Consent and Refusal

by Mark Hughes, MD, MA

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      Slides Introduction to Informed Consent.pdf
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      Reference List Clinical Ethics Nursing.pdf
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    00:01 Alright, so after there's been the disclosure of information and the checking of understanding, Then, you actually have to get to reaching the decision.

    00:10 And there are four ways that a decision might be made.

    00:14 There could be implied consent.

    00:15 There might be expressed consent.

    00:17 There could be expressed refusal. The patient's saying, "No".

    00:20 For patients that don't have the capacity to make their own decisions.

    00:24 They might still be able to say yes or no, which is called an assent or dissent.

    00:29 That's an important element to assess.

    00:31 But you're still going to rely on someone else as we'll get into someone else to make the decision for them.

    00:38 So let's go through each of those.

    00:39 So first of all, implied consent is the patient's actions or behaviors, even a gesture that they make, or an inaction not moving away from us might be a sign that they are implying consent, we can infer that they agree to what we're going to do.

    01:00 And it's based on the certain circumstances.

    01:04 And it's important to point out that implied consent can be withdrawn at any time.

    01:08 So even though the patient you might presume that they are consenting, they could then verbally say, No, stop, I don't want you to proceed.

    01:17 And then you have to respect that decision.

    01:20 So a common example would be, the doctor says, "I would like to take your pulse." The patient, hold out their their wrist, the doctor starts taking their pulse and sits quietly.

    01:33 it's an implied consent.

    01:35 You don't need to sign a contract, or consent form for that.

    01:38 It's presumed by based on the patient's behavior, that they're agreeing to let you check their pulse.

    01:45 Or same thing for something like phlebotomy.

    01:47 Common practice, when a patient is admitted to the hospital.

    01:51 If they put their arm out, to allow the needle to be inserted to draw blood out, you can infer that there's an implied consent.

    02:00 So the behavior sort of leads to the inference, and then you can proceed.

    02:06 But it's important to note that there's also concerns about battery.

    02:11 So intentional touching of another person without their consent is forbidden.

    02:15 You should not do that.

    02:17 The mere fact that a person voluntarily comes to seek medical attention, comes to the hospital, or comes to a clinic, and, is admitted, does not automatically imply that they're agreeing to examination, investigation, or treatment.

    02:32 There still has to be an exchange of information.

    02:35 And a willingness by the person to be touched, to be examined, and so on.

    02:42 So if you've have a surgeon that performs surgery and has not gotten consent, that can be a consideration of battery.

    02:50 There hasn't been that actual permission by the patient to perform the surgery.

    02:56 Or the physician decides to go well beyond what was proposed in the procedure.

    03:02 The patient might have consented for surgery, but now the physician is doing more than what was proposed in the original consent.

    03:09 That also might be considered grounds for battery.

    03:13 So let's talk about the situations where the patient does consent or does authorize us to proceed with the proposed treatment.

    03:20 So this is called expressed consent. And it can be oral.

    03:24 So the patient verbally telling us, yes, let's proceed or it could be in written form.

    03:29 Now, although orally expressed consent may certainly be acceptable in many circumstances, often it's the case that there's going to be a need for written confirmation.

    03:39 You know, it can be the case that a physician, if they document in the medical record, that they've had a discussion with the patient, they've gone through the elements of disclosure, the risks, the benefits, the alternatives, and the opportunity for the patient to ask questions and have those questions answered. And that then the patient consented.

    03:59 If that's all documented by the physician, that may be adequate in a lot of jurisdictions, but there may be situations where it's important to actually have a written consent form.

    04:08 And that's often going to be the case for surgery, any kind of invasive diagnostic or therapeutic procedures, things that involve anesthesia with either deep or moderate sedation, or any treatments or tests that you think are going to carry substantial risk, then you're going to require a written consent.

    04:28 And the consent is just another way to demonstrate that you've gone through the elements of the consent process.

    04:35 You've confirmed it.

    04:36 This is a way for the patient to validate that they've received the information, they've adequately understood what's been described to them.

    04:43 And that then means that they will be willing to proceed with it.

    04:46 And that gets documented in the medical record.

    04:51 So if you're thinking about an informed consent form, again, this additional proof that the discussion has occurred, there are going to be various elements that you want to have included on the form.

    05:02 So first of all, if it's a surgery or procedure list, you want to describe who will be performing that procedure.

    05:09 Also, if it involves trainees, who's going to be supervising those trainees in the performance of that surgery or procedure.

    05:19 You again, want to make sure that there's a description of the intervention, its benefits, risks, the potential complications, the alternatives to doing the intervention.

    05:29 You want to make sure that it's specific.

    05:33 So if you're doing knee surgery, you want to say that it's we're going to do surgery on your left knee, not your right knee.

    05:39 So everyone's clear about what the plan is.

    05:41 If it's something that's going to repeat over time, something called serial consent, let's say it's consenting for a blood transfusion.

    05:51 You anticipate that the patient might need future blood transfusions, this consent form is to apply to those future situations as well.

    06:00 Now, if the risk benefit calculation changes, there might be a need to do a new informed consent.

    06:05 But if everything stays the same, in terms of the risk benefit calculation, that serial consent can be permissible.

    06:13 Generally, the consent forms are going to have some kind of language that says the patient acknowledges, that they've had the opportunity to ask questions.

    06:20 So another way for them to make sure that their autonomy has been respected, that they've been able to ask questions that help them understand what's being proposed.

    06:31 And then some evidence of the consent, usually, that's going to be a signature by a patient.

    06:38 If they're not able to sign they could put an X on the form.

    06:41 Generally, you know, for legal reasons, you might want to have an actual date on the form.

    06:46 So the date and signature would be demonstration.

    06:49 This is when it occurred, the consent process, this is what the patient agreed to.

    06:55 Also, there often is a requirement that the healthcare provider themselves that practitioner signs the consent form and dates the form as well.

    07:06 And in some jurisdictions might require a witness to also do this.

    07:10 It's also important for what we call telephone consents.

    07:14 So where you don't have the opportunity for an in person contact with the person, they can actually sign a piece of paper, but you have a witness listening in on the conversation.

    07:25 And they say yes, the patient received the information or the authorized decision maker, received the information.

    07:30 And I witnessed this and attest to it.

    07:33 They put their signature on the form.

    07:37 And you know, it's also important if a lot of times nowadays, we have pre printed forms, which aids and making sure that everything is legible.

    07:45 But if you're writing anything down, you make sure that it's legible and understandable.

    07:50 Again, you're using terminology that the patient will understand.

    07:54 You're not just using medical jargon.

    07:58 Alright, so you've gone through the disclosure, the checking of the understanding, you've gotten consent by the patient, so we consider that authorization.

    08:08 It's not just a signature on the form.

    08:09 That's not up to your goal or your intent.

    08:12 You're really trying to make sure that the patient understands and is making a decision that's best for them.

    08:20 And it also means that they're authorizing you to act on the decision that they have made.

    08:25 So authorizing that healthcare practitioner to do somethings.

    08:29 So perform a surgery, prescribe a medication, whatever the case may be.

    08:36 Now, there's also the possibility, as I said, this is really informed decision making.

    08:40 There's also the possibility that there's expressed refusal.

    08:43 So a patient has the right to decline the treatment or a diagnostic test, whatever we're proposing to them, they can say, "No, that's not right for me." So after they've been given adequate information about the proposed intervention, if they have capacity, they may voluntarily decide against the proposed intervention that is perfectly within their rights to do.

    09:05 And also, it's the case that even though they might have agreed at one point in time, they could withdraw or modify their decision at a future time.

    09:14 You know, maybe it's not possible, right, in the midst of a procedure or certainly if they're in the operating room, under anesthesia, they can't change the mind at that point.

    09:24 But if it's possible for them to maybe change their mind, they can withdraw their consent at any time.

    09:33 Now, it's important, if the patient does say, "No, I do not agree with what you're proposing." You really want to make sure the as the healthcare practitioner, that you ensure the patient understands the implications of the refusal.

    09:48 Now, I think there is a role for what I would call do persuasion to trying to convince the person, but if that becomes badgering the patient, or really trying to force the issue, then it becomes coercion, where manipulation of the patient.

    10:03 Really, we should respect their right to say, no.

    10:06 We want to do our due diligence to try to convince them, if really, we think it's for their medical good, but if they say no, we should accept their response.

    10:17 We still have a need to take care of them.

    10:19 So we still have an obligation to provide care to them for their condition, even if they're not going with what we recommended.

    10:26 So let's say they decide to go with sort of the just the natural history of their disease process, we need to still take care of them, maybe they're going to change their mind in the future.

    10:36 So we need to be available to them.

    10:37 Whatever the limits of the consent that they put in place, know that might change in the future.

    10:44 And we need, again, this exchange of information along the way to see if they might modify that consent or refusal.

    About the Lecture

    The lecture Consent and Refusal by Mark Hughes, MD, MA is from the course Informed Consent and Capacity.

    Included Quiz Questions

    1. Agreement inferred by the patient's action or inaction
    2. Agreement that cannot be withdrawn at any time
    3. Agreement that can be applied only to a situation in the emergency room
    4. Agreement that relies on the application of force on the person
    5. Agreement that must include a signature from the patient
    1. Treatment carrying a minor risk
    2. Surgery
    3. Invasive procedure
    4. Anesthesia with deep or moderate sedation
    5. Therapeutic procedure
    1. Past surgical history
    2. Name of clinician
    3. Benefits
    4. Complications
    5. Alternatives
    1. Risks
    2. Name of patient's spouse
    3. Home address
    4. Telephone number
    5. Age of patient
    1. A patient with decision-making capacity may voluntarily decide against an intervention.
    2. A physician with decision-making capacity may voluntarily decide against an intervention.
    3. A physician without decision-making capacity may voluntarily decide against an intervention.
    4. A patient without decision-making capacity may voluntarily decide against an intervention.
    5. A patient can refuse consent only in the clinic consultation room.
    1. Ensuring that the patient understands the implications
    2. Persuading the patient to receive treatment
    3. Restraining the patient and forcing them to undergo treatment
    4. Recommending that the patient see another physician
    5. Speaking to the patient at a high-school verbal level

    Author of lecture Consent and Refusal

     Mark Hughes, MD, MA

    Mark Hughes, MD, MA

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