Our next speaker is the vice chair of this course, like I said, just arrived after all the flights, disasters. Dr. Mike O'Shea, he's a professor of pediatrics at Albert Einstein College of Medicine and attending the Pediatric Intensive Care Unit at Montefiore. I guess I'd have to start, since we're talking about ethics, I think I'll just mention a little bit about futility. One thing I've learned in the last couple of days, the definition of futility is trying to fly from LaGuardia to Chicago post-call in the middle of a hurricane at the time the Democratic National Convention is happening. I've learned a little bit. So today I'm going to talk a little bit about pediatric ethics related to our world in the ICU. I have nothing to disclose. As far as the American Board of Pediatrics is concerned on our upcoming exam, about 5% of the exam may be focused on ethical issues, about 4% on end of life, and about 1% on clinical ethics. So not all that much, but hopefully some questions that can give you some points. So let's start with just look at the basic core principles of bioethics, just for remembering. According to Beauchamp and Childress, the core principles are autonomy, beneficence, non-maleficence, and justice. And it's in terms of decision making in kids. We're always focused on surrogate decision making. Our patients have not been capacitated to make decisions, for the most part. It gets a little bit tricky up in those adolescent years. But we want to distinguish substituted judgment, which is what we don't often use in pediatrics. And that's when we have to ask ourselves, what would the patient have wanted if they were able to answer the question? Our patients haven't been capacitated. We're not usually able to use that process. What we usually use is the best interest standard. And when we're trying to decide what is in the perceived best interest of the patient. Beyond just that simple definition of best interest standard, we can go a little bit further. And we talk about surrogate decision making in the realm of the harm principle, and where we identify a harm threshold below which parental decisions won't be tolerated. We may constrain parental autonomy, in which the parents may balance the best interest of the patient with the family's best interest, if the patient's basic needs are met. And then something we deal with more frequently now, and this is one of the key terms of modern bioethics, is shared decision making, where we have a collaborative mechanism between the families and clinicians in order to make decisions for our patients. Something that's liable to show up on your examinations, while something that comes up often even in the clinical space, is this idea of the doctrine of double effect. And this has been legally substantiated through this decision by Justice Rehnquist in the case of Vaco versus Quill, one of the really key bioethical cases that went to the Supreme Court. And it's widely recognized that the provision of pain medication is ethically and professionally acceptable, even when the treatment may hasten the patient's death if the medication is intended to alleviate pain and severe discomfort and not to cause death. And here's a diagram and a little explanation of the doctrine of double effect. One, you might want to give an act, such as giving morphine. Our purpose of giving morphine is a good effect, and that's to relieve pain. But there is a possible concomitant bad effect, and that is in a precarious patient, that morphine may actually hasten death, particularly in the amounts of morphine you might want to give to treat severe pain at end-of-lifetimes. So how do we rationalize this? Well, one, the act itself must be morally good or neutral, such as relieving pain. Two, the good effect is what we're intending. We're intending to relieve pain. We're not intending to relieve pain by killing the patient. The bad effect is foreseen, and the bad effect is not the means to the good effect. And lastly, proportionality tells us that the good must outweigh the bad. So remember the doctrine of good effect. In general, as far as paralytic agents go, it is highly recommended not to paralyze a patient at end-of-life who have not already been paralyzed. And in general, in patients that have been receiving paralytics, it is optimal to let the paralytics wear off at the end of life, unless a withdrawal or end-of-life care will be delayed until paralysis has worn off or been reversed. And when waiting would create an unacceptable delay, it is OK to withdraw supportive care in a patient that is paralyzed, but with very careful attention to the patient's comfort. Something I'd like to mention, as this doesn't come up so much anymore, is the Child Abuse Protection and Treatment Act. This is an old federal law, which is still in the federal books and still actually affects how states receive grants for child care from the federal government, and as well as from certain grant-delivering organizations. This is a descendant of the original baby-on-dough situation back in the mid-'70s. And this states that extremely ill, premature, and terminally ill infants under one year must receive nutrition, hydration, medication, and all medically indicated treatment. Treatment is not medically indicated in a situation where the patient is irreversibly dying or is irreversibly comatose. It's still on the books. It's been revised a couple of times. It continues to be revised through Congress. And the judgment of a reasonably prudent physician is acceptable. They still do not like quality-of-life arguments. And it also recognizes that the parents do have a role in this decision-making process. So a little bit more about decision-making in pediatrics. We're always looking at surrogate decision-making. We're looking at the best interest. Parents usually act in the best interest of their child, almost, but not always. And that's when we make our jobs as pediatricians and pediatric intensive. It's very challenging. And parents may martyr themselves, but might not make martyrs of their children. And that was from a 1944 Supreme Court ruling in the case of Prince versus Massachusetts. But just pay attention to the fact that they talk about martyrs. And they're very specific about religious oppositions to care. Every state has different rules and regulations concerning decision-making. In my own state, New York, just as recently as 2010, they passed legislation that said that parents or guardians have authority to make decisions about life-sustaining treatment, including decisions to withhold and withdraw. Parent or a guardian of a minor patient shall make decisions in accordance with the minor's best interests, taking to account the minor's wishes. Remember, this is very logical, and it should be extended across. But this is state legislation. The term that we're using very frequently now is shared decision-making, which is a descendancy of the original paternalistic way in which physicians practiced. That then went, through a good portion of my career, to the sense of menu choice autonomy, where we just gave parents options and said, what do you want to do? And we weren't permitted to weigh in about what we wanted to do or what we recommended. In the shared decision-making model, we try to take what the family wants. At the same time, we're allowed to offer our recommendations and what our suggestions, and we try to come to a shared decision. Well, what happens when families want something that we don't want, or we want something that families don't want? This is a rubric that was in Cassidy and Fleischman's textbook on some guidance in making assessments and judgments in relation to the parents' preference. And the rubric mentions, well, a physician's assessment of treatment options, whether the parents prefer to provide treatment or the parents prefer to forego treatment. If it's clearly beneficial and the parents prefer to provide treatment, then we should provide the treatment. If it's ambiguous or uncertain, we can provide treatment if the parents prefer to provide it. But it is also ethically acceptable to forego the treatment if it's ambiguous or uncertain and the parents prefer to forego it. If we feel as physicians the treatment is futile and the parents prefer to provide it, we can provide it unless we decline to do so. But if the parents prefer to forego it, we should forego treatment. A little bit more about this on the limits of parental discretion in health care decision making is talking about, one, is the treatment ethically obligatory? One, is the treatment ethically optional? And one, is the treatment ethically inappropriate? Of course, that is a really tough decision to make. And that's when you have to bring your ethics committee and your hospital administration into line to discuss this in a very multidisciplinary manner. If a treatment is ethically obligatory, the parents may not refuse it. If it's ethically optional, the parents may decide to consent or refuse. If it's ethically inappropriate, parents may not demand the therapy. And this is something that's clearly non-beneficial, may be futile. But as we all know, and I'm sure you've all learned, that futility is something very, very tough to define. The American Academy of Pediatrics has made a statement about the foregoing life-sustaining medical treatment. And in general, in a situation where the harm outweighs the benefits of life-sustaining medical treatment, it is ethically acceptable to withdraw care if there's no benefit to the patient beyond the postponement of death. So informed consent is a very important concept in that, in a sense, we're asking for consent for something to be done to someone else when we're talking about a child. We're actually asking for permission and not for consent. Consent is a personal thing. But the components of informed consent, which are important to remember, are disclosure, assessment of understanding, assessment of competency to make decisions, assurance that the patient has the freedom to choose among medical alternatives without coercion, voluntariness, and remembering that consent is personal. It makes a lot of sense to me. But just remember, every time we're asking for consent to put a central line in, this is exactly what we should be going through. And I wonder how often that actually happens. Competency. To be competent, a patient must understand the therapy in question, can consider the risks and benefits, is able to decide on the course of the action, and can appreciate the consequences of a choice. Adults are presumed legally competent. Children are usually incompetent until the age of 18 or 21, unless they're deemed to be competent by means of emancipation or being deemed a mature minor. An important number to remember is 14 years. That seems to be the widespread age at which adolescents are presumed to be able to make decisions concerning their health care. They are intellectually capable at that time. They're sometimes not quite emotionally capable. There is the entity of a mature minor, which is that a legal decision made in court for an older adolescent who's then given the rights to decide on care for their own benefit. Care should be in the mainstream medical practice. The minor has to be informed of the risks and benefits, has to be capable of informed consent, and it must be voluntary. Minor consent laws differ from state to state. 14 states have minor consent laws. 33 states, the parents or the guardian has the right to consent. And basis for minor consent laws are either legal status, such as whether they're emancipated, married, in the military, pregnant, living apart from their parents, or in jail. Service basis, which we're probably much more familiar with, deals with consent related to reproductive care, sexually transmitted infections, reportable diseases, HIV-AIDS, emergency care, drug and alcohol counseling. We are able to treat children emergently in the absence of their parents, depending on certain circumstances being met. One, the child is suffering from an emergent condition that places his or her life or health in danger. The child's legal guardian is unavailable or unable to provide consent for the treatment. Treatment or transport cannot be safely delayed until consent can be obtained. And the professional administers only the treatment for the emergent conditions that pose an immediate threat to the child. Research, these questions on research in children are likely to come up. Children are given additional regulatory protection in research because their ability to consent is limited. And they tend to be less guarded in their response to questions and even just survey consent. Permission of the parents or guardians and assent of a minor subject is usually considered adequate substitute for consent. Assent is not required in life-threatening illness. And one question that does come up is do both parents need to give permission for a child to participate in research? And it depends. In general, permission should be obtained from both parents before a child is enrolled in research. However, the IRB may find that the permission of one parent is sufficient. It depends under which federal codes it's conducted. And under some research, such as that falls under 46406 or 46407, codes in the Federal Register, consent must be obtained from both parents unless one parent is deceased or unavailable. A term that we frequently hear these days is moral distress. It's not too typical that we go more than a few weeks in the ICU where someone's coming to someone else and saying there's a lot of moral distress going on here. Moral distress is the extension of a moral dilemma. A dilemma occurs when there's one more than one ethically or morally acceptable path to take. And distress occurs in someone who knows which is the right thing to do, but that is not the path that's being taken. There are barriers or constraints exist to following what is considered what someone may consider the right path. They might be told what to do against their better judgment. And this comes from the nursing literature. Let me see here. OK, I just want to get through a couple more things. And I do have some questions that we could potentially look at. Just a couple of references, not for the test itself, but the recent COVID pandemic brought a lot of ethical issues to bear and brought up a whole new literature of ethics concerning allocation, withdrawal of therapy, whether disabled and children have the same rights as undisabled and adults. And it was a very interesting and scary time from the ethical perspective. So just a couple of questions. OK, a three-year-old girl is in a persistent vegetative state and the ventilator dependent after a prolonged status of lepticus. In several multidisciplinary family meetings, physicians have told the mother there is no hope of meaningful recovery and that it is an option to remove the child from the ventilator knowing that the patient will likely die. The mother requests that the ventilator be removed to end her daughter's suffering and to let her die. All involved parties, including the Pediatric Ethics Committee, agree. The patient is made DNR, DNI, and mechanical ventilator is discontinued with appropriate administration of IV morphine to ensure there's no pain and reduced gasping. Which of the following best describes the process used to arrive at this conclusion? Patient and parental autonomy, paternalism, shared decision-making, family-centered care, or non-maleficence? Well, there's nothing to no button to do. Any ideas real quick? Perfect, thank you. Next question. Have any more time, Anna-Lea? As part of a research project being carried out by a third-year GI fellow, I love to pick on the GI fellows, a blood sample is to be drawn at 5 o'clock in the morning for the first five post-operative days after a liver transplant. Parents of a seven-year-old patient signed consent for this IRB-approved study prior to surgery. The patient participated in an assent discussion and assented to participate, having been informed there was a chance he would undergo needle stick if there was no other way to obtain the blood. On post-op day four, there is no other way to obtain blood other than the needle stick. The patient refuses. What should be done? Call the parents, have them convince the patient. Call the GI fellow and have them draw the blood. That'll work. Notify the IRB, hold the patient down and draw the blood sample, or accept his refusal. Accept. Good. Last question. 10-year-old boy has been on VVACMO for 45 days with severe PARDS due to idiopathic pneumonia syndrome, status pathology, and a hematopoietic stem cell transplant for AML. There has been no recovery of lung function. Decision is made to withdraw support. The patient is made DNR-DNI. A plan is enacted with the palliative care team to treat post-withdrawal dyspnea and gasping with doses of IV morphine. The patient is decannulated and extubated, and after IV and nebulized morphine are administered to ensure comfort, he expires. In the debrief, a medical student on the team expresses discomfort in that it appears that the morphine may have contributed to the patient's death. You explain that the use of morphine, as well as other sedatives, is ethically permissible in this situation due to, one, non-maleficence, two, beneficence, three, the principle of double effect, or four, justice. What? OK. Thank you very much. Thank you.

pediatric intensive care

bioethical principles

surrogate decision-making

shared decision-making

informed consent

COVID-19 ethics