What Does Implied Consent Law Mean?
Marvin Harvey
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INTERPRETATION OF IMPLIED CONSENT LAWS BY THE COURTS BACKGROUND, OPERATION AND APPLICATION OF THE LAW REQUIRING DRIVERS TO SUBMIT TO A CHEMICAL TEST TO DETERMINE BLOOD ALCOHOL CONTENT OR LOSE THEIR LICENSES. ALL FIFTY STATES HAVE ENACTED THE SO-CALLED IMPLIED CONSENT LAW.
THESE LAWS TYPICALLY PROVIDE THAT ANY PERSON WHO OPERATES A MOTOR VEHICLE ON A PUBLIC HIGHWAY IS DEEMED TO HAVE GIVEN HIS CONSENT TO A CHEMICAL TEST TO DETERMINE THE ALCOHOLIC CONTENT OF HIS BLOOD. THE TEST IS ADMINISTERED BY A LAW ENFORCEMENT OFFICER WHO HAS PROBABLE CAUSE TO BELIEVE THAT THE PERSON IS UNDER THE INFLUENCE OF ALCOHOL WHILE IN ACTUAL PHYSICAL CONTROL OF A MOTOR VEHICLE.
What Is Implied Consent? (Don’t Get Behind The Wheel Without Watching This)!!!
IF A DRIVER REFUSES TO SUBMIT TO THE TEST, HIS LICENSE WILL BE REVOKED. A COMMON OBJECTION TO THIS LAW IS THAT IT SEEMS TO VIOLATE THE RIGHT AGAINST SELF-INCRIMINATION, BUT COURT DECISIONS HAVE HELD THAT THIS PRIVILEGE PERTAINS ONLY TO SELF-INCRIMINATING STATEMENTS AND DOES NOT INCLUDE COMPULSION WHICH MAKES A SUSPECT OR ACCUSED THE SOURCE OF REAL OR PHYSICAL EVIDENCE.
- IN ADDITION TO DISCUSSING THIS CONSTITUTIONAL ISSUE, THE STUDY ALSO CONSIDERS ARREST, PROBABLE CAUSE, REVOCATION OF LICENSE, PROCEDURES AT HEARINGS, WARNINGS, AND APPEALS.
- THIS DESCRIPTION OF THE BACKGROUND, OPERATION AND APPLICATION OF THE IMPLIED CONSENT LAW WILL BE PARTICULARLY USEFUL FOR LAW ENFORCEMENT OFFICERS IN STATES WHICH HAVE RECENTLY ENACTED OR REVISED DRUNK DRIVER IMPLIED CONSENT LAWS.
: INTERPRETATION OF IMPLIED CONSENT LAWS BY THE COURTS
What does implied consent mean?
Implied consent, compared to express consent (where consent is directly and clearly given with explicit words), is the agreement given by a person’s action (even just a gesture) or inaction, or can be inferred from certain circumstances by any reasonable person,
The person who gives consent can withdraw the consent anytime and should have the capacity to make valid consent, The actor who gets the consent is bound by the consent and cannot exceed its scope. In tort law, implied consent is a defense to an intentional tort, The plaintiff’s consent is implied when the plaintiff fails to object, or is silent in a situation in which a reasonable person would object to the defendant’s actions.
Implied consent can arise from the actor’s reasonable interpretation of objective circumstances or from the consenter’s conduct. Consent can be implied by law, to save life, or protect property. For instance, under a medical emergency, when the person is unconscious and giving consent is impossible, but operating is necessary, consent is implied.
- Implied consent can also be inferred in custom; a person will be inferred to consent to an action when they participate in an activity in which certain action is necessary or customary.
- Especially when the activity with harmful or offensive contact can result in battery, the implied consent will be a defense of the actor (e.g., athletes have assumed the risk of violent contact within reasonable boundaries) unless the actor intentionally used force exceeding the consent or the consent was forced to submit.
In contract law, the form of a contract requires mutual consent, When the offeror gives the offer, the offeree may give consent by performing on the contract. Such consent is implied by the offeree’s performance. When a person applies for a driving license or drives a car in a state that has an “implied consent” law (e.g., NY ), they are considered to give implied consent to take a chemical test using blood, breath, or saliva to measure the blood alcohol content,
Is implied a type of consent?
All patients have a right to be informed about any treatments and procedures a doctor has proposed. Physicians have a duty to make sure their patients can make informed decisions about their health. There are two types of consent that a patient may give to their medical provider: express consent and implied consent.
What is an example of implied consent quizlet?
Consent is implied by the patient holding out his or her arm. Expressed consent is verbal or written. The only emergency consent is one that is ‘life or limb’ threatening.
What is implied consent law UK?
What is implied consent? | Lawtons Criminal Defence Solicitors To provide sexual consent is to give permission to engage in a sexual act with a partner. It is mandatory to gain consent from a partner before engaging in sexual activity, as failure to do so can result in committing the offence of or even rape.
- Consent must be given freely, by each partner and before every sexual act or encounter.
- The states that for someone to consent to a sexual act he or she must ‘.agree by choice.(with).the freedom and capacity to make that choice.’ If someone has verbally agreed to participate in a sexual act yet they lack the freedom or capacity to do so, they have not truly – or freely – consented.
If they are threatened, coerced, or bullied into sexual activity as a result of fear, they lack the capacity to consent freely. An individual is unable to provide their consent if they are:
- Under the legal age of consent – anyone under the age of 16 does not have the legal capacity to consent to sexual activity of any kind
- If they are unconscious
- If they are asleep
- If they are being held against their will
- It is an offence under the Sexual Offences Act 2003 to cause or encourage someone to engage in any sexual activity without their consent.
- Verbal consent – also known as express consent – is the clearest form of consent, yet implied consent is also permissible, providing you can prove you reasonably believe consent was given for the sexual act to take place.
- Implied consent relies upon non-verbal signals, but these are ambiguous and open to misinterpretation, so you should always be sure that consent from a partner has been given before engaging in any sexual activity.
What is the difference between consent and implied consent?
What is the Main Difference Between Implied Consent and Express Consent? – The main difference is the clarity of the consent. Express consent is extremely clear. The person verbally gives consent or signs a document stating they understand all risks involved and consent to proceed with the procedure or treatment.
What three elements are implied with consent?
Clinical Significance – Informed consent is required for many aspects of health care. These include consent for:
- Treatment,
- dissemination of patient information,
- discussion of HIPPA laws,
- specific procedures,
- surgery,
- blood transfusions, and
- anesthesia.
Obtaining informed consent in medicine is process that should include: (1) describing the proposed intervention, (2) emphasizing the patient’s role in decision-making, (3) discussing alternatives to the proposed intervention, (4) discussing the risks of the proposed intervention and (5) eliciting the patient’s preference (usually by signature).
Discussion of all risks is paramount to informed consent in this context. Most consent includes general risks, risks specific to the procedure, risks of no treatment and alternatives to treatment. Additionally, many consent forms express that there are no guarantees that the proposed procedure will provide a cure to the problem being addressed.
Patient safety is a major focus in health care, and effective informed consent is considered a patient safety issue. The Joint Commission recently addressed the challenges to ensuring effective informed consent. The emphasis of a patient signature as an indication of understanding is being called into question.
- The process of informed consent is shifting to focus more on communication and less on signatures.
- Studies of informed consent have found that there are many barriers to obtaining effective informed consent.
- One major barrier is that some consent forms contain language that is at too high a reading level for many patients.
Use of visual and digital communication tools is being encouraged to address some the inefficiencies in the process of obtaining consent. Patients should be actively engaged as a way to enhance communication and ensure patient safety and understanding.
- Informed consent may be waived in emergency situations if there is no time to obtain consent or if the patient is unable to communicate and no surrogate decision maker is available.
- Also, not every procedure requires explicit informed consent.
- For example taking a patient’s blood pressure is a part of many medical treatments.
However, a discussion regarding the risks and benefits of using a sphygmomanometer usually is not required. Clinical Significance in Human Clinical Studies Informed consent is mandatory for all clinical trials involving human beings. The consent process must respect the patient’s ability to make decisions and adhere the individual hospital rules for clinical studies.
- Adherence to ethical standards in study design and execution is usually monitored by an Institutional Review Board (IRB).
- The IRB was established in the United States in 1974 by the National Research Act which called for regulation in human research that was prompted by questionable research tactics used in the Tuskegee syphillis experiments and others.
Ethical and safe research standards have been an area of federal and presidential interest since then, with the development of many organizations and task forces since 1974 dedicated to this topic alone. 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.
- An IRB may waive informed consent if certain conditions are met.
- Paramount to this is that there be ‘minimal risk’ to the research participants.
- One example of minimal risk research is the assessment of interventions that normally occur in emergency situations.
Examples of this include studying medications used for intubations in the emergency room or conducting a retrospective chart review. Shared Decision Making Informed consent is a collaborative process allowing patients and healthcare providers to make decisions together when more than one reasonable alternative exists, accounting for the patient’s unique preferences and priorities and the best scientific evidence available.
It is most appropriate in weighing the benefits and harms of invasive procedures, computed tomography (CT), and post-ED disposition including the use of thrombolytics for acute ischemic stroke, lumbar puncture to rule out subarachnoid hemorrhage, and CT for minor pediatric head injuries. Shared decision-making (SDM) challenges in Emergency Medicine include patient, provider, system and evidence level limitations.
Examples include: (1) if patients are capable of or willing to engage in decision making (2) if providers feel it provides more or less medico-legal protection, (3) if the Emergency Department is overwhelmed and time is of the essence to make decisions, and (4) if the facility lacks well-validated risk prediction tools to guide decision making.
What are the 3 types of consent?
Types of consent include implied consent, express consent, informed consent and unanimous consent.
What is an example of lack of informed consent?
What is an Example of Lack of Informed Consent? – The most common examples of a lack of informed consent includes a physician not letting a patient know the known risks associated with the procedure. While this may not seem like a big deal if a procedure is successful, if a patient does suffer from one of these known risks that they did not know about, this could be a case of lack of informed consent causing harm.
When can you rely on implied consent?
II. General Interpretations by the Courts –
- “The form of the consent sought by the organization, and the way in which the organization seeks consent, may vary, depending on the circumstances and the type of information (clauses 4.3.4 and 4.3.6). In obtaining consent, the reasonable expectations of the individual are relevant (clause 4.3.5). Implied consent would generally be appropriate when the information is less sensitive (clause 4.3.6). Examples of ways in which individuals can give consent are: on application forms, on checkoff boxes, over the telephone, at the time of use, all of which imply that the consent is given at the time of collection and before use.” ( Englander v. Telus Communications Inc., 2004 FCA 387 at para.60)
- Principle 4.3.4 makes it clear that “medical information is almost always considered to be sensitive, calling for a rather more explicit form of consent.” ( Townsend v. Sun Life Financial, 2012 FC 550 at para.25)
- “I agree with the respondent that is at the lower end of the scale of sensitivity, viewed objectively. The content was limited to the number of times per week that the applicant attended one of the respondent’s fitness centres. The information disclosed said nothing about what he did at the fitness centres, how long he remained, the nature of his training regime, level of fitness or any other personal information. In other circumstances, implied consent for the disclosure of information at a low level of sensitivity may be found. I accept the applicant’s submission that in the circumstances of this case the information was sensitive particularly as it was being disclosed to his work colleagues at a staff meeting and encouraged rivalry with colleagues that made him uncomfortable. The employer should have been aware that some employees might not be comfortable with disclosure of the information to their colleagues in a public forum. In these circumstances, the level of sensitivity of the information was not so low that I would consider that consent to its disclosure could be implied.” ( Randall v. Nubody’s Fitness Centres, 2010 FC 681 at paras.42-43)
- “A consent is not informed if the person allegedly giving it is not aware at the time of giving it that he or she had the possibility to opt out.” ( Englander v. Telus Communications Inc., supra at para.67)
What is another word for implied consent?
Acceptance, acquiescence, agreement, assent, nod, yes.
Which of the following is true of implied consent?
Which of the following is true of implied consent? A patient gives implied consent by directly affirming that he/she understands and consents to treatment.
What 3 factors must you consider for valid consent?
Defining consent – For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. The meaning of these terms are:
voluntary – the decision to either consent or not to consent to treatment must be made by the person, and must not be influenced by pressure from medical staff, friends or familyinformed – the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go aheadcapacity – the person must be capable of giving consent, which means they understand the information given to them and can use it to make an informed decision
If an adult has the capacity to make a voluntary and informed decision to consent to or refuse a particular treatment, their decision must be respected. This is still the case even if refusing treatment would result in their death, or the death of their unborn child.
- If a person does not have the capacity to make a decision about their treatment and they have not appointed a lasting power of attorney (LPA), the healthcare professionals treating them can go ahead and give treatment if they believe it’s in the person’s best interests.
- But clinicians must take reasonable steps to discuss the situation with the person’s friends or relatives before making these decisions.
Read more about assessing the capacity to consent, which explains what someone can do if they know their capacity to consent may be affected in the future.
What are the 5 elements of consent?
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 implied consent unconstitutional?
In a Nutshell: California’s implied consent law, making punishable a refusal to submit to a breath or blood test (at Vehicle Code § 23612), is not unconstitutional as a violation of the Fourth Amendment.
When would implied consent be used?
Introduction Implied consent is the act of granting permission to perform a medical treatment or procedure without explicitly asking for permission. Implied consent is different from explicit consent in that it does not have to be expressed verbally, but can be implied through actions.
- This article will touch on implied consent especially in the healthcare industry.
- Read on! What is implied consent? Implied consent is a legal term that refers to the idea that a patient does not have to specifically consent to treatment or care by a healthcare provider.
- It is when a patient, without any explicit request for consent, implicitly agrees to participate in a medical procedure.
A patient can agree to be treated without explicitly asking for it. This type of agreement is usually implied when a patient goes to the doctor and receives treatment, such as medication or medical procedures, without having expressly asked for them. Implied consent can be inferred from a patient’s behavior while they are receiving treatment.
If you’re at the doctor and ask them what they’re doing and why they’re doing it, this would be considered an implied agreement with the doctor that you’ll receive whatever treatment they deem necessary for your health. For example, in the case of blood testing, a doctor can draw blood without asking permission from the patient because they are subject to legal professional privilege laws.
Implied consent can be found in many different areas of healthcare, including: -Hospitals -Clinics -Emergency departments -Outpatient centers -Private physicians’ offices Purpose of consent in healthcare In healthcare, there’s an important distinction between consent and implied consent.
- Implied consent is when a person has given permission for their medical information to be shared with another party, but they haven’t explicitly stated that they agree to it.
- For example, if you go to the doctor and agree to let them poke around in your body and examine you for any reason, you’re giving implied consent.
However, if you’ve asked what information someone wants from your medical records and been told that it’s for research purposes only, and then later find out that it’s not just research but also marketing or other commercial uses, you may have been given implied consent even though you never explicitly gave it.
When a patient is unable to communicate for some reason, such as if they are unconscious or in shock.
When a patient’s ability to communicate is limited by their age, mental state or physical condition.
If a patient has been injured or has an illness that makes it difficult for them to express their wishes.
In situations where there is no formal agreement between the patient and doctor or nurse about whether or not treatment should be administered, implied consent means that the doctor or nurse can administer treatment without obtaining explicit approval from the patient beforehand.
- The most common example of implied consent occurs when a doctor performs a procedure on someone who is unconscious or unable to give consent.
- Principles and requirements for implied consent in healthcare Consent is an important principle that every healthcare professional should follow.
- It is the right of a patient to give or withhold consent to treatment, and it applies to any form of healthcare.
Implied consent means that if you are treated in a hospital or clinic, you have given your consent for your treatment by virtue of your presence there. This means that the person treating you has assumed that you want to be treated and are not acting under duress (for example, being restrained by a nurse).
Be acting in the professional capacity of their role as a healthcare provider;
Have completed training on how to recognize and respect implied consent; and
Be able to document their actions clearly with written records or other evidence (such as video footage).
Examples of implied consent Here are some of the examples of implied consent.
- You consent to examine your own medical records
- You consent to having your medical records sent to another physician
- You consent to be admitted into the hospital and receive treatment
- You consent to being enrolled as a patient in a clinical trial
- You consent to having blood drawn or other tests performed on you
Below are some instances to expanciate on how implied consent in healthcare works:
- You have an appointment to see a doctor. You don’t know what’s wrong with you, so you ask the receptionist if they’ll fill out a consent form for you. They agree, and you walk into the office.
- You go to get a physical exam because you’re having trouble breathing. The nurse checks your vitals and sees that there’s no problem, but she still asks if it’s OK to draw blood for testing.
- You go to get a flu shot at the doctor’s office, but since you already had one last year, the nurse explains that there are other ways for people who get the flu shot every year to get immunity from it. She shows you how to do it yourself and makes sure you understand what she told you so no one gets confused about what they need to do next time around.
When the doctor or nurse asks if you have any questions, it is implied. If you don’t ask, then you agree to the treatment. However, there are many types of treatments that can be performed without consent including blood tests, injections, and surgeries.
- It doesn’t apply when a child that is not of consent giving age is involved or when a very ill person is involved. In this case, a mentally impaired, demented or unconscious, or merely frail or confused person cannot give consent. This is because oftentimes, people cannot give informed consent to emergency treatment.
- It doesn’t apply in public health policies that are general. Public health policies such as water purification or vaccinations and quarantine programs in times of emergency cannot be made to suit an individual or their preferences. Implied consent does not apply in this instance.
- Implied consent does not apply to a third party information given by a patient to their Doctor. For example, giving out information about your family history or genetic information or information about family exposure to an infection. The consent of the entire family cannot be sought in this case before their information is used.
- Implied consent does not apply when people that are adequately competent to consent are under duress or constraint, and unable to refuse others’ demands. This occurs mostly with prisoners and soldiers, the vulnerable, and the dependent. These people often have ordinary capacities to consent but cannot refuse because of the power dynamics, thus undermining any “consent” they offer.
Other Types of consent in healthcare There are a few other types of consent in healthcare, including express consent, informed consent and unanimous consent.
- Express consent occurs when the patient gives a verbal yes or no to the proposed treatment or procedure, without the need for additional explanation. For example, a doctor might ask, “Do you want me to give you a shot?” The patient could respond with a simple, “Yes.” If the doctor then proceeds with giving that patient a shot, this is express consent for that particular injection.
- Informed consent occurs when patients are given enough information about their treatment options so that they can make informed decisions about what course of action they would like to pursue. It is important to remember that patients are not required to accept any particular treatment or procedure just because it has been suggested by their doctor; they must be provided with sufficient information about any treatment options available and given enough time to discuss them with their doctor before making any final decisions. Informed consent is different from mandatory requirements imposed by law or regulation concerning how certain treatments must be offered or provided (such as vaccinations).
- Unanimous consent is also very important: You must all agree unanimously before any procedures can be performed on any patient. If there are any disagreements among members of your healthcare team over whether or not something should be done or if they have conflicting interests, then there will be no effective participation in the process whatsoever.
Difference between implied consent and expressed consent There are two important concepts related to consent in healthcare: expressed consent and implied consent. Expressed consent is a form of informed consent that is given by an individual who chooses to participate in a study or clinical trial, or who consents to be treated by a particular provider.
- This type of consent requires the participant to sign a written document that describes the nature of the study (e.g., what it will entail) and gives permission for their future participation.
- Implied consent is based on the idea that if a person says “yes,” they have agreed to participate in a study or clinical trial; there is no need for them to sign any paperwork or give their signature on any documents that describe their participation in the study.
Implied consent can take place through verbal communication (e.g., when someone indicates they understand something). It can also be nonverbal communication (e.g., nodding or smiling while someone explains something), or through other means (e.g., if someone has agreed verbally but then changes their mind later).
- Implied consent is the legally recognized process of granting permission to perform a medical procedure on a patient, while expressed consent is the permission given verbally or in writing by a patient.
- Implied consent is given when a patient’s failure to object to treatment would not be considered an objection to the treatment itself. For example, if you are unconscious and have been admitted to the hospital for surgery, it may be inferred that you agree to the operation.
- Express consent must be obtained from patients before performing any medical procedure on them. This can be done through a written document or verbally during face-to-face meetings with doctors or nurses. It also depends on state laws and regulations in each state around the country as well as federal guidelines set forth by the Department of Health and Human Services (HHS).
How to obtain patient consent (general steps and by using formplus templates) If you’re a healthcare provider, it’s important to know how to obtain patient consent. When you’re seeking consent, the following steps are recommended:
- Start by explaining what your study is about and why you’re doing it. Do not ask directly for permission, just explain your intentions and what you need from the patient.
- If possible, ask if they want to participate in your study. If they say yes, ask them how much time they have available to help you out with your research project.
- Ask if they would be willing to provide a blood sample or saliva sample (a cheek swab). You may also want to offer the opportunity for them to speak with others who have been through similar experiences as their own before deciding whether or not they would like to participate in the study. this can be helpful when determining whether or not participants will feel comfortable being interviewed about their experience with a particular topic or question without first having had an opportunity to learn more about it beforehand; as well as providing insight into how other people might react if asked these same questions during future interviews (e.g., “What do you think about this idea?”
If you are a healthcare professional, you must obtain consent from your patient before beginning any service or treatment. In most cases, a signed written permission form is required. You can use formplus form templates to create a consent form that all patients will understand and sign.
- This ensures that no one feels pressured into participating in any way.
- Formplus form templates are free and easy to use.
- There are over 1000 form templates for you to choose from to get started.
- You can customize the form to suit your needs.
- Simply input the information you would like to receive and proceed to share it with the patient.
You can print it, or share it through the email. You can even monitor the responses as they are filled and received. Implications of consent (and lack) in healthcare Consent is a huge issue in healthcare, and it’s not just because of the fact that it’s so hard to get.
- When you’re a patient, consent is central to your experience.
- You need to give your consent for your doctor to do things like prescribe medicine or perform procedures.
- If your doctor doesn’t ask for your consent or if you feel pressured into giving it, that can be bad for your health and make you feel even more vulnerable than usual.
The American Medical Association recommends that doctors ask patients about their medical history and current health status before prescribing any medication or performing any procedure. Of course, this depends on how comfortable the patient feels with sharing this information with them but it’s important that everyone has this conversation before anything happens.
- If you don’t want to share personal information with your doctor, you should feel comfortable saying so too.
- Healthcare providers often fail to get consent from patients for tests and procedures.
- This can lead to issues such as inaccurate diagnoses, unnecessary treatments, and negative experiences with providers.
In order to provide the best care possible, health practitioners should always be sure to ask for consent before performing any procedure or test on their atients. If you do not have time for a consent form or are concerned that your patients won’t understand what they are signing up for, you can use a consent form template to gather their verbal consent in a more efficient manner.
Conclusion Implied consent is an important part of the healthcare system because it allows medical practitioners to provide care to people who may not be able to give explicit consent themselves. It also allows them to provide care that might otherwise be too overwhelming or complicated for patients to handle on their own.
FAQs How long is a consent form valid for: Consent forms are valid for up to one year after the event they were signed in relation to. This means that if you’re signing a consent form for a procedure, you need to sign it again at the end of your treatment.
- If there’s any complication, you’ll need to sign it again before the treatment begins.
- How to get consent from an unconscious patient: If the patient is unable to give consent, make sure that an emergency contact has been designated for them in case something happens and they can’t talk for themselves.
If there isn’t one, ask their family or friends if they can act as an emergency contact. Do not forget to update them with any changes in their condition or condition history during this time. You don’t want anyone getting stuck with the bill if something goes wrong.
What are the 4 types of consent?
Types of consent include implied consent, express consent, informed consent and unanimous consent.
What do you mean by implied consents and provide an example?
What is Implied Consent? – Implied consent means that the patient’s actions reflect the patient’s consent to treatment or procedures. For example, a patient who makes an appointment for a flu shot, keeps the appointment, and then rolls up his sleeve for the doctor to give the shot is presumed to have consented to receive the flu shot.
Likewise, if a patient comes to a lab for blood work and voluntarily holds out her arm for the nurse to take blood, she has given implied consent. Implied consent also applies in emergency situations. If a person is unconscious, a doctor is covered by implied consent when the doctor performs life-saving procedures.
If a patient is in surgery and complications arise that require the surgeon to perform additional procedures, the doctor is also covered by implied consent. It is presumed that a patient would give consent to life-saving treatments if the patient were able to do so.
What three elements are implied with consent?
Clinical Significance – Informed consent is required for many aspects of health care. These include consent for:
- Treatment,
- dissemination of patient information,
- discussion of HIPPA laws,
- specific procedures,
- surgery,
- blood transfusions, and
- anesthesia.
Obtaining informed consent in medicine is process that should include: (1) describing the proposed intervention, (2) emphasizing the patient’s role in decision-making, (3) discussing alternatives to the proposed intervention, (4) discussing the risks of the proposed intervention and (5) eliciting the patient’s preference (usually by signature).
Discussion of all risks is paramount to informed consent in this context. Most consent includes general risks, risks specific to the procedure, risks of no treatment and alternatives to treatment. Additionally, many consent forms express that there are no guarantees that the proposed procedure will provide a cure to the problem being addressed.
Patient safety is a major focus in health care, and effective informed consent is considered a patient safety issue. The Joint Commission recently addressed the challenges to ensuring effective informed consent. The emphasis of a patient signature as an indication of understanding is being called into question.
The process of informed consent is shifting to focus more on communication and less on signatures. Studies of informed consent have found that there are many barriers to obtaining effective informed consent. One major barrier is that some consent forms contain language that is at too high a reading level for many patients.
Use of visual and digital communication tools is being encouraged to address some the inefficiencies in the process of obtaining consent. Patients should be actively engaged as a way to enhance communication and ensure patient safety and understanding.
Informed consent may be waived in emergency situations if there is no time to obtain consent or if the patient is unable to communicate and no surrogate decision maker is available. Also, not every procedure requires explicit informed consent. For example taking a patient’s blood pressure is a part of many medical treatments.
However, a discussion regarding the risks and benefits of using a sphygmomanometer usually is not required. Clinical Significance in Human Clinical Studies Informed consent is mandatory for all clinical trials involving human beings. The consent process must respect the patient’s ability to make decisions and adhere the individual hospital rules for clinical studies.
Adherence to ethical standards in study design and execution is usually monitored by an Institutional Review Board (IRB). The IRB was established in the United States in 1974 by the National Research Act which called for regulation in human research that was prompted by questionable research tactics used in the Tuskegee syphillis experiments and others.
Ethical and safe research standards have been an area of federal and presidential interest since then, with the development of many organizations and task forces since 1974 dedicated to this topic alone. 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. An IRB may waive informed consent if certain conditions are met. Paramount to this is that there be ‘minimal risk’ to the research participants. One example of minimal risk research is the assessment of interventions that normally occur in emergency situations.
Examples of this include studying medications used for intubations in the emergency room or conducting a retrospective chart review. Shared Decision Making Informed consent is a collaborative process allowing patients and healthcare providers to make decisions together when more than one reasonable alternative exists, accounting for the patient’s unique preferences and priorities and the best scientific evidence available.
- It is most appropriate in weighing the benefits and harms of invasive procedures, computed tomography (CT), and post-ED disposition including the use of thrombolytics for acute ischemic stroke, lumbar puncture to rule out subarachnoid hemorrhage, and CT for minor pediatric head injuries.
- Shared decision-making (SDM) challenges in Emergency Medicine include patient, provider, system and evidence level limitations.
Examples include: (1) if patients are capable of or willing to engage in decision making (2) if providers feel it provides more or less medico-legal protection, (3) if the Emergency Department is overwhelmed and time is of the essence to make decisions, and (4) if the facility lacks well-validated risk prediction tools to guide decision making.