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 the process of understanding the risks and benefits of treatment is known as informed consent
based on the moral and legal premise of patient autonomy

— ©ou 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).

V aor many types of interactions (for example, a physical exam with your doctor), implied
consent is assumed.
V aor more invasive tests or for those tests or treatments with significant risks or
alternatives, you will be asked to give explicit (written) consent.

— nder certain circumstances, there are exceptions to the informed consent rule. The most
common exceptions are these:

V emergency ї medical care is needed immediately to prevent serious or irreversible

harm
V incompetence ї someone is unable to give permission (or to refuse permission) for
testing or treatment




 

There are 4 components of informed consent:

— have the capacity (or ability) to make the decision.

V The ability to understand the options

V The ability to understand the consequences of choosing each of the options
V 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

— 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.

— must comprehend the relevant information.

— must voluntarily grant consent, without coercion or duress.


D

 

aor 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. aor 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:

V 0n explanation of the medical condition that warrants the test, procedure, or treatment
V 0n explanation of the purpose and benefits of the proposed test, procedure, or
treatment
V 0n explanation or description of the proposed test, procedure, or treatment, including
possible complications or adverse events
V 0 description of alternative treatments, procedures, or tests, if any, and their relative
benefits and risks
V 0 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. ©ou
would sign for your child. ©ou may ask for a copy of the signed consent form.


    



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.

— Gefusing 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.

— The law presumes that the average reasonable person would consent to treatment in most
emergencies to prevent permanent disability or death.

— legal documents (advance directives and living wills)direct doctors and other health care
providers as to what specific treatments you want, or do not want, should illness or injury
prevent you from having decision-making capacity.
 
 


 

 an important part of health care research

 available to advance the quality of medical care
 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.

V 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.

V 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.

V 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:

ÿ chy the research is being done

ÿ chat the researchers hope to accomplish
ÿ 0 description of what will be done during the study and how long you are
expected to participate
ÿ The risks to you from participation in the study
ÿ The benefits that you can expect from participation in the study
ÿ Other treatments that are available if you decide not to participate in the study
ÿ erification 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

V 0lthough 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. ©ou 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.


  
 

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.

— [ost states have laws that designate certain minors as emancipated and entitled to the full
rights of adults, including children in these situations:

V Self-supporting and/or not living at home

V [arried
V ‰regnant or a parent
V In the military
V eclared emancipated by a court

— [ost 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.