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:
o An emergency in which medical care is needed immediately
to prevent serious or irreversible harm.


 o Incompetence in which someone is unable to give permission
(or to refuse permission) for testing or treatment

Components of Informed Consent

There are 4 components 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

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 other

Exercise Tips for

Disclosure

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 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

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:
o Why the research is being done
o What the researchers hope to accomplish
o A description of what will be done during the study and how
long you are expected to participate
o The risks to you from participation in the study
o The benefits that you can expect from participation in the
study
o Other treatments that are available if you decide not to
participate in the study
o 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

o 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:
o Self-supporting and/or not living at home
o Married
 o Pregnant or a parent
o In the military
o 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.