always make "good" decisions, or decisions that your doctor agrees with. Likewise, making a "bad" decision does not mean that you, as a patient, are "incompetent" or do not have decision-making capacity.
Decision-making capacity, or competency, simply means that you can understand and explain the options, their implications, and give a rational reason why you would decide on a particular option instead of the others.
In order for you to give your informed consent for treatment or tests, the doctor or health care provider must give (or disclose) to you enough information so that you can make an informed decision. It is not necessary or expected that you would receive every detail of the test, treatment, or procedure. You need only the information that would be expected by a reasonable person to make an intelligent decision. This information should include the risks and likelihood (or probability) of each of the risks and the benefits, and likelihood (or probability) of benefit. Any questions you have should be fully explained, in language and terminology that you can understand.
Documentation of Consent
For many tests and procedures, such as routine blood tests, X-rays, and splints or casts, consent is implied. No written documentation of the consent process is obtained. For many invasive tests or for treatments with significant risk, you should be given a written consent form and a verbal explanation, both preferably in your native language.
The following components should be discussed and included in the written consent form. If they are not, you should request that information:
- An explanation of the medical condition that warrants the test, procedure, or treatment
- An explanation of the purpose and benefits of the proposed test, procedure, or treatment
- An explanation or description of the proposed test, procedure, or treatment, including possible complications or adverse events
- A description of alternative treatments, procedures, or tests, if any, and their relative benefits and risks
- A discussion of the consequences of not accepting the test, procedure, or treatment
The consent form should be signed and dated both by the doctor and by you, as the patient. You would sign for your child. You may ask for a copy of the signed consent form.
Competency is a legal term used to indicate that a person has the ability to make and be held accountable for their decisions. The term is often used loosely in medicine to indicate whether a person has decision-making capacity, as described previously. Technically, a person can only be declared "incompetent" by a court of law.
Informed Consent, The Right to Refuse Treatment
Except for legally authorized involuntary treatment, patients who are legally competent to make medical decisions and who are judged by health care providers to have decision-making capacity have the legal and moral right to refuse any or all treatment. This is true even if the patient chooses to make a "bad decision" that may result in serious disability or even death:
- To document that you have been given the option of obtaining a recommended treatment or test and have chosen not to, you may be asked to sign an Against Medical Advice (AMA) form to protect the health care provider from legal liability for not providing the disputed treatment. Refusing a test, treatment, or procedure does not necessarily mean that you are refusing all care. The next best treatment should always be offered to anyone who refuses the recommended care.
- If, because of intoxication, injury, illness, emotional stress, or other reason, a healthcare provider decides that a patient does not have decision-making capacity, the patient may not be able to refuse treatment. The law presumes that the average reasonable person would consent to treatment in most emergencies to prevent permanent disability or death.
- Advance directives and living wills are documents that you can complete before an emergency occurs. These legal documents direct doctors and other healthcare providers as to what specific treatments you want, or do not want, should illness or injury prevent you from having decision-making capacity.
Clinical Trials and Research
Clinical research trials, or studies, are an important part of healthcare research. They are one of the most important means available to advance the quality of medical care. Clinical studies are often used to determine whether new drugs, procedures, or treatments are safer or more effective than drugs or treatments currently being used.
Enrollment in a clinical study often gives you the opportunity to receive a new drug or treatment before it is widely available. The trade-off is that you may be exposed to risks of the drug or treatment that are not known at the time of the study.
- In most studies, there is a control group that receives what is considered the current standard of care or best treatment available. One or more experimental groups receive the new treatment.
- There is usually no cost associated with participation in a study. In some cases, participants may receive payment, medications, tests, or follow-up care at no cost.
- Informed consent is needed before you may be enrolled in clinical research trials. The purpose of informed consent in this setting is to allow you to learn enough about the study to decide whether or not to participate. Informed consent for a research study (clinical trial) should include the following information:
- Why the research is being done
- What the researchers hope to accomplish
- A description of what will be done during the study and how long you are expected to participate
- The risks to you from participation in the study
- The benefits that you can expect from participation in the study
- Other treatments that are available if you decide not to participate in the study
- Verification that you have the right to leave the study at any time and that standard medical care will be provided without penalty if you choose to withdraw from the study
- Although an informed consent document must be signed before enrollment in a study, it is important to remember that informed consent is a process that continues throughout the study. You may ask questions of the health care providers at any time before, during, or after the study. Because deciding whether to participate in a clinical study is an important decision, it is often helpful to discuss the study and the informed consent documents with family members or friends before deciding whether to participate.
Children and Consent
The concept of informed consent has little direct application in children. Although minors may have appropriate decision-making capacity, they usually do not have the legal empowerment to give informed consent. Therefore, parents or other surrogate decision-makers may give informed permission for diagnosis and treatment of a child, preferably with the assent of the child whenever possible.
- In most cases, parents are assumed to act in the best interest of their child. But circumstances may occur where there is a conflict between what the parents and the health care providers feel is in the best interest. State laws cover some of these areas of potential dispute, for example, in cases of suspected child abuse.
- Other disagreements in care may result in court orders that specify what treatment should occur (for example, blood transfusions), or in the court-ordered appointment of a guardian to make medical decisions for the child.
- Most states have laws that designate certain minors as emancipated and entitled to the full rights of adults, including children in these situations:
- Self-supporting and/or not living at home
- Pregnant or a parent
- In the military
- Declared emancipated by a court
- Most states also give decision-making authority to otherwise unemancipated minors with decision-making capacity (mature minors) who are seeking treatment for certain medical conditions, such as drug or alcohol abuse, pregnancy, or sexually transmitted diseases.
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American Academy of Pediatrics, Committee on Bioethics.Informed consent, parental permission, and assent in pediatric practice.Pediatrics.Feb1995;95(2):314-7.[Medline].
Food and Drug Administration.Food and Drug Administration.Available at http://www.fda.gov/.
Iserson KV, Sanders AB, Mathieu D.Autonomy and informed consent.In: Ethics in Emergency Medicine.2nd ed.Galen Press Ltd;1995.
National Institutes of Health.National Institutes of Health.Available at http://www.nih.gov/.