Clinical Ethics Discussion 4: Urgent "lifesaving" clinical research

- Atsushi Asai, MD, MBioeth., PhD.,
Associate Professor, Department of Biomedical Ethics, School of Public Health, Kyoto University Graduate School of Medicine, Konoe-cho, Yoshida, Sakyo-ku, Kyoto 606-8501, Japan
- Koichiro Itai, MA,
Assistant Professor, Department of Philosophy and Ethics, School of Medicine, Miyazaki Medical College, Miyazaki, Japan
Correspondence address: Atsushi Asai, MD,
Email: aasai@pbh.med.kyoto-u.ac.jp
Email: aasai@pbh.med.kyoto-u.ac.jp

Eubios Journal of Asian and International Bioethics 14 (2004), 52-7.


Abstract

No matter how far medicine advances, incurable disease will inevitably exist; and the dying patient's last resort will likewise look to medical research. In this report, we examine a case concerning the use of experimental medical therapy on a critically ill child. We discuss the ethical argument pertaining to the recommending of experimental medical therapy to the family of a dying patient.

Under the circumstances of having to face the impending death of one's own child, parents of a terminally ill child are extremely vulnerable to suggestion and often loose the ability to make a composed decision._Moreover, there exists the possibility of not only patients, but also medical staff and researchers, to fall into therapeutic misconception. Likewise, for the terminal patient and his/her family though, experimental medical therapy is often the only hope, which is, however, always accompanied by a factor of uncertainty and is considered to be merely an unapproximated gamble. The proposing of experimental medical therapy can result in being cruel by shattering the parent's expectations of saving their child._

We examine the issues involved in proposing an experimental medical therapy to patients who are in dire need of a last hope; and conclude that, in times of emergency, we must take great consideration in recommending an experimental medical therapy as an "innovative treatment." In extreme circumstances where an individual's life is on the line, doing nothing can be quite trying; yet, what is right is not necessarily doing something, but rather making the right decision.

Key words: vulnerability, experimental medical therapy, critically ill, cruelty, double uncertainty, and pediatric patient.


1. Introduction

No matter how far medicine advances, incurable disease will inevitably exist; and the despair that lingers in the hearts of those to whom have lost a child or spouse unfortunately does not fade away. Likewise, the medical staff whom stand before a suffering patient and his/her family are faced with a feeling of utter powerlessness. This runs deep for the many who are affectionate and see their work as a mission. While death that lies in the wake of longevity is rather easy to accept, death of an infant or of one's own child is seen to be subversive and absurd. Unfortunately, this absurdity is dealt with all too often for those whom are in pediatrics. Here, medical research exists as the last hope for the many patients and their families.

In this paper, we examine a case concerning the use of experimental medical therapy (EMT) on a critically ill child. We discuss the ethical argument pertaining to the recommending of EMT to a family of a dying patient. We explore: 1) how the parent's initiative of consent is influenced by the critical situation; 2) the commission/omission of treatment; 3) the psychology of therapeutic misconception; 4) lastly, we examine if it is permissible for the medical provider to propose an unproven EMT as innovative treatment to the family of a critically ill minor.

On the one hand, the argument for allowing the use of EMT considers the following three points: 1) the patient's approaching death; 2) the family and patient's right to receive EMT; and 3) how such lies in accord with the fundamental goal of medicine. On the other hand, the argument against the use of experimental therapy considers the respecting of a patient's dignity, the factor of double uncertainty, the issue of cruelty, the limits to providing access to information, the dangers of a slippery slope effect, possible therapeutic misconception by medical staff, and the impartial allocation of medical resources.

Following a review of the various discussions and arguments, we conclude by investigating the following points: 1) the patient's proxy's loss of decision making capacity; 2) the risk of therapeutic misconception by the medical provider; 3) the fact that EMT, while seen as a last hope, is a gamble with an unclear outcome and carries an inevitable uncertainty; and 4) the cruelty of shattered expectation as associated with this gamble. Here, we consider the distress involved in proposing EMT to those who are in dire need of a last hope; and conclude that, in times of emergency, we should not recommend EMT.

Lastly, we investigate the role of an Institutional Review Board and Research Ethical Committee (hereafter referred to as IRB). We conclude that, in circumstances similar to the case of discussion, it is necessary for such committees to stop EMT upon an objective examination concerning the possible merits and demerits of the EMT, the shading of therapeutic misconception and the possible alterative motives of the medical staff and so on. In extreme circumstances where an individual's life is on the line, doing nothing can be quite trying; yet, what is right is not necessarily doing something, but rather making the right choice.

The case we present is based on our hands on experience; however, all peoples, diseases and treatments are products of our imagination. Any similarities between the presented case and real life occurrences are merely coincidental and shall not be seen as in any way related.

2. The Case

Patient D, a five-year-old boy with a rare autoimmune disease A has been in and out of a university hospital since the onset of disease A. Currently, there exists no proven effective therapy for disease A. Treatment has been limited to attending to any and all complications.

Patient D is gradually slipping into a state of unconsciousness; his chart shows that his blood pressure is highly instable caused by pericarditis and myocardosis, which eventually lead to pulmonary edema and heart failure. His level of nutrients, his liver and kidney function continue to deteriorate leaving little or no room for possible treatment.

Patient D's parents have tried every possible means of treatment, each a disappointment. Now, as they burden in sorrow, they are having to face the arriving death of their son. Upon hospitalization, D has undergone medical therapy including the use of vasopressors; after undergoing a tracheotomy, he is hooked to a respirator. Due to the use of tranquilizers and being in a state of unconsciousness, however, D seems to be in a painless state.

D's physician, Dr. I, is a specialist in autoimmune diseases and is head of the department of collagen diseases. He has been treating D since the very onset. Not only does he feel professionally responsible, but also has come to feel emotionally responsible for D.

Throughout the two years of treating D, he and D's parents have become quite close. While D has become attached to Dr. I, Dr. I has gained a reciprocal trust from D's parents. Dr. I has consulted physicians located both domestically and abroad; he has reviewed the most recent literature in the field. All of his efforts, however, have come up with nothing.

A few days ago, Dr. I discovered a report in a medical journal for collagen diseases. This report looked at a series of cases whereby large doses of immune suppressants where prescribed to adults with final stage disease A. The results showed that while three of the 20 patients who participated in the study passed away, three also improved (1 life year increased). The remaining 14 participants showed neither signs of improvement nor deterioration; yet, with continual therapy, a decrease in lymphocyte count and the onset of a fever were observed. Ten of the patients had complications including vomiting, fatigue, and reversible liver/kidney damage. Bacterial infection was observed in five of the patients. (Note: The medicine used in this study can be covered by the national health insurance as a conventional therapy for autoimmune disorder.)

Dr. I believes that this EMT is D's last and final hope. The treatment, however, has never been used on a child or infant with disease A. Regardless of whether or not it could rescue D from the wraths of death, treatment of D could be used as an observational case for a further report.

Due to this treatment being nonstandard, it is necessary for Dr. I to submit a protocol to the IRB for approval. The IRB review process, which usually takes approximately two months, is too long for D to wait. D has only a number of days left. After staying up all night devising a protocol, Dr. I submits it to the IRB with a request for urgent review.

At this stage, we need to consider the following questions: Is it ethical to recommend this EMT to patient D and to D's family? Should the IRB prioritize the review of Dr. I's protocol? And what decision should the IRB make in this situation?

3. Looking Inside The Mind Of A Dying Child's Parents

Sentimentality and Reason

We are creatures of reason. Yet, at the same time, we exist within an emotional web of human relationships between child and parent, wife and husband, man and man. Our mind breathes in this dichotomy between emotion and reason. Likewise, at times our emotions drive our actions. As in the case of patient D, everyone involved is emotionally invested. In cases where a parent's adored child is on his/her deathbed, a "reasonable" ethical decision is often difficult to reach.

In the case of discussion, patient D is dying; his physician, to whom D's parents trust, proposes an EMT with a 15% mortality rate, 15% success rate, and 50% probability of side effects. In light of D's condition, the occurrence of side effects could be lethal; the possibility of death needs to be taken into consideration. Likewise, due to this high risk associated with the occurrence of side effects and the lack of evidence concerning this EMT on minors, it is fair to estimate a mortality rate of 30%.

If we were in the shoes of D's parents, how would we feel? We do not even have concrete data from descriptive research. What we do have, however, is the fact that we love our son and would sacrifice anything in order to save him. We can see here that in times of desperation, we become "drowners" in a sea of hope. Well aware that their son will soon pass away, the parents of D are desperate in finding a means of saving him.

Here, we need to ask whether or not persons, under the circumstances similar to our discussion at hand, are capable of making a composed and reasonable decision. In the case of D's parents, their consenting to the recommended EMT is most likely a paternal instinctual response and not a product of reasonable thought.

Next, we need to consider the following question: if a composed reasonable decision cannot be made, should consent be acquired from a suitable proxy and not from the parents? D's parents have experienced the many bitter stages of D's illness with him; they see their child as first priority and they will, ultimately, have to bear the death of D more than anyone else. In rare cases, however, parents are not always suitable to represent the welfare of the child. For instance, when a parent is incapable of feeling the same kind of compassion and love towards their child.

In the case of D, his parents would sacrifice anything, including their own lives. Even though they may be approaching things from an emotional standpoint and not one reason, this is natural. Accordingly, this cannot be seen as sufficient grounds for the use of a proxy.

D's parents are most suitable to represent D not because they are capable of making a rational decision based on reason, but rather because they have an unconditional love for D as his parents. On the other hand, however, this is the precise reason for their increased vulnerability to both good and evil measures of hope. Although they very well may be unaware of their vulnerability, their intention and will to save D is as strong as rock. In short, the fact they are willing to do anything in order to save D invites an abyss of vulnerability and an abundance of desperate hope.

Commission versus omission

In the following section, we discuss the issue of commission versus omission. In our case of discussion, D is critical and there is nothing else medicine can do. We can only wait. Our last resort is using high dosages of immune suppressors. However, while this EMT could save him, it could also turn out to kill him. Nobody knows to which will result.

We are faced with the decision of whether we choose to attempt to treat him with an EMT or let him pass away in peace. Certainly enough, we neither are causing him to suffer nor are we hastening his death. But then again, we are dealing with a double bladed sword; that is, while we could be saving him with this EMT, we could also be killing him. In short, we are incapable of knowing to which will result; we are incapable of calculating which will be best for him. Omission will inevitably result in letting him pass away.

In these circumstances, the act of trying to save one's child and patient is psychologically easier. For D's parents, the act of trying is essential. "By doing what we can do now, we won't feel regret later," is the greatest psychological gain possible. Accordingly, by saying "we may be able to doing something" to D's patients, we are not increasing the possibilities, but rather, we are decisively revealing a path where the possibility of merely waiting disappears.

Therapeutic Misconception

Will D's parents be willing to agree to the proposed innovative treatment knowing that it is experimental? Are they really able to comprehend that this EMT: 1) is considered an initial step towards understanding whether or not it is an effective treatment, 2) can not be considered certain to be able to save D, and 3) is clinical research that will benefit patients in the future by adding to the expanding knowledge concerning clinical medicine. In fact, will they be able to realize that by agreeing to treatment, they are placing their son on the "experimental stone." This decision is extremely complicated. As stated supra, in light of D's parents both emotionally and psychologically being desperate, they see this EMT as an indisputable treatment and as the last resort to saving their child. This inevitably points to a high possibility of therapeutic misconception.

The experimental use of high dosages of immune suppressors may be comparable to an emergent life saving surgery with a high probability of death. For instance, suppose a patient is brought to the emergency room from a lethal car accident where her organs have been severally damaged. If nothing is done, the patient will die. If we open her up and attempt to stabilize her, we may save her; however, the risk of death during operation is also extremely high. What would the parents do under these circumstances? This decision involves a psychology of "we have to do something...," a natural reaction to wanting to save one's child.

To a certain extent, this example resembles our case of discussion. However, because our case is dealing not with a proven and accepted treatment, there is a great tendency to fall into therapeutic misconception. We are dealing with the experimental use of high dosages of immune suppressors on patient D and there is no supporting evidence for it being an effective or it being a beneficial treatment. On the one hand, the emergent surgery has a high risk but a proven effectiveness; on the other hand, we know neither the degree of risk nor the value of our EMT.

The parent's state of mind and its significance

In our case, the circumstances are decisive. We can overlook the fact that the imminent death in our case has a great impact on the person who has to decide. If D were in a stable condition and his death were not pressing, would D's parents really agree with the experimental use of high dosages of immune suppressors? For instance, if D's condition was not as pressing as in our case and if D still had an estimated six months to live, would D's parents agree to an experiment with a 15% mortality rate? The problem we need to consider is whether or not it is appropriate to propose this EMT to D's parents when D is on his deathbed. If this treatment were not proposed to D's parents, they would not hope its success; they would not need to struggle with the decisions of doing this or doing that.

If our psychological analysis in not mistaken, once the slight possibility of saving D is suggested by his physician to D's parents, his parents will cling onto the hope of saving him until the end. Accordingly, the imperative problem is of whether or not it is suitable to recommend this kind of EMT to desperate parents, and whether or not it is appropriate for physicians and medical researchers to throw a lost hope to a person in desperation.

4. Arguments For Disclosing Information Concerning EMT

Up until now, we have described the decisive importance of recommending an EMT to D's parents and the associative psychological replications. In the following section, we review the possible benefits of using an EMT on a critical patient. These arguments for the use of EMT pertain to the patient's imminent death, the patient's right to know, the disclosure and right to access to information, and lastly, the fact that the purpose of medical therapy is to save lives.

Argument #1: The patient's imminent death.

Comparing the benefits and risks in the case of EMT is meaningless if set on premise that "if we do nothing, the patient will unmistakably die," the fact is that even with the best standardize therapy, D can not be saved. By prescribing D immunosupressors, there lies the possibility of bringing about his death sooner; however, we could not consider this risk without holding it contrast to the null probability of saving D with the best standardized therapy. Without question, we would not recommend this experimental treatment with a mortality rate of 100% and a survival rate of 0%.

However, with a success rate of 15% and a mortality rate of 15%, one could justify proposing this EMT. As mentioned infra, omission of EMT would result in the patient dying for no standard therapy is effective. In the case of a chronic illness where there is no risk of dying, a 15% success rate and a 15% mortality rate would not be sufficient in justifying the use of this type of EMT. Nevertheless, the patient presently lying on his deathbed and the ever-pressing need to do something has a great impact on the situation.

What are we to do with a 15% success rate and to an 85% mortality rate? On the premise that "if we were to do nothing, he will inevitably die," any possibility of saving the child could be considered as a high probability. Physicians would certainly recommend a treatment with a 50% success rate and 10% mortality rate in the case where omission of medical treatment lead to an imminent death.

It is possible to consider the lowering of a patient's quality of life (QOL) subsequent to EMT. In the case of D, however, the lowering of QOL is irrelevant for he is neither conscious nor in a state of pain. Accordingly, there is no evident reason for not recommending this EMT to D's parents. A 15% chance of saving D from dying is seen as relatively hopeful. Yet on the other hand, the low rate of success and apparent uncertainty indicate that this therapy is no lifeline. Thus, the proposed experimental therapy is seen to lie somewhere in-between being hopeless and acting as a lifeline.

Argument #2: The right to access to information.

If D and D's parents are looking for anything with even slight efficacy, they have the right to know about an EMT and the right to undergo treatment. The covering up options by the medical staff in the name of nonmaleficence is nothing more than paternalism. Trying to protect D from EMT in the name of nonmaleficence will only lead to his death. One could say, rather, that the EMT is an attempt to save D from dying. Accordingly, when acquiring informed consent, it is permissible to provide the parents information regarding EMT.

In today's age of the Internet, there is a high possibility that D's parents could look up information regarding the experimental use of high dosages of immunosupressors and, subsequently, request "innovative therapy." In the case where D's parents request treatment, despite realizing that 15% success rate is based on data collected with a small number of adult patients and that D's dying is ever-impending, the physician should sit down and talk with D's parents about the specifics of using this EMT. Regardless of whether or not the therapy is experimental, or whether or not the probability of actually saving D is outlandish, D's parents and physicians should sit down and discuss the various options. The disclosure of information concerning this type of EMT does not provide D's parents more options, but rather, even if it is seen as a last resort, it could provide D's parents a means to continue to believe.

The use of EMT in our case of discussion may need not to be approved by an IRB. We are not dealing with standard clinical research. We are dealing with a preliminary innovative therapy that could save D from dying. Accordingly, if the team of physicians and D's parents both consent to it's use, EMT could be suitable in treating D.

Argument #3: The objective of medical therapy

The most vital objective of medicine is to save the dying patient. In our case of discussion, "omission," defined here as the continuing of conventional therapy, would inevitably lead to D dying. Experimental intervention, however, provides two paths: one of living and one of dying. As a medical professional, one has the duty to propose all the options that have even a slight hope of saving the patient; there also exists the issue that unless D is treated with the EMT, other pediatric patients under similar circumstances cannot benefit from possible future use of the therapy. If the treatment is effective with D, it could be used as the starting point for further evidence. A random control trial could then prove this EMT to be clinically effective against disease A and safe.

5. Arguments For The Nondisclosure Of Information Regarding EMT

Several arguments suggest that, when conventional treatment is ineffective, it may be permissible to propose an EMT as an option to the patient's family on the condition that there exists a slight possibility of saving the child and that the EMT would neither harm nor lower the patient's QOL. However, there exists a few highly justified arguments against this standpoint. In the following section, we discuss those reasons against disclosing information regarding an EMT to the family of a dying pediatric patient.

The respect for D as an independent individual

The argument that one should respect D's human dignity is valid. Despite he being only 5 years of age and unconsciousness, D's dignity must be observed. He has the right to be protected from being treated inhumanely. Although the possibility of D's parents voluntarily consenting to the EMT is quite low, it can be considered unethical to conduct clinical research without final consent from the subject.

In the case where D could realize his physiological condition and make a decision, he may accept to undergo treatment knowing that this was, although uncertain, the only possibility of being saved. He is to decide whether to undergo or to refuse treatment based on it being a harmful approach. It is the patient's right to choose and to feel comfortable with his reasonable decision.

The patient also has the right to know and the right to disclosure. D, however, is five years old and, moreover, unconscious; he is neither capable of communicating nor of making a decision. Proxies, representing a patient with a loss of decision-making capacity, are allowed to make decisions regarding conventional therapies. In the case of clinical research, however, the use of a proxy is recognized only when the experimental therapy has a high probability of directly benefiting the patient.

Double Uncertainty

In the following section, we examine the aspect of double uncertainty inherent to cases where the EMT has only a certain probability of saving the patient's life. There is a vital difference in quality between conventional therapy and this type of EMT. The probabilities of success versus risk of a conventional therapy are statistically known. For instance, let us suppose that a treatment X is effective on 70 patients out of 100. Here, uncertainty rests on whether a patient falls in the remaining 30 or the successful 70. With the use of an EMT, however, the supposed 15% efficacy is itself uncertain. In order to prove the rate of efficacy, a clinical trial needs to be conducted. Additionally, even if this 15% were proven, whether or not D would fall into this 15% is again uncertain. Our case exemplifies this kind of double uncertainty.

Even if the success rate of using high dosages of immunosuppressors on adult patients with disease A was 50% or 100% instead of only 15%, one could still find validity in the argument against recommending this treatment to D's parents based on the principle of double certainty. The mere probability of 50% or 100% is all too uncertain when it comes to saving a patient from dying. Conducting EMT in the name of saving a life, accordingly, is impermissible in times of emergence.

There exists an increased level of uncertainty inherent to the nature of EMT. For instance, the data concerning side effects of the EMT on adult patients is inapplicable. The level of uncertainty ascribed to possibly harming subjects is significantly high. One can only deny those side effects that have been seen in previous studies on adult subjects. It is possible that D may suffer and experience pain unforeseen by I or D's parents. While a patient's needs increase while being in critical condition, the same often is true regarding risk. Despite D's needs increasing, the expected benefits of EMT do not necessarily increase.

Cruelty

Providing false hope to persons having to face and slowly accept the tragic fate of soon loosing their child is far from being an act of beneficence. Even if that hope is founded on concrete data, there is merely a 15% chance of success. Although the patient may die with an omission of therapy, EMT carries a mortality rate of 85%. Giving hope to parents who will later have to face, once again, the unbearable fact that their son will soon die can be considered to be cruel.

As explained infra, proposing the experimental use of high doses of immunosupressors revokes any other options. That is, there is always the option of allowing D's parents to resign their hopes of saving their son. They would then be able to spend his remaining days quietly by his bedside. The irresponsible act of throwing a lost hope to D's parents consequently rids them of the limited and precious time left with their child; it is far from being a beneficiary act.

Treatment has the objective of benefiting the patient. Conventional therapy with a success rate of over 50% benefits the patient. A treatment with a 15% success rate and a 15% mortality rate can also be considered beneficial. However, in the case where the probabilities of harm versus effectiveness are not yet substantiated as evident, the decision of whether or not such a therapy is beneficial is impossible. To even slightly suggest the possibility of saving a dying child's life without providing any substantial means of making a decision regarding the treatment itself is, needless to say, cruel.

Therapeutic misconception held by the medical staff

Therapeutic misconception is considered to be one of the factors behind proposing and accepting EMT. While the parents of D inevitably are influenced by this therapeutic misconception, what about Dr. I in this case? The possibility of Dr. I having become emotionally involved with patient D's circumstances is high. In this sense, Dr. I is just as vulnerable to therapeutic misconception as D's parents. EMT is conducted not on the premise of expecting effectiveness, but rather, in order to prove a therapy's effectiveness. To justify the use of an EMT as a reason to save a life is nothing more than therapeutic misconception.

Justice

In our case of discussion, the issue of justice is pressing. Firstly, asking D and D's parents, in all their vulnerability, to participate in research that one is conducting could be seen as "using" them. It would be difficult for D's parents to refuse EMT based on: 1) the recommended therapy is D's last and only hope, 2) it is would be quite difficult to refuse the suggested EMT in the context of having relied upon Dr. I throughout D's treatment, 3) the relationship of fidelity between physician and family would fall into strain subsequent to refusing the suggested therapy, and 4) compared to other circumstances, D's parents are very likely to be therapeutically misconceived.

Secondly, this type of EMT should not be carried out under conditions where a patient is on the verge of death. One should recruit patients with the same disease yet not in a critical state. Unlike research concerning cardiac pulmonary resuscitation, this type of EMT does not require subjects to be in critical condition. Accordingly, one should not conduct this type of EMT under critical circumstances.

Thirdly, regardless of how much Dr. I wishes to save patient D, the fact is that he has invested interests in conducting the first trial internationally on pediatric patients with disease A. Accordingly, when Dr. I explains the EMT to D's parents, consciously or subconsciously, he may phrase it in an all too convincing way. The mere fact that the medical staff may hold the subconscious desire to carry out this research points to a significant frame effect. We need not only to consider the psychological state of the patient's parents, but also of the medical staff.

Fourthly, according to the principle of justice, the IRB should not review Dr. I's protocol with priority over others. In the case of the IRB reviewing this case as urgent indicates an unfair prioritizing based on the rule of rescue. The average two months common for the IRB to review a case is a result of the numerous research protocols that are proposed. Even in the case where the circumstances are not urgent, there are hundreds of patients dying of an incurable disease. It is unjust to prioritize D's research due to our incidentally knowing D's situation personally and not knowing the many other hundreds dying. For instance, suppose that the approval of another proposal is postponed a week due to the prioritizing of D's experimental treatment. The subjects who may have participated in the postponed clinical research may pass away within that week subsequent to not being able to undergo therapy. The limited time of the IRB needs to be justly proportioned and not determined by a proposal's degree of urgency or necessity. One needs to take into consideration the effect of the research, the order of proposal and the waiting time. We need to treat equally those patients dying who lay not before us with those patients dying before our eyes.

Slippery slope effect

There is a slippery slope effect inherent to our case of discussion. If D's experimental therapy were prioritized as an urgent review and approved, there would exist the concern of a slippery slope effect on the process of reviewing research. A priority-based review conducted with D's case may lead to a similar process regarding other critically ill patients, other patients under urgent circumstances, and other families with a dying child. This prioritizing of urgency, likewise, may lead to proposals becoming increasingly risky with lower probabilities of success and greater side effects. Additionally, the number of urgent proposals from ambitious researchers would, more than likely, proliferate. Concurrent to this slippery slope would be the increased number of non-urgent proposed being overlooked or postponed. Moreover, critical patients like D would more and more become subjects of clinical research. Here, we need to consider whether or not Dr. I's behavior can be universalized, that is, would it remain ethical on a universal level.

The limits of information disclosure

A patient's right to access to information concerning treatment should be respected. In the case of EMT, one has the right to access to information concerning the protocols reviewed by the IRB and used to recruit subjects. The medical staff, however, should have the right of discretion regarding EMT. Even if the subject him or herself expresses the desire to undergo a certain EMT, there is no ethical obligation to go against one's conscience by carrying out this EMT. In the case where the physician feels an obligation to disclose information concerning the EMT, does he or she have this same obligation to those subjects recruited from other countries with a similar critical condition? What about research that is not published? It would be impossible to disclose all information regarding the research protocol to subjects in studies conducted internationally.

6. Conclus§on

This paper has discussed whether or not it is permissible to recommend an EMT under urgent circumstances to the parents of a dying pediatric patient. The imperative problem is deciding whether or not it is appropriate to recommend EMT to desperate parents and whether or not it is suitable for physicians and medical researchers to throw a lost hope to people in desperation. On the one hand, we have examined arguments of it being permissible based on the fact that the patient faces an imminent death, that the patient's parents have the right to choose and the right to access to information, and lastly, that the objective of medicine is to try to save patients' lives. On the other hand, we have found it impermissible based on the following arguments: it can be seen as undignified treatment of D, the factor of double uncertainty, the cruelty of proposing an EMT as a last resort, therapeutic misconception of the medical staff, subconscious motives held by researchers including self-benefit, various issues pertaining to research justice, collapse of the review process subsequent to the slippery slope effect, limitations of information disclosure, the disparity between patient's decision and his proxy's decision, and lastly, the unknowable likelihood of side effects. We see that one cannot justify an overlooking of these factors based on an intention of wanting to the save the life of a dying child. The members of the IRB and the medical staff involved need to remain objective even when feeling compassion towards the patient. The position of justifying the use of an EMT based on the principle of wanting to save a dying patient could be understood emotionally; nonetheless, members of the IRB need to reconfirm their decision beyond the multiple number of possible misapprehensions.

The role of an IRB is to act as a brake regarding the self-interest of medical researchers, the use of therapeutic misconception by medical staff, and the probability of risks over benefits. Dr. I requested his proposal be reviewed urgently in order to save D's life. The subject of Dr. I's proposed EMT is a dying patient being treated under Dr. I. Even the members of the IRB could fall into therapeutic misconception emotionally. However, what is needed is for the IRB to make a decision from an objective standpoint. For the medical staff and proxies, final decisions regarding treatment of dying patients are ever pressing. While "doing nothing" is heart rendering, the right thing to do is not a matter of what to do, but rather of making the best decision.


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