Informed Consent | What Is Informed Consent? (2022)

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. Every 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 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 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.

  • Written by
  • References
  • Additional resources

The American Cancer Society medical and editorial content team

Our team is made up of doctors andoncology certified nurses with deep knowledge of cancer care as well as journalists, editors, and translators with extensive experience in medical writing.

(Video) What is Informed Consent // Informed Consent Training

Agency for Healthcare Research and Quality.Strategy 61: Shared decisionmaking.2017. Accessed athttps://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 athttps://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdfon February 19, 2019.

(Video) What is informed consent?

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 athttps://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 athttps://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Twenty-One_February_2016.pdfon February 19, 2019.

Along with the American Cancer Society, other sources of information include:

American Bar Association
Website:https://www.americanbar.org/

Your community’sLegal 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 cityBar Association
Check your local phone book or find it online at the American Bar Association

American Hospital Association
Website:www.aha.org

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

Cancer Legal Resource Center

Toll-free number: 1-866-843-2572
Email:CLRC@drlcenter.org(please read email notice)

Website:www.cancerlegalresources.org

(Video) What is Informed Consent?

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

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.

References

Agency for Healthcare Research and Quality.Strategy 61: Shared decisionmaking.2017. Accessed athttps://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 athttps://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdfon 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 athttps://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 athttps://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Twenty-One_February_2016.pdfon February 19, 2019.

Additional resources

Along with the American Cancer Society, other sources of information include:

American Bar Association
Website:https://www.americanbar.org/

Your community’sLegal 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 cityBar Association
Check your local phone book or find it online at the American Bar Association

American Hospital Association
Website:www.aha.org

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

Cancer Legal Resource Center

Toll-free number: 1-866-843-2572
Email:CLRC@drlcenter.org(please read email notice)

Website:www.cancerlegalresources.org

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

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.

(Video) What is informed consent?

Last Revised: May 13, 2019

(Video) What is Informed Consent? | Kaiser Permanente

American Cancer Society medical information is copyrightedmaterial. For reprint requests, please see our Content Usage Policy.

FAQs

What is meant by informed consent Please indicate the best answer? ›

The answer is: informed consent involves discussing the potential risks and benefits of the research. Your answer has been saved.

What is meant by informed consent? ›

A process in which patients are given important information, including possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This is to help them decide if they want to be treated, tested, or take part in the trial.

What is informed consent in a study? ›

Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work. A central part of the informed consent process is the informed consent document.

Why informed consent is very important discuss your answer? ›

Informed consent creates trust between doctor and patient by ensuring good understanding. It also reduces the risk for both patient and doctor. With excellent communication about risks and options, patients can make choices which are best for them and physicians face less risk of legal action.

What is an example of informed consent? ›

I have read and I understand the provided information and have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost.

What are the 3 types of informed consent? ›

There are three common ways to collect informed consent from your patient before a medical procedure. You can request written consent, use an online form or ask for oral consent.

What is right to informed consent? ›

The process is known as informed consent. People have the right to information about risks, benefits, and alternative treatments when making decisions about medical care and the freedom to choose. (See also Overview of Legal and Ethical Issues in Health Care.

Which is true about informed consent? ›

For simplicity's sake, informed consent essentially means that a medical provider must explain a situation in a way the patient (or patient's medical DPOA, proxy, or caregiver) can understand of all the risks, benefits, and alternative options associated with the care being provided. The principle is simple.

What must informed consent consider? ›

Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision.

What are the 4 elements of informed consent? ›

There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency. 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.

Why do we need informed consent in research? ›

Informed consent allows potential research participants to volunteer their participation freely, without threat or undue coaching. The potential participant is also provided with information an individual would want to know before participating, so an educated decision can be made whether or not to participate.

What is consent and why is it important? ›

Consent represents the ethical and legal expression of a person's right to have their autonomy and self-determination respected.

What is difference between consent and informed consent? ›

As autonomy is the main ethical principle for informed consent an absolute right to consent cannot exist. The basic difference between consent and informed consent is the patients' knowledge behind the consent decision.

What are the 5 essential elements of the informed consent process? ›

The Elements of Informed Consent. Literature of bioethics often analyzes informed consent in terms of the following elements: (1) disclosure; (2) comprehension; (3) voluntariness; (4) competence; and (5) consent (see U.S. National Commission, 1978, U.S. President's Commission, 1982; Meisel and Roth, 1981).

Is informed consent always necessary? ›

Yes, in some circumstances. The HHS regulations require that an investigator obtain legally effective informed consent from subjects or a legally authorized representative before the subjects may be involved in research (45 CFR 46.116), unless this requirement has been waived by an IRB.

When informed consent is not required? ›

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.

What defines consent? ›

What is consent? Consent is an agreement between participants to engage in sexual activity. Consent should be clearly and freely communicated. A verbal and affirmative expression of consent can help both you and your partner to understand and respect each other's boundaries.

What are the 2 types of consent? ›

There are two types of consent that a patient may give to their medical provider: express consent and implied consent. Express consent is typically done in writing, while implied consent is typically conveyed through a patient's actions or conduct.

What consent is not? ›

You don't have consent if you use guilt, intimidation, or threats to coerce someone into sex, even if that person says “yes.” Saying yes out of fear is not consent. Silence or a lack of a response is not consent. Be clear and concise when getting consent.

How is informed consent obtained? ›

Obtaining Written or Verbal Informed Consent. Obtaining consent involves explaining the research and assessing participant comprehension using a consent document, usually a written consent form or information sheet, as a guide for the verbal explanation of the study.

Who does informed consent protect? ›

Legally, simple consent protects patients against assault and battery in the form of unwanted medical interventions. The higher standard of informed consent further safeguards patients' rights to autonomy, self-determination and inviolability.

What is the meaning of informed consent quizlet? ›

True:informed consent means a decision made by or for a patient after being informed about the proposed procedures, risks, benefits, and alternatives to the proposed treatment.

What are the two exceptions to informed consent? ›

There are two well-recognized exceptions to the need for informed consent to medical treatment. The more common is a medical emergency, in which an unconscious or delirious patient cannot consent. The second is rare and involves certain court-ordered treatments or treatments and tests mandated by law.

What is the ethical basis for informed consent? ›

Autonomy is the basis for informed consent, truth-telling, and confidentiality. A model to resolve conflicts when ethical principles collide is presented.

What is the focus or basis of informed consent today? ›

The focus of any consent process should be on informing and protecting research participants, through disclosure and discussion of relevant information, meaningful efforts to promote participants' understanding, and by ensuring that decisions to participate, or to continue participating, are always made voluntarily.

What is an example of informed consent in healthcare? ›

I (patient name) give permission for [practice name] to give me medical treatment. I allow [practice name] to file for insurance benefits to pay for the care I receive. I understand that: [practice name] will have to send my medical record information to my insurance company.

What is informed consent in healthcare? ›

Informed consent is when a healthcare provider — like a doctor, nurse, or other healthcare professional — explains a medical treatment to a patient before the patient agrees to it. This type of communication lets the patient ask questions and accept or deny treatment.

What are the advantages of informed consent? ›

The benefits of informed consent in relation to research on human participants can be seen as respect for participants, engaging the participants with the study and enhancing the researcher-participant relationship, which may reduce discontent and litigation.

Can informed consent be verbal? ›

In cases where a waiver of documentation of informed consent is requested, verbal informed consent may be allowed. Verbal informed consent occurs when a member of the research team and a potential subject verbally interact, and the subject gives their consent to participate verbally.

What are the limits of informed consent in research? ›

Evidently informed consent cannot be relevant to all medical decisions, because it cannot be provided by patients who are incompetent to consent, cannot be used in choosing public health policies, cannot be secured for all disclosure of third party information, and cannot be obtained from those who are vulnerable or ...

What is active consent? ›

Active consent means affirmative, honest, conscious, voluntary, sober and ongoing agreement to participate in sexual activity. Each person involved is responsible for ensuring that there is active consent to engage in each sexual act.

What is the meaning of informed consent quizlet? ›

True:informed consent means a decision made by or for a patient after being informed about the proposed procedures, risks, benefits, and alternatives to the proposed treatment.

What is informed consent in healthcare? ›

The process of informed consent occurs when communication between a patient and physician results in the patient's authorization or agreement to undergo a specific medical intervention.

What is an example of informed consent in healthcare? ›

I (patient name) give permission for [practice name] to give me medical treatment. I allow [practice name] to file for insurance benefits to pay for the care I receive. I understand that: [practice name] will have to send my medical record information to my insurance company.

How do you explain informed consent to a client? ›

Informed Consent Essentials

Consent must be given voluntarily. The client must be competent (legally as well as cognitively/emotionally) to give consent. We must actively ensure the client's understanding of what she or he is agreeing to. The information shared and all that is agreed to must be documented.

Which is true about informed consent? ›

For simplicity's sake, informed consent essentially means that a medical provider must explain a situation in a way the patient (or patient's medical DPOA, proxy, or caregiver) can understand of all the risks, benefits, and alternative options associated with the care being provided. The principle is simple.

What are the main principles of informed consent? ›

Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.

What is the first part of informed consent quizlet? ›

The first part of informed consent is a clear explanation of a procedure or test. This also includes the procedure or test's benefits, its risks, and the consequences of not performing the procedure or test as well as alternative options.

What are the 4 types of consent? ›

Types of consent include implied consent, express consent, informed consent and unanimous consent.

What are the 4 types of consent in healthcare? ›

What are the Different Types of Consent?
  • Informed consent.
  • Implied consent.
  • Explicit consent.
  • Active consent.
  • Passive consent.
  • Opt-Out consent.
  • Key takeaway.
16 Mar 2021

Who does informed consent protect? ›

Legally, simple consent protects patients against assault and battery in the form of unwanted medical interventions. The higher standard of informed consent further safeguards patients' rights to autonomy, self-determination and inviolability.

When informed consent is required? ›

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.

What is difference between consent and informed consent? ›

As autonomy is the main ethical principle for informed consent an absolute right to consent cannot exist. The basic difference between consent and informed consent is the patients' knowledge behind the consent decision.

When informed consent is not required? ›

In an emergency, a doctor must act quickly to save a life. If stopping life-saving efforts and describing the risks of a procedure will cause a delay that puts the patient's life further at risk, then the doctor does not need to obtain informed consent. The patient is mentally incapacitated or emotionally fragile.

Is informed consent always possible? ›

The problem is that informed consent is not always possible. There are some contexts in which the nature of the information is such that the patient's understanding and capacity for decision making are overwhelmed, making informed consent impossible.

What is informed consent and why is it important in Counselling? ›

Obtaining consent from clients prior to providing them with psychological services is a fundamental given. 'Informed consent' is a procedure that involves providing clients with comprehensive information about the psychological service and gaining their agreement to take part in the service (1).

What is the purpose of informed consent in social work? ›

Through informed consent, the social worker and client outline what the client can expect from the professional relationship, as well as what the social worker expects from the client's participation.

Videos

1. Confidentiality and Informed consent || Nursing Ethics | unit-4 || in Urdu and Hindi part-1
(Lectures BY Anaya KMU)
2. Informed Consent: The 9 Elements of Informed Consent
(OSU Center for Clinical and Translational Science)
3. Informed Consent
(WTH is Bioethics?)
4. Informed Consent for Research: What to Expect
(U.S. Department of Health and Human Services)
5. Basics - Part 9 - Informed Consent
(GCP-Mindset - All About Clinical Research)
6. Informed Consent
(Dirty Medicine)

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