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More and more, patients and their families are becoming
responsible partners in their health care. When you seek medical care,
you usually talk with the doctor to get his or her recommendations
about the next step in your treatment. Most people follow these
recommendations, but they are not required to do so. If you are an
adult who is able to make your own decisions, you are the only person
who can choose which course of action to take.
All medical care requires the consent of the patient (or
someone who is authorized to consent for the patient) before the care
plan is carried out. In some cases, you approve the doctor's plan by
simply getting a prescription filled, allowing blood to be drawn for
lab tests, or seeing a specialist. This is called simple consent, and
is okay for treatments that carry little risk for you.
What is informed consent and what does it
involve?
In cases where there are larger possible risks, you may be
asked to agree in writing to the doctor's plan for your care. Informed consent
recognizes your need to know about a procedure, surgery, or treatment,
before you decide to have it.
After your first talk with your doctor, you may have only a
general idea of your doctor's treatment plan for you. You will likely
want to know more so that you can think about the ways this plan may
affect your health and your life. You must understand the risks and
drawbacks of the plan so that you can freely decide whether the risks
are worth the benefits you expect to get from the treatment plan. Most
people find that they need to get some questions answered before they
can decide on a treatment plan that carries some risk for them.
Informed consent is a process in which:
- you are told (or get information in some other way) about
the possible risks and benefits of the treatment
- you are informed of the risks and benefits of other
options, including not getting treatment
- you have the chance to ask questions and get them answered
to your satisfaction
- you have had time (if needed) to discuss the plan with
family or advisors,
- you are able to use the information to help make a decision
that you think is in your own best interest, and
- you communicate that decision to your doctor or treatment
team.
If you have gone through these steps and decide to agree to
the treatment or procedure, you are usually asked to sign a paper
called a consent form.
The completed and signed consent form is a legal document that permits
your doctor to continue with the treatment plan. The consent form names
the procedure or treatment to be performed. The rest of the language of
the consent form may be very general, stating only that you have been
informed of the risks of the treatment and other options that are
available. Or it may be very specific, outlining in detail what the
risks and other options are. Depending on how it is presented, you may
sign for one specific procedure or treatment, or you may give blanket
approval for any treatments and procedures that the health provider
decides are necessary.
From the doctor's viewpoint, informed consent means that:
- A doctor or nurse must make sure the patient understands
the purpose, benefits, risks, and other options of an invasive test or
treatment, and then must obtain the patient's consent before starting.
In some cases, even a simple blood test or an injection requires
written permission from the patient.
- As long as the patient is mentally and physically able to
make his or her own decisions, medical care cannot begin unless the
patient gives informed consent. If the patient is a minor (under age),
or has a serious mental disability, or cannot give consent, then the
parents or legal guardian or a person authorized by the court must give
consent. This is usually a close family member who has reason to know
what the patient would want (see section below, "Who besides the
patient can give consent?"). As some very public court cases have
shown, an elaborate legal system is in place to guide cases in which
the patient is mentally or physically incapable of giving informed
consent for treatment. Such cases often arise if the patient is in a
coma (unconscious) or on life-support equipment.
Sometimes health care workers refer to the consent form itself
as an informed consent.
This is not quite accurate. Informed consent is the process or action
that takes place as you learn about and consider a treatment before you
agree to it. Your signature on the form is taken to be evidence that
this took place. If you decide that you do not want the procedure or
treatment, you may be asked to sign a refusal form (see section below,
"What if I don't want the treatment being offered?").
Why does the doctor need me to sign a
consent form?
The main purpose of the informed consent process is to protect
the patient. As mentioned earlier, a competent adult cannot be forced
to take any type of medical treatment. In general, anything other than
a life-threatening emergency in which the patient is unconscious
requires consent before treatment. Even in that situation, consent may
sometimes be required if the patient is known to have an advance
directive (see section below, "Who besides the patient can give
consent?").
For simple diagnostic tests and situations in which consent is
implied by your actions, a consent form is not needed. If you see your
doctor and allow a blood sample to be taken for lab tests, your consent
is usually assumed because you went to the doctor seeking care and
allowed the blood to be drawn. At any point, you could change your mind
and decide to refuse testing, leave the doctor's office, or seek care
elsewhere. This is different from a treatment that puts you in a
vulnerable position or can possibly cause harm. More risky treatment is
likely to require more information so that you can weigh your options
and consider your risks before making your decision.
Even when there are no other accepted medical treatment
options, it is still your right as a competent adult to refuse to have
a treatment that you do not want, or not to be in a study that you
didn't choose. But once you sign the consent form, it is considered to
be your formal, legal agreement that you are okay with the plan or
procedure that is listed on the form unless you revoke (take back) your
consent before treatment is given. The doctor or facility will usually
give you a copy of the consent form, but they keep the original as a
legal record that you agreed to the treatment.
What are the legal requirements of informed
consent?
State laws have been developed to govern certain types of
communication between health providers and patients. Called informed consent laws,
they list the types of information that patients must be given so they
can make an informed decision about having medical care, diagnostic
studies, or treatment.
These laws apply to doctors and sometimes to nurses. They vary
from state to state. Some states have very specific laws governing
particular situations; for example, the issues of treatment for breast
cancer or for clinical trials (scientific studies of promising new
treatments). Some states call only for "reasonable" information; others
require "full and complete disclosure." (Disclosure means making
information known.)
In general, informed consent assumes that you are legally able
to make your own decisions. If you are not, the person who is legally
allowed to make it for you goes through the same process on your behalf
(see section below, "Who besides the patient is allowed to consent?").
For informed consent to take place, the information that is
shared must be understood. This responsibility is shared by the
patient, since the doctor won't know what you don't understand until
you ask about it. The patient must have the chance to consider the
information and ask questions.
And finally, informed consent assumes that when you make your
decision, you are not pressured -- that you freely choose based on what
you feel is best for you.
Informed consent for a clinical trial is usually required to
be more detailed and thorough than consent for a standard medical
procedure or treatment. This is because there is a bigger chance of
unknown effects with new treatments, and it is even more important that
you know about these possibilities (see section, "How is informed
consent for a clinical trial or research treatment different?").
Who besides the patient is allowed to
consent?
For children or others who are unable to make the decision for
themselves, the parent or legal guardian is legally responsible for
getting the information, making the decision, and signing the consent
form. However, that does not mean that the child or patient who is not
considered mentally competent is always left out of the process. Some
facilities require the assent of older children before they go into a
research study, even after the parents have agreed on his or her
behalf. This means that, even though the parents sign the form, the
child must also be okay with it before the facility will do the
treatment. Along the same lines, people who are unable to manage their
daily affairs due to mild dementia (impaired thinking) or emotional
problems may still be able to understand the medical situation and make
their wishes known.
In the event that you are unable to take in information and
make your wishes known, another person may be called upon to take part
in the process of informed consent. There are several ways that person
can be selected. The only way you have a voice in choosing the person
to make those decisions for you is if you have previously set up a durable power of attorney for
health care (also called a health care power of attorney).
In that case, if you are unable to speak for yourself, the person you
chose becomes legally responsible for making medical decisions on your
behalf. This person is sometimes called your proxy, agent, or
surrogate. A few states restrict the ability of your proxy to carry out
certain requests. For more on health care powers of attorney, see the
American Cancer Society document, Advance Directives.
Another way is a court-appointed surrogate or proxy, in which
a judge appoints someone to make medical decisions for you. If you
become unable to make decisions for yourself, someone else -- such as
the doctor, facility, friend, or even a family member -- may ask
(petition) the court to appoint someone to do it for you. The process
varies from state to state.
Many states have passed family
agency acts that choose which family members (in a listed
order of priority) may act on behalf of a person who cannot speak for
her or himself. This way is likely to be used only if you do not have
an advance directive or court-appointed proxy. Depending on your family
situation and which state you are in, that person may be your legal
guardian, spouse, parent, child, sibling, or other relative.
How will I be given information for an
informed consent?
The manner in which the information about the treatment must
be given (for example, verbally or in writing) may also be listed in
your state's laws. Other methods may be used by your doctor or facility
to make the information easier to understand, such as videos,
interactive computer modules, educational booklets, etc. The most
important part is that you understand and are allowed to get answers to
your questions, so that you have all the information you need as you
consider your decision.
Sometimes, a person other than the physician who will be
carrying out the treatment is asked to give you the information for
your informed consent. If this person is unable to answer your
questions to your satisfaction, you may want to wait to sign the
consent form until you can talk to someone who can answer your
questions more completely.
How much detail should I expect?
Material
information: Informed consent requires disclosure of
"material" (significant or important) information that will help the
patient make an informed choice. The law defines material information
in 2 ways.
- The
professional's point of view: In this view, the health
provider's responsibility is limited to telling you those things that a
health professional practicing in your community would tell you under
the same or similar circumstances.
- The patient's
point of view: A patient-oriented standard of disclosure
is different. It means that the health provider is required to make
known all the facts, risks, and alternatives that a reasonable person
in the patient's situation would consider important in deciding whether
to have a recommended treatment.
Some of the material information a patient wants may not be
available. For example, the long-term risks of a new method of
treatment may not be known. If this is the case, the spirit of the laws
of informed consent require the health provider to give the best answer
possible, which may be "we don't know that yet."
However, this shouldn't stop you from asking questions at
whatever level of detail you want. Some people want to know as much as
possible about their treatment or procedure before they agree to it,
while others want very little. Again, the doctor may not have all the
information you would like, but at least you can find out more about
what is and isn't known.
How long does the informed consent process
take?
The entire informed consent process can take place in one
short visit for a fairly simple procedure about which you have few
questions. On the other hand, it may take two or more conversations for
something more complex, for instance, if you are considering more than
one treatment option, a long course of treatment, or a clinical trial.
In fact, even after you have signed up for a clinical trial and signed
a consent form, the researchers conducting it should continue to keep
you posted about new information that affects you as a participant.
This is part of an ongoing informed consent process, which can
sometimes extend past the clinical trial itself.
What if I decide I don't want to continue
treatment and I've already signed the consent?
Most consent forms mention that you also have the right to
stop a long course of treatment or withdraw from a study even if you
have already signed a consent form. Even if the form does not mention
it, you still have this right. You would need to contact the doctor in
charge of your treatment or of the clinical trial to make your wishes
known. You may be asked to sign a form refusing further treatment so
that the doctor or facility will have a legal record (see section
below, "What if I don't want the treatment that is being offered?").
How is informed consent for a clinical trial
or research study different?
Informed consent for a clinical trial or investigational
procedure (where new treatments are compared to the current standard
treatment) usually includes more information than the consent for any
standard treatment. The informed consent process should tell you what
the clinical trial is set up to find out, what is expected of you,
expected benefits, what is known and not known about the new drug or
procedure, and other possible treatment options.
The informed consent process is meant to give you ongoing
explanations that will help you make educated decisions about whether
to start or stay in a clinical trial. The most important part of this
process is your everyday interaction and discussions with the research
team and other medical staff before, during, and after the trial. The
consent form can be a great tool to help get this conversation started.
This is all done so that you can make the best decision for
yourself, and to be sure that you are able to choose freely whether to
enroll in or stay in the study. Much of this information may be on the
consent form itself, which also usually explains that you can withdraw
from the study at any time without penalty. The doctor or nurse may
encourage you to take extra time to think it over and come back with
any questions. If you are giving consent for your child, both parents
may be required to sign the form in order for your child to take part
in the clinical trial.
Before you make your decision, the research team will talk
with you about the clinical trial’s purpose, procedures,
risks, possible benefits, and your rights as a participant. If you
decide to participate, the team will continue to update you on any new
information that may affect you and your situation. Before, during, and
even after the trial, you will have the chance to ask questions and
voice your concerns. Informed consent for clinical trials goes on for
as long as the research lasts, and even afterward.
While this process varies among different research
institutions and clinical centers, it normally includes the following
steps:
A first meeting.
This is when you meet with a member of the research team who gives you
the informed consent document and explains it to you. This discussion
may also include your oncologist (cancer specialist), primary care
doctor, and a nurse. Sometimes a social worker, patient representative,
or staff psychologist may be there. You can bring along a family member
or friend for support, and to help you keep track of the information.
The information should be given in a way you can understand. It should
also be given at a comfortable pace, with time allowed for you to think
it over and ask questions. Some centers offer a video, audiotape, or
even an interactive computer module to help you better understand the
information in the consent form.
Time to take in the information.
It can be hard to absorb this much new information in one sitting,
especially at a time of emotional stress. You should be given a copy of
the consent information so that that you can take it home, review it as
many times as you need, and talk it over with family, friends, clergy,
counselors, therapists, patient representatives, or other trusted
advisors.
A check of your understanding of
the information. The research team should be sure that you
understand the information they give you. They can do this by having
you fill out a questionnaire, asking you questions, or having you tell
them about the clinical trial in your own words. You also should tell
team members about anything you do not understand. If you find that the
consent form or related information is written in words that are too
technical for you, let them know. Otherwise they may assume that you
understand when you really don't.
Chances to ask questions.
During the first meeting and in later discussions, you should be given
the chance to ask questions and raise concerns. Keep asking questions
until you know enough to make your decision.
Continued updates on new
information. As the clinical trial goes on, the research
team may make new discoveries that could affect your health,
well-being, or willingness to remain in the study. They will share this
with you and may ask you to sign a new consent form. Of course, you are
free to leave the study if this information leads you to have doubts
about staying in it.
A contact person and phone number for more information should
be given to you at the first meeting. While your doctor is likely to be
a helpful source of information, only you can make the decision about
being in a study. Not even the best medical experts can predict whether
a treatment, screening, prevention, or supportive care method being
studied in a clinical trial will work for you. The informed consent
process is designed to help you weigh all of the pros and cons and make
the best choice for you or your child.
Tips about clinical trials
- Keep a copy of the consent form as a helpful resource. Ask
for a copy if one isn't offered to you. You may also request a copy of
the protocol (full study plan) that describes all the details of the
clinical trial.
- According to United States regulations, no informed consent
document may say anything that asks or seems to ask you to give up
(waive) any legal rights. It also may not include anything that
releases or appears to release the investigator, doctor, sponsor, or
facility from liability if they are negligent or careless.
- If you cannot understand the forms you are asked to sign,
don't be afraid to let someone know that you are having trouble. Many
people feel nervous about signing consent forms and talking with
physicians. Take your time, and ask for help when you need it.
What if I am having trouble understanding
the information?
Informed consent is not only the health provider's
responsibility. You have a duty to be sure that you understand the
information you have been given, even if it means going over the
information many times. Sometimes health care workers use words that
are very hard to understand. Ask the doctor to define words and explain
terms, and tell him or her what you understand and what you don't.
Sometimes it helps to have a nurse, social worker, or patient advocate
in the room. They may be able to re-phrase and explain things in ways
that are clearer to you.
If you are facing an important health decision, it may be also
helpful to bring a spouse, relative, or friend to your appointments.
That way, there will be a second listener to help process the
information and to ask questions.
What questions should I ask during informed
consent?
You will, of course, have your own questions, especially once
the doctor starts sharing information. However, some basic questions
you might ask include:
- What is my diagnosis (the medical name for the illness I
have) and what does that mean?
- How serious is my diagnosis?
- What methods of treatment are recommended?
- Are there other treatment options? What are they?
- What benefits would you expect from the recommended
treatments and other options?
- What are the risks or complications of the recommended
treatment and the other treatment options?
- Are there discomforts that may be caused by the treatments?
- What methods will be used to prevent or relieve these
discomforts?
- What are the side effects of the treatment -- immediate,
short-term, and long-term?
- How will having treatment affect my normal functions and
everyday activities?
- How would having not having treatment affect my normal
functions and everyday activities?
- How long will treatment last?
- How long will it be before I can go back to my normal
activities?
- How much does the treatment cost?
It's a good idea to write down your questions and bring the
list to your appointments, take notes on the responses, or bring a tape
recorder to record the discussion. (You may want to check with the
doctor before you record him or her.) Good health providers usually
appreciate a patient's efforts to understand the challenges they face
and to make informed decisions.
What if I want my doctor make the decisions
about my care, and I don't want more information?
Some people prefer not to know a great deal about their
diagnosis or treatment. Just as you have a right to informed consent,
you have a right to refuse information. Or you can ask for only minimal
information and entrust the decisions about your care to your health
provider. At the same time, informed consent laws do not allow a health
provider to keep a diagnosis from the patient, even at the family's
request. If you wish to refuse information in today's legal
environment, a wise health provider will likely require you to put that
in writing in the form of a waiver or other document.
What if I don't want the treatment that is
being offered?
Part of the informed consent process includes allowing you to
ask questions about other treatments that may help you or other options
that may offer you something that you prefer. You may choose other
options, even if they are not as well proven as the one your doctor
recommends. However, it may be up to you to find someone who will treat
you with such an approach, and you may need to seek care elsewhere,
with another doctor or facility.
As mentioned earlier, if you are competent to make your own
medical decisions, you have the right to refuse any and all medical
treatment and diagnostic procedures. Even if not treating the disease
or condition means that the person will die, US courts have mostly
affirmed the right of patients to reject treatment. If you have decided
to refuse treatment or diagnostic tests, the health provider may inform
you of the risks or likely outcomes of this choice. This is called informed refusal.
The doctor or facility may ask you to sign a form that states you
received this information, and that you still choose not to be treated.
If you do not wish to sign, the doctor may ask witnesses to sign that
you were so informed.
How can I find out more?
Organizations and resources: If you need
more information about informed consent, the following individuals and
organizations may be able to help:
Additional resources
More information from your American Cancer
Society
We have selected some related information that may also be
helpful to you. These materials may be ordered from our toll-free
number, 1-800-ACS-2345.
Advanced
Directives
Clinical Trials:
What You Need to Know (also available in Spanish)
Patient's
Bill of Rights (also available in Spanish)
National organizations and Web sites*
In addition to the American Cancer Society, other sources of
patient information include:
National Cancer Institute
Toll-free number: 1-800-4-CANCER (1-800-422-6237)
Web site: www.cancer.gov
American Hospital Association
Read their "Patient Care Partnership" brochure online at the internet
address below for more information on patients' rights and
responsibilities while in the hospital. Also available in Spanish and
several other languages:
Web site:
http://www.aha.org/aha/issues/Communicating-With-Patients/pt-care-partnership.html
*Inclusion on this list does not imply endorsement by the
American Cancer Society.
No matter who you are, we can help. Contact us anytime, day or
night, for information and support. Call us at 1-800-ACS-2345 or
visit www.cancer.org.
References
Derse AR. What part of "no" don’t you understand?
Patient refusal of recommended treatment in the emergency department. Mt Sinai J Med.
2005;72:221-227.
Emedicine Health. Informed Consent. Available at:
http://www.emedicinehealth.com/informed_consent/article_em.htm.
Accessed February 20, 2008.
National Cancer Institute. A Guide to Understanding Informed
Consent. Available at:
http://www.cancer.gov/ClinicalTrials/AGuidetoUnderstandingInformedConsent/page2
.
Accessed February 20, 2008.
White G. Obtaining informed consent: It’s more than
a signature. Am J
Nursing. 2000;100:83.
Whitney SN, McGuire AL, McCullough LB. A typology of shared
decision making, informed consent, and simple consent. Ann Intern Med.
2003;140:54-59.
Revised: 03/25/2008
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