There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency.
There are 4 principles of informed consent:
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:
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. See Slideshow
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.
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:
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.
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:
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.
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.
Medically reviewed by Joseph Palermo, MD; Board Certificate Internal Medicine/Geriatric Medicine REFERENCES: 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/. |