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Informed Consent
Patients, their caregivers, and health care providers are partners in health care
decisions. When you seek medical care, you usually get recommendations about
needed treatment. Most people follow these recommendations, but some choose not to
follow them. You do have the right to either accept or refuse a treatment. If you are an
adult and you’re able to make your own decisions, you are the only person who can
choose whether to get treatment and which treatment to get. This is done through a
process called informed consent.
All medical care requires consent (agreement) by the patient (or someone who is
authorized to consent for the patient) before care is given. This includes treatments for
illnesses such as cancer. In some cases, you approve or agree with the doctor’s plan by
simply getting a prescription filled, signing a form that allows blood to be drawn for lab
tests, or saying yes to seeing a specialist. This is called simple consent, and is OK for
treatments that carry little risk for you. Many times, though, the more careful process of
informed consentis needed.
● What Is Informed Consent?
● When Is Informed Consent Needed?
● Informed Consent for a Clinical Trial
What Is Informed Consent?
Informed consent is a process of communication between you and your health care
provider that often leads to agreement or permission for care, treatment, or services.
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Evey patient has the right to get information and ask questions before procedures and
treatments. If adult patients are mentally able to make their own decisions, medical care
cannot begin unless they give informed consent.
The informed consent process makes sure that your health care provider has given you
information about your condition along with testing and treatment options before you
decide what to do.
This information can include:
● The name of your condition
● The name of the procedure or treatment that the health care provider recommends
● Risks and benefits of the treatment or procedure
● Risks and benefits of other options, including not getting the treatment or procedure
Signing informed consent means
● You have received all the information about your treatment options from your health
care provider.
● You understand the information and you have had a chance to ask questions.
● You use this information to decide if you want to receive the recommended
treatment option(s) that have been explained to you. Sometimes, you may choose
to receive only part of the recommended care. Talk to your health care provider
about your options.
● If you agree to receive all or some of the treatment options, you give your consent
(agree) by signing a consent form. The completed and signed form is a legal
document that lets your doctor go ahead with the treatment plan.
Why do I have to sign a consent form?
The main purpose of the informed consent process is to protect the patient. A consent
form is a legal document that ensures an ongoing communication process between you
and your health care provider. It implies that your health care provider has given you
information about your condition and treatment options and that you have used this
information to choose the option that you feel is right for you.
The way in which your treatment options must be given to you (for example, verbally or
in writing) may be listed in your state's laws. Your health care provider works with you to
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figure out the best way to give you the information you need. The provider may choose
to use methods other than a verbal discussion or a written document, such as videos,
interactive computer modules, audio files or other methods to help you understand the
information better. Be sure you understand all the information given, even if it means
going over it many times or asking your provider to explain it in different ways.
Can I change my mind after I've signed the consent?
Yes, you can change your mind at any time, even if you have already started treatment.
Let your health care provider know of your wishes.
What if I don't want the treatment being offered?
You have the right to refuse any and all treatment options. You may also choose other
treatment options that have been presented to you by your health care provider, even if
they are not as well proven as the one your health care provider recommends. You may
also refuse part of the treatment options, without refusing all care.
For example, you may choose to refuse surgery, but still wish to be treated for pain. In
this case, it may be up to you to find another health care provider or facility to treat you
with such an approach if your health care provider is not comfortable with it.
If you have decided to refuse treatment or diagnostic tests, your health care provider
may tell you about the risks or likely outcomes of this choice, so you can make an
informed refusal (meaning, you understand what could happen to your health by
refusing the recommended treatment but you still don't want the treatment). In this case,
you might be asked to sign a form to state that you received this information and that
you still chose not to be treated.
What is shared decision-making?
Shared decision-making is actually part of the informed consent process and allows
patients to play an active role in making decisions that affect their health. In shared
decision-making, the health care provider and patient work together to choose tests,
procedures, and treatments, and then to develop a plan of care. As described by the
informed consent process, the provider gives the patient information about their
condition and the pros and cons of all the treatment options. The patient then has a
chance to ask questions and read more about the options. The patient also tells the
health care provider what their preferences, personal values, opinions and such are
about their condition and treatment options. The health care provider should always
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respect the patient's preferences and goals, and use them to help guide the patient's
treatment recommendations. This type of decision-making is especially helpful when
there is no single "best" treatment option.
What if I want the doctor to make the decisions about my care?
Treatment cannot be given without your consent, Unless care and treatment are needed
in an emergency and you are unable to give consent. However, you have the right to
refuse information and treatment. Or, in advance, you can assign a person to make
decisions for you through an advance directive or other legal document. You can also
ask for minimal information and trust your health care provider to make decisions for
you. At the same time, informed consent laws do not allow a health care provider to
keep a diagnosis from the patient, even at the family's request.
Hyperlinks
1. www.americanbar.org/groups/law_aging/resources/health_care_decision_making
2. http://www.aha.org/advocacy-issues/communicatingpts/pt-care-partnership.shtml
3. mail.google.com/mail/?view=cm&fs=1&tf=1&to=CLRC@drlcenter.org
4. http://www.cancerlegalresources.org/
5. http://www.cancer.gov/
6. www.americanbar.org/groups/law_aging/resources/health_care_decision_making
7. http://www.aha.org/advocacy-issues/communicatingpts/pt-care-partnership.shtml
8. mail.google.com/mail/?view=cm&fs=1&tf=1&to=CLRC@drlcenter.org
9. http://www.cancerlegalresources.org/
10. http://www.cancer.gov/
References
Agency for Healthcare Research and Quality. Strategy 61: Shared
decisionmaking. 2017. Accessed at https://www.ahrq.gov/cahps/quality-
improvement/improvement-guide/6-strategies-for-improving/communication/strategy6i-
shared-decisionmaking.html, on February 19, 2019.
Centers for Medicare & Medicaid Services (CMS). Revisions to the hospital interpretive
guidelines for informed consent. 2007. Accessed
at https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdf on February 19,
2019.
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Katz AL, Webb SA, Committee on Bioethics. Informed consent in decision-making in
pediatric practice. AAP News & Journals; 2016; 138(2):e1-e13.
MedlinePlus. Informed consent-adults. 2017.Accessed
at https://medlineplus.gov/ency/patientinstructions/000445.htm. on February 19, 2019.
Spruit SL, Van de Poel I, Doorn N. Informed consent in asymmetrical relationships: An
investigation into relational factors that influence room for reflection. US National Library
of Medicine National Institutes of Health; 2016;10:123-138.
Storm C, Casillas J, Grunwald H, Howard DS, McNiff K, Neuss MM. Informed consent
for chemotherapy: ASCO member resources. Journal of Oncology Practice; 2008 (or
2016);6:289-295.
The Joint Commission, Division of Health Care Improvement. Informed consent: More
than getting a signature. 2016. Accessed
at https://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Twenty-
One_February_2016.pdf on February 19, 2019.
Additional resources
Along with the American Cancer Society, other sources of information include:
American Bar Association Website: https://www.americanbar.org/
(www.americanbar.org/groups/law_aging/resources/health_care_decision_making)1
Your community’s Legal Aid Society If your income is limited, look in your phone book
or check the online information at the American Bar Association website; click on your
state and look for Free Legal Help
Your state or city Bar Association Check your local phone book or find it online at the
American Bar Association
American Hospital Association Website: www.aha.org (http://www.aha.org/advocacy-
issues/communicatingpts/pt-care-partnership.shtml)2
Read their Patient Care Partnership brochure online for more on patients’ rights and
responsibilities in the hospital. Also available in Spanish, Arabic, Chinese, Tagalog,
Vietnamese, and Russian
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Cancer Legal Resource Center
Toll-free number: 1-866-843-2572 Email: CLRC@drlcenter.org
(mail.google.com/mail/?view=cm&fs=1&tf=1&to=CLRC@drlcenter.org)3 (please read
email notice)
Website: www.cancerlegalresources.org (http://www.cancerlegalresources.org/)4
Offers free, confidential information and resources on cancer-related legal issues
National Cancer Institute Toll-free number: 1-800-4-CANCER (1-800-422-6237) TTY:
1-800-332-8615 Website: www.cancer.gov (http://www.cancer.gov/)5
Offers current information about cancer and cancer treatment, living with cancer, clinical
trials, and research
*Inclusion on this list does not imply endorsement by the American Cancer Society.
Last Medical Review: May 13, 2019 Last Revised: May 13, 2019
When Is Informed Consent Needed?
The informed consent process should begin before you start cancer treatment. If you
are getting more than one treatment, you will probably need to sign separate informed
consent forms. For example, if you are having surgery to remove cancer and then will
have chemotherapy or radiation to treat it, you will need to give consent for both surgery
and either the chemotherapy or radiation.
Some medical procedures that may require you to give written informed consent
include:
● Radiation1
● Chemotherapy2 (including targeted therapy and immunotherapy)
● Surgery3
● Some complex or advanced medical tests and procedures, such as a biopsy4
(removing cells from a suspicious area so that they can be looked at in the lab to
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see if cancer cells are present)
● Some vaccines
● Some blood tests or other tests or procedures
Parts of informed consent are regulated by state and case law. In general, those who
make medical decisions must be recognized as adults in the state where the treatment
is to be given. For children or others who are unable to make the decision for
themselves, a parent or legal guardian is legally responsible for getting the information,
making the decision, and signing the consent form. Some facilities require mentally
competent older children who are being treated to give assent (willingness to
participate) before they go into a research study, even after the parents have agreed on
the child’s behalf. Assent means that, even though the parents sign the form, the child
must also be okay with the plan before the facility will do the treatment.
There are times when the usual informed consent rules do not apply. This varies from
state to state and may include:
● In an emergency, if a person is unconscious and in danger of death or other serious
outcomes if medical care is not given right away, informed consent may not be
required before treatment.
● If those who are giving treatment know that the patient has an advance directive
that states the patient refuses the care, the treatment may not be given.
● When a decision made by the parent or guardian of a child or an incompetent adult
may be challenged by the doctor or facility, the courts may evaluate the situation.
● An older teen (for example, one who is self-supporting and doesn't live at home, is
married, pregnant, or in the military) does not need parental consent for treatments
or procedures.
A patient may wish to delegate his/her right to make informed decisions to another
person. (See Advance Directives5 for more detailed information on this process.) This
choice should be made to the extent permitted by the law. Sometimes, the patient may
be unconscious or unable to make an informed decision. In these cases, the hospital
must check their records for the patient's advance directives , medical power of attorney
or the patient's representative. As soon as the patient is able to be informed of his/her
rights, the health care provider must give the patient that information.
Another option is a court-appointed surrogate or proxy. This is someone a judge
chooses to make decisions for you if you become unable to make decisions for yourself.
Some states have passed family agency acts that choose which family members (listed
in order of priority) may act on behalf of a patient if the patient doesn't have an advance
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directive or medical power of attorney.
Hyperlinks
1. www.cancer.org/treatment/treatments-and-side-effects/treatment-
types/radiation.html
2. www.cancer.org/treatment/treatments-and-side-effects/treatment-
types/chemotherapy.html
3. www.cancer.org/treatment/treatments-and-side-effects/treatment-
types/surgery.html
4. www.cancer.org/treatment/understanding-your-diagnosis/tests/testing-biopsy-and-
cytology-specimens-for-cancer/biopsy-types.html
5. www.cancer.org/treatment/finding-and-paying-for-treatment/understanding-
financial-and-legal-matters/advance-directives.html
References
Centers for Medicare & Medicaid Services (CMS). Revisions to the hospital interpretive
guidelines for informed consent. 2007. Accessed
at https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdf on February 19,
2019.
Katz AL, Webb SA, Committee on Bioethics. Informed consent in decision-making in
pediatric practice. AAP News & Journals; 2016;138(2):e1-e13.
MedlinePlus. Informed consent-adults. 2017.Accessed
at https://medlineplus.gov/ency/patientinstructions/000445.htm on February 19, 2019.
Moye J, Sabatino CP, Brendel RW. Evaluation of the capacity to appoint a health care
proxy. American Journal of Geriatric Psychiatry; 2013;21(4):326-336.
Storm C, Casillas J, Grunwald H, Howard DS, McNiff K, Neuss MM. Informed consent
for chemotherapy: ASCO member resources. Journal of Oncology
Practice; 2016;6:289-295.
Last Medical Review: May 10, 2019 Last Revised: May 10, 2019
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Informed Consent for a Clinical Trial
Informed consent for a clinical trial or study may include an investigational drug or
procedure (where new treatments are compared to the current standard treatment).
This process usually include more information than the consent forms for standard
treatment. The informed consent process for clinical trials is meant to give you ongoing
information to help you make an educated decision about whether to start or stay in a
clinical trial.
A person who is thinking about being part of a clinical trial is called a potential research
subject. If a person decides to be part in a clinical trial, this is referred to as enrolling or
enrollment in the study. As a potential research subject, you must be given an
opportunity to read the consent document fully, and to ask questions about anything you
do not understand. The consent form for a clinical trial or research study should clarify
the following information.
● The purpose of the research
● How long it is expected to take.
● A statement saying the study involves research.
● That research subject participation is voluntary and that refusing treatment will not
result in not receiving the care that they need.
● All the procedures that will be completed during the enrollment into the clinical trial.
● Any possible benefits and risks that may be expected from the research.
● Any possible discomfort (e.g., injections, frequency of blood tests etc.)
● Any alternative procedures or treatment (if any) that might benefit the research
subject.
● How the potential subject's information will be kept private during the clinical trial
and that the FDA (Food and Drug Administration) may inspect the records at any
time.
● Whether any compensation (payment) or medical treatments are available if injury
occurs and where that information may be found.
● The research subject's rights; such as the right to refuse treatment or stop
participation in the clinical trial at any time, without losing any treatment benefits.
● Contacts for answers to questions related to the clinical trial and to report any
injuries that may occur.
Before signing the form be sure you understand all the information given to you and
have had a chance to ask questions about what you don't understand. You can bring a
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family member or friend that you trust to help you keep track of your information. If you
need extra time to review the information, you may ask your health care provider to give
you a copy of the informed consent form so you can take it home and review it as many
times as you need before making a decision.
If you take part in a clinical trial, during the study it's possible that the research team
may make new discoveries that could affect your health, well-being, or willingness to
stay in the clinical trial. They will share this with you and might ask you to sign a new
consent form. Remember, you can leave the clinical trial if anything happens or any
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 where the informed consent forms are presented to you. While your health
care team will likely 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 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
yourself
Tips about clinical trials
● Keep a copy of the consent form. 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 US 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 appears to not hold the investigator, doctor, sponsor, or facility
accountable 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 health care providers. Take your time and
ask for help when you need it.
We have more information that can help you understand clinical trials. Call us at 1-800-
227-2345 or visit Clinical Trials1 online to find information, worksheets, and videos that
can help you decide if a clinical trial is right for you.
Hyperlinks
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1. www.cancer.org/treatment/treatments-and-side-effects/clinical-trials.html
References
Kadam RA. Informed consent process: A step further towards making it
meaningful! Perspectives in Clinical Research; 2017; 8(3): 107-112.
National Cancer Institute (NCI). Informed consent. 2016. Accessed
at https://www.cancer.gov/about-cancer/treatment/clinical-trials/patient-safety/informed-
consent on February 19, 2019.
Office for Human Research Protections. Informed consent FAQs. 2017. Accessed
at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-
consent/index.html on February 19, 2019.
U.S. Food & Drug Administration (FDA). Informed consent for clinical trials. 2018.
Accessed
at https://www.fda.gov/ForPatients/ClinicalTrials/InformedConsent/default.htm, on
February 19, 2019.
Last Medical Review: May 13, 2019 Last Revised: May 13, 2019
Written by
The American Cancer Society medical and editorial content team
(www.cancer.org/cancer/acs-medical-content-and-news-staff.html)
Our team is made up of doctors and oncology certified nurses with deep knowledge of
cancer care as well as journalists, editors, and translators with extensive experience in
medical writing.
American Cancer Society medical information is copyrighted material. For reprint
requests, please see our Content Usage Policy (www.cancer.org/about-
us/policies/content-usage.html).
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