case study medical law and ethics

  • Cases in Medical Ethics: Student-Led Discussions
  • Markkula Center for Applied Ethics
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Cases in Medical Ethics

Student-led discussions.

A selection of medical ethics cases designed to help determine whether medicine is the correct calling for pre-medical students.

I was a Hackworth Fellow for the Markkula Center for Applied Ethics at Santa Clara University. I was also a pre-medical student, and am currently attending the Loyola University Chicago Stritch School of Medicine. During my senior year at Santa Clara, I led discussions on medical ethics with students interested in medicine. The purpose of these discussions was two-fold. First, they were created to help bring current ethical issues onto our campus. Second, they were intended to help students who were interested in a career in the health sciences determine whether or not medicine is their correct calling. Most of the discussions followed a simple format. One to two cases were formulated for the students to read. Then I presented the students with various questions related to some of the ethical issues contained in the situations described. The following cases are the ones that I presented to the groups. Each case also has a short history and summary of the ethical issues being reviewed. The questions I asked of the students are included as well. These cases and questions are public domain, and can be re-used or modified for educational purposes. I hope that you find them useful, and that they spawn the same thoughtful enjoyment in you as they did in me.

Note: The cases were not based on specific events. However, it is possible that they share similarities with actual events. These similarities were not intended.

Autonomy essentially means "self rule," and it is a patient's most basic right. As such, it is a health care worker's responsibility to respect the autonomy of her patients. However, at times this can be difficult because it can conflict with the paternalistic attitude of many health care professionals. The following two cases address patient autonomy. The first involves the rights of an individual to decide her own fate, even against her physicians' judgments. The second case involves the rights of a parent to care for her child in the manner that she sees fit.

A woman enters the emergency room with stomach pain. She undergoes a CT scan and is diagnosed with an abdominal aortic aneurysm, a weakening in the wall of the aorta which causes it to stretch and bulge (this is very similar to what led to John Ritter's death). The physicians inform her that the only way to fix the problem is surgically, and that the chances of survival are about 50/50. They also inform her that time is of the essence, and that should the aneurysm burst, she would be dead in a few short minutes. The woman is an erotic dancer; she worries that the surgery will leave a scar that will negatively affect her work; therefore, she refuses any surgical treatment. Even after much pressuring from the physicians, she adamantly refuses surgery. Feeling that the woman is not in her correct state of mind and knowing that time is of the essence, the surgeons decide to perform the procedure without consent. They anesthetize her and surgically repair the aneurysm. She survives, and sues the hospital for millions of dollars. Questions for Case 1:

Do you believe that the physician's actions can be justified in any way?

Is there anything else that they could have done?

Is it ever right to take away someone's autonomy? (Would a court order make the physicians' decisions ethical?)

What would you do if you were one of the health care workers?

You are a general practitioner and a mother comes into your office with her child who is complaining of flu-like symptoms. Upon entering the room, you ask the boy to remove his shirt and you notice a pattern of very distinct bruises on the boy's torso. You ask the mother where the bruises came from, and she tells you that they are from a procedure she performed on him known as "cao gio," which is also known as "coining." The procedure involves rubbing warm oils or gels on a person's skin with a coin or other flat metal object. The mother explains that cao gio is used to raise out bad blood, and improve circulation and healing. When you touch the boy's back with your stethoscope, he winces in pain from the bruises. You debate whether or not you should call Child Protective Services and report the mother.

Questions for Case 2:

Should we completely discount this treatment as useless, or could there be something gained from it?

When should a physician step in to stop a cultural practice? (If someone answers "when it harms the child" remind that person that there is some pain in many of our medical procedures, for example, having one's tonsils removed)

Should the physician be concerned about alienating the mother and other people of her ethnicity from modern medicine?

Do you think that the physician should report the mother?

Autonomy Part 2 Maintenance of patient autonomy is one of the major ethical focuses of physicians. Therefore, a second discussion was also held that focused primarily on patient autonomy. This discussion also took a superficial look at euthanasia. For this discussion, a 58 minute video, Dax's Case (produced by Unicorn Media, for Concern for Dying ; produced by Donald Pasquella, Keith Burton ; directed by Donald Pasquella New York : Filmakers Library, c1984) was used. The video tells the story of Dax Cowart, a man who was severely burned by an accidental propane explosion. The burns disabled Dax, and the physicians forced treatment on him. Though he survived the treatment, he still argues that he should have been allowed to refuse it so that he could die. The video is very useful; however, the videos of Dax's burn treatments are very graphic and the video should be reviewed before it is shown to a group of students.

In the video, one of the physicians says that burn patients are incompetent to make decisions when they first enter the hospital because they are in such a great deal of pain. However, patients such as Dax can be in a great deal of pain for a very long time. In such cases, what should be done to determine competence, and when should this be done?

Do you think the fact that Dax could not see a future for himself should have been taken into account when determining his competency? Could this have clouded his judgment? (He thought that he would end up on the street corner selling pencils)

Do you think that the fact that Dax was going to recover, and had the possibility of living a happy life, made not treating Dax like suicide… or murder? What if he did not have this possibility?

After his recovery, Dax attempted suicide. Should the physicians have let him die? Is it ever correct for a doctor to allow a patient to kill himself?

Do you ever think that it is correct for a physician to break a competent patient's autonomy? If so, is this one of those cases?

Do you think that in this case, that the ends justified the means?

The word "euthanasia" draws its roots from Greek meaning "good death." As it is used in this discussion, it means "the act of ending the life of a person suffering from either a terminal illness, or an incurable disease." The AMA is against physicians assisting in euthanasia. There is currently only one state in the US that allows for euthanasia, and that is Oregon, where in 1997, the "Death With Dignity Act" went into effect. Euthanasia advocates stress that it should be allowed as an extension of a person's autonomy. Those who are against euthanasia often say that it can lead to the devaluation of human life, and to a slippery slope in which the old and disabled will be killed on the whims of healthy people. We examined one case and the Oregon law to view the ethics of euthanasia.

Case One: A woman was diagnosed with motor neurone disease (the same disease that Stephen Hawking has) 5 years ago. This is a condition that destroys motor nerves, making control of movement impossible, while the mind is virtually unaffected. People with motor neurone disease normally die within 4 years of diagnosis from suffocation due to the inability of the inspiratory muscles to contract. The woman's condition has steadily declined. She is not expected to live through the month, and is worried about the pain that she will face in her final hours. She asks her doctor to give her diamorphine for pain if she begins to suffocate or choke. This will lessen her pain, but it will also hasten her death. About a week later, she falls very ill, and is having trouble breathing.

Questions for Case 1:

Does she have a right to make this choice, especially in view of the fact that she will be dead in a short while (say six hours)? Is this choice an extension of her autonomy?

Is the short amount of time she has to live ethically relevant? Is there an ethical difference between her dying in 6 hours and dying in a week? What about a year, and how do you draw this distinction?

Is the right for a patient's self-determination powerful enough to create obligations on the part of others to aid her so that she can exercise her rights? She clearly cannot kill herself. She can't move, but should someone be FORCED to help her, or to find someone to help her?

Should the money used to care for this woman be taken into account when she is being helped? Do you think that legalizing euthanasia could create conflicts of interest for the patient/ or the doctor? Will people feel that they need to end their lives earlier to save money?

Ask each student: If you were the physician, what would you do? Note: if you would pass her off to another doctor knowing he or she would do it, does this free you from you ethical obligations?

Oregon's Death With Dignity Act: We discussed the following questions pertaining to the Death With Diginity Act.

Death With Dignity Questions:

Look at the requirements for the request. Do you see any problems with them? (The woman from case 1 would not qualify.)

Why would they put in these guidelines? Should they be there, if they keep a competent person like the woman above from living her autonomy? (Is it to protect the doctors so they will not have to GIVE the medication?)

Is there a moral difference between prescribing the drug and actually giving it to the patient? If not, why put in the rules?

Why do you think they wouldn't let a person who is terminally ill and in pain with possibly more than 6 months receive assistance in dying? Say someone is diagnosed with HIV?

Does the justification of euthanasia necessarily justify the assisted suicide of a healthy person?

Do you think a weakness of this law is the probability of patients being influenced by family members? (For example, for financial or other reasons?) Note: Approximately 60% of Oregonians in 2000 said (before they died) that they used the prescription at least in some part due to fear of being a burden on their family.

The AMA says that euthanasia is fundamentally incompatible with the physician's role as healer. What do you think about this statement? Why should a physician have to be the one who does this?

Assisted Reproduction:

This is a difficult subject because it involves reproductive issues. In our culture, reproductive liberty, the freedom to decide when and where to conceive a child is highly protected, and this can make these cases much more difficult.

Case 1: There are two types of surrogacy. One type involves a surrogate mother who uses her own egg and carries the baby for someone else. The other type is a "gestational surrogacy" in which the mother has no genetic tie to the child she carries. In the case presented, a gestational surrogate is used.

A woman, after a bout with uterine cancer had a hysterectomy (surgical removal of the uterus). Before, its removal, however, she had several eggs removed for possible fertilization in the future. Now married, the woman wishes to have a child with her husband. Obviously she cannot bear the child herself, so the couple utilizes a company to find a surrogate mother for them. The husband's sperm is used to fertilize one of the wife's eggs, and is implanted in the surrogate mother. The couple pays all of the woman's pregnancy-related expenses and an extra $18,000 as compensation for her surrogacy. After all expenses are taken into account the couple pays the woman approximately $31,000 and the agency approximately $5,000. Though the surrogate passed stringent mental testing to ensure she was competent to carry another couple's child, after carrying the pregnancy to term, the surrogate says that she has become too attached to "her" child to give it up to the couple. A legal battle ensues.

In the United States it is illegal to pay a person for non-replenishable organs. The fear is that money will influence the poor to harm their bodies for the benefit of the rich. Do you see a parallel between this case and this law? Can allowing surrogate mothers to be paid for their troubles allow poorer women to be oppressed?

Does paying the surrogate harm her and/or the child's dignity?

Is it selfish/conceited for this couple to want children of their own genetic make-up? If yes, does this change if you can "easily" have a child? (Note: Over 100,000 children in the U.S. are waiting to be adopted. However, most are older, have several siblings, or have special needs.)

On their website, the AMA says "that surrogacy contracts [when the surrogate uses her own egg], while permissible, should grant the birth mother the right to void the contract within a reasonable period of time after the birth of the child. If the contract is voided, custody of the child should be determined according to the child's best interests." Do you see any problems with this? (What's a reasonable time? In a way can you steal the surrogate's child?)

One of the main arguments against the use of surrogate mothers is that carrying and giving birth to a child is such an emotional event that it is impossible to determine if the surrogate will be able to give up the child. Though adults enter into the contract, the child could ultimately suffer if a long custody battle ensues (as it could in states where surrogacy contracts hold no legal value, such as Virginia). With the possibility of such battles, do you think it is acceptable for parents to use a surrogate mother?

Do you think that if the surrogate is awarded the baby, this could cause emotional harm to the child?

Who do you think should receive the child, and why?

A married couple wishes to have a child; however, the 32 year old mother knows that she is a carrier for Huntington's disease (HD). HD is a genetic disorder that begins showing signs at anywhere from 35-45 years of age. Its symptoms begin with slow loss of muscle control and end in loss of speech, large muscle spasms, disorientation and emotional outbursts. After 15-20 years of symptoms HD ends in death. HD is a dominant disorder which means that her child will have a 50% chance of contracting the disorder. Feeling that risking their baby's health would be irresponsible, the couple decides to use in vitro fertilization to fertilize several of the wife's eggs. Several eggs are harvested, and using special technology, only eggs that do not have the defective gene are kept to be fertilized. The physician then fertilizes a single egg, and transfers the embryo to the mother. Approximately 9 months later, the couple gives birth to a boy who does not carry the gene for the disorder.

Is this a case of eugenics? "Eugenics" is defined as "the hereditary improvement of the human race controlled by selective breeding" (dictionary.com)

Would it be acceptable for the parents to select for sex as well, or should they only select an embryo that does not have HD? How would this be different?

Is it ethical for this couple to have a baby when the mother could begin showings signs of HD when the baby is just a few years old?

With this technology possible, would it be ethical for this couple to have a child without genetically ensuring it would not have the disease? What if we did not have this technology, would it be ethical for a known carrier to have a child? (If not, how far should this carry? a carrier for cystic fibrosis ( which is recessive)? )

Weighing everything we have discussed, do you believe the couple acted ethically?

Response To Bio-Terrorism

The possibility of terrorists using biological weapons on the citizens of the United States has been a major topic in the press for the last several years. Smallpox has been speculated to be the perfect biological terror agent because of the potency of the virus, and because of the lack of herd immunity present in the US population. The following case presents a possible way in which the virus could be released in the population and a possible response. The questions following the case involve the ethics surrounding the government's response.

Smallpox Facts:

Smallpox initially has flu-like symptoms, which are recognizable 7-19 days after exposure. After 2-4 days of flu-like symptoms, the fever begins to decrease, and pox will form.

An infected person is contagious one day before the characteristic pox appear.

Approximately 30-50% of unvaccinated people exposed to smallpox will contract the disease.

The mortality rate for smallpox was approximately 20-40%.

The vaccine that was used was approximately 90% effective.

It is possible that if terrorists were to use the smallpox virus, that they would genetically modify it. If this were the case, then the vaccine may not prevent all of the disease symptoms for those vaccinated.

Facts gathered from: http://www.vbs.admin.ch/ls/e/current/fact_sheet/pocken/

Date: June 22, 2005. A 27-year-old man is brought into a New York City emergency room with a 101-degree fever, and what he believes is chickenpox (Varicella). After a brief examination, the 35-year-old physician is puzzled because the pox do not appear to be typical of the varicella-zoster virus. Worried, he calls in another physician for her opinion. She takes one look at the patient, determines he has small pox, and immediately orders him to be quarantined. She notifies the Centers for Disease Control and Prevention (CDC) and asks them what should be done. While doing background on the patient, he tells the physicians that he is a flight attendant and that he has flown to Orlando, FL, Los Angeles, CA, Chicago, IL, and Seattle, WA in the past few weeks while working. Though he is given excellent treatment, and had been in perfect health a few days earlier, the patient dies 7 hours after admittance to the hospital.

The CDC decides that mandatory small pox vaccines will be administered to all workers in the NYC hospital, and to all patients who were in the ER. His co-workers are all given mandatory vaccines as well, as are all people living in his apartment complex. They also ship stored quantities of the vaccine to all of the cities where the man had flown to for work. The vaccines are offered to citizens of these cities. Finally, all people, along with their families who had been on the man's flights in the weeks preceding the appearance of the disease are forced to receive the vaccine.

Questions: Note: The flight attendant was most likely given small pox by a bio terrorist who flew on his plane sometime during the past week/week and a half. The terrorist would have been contagious but would not have shown symptoms. Virtually every person the man came into contact with would have gotten the virus.

Is it ethical for the CDC to force people to get the vaccine?

An LA woman on the flight is religiously opposed to vaccines. Under California law she can normally refuse vaccines on religious or personal grounds. However, the government says she must receive the vaccine or face mandatory quarantine. What do you think of this?

Do you think that for more common diseases, for example measles, that it is ethical for the state to allow people to refuse vaccines (even for religious grounds)? What if their refusal can harm others who cannot have the vaccine, such as people who are immunocompromised like AIDS patients?

Is it ethical for someone to refuse the vaccine?

You had driven down to Los Angeles 5 days ago to visit a friend for the weekend. While in town, you visited many tourist attractions. You are worried and you try to get the vaccine, but are denied it because of limited resources. What do you think of this?

Citizens begin calling for the mandatory quarantining of people directly exposed to the victim, i.e those living in his apartment complex, those working in the ER, those who flew on the plane in the prior week. What do you think of this?

The smallpox vaccine, like many other vaccines (example: oral polio vaccine) can actually transmit the virus to others. In light of this, is it ethical for people to get the vaccine? (Note: they are vaccinating those who may not want to be vaccinated)

Today, should health care workers be allowed/forced to get the smallpox vaccine? What about non-health care worker citizens?

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  • J Med Ethics Hist Med

Ethical and legal aspects of patient’s safety: a clinical case report

Maliheh kadivar.

1 Professor, Division of Neonatology, Department of Pediatrics, Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran.

Arpi Manookian

2 Assistant Professor, School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran.

Fariba Asghari

3 Associate Professor, Medical Ethic s and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Nikoo Niknafs

4 Assistant Professor, Division of Neonatology, Department of Pediatrics, Vali-e-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Arash Okazi

5 Assistant Professor, Department of Forensic Medicine, Tehran University of Medical Sciences, Tehran, Iran.

Asal Zarvani

6 Nursing Student, School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran.

Since patient safety is multidimensional and grounded in ethical and legal imperatives, both ethical and legal challenges should be taken into account. In this regard, a falling incident case of a 12-day-old newborn was raised in the monthly ethics round in the Children's Medical Center of Tehran University of Medical Sciences, Iran, and the ethical and legal dimensions of patient safety were discussed by experts in various fields.

This report presents different aspects of patient safety in terms of root cause analysis (RCA) and risk management, the role of human resources, the role of professionalism, the necessity of informing the parents (disclosure of medical errors), and forensic medicine with focus on ethical aspects.

Introduction

According to the non-maleficence principle of medical ethics, ensuring patients’ safety and preventing any injury or damage to them is a major priority for healthcare providers ( 1 ). Thus, it has been the most emphasized component of the quality of health care services all around the world. The Institute of Medicine (IOM) released a report in 1999 entitled "Man is fallible: create a safe health system" in relation to the incidence of medical errors in United States, and consequently, initiated widespread international change in the field of patient safety ( 2 ). Correspondingly, the Iranian health care system implemented special plans purposed to deliver standard health care services and prevent any mistakes and an organized approach to risk management, systematic deficiency, and patient safety improvement ( 3 ). One of these programs is clinical governance which was introduced by the Ministry of Health and Medical Education (MOHME) and initiated since November 2009. Although great emphasis has been placed on the importance of clinical governance by the MOHME, there are some challenges in achieving the desired outcomes ( 4 ). This could be the result of healthcare providers’ inadequate understanding about the importance of clinical governance and lack of organizational safety culture ( 5 , 6 ).

Studies showed that a non-negligible percentage of patients are exposed to health care-related injuries. Based on World Health Organization (WHO) report, the possibility of harming patients in the process of providing health care services is 1 out of 300, whereas the possibility of aviation accidents is 1 out of 100,000. Since 2004, with the beginning of the patient safety project, so far 140 countries have attempted to improve their patients' safety plans in their own health system ( 7 ). The most common cause of injury is medication errors and falling. Although falling includes 21% of total incidents, only 4% of them are serious. Meanwhile the neonatal falling statistics in the USA is 1.6-4.4 in 10,000 live births, an estimated 600-1600 falling incidents in a year. These cases are often the result of shortcomings in systems and processes, organizational complexity and ambiguity, and poor communication ( 8 , 9 ).

Despite various patient safety guidelines and standards, less attention is paid to the ethical and legal aspects of this issue. From a moral perspective, the main goal of patient safety in the health system can be studied from two aspects. It can be studied as a practical value, in the sense that the main focus is its positive outcomes and benefits. It can also be studied as a moral value by focusing on the protection and promotion of humanity and human dignity. It should be emphasized that both aspects are important in the health system. From a professional point of view, moral values in patient safety are not separated from basic medical obligations, but are so central that they may be the source of other moral values emphasized in medicine. This means that patient safety is closely related to the concept of human dignity and all patient safety measures taken must insure the protection of human’s dignity ( 10 ). In other words, the responsibility of the health care staff and professional commitment, in general, are closely related to human dignity ( 11 ).

This case was raised in the monthly ethics round in the Children's Medical Center of Tehran University of Medical Sciences, Iran, and ethical dimensions of patient safety were discussed by experts in various fields. The opinions expressed in this article are a summary of the views of experts in various fields including neonatology, medical law, ethics, and nursing.

It is worth mentioning that the ethics round has been held every month for more than 5 years in the Children's Medical Center. A complicated case is discussed in each session with the presence of different relevant experts.

The clinical case

A 12-day old newborn infant was hospitalized in the neonatal intensive care unit (NICU) because of multiple seizures. He was the first child of the family. The mother’s and family history was negative for seizures or any other disease. Seizures were controlled by medications, and diagnostic assessments including electroencephalography (EEG) were ordered. As the infant was stable and had tolerated breast feeding, it was planned to transfer him to the level II NICU, but it was postponed due to lack of available beds.

On the evening shift of the third day of admission, his nurse heard a sudden noise and noticed that the incubator door was open and the baby was on the floor. The in-charge nurse immediately announced the incident to the on-call physician. The newborn was examined thoroughly and no physical injuries were found. Moreover, the incident was reported to the chief physician of the department and the record of this incident was immediately sent to the hospital officials. Later, all other incubators were inspected to make sure they were secure enough.

When the staff informed the newborn’s father of the falling, he accused the mother of neglecting the child, although she had said that she was resting at the time of the incident.

The questions raised in the meeting were as follows:

What are the factors leading to this incident? How could this incident been prevented? What is the responsibility of the staff in dealing with this incident? Based on professional commitments, what is the duty of medical and nursing staff in such events? What are the ethical issues of patient safety in this case? What are the legal obligations and consequences of this case?

Root cause analysis and risk management

Searching for the causes and finding the right solution, in other words, the basic analysis of the incident is one of the initial and essential measures taken to decrease the incidence of patient injuries. It should be noted that the mentioned process must be free of any bias and should focus on finding the main cause and resolving it instead of identifying the responsible person. One way of preventing such events is to have a special guideline for reporting the event in a suitable organized ethical atmosphere without accusing anyone. Indeed, fear of blame, penalties, limited organizational support, inadequate feedback, and lack of knowledge about the associated factors are some of the barriers to reporting medical errors in hospitals ( 12 ).

Assessment and reduction of patients’ risk of injury, or risk management in the clinical setting is influenced by several factors. One way is the establishment of an organizational culture based on mutual trust and effective communication in all hospital levels ( 13 , 14 ).

From an ethical perspective, the value of trustworthiness is a prerequisite of successful risk management. This value is connected to safety culture since it refers to physical safety, psychological safety, and cultural safety. Thus, the managers’ responsibility is to create mental and physical safety settings based on openness in order to promote patient safety and care quality. Furthermore, it is important for the managers to encourage multidisciplinary collaboration to facilitate transparent reporting ( 10 ).

In this case, the apparent reason was that the incubator door was left open by someone or was not correctly closed. Questions raised in this context include the following: Was the nurse occupied with other emergency and essential actions? Was the incubator door latch broken? Why would the nurse forget to accurately examine the door? Is it possible that lack of guidelines for patient safety led to this incident?

The most important step to reduce the possibility of such events in clinical settings is to establish policies and procedures that work best for each ward. Furthermore, the continuous training of the personnel in patient safety, steady supervision, and controlling the efficacy level of the performed actions are some other steps that can be taken in this regard. For instance, in this case, frequent checking of the incubator door, the use of two locks, and explanation of safety tips regarding the incubator to the staff are also important. Furthermore, evaluation and constant controlling of compliance with patient safety rules, and feedback are also necessary.

The role of human resources

The quantity of human resources is also noteworthy in the field of patient safety. In other words, quality assurance depends on the quantity of manpower. Therefore, in order to prevent similar incidents, providing an adequate number of staff at the bedside is essential ( 12 ).

The role of professionalism

Professional ethics and patient safety are intertwined fundamental concepts in medicine. Patient safety is grounded in ethical principles which are considered as care quality indicators ( 15 ). The realization of patient safety requires the provision and implementation of a professional code of ethics. Based on the Iranian healthcare professional code of conduct, it is expected that all patients be treated with dignity and be protected from any possible harm ( 16 ). Accordingly, adherence to ethical principles requires healthcare providers to identify potential safety failures to prevent falling incidents ( 15 ).

The establishment of patient safety has different individual, professional, and organizational aspects with a special focus on ethics. Professional and organizational commitment leads to detecting and reporting of both one’s own and others’ errors ( 10 ).

From an ethical view, the following actions are recommended:

Following professional and institutional guidelines (if any exist) related to falling incidents; Taking basic actions to assess the patient’s physical health and rescue his/her life; Informing the in-charge staff; Punctual assessment of the situation, and complete documentation and reporting of the event (important data such as the time of the incident, the infant’s position, level of consciousness, vital signs, those present at the scene, actions taken in the process, and etc.) should be documented; Informing the parents and providing them with emotional support.

Informing parents (Disclosure of medical errors)

It seems in case of any error made by the care team, the event must be announced to the parents honestly without blaming the care providers. Moreover, irritating phrases such as “It happens” and “Nothing has happened though” should not be used.

Under circumstances in which errors were caused by inappropriate pattern of providing hospital services, parents should be reassured that all services will be paid for by the hospital. It would be better if the parents were informed by the chief physician or the head nurse and given enough time to express their concern or anger.

Although anger under such circumstances is a natural reaction, we cannot hide medical errors because of fear of parents’ reaction. Moreover, parents’ anger would be more severe if they found out that the hospital personnel have concealed the truth.

It should be considered that knowing the truth is one of the basic rights of patients and their family members. According to similar studies, explaining the error to the patients could be a stressful situation combined with intense emotional reactions from patient/family members or the care team. Generally, the person who committed the error has a sense of guilt or fear of punishment, and patient/family members experience feelings such as anger and anxiety. Furthermore, it should be noticed that primary conversations usually take place when there is not accurate and comprehensive information about the event, so recognizing, understanding, and explaining all the details in complicated clinical situations is not possible. Thus, it is suggested that in such situations, information be given in several stages and by providing psychological support for the patient. Furthermore, while they may need supportive interventions, the patient's family can be considered as an important source of information in the process of root cause analysis (RCA) of similar incidents ( 17 - 20 ). Since creating ethical patient safety is a multidimensional accomplishment, it should be considered that actively partnering with the patient’s family may be a high-yield approach to detecting and preventing medical errors ( 10 ).

In addition, regarding the presented case, the father should be ensured that hospitalizing the newborn was necessary and the mother should not be blamed. In fact, he should be ensured that the incident was entirely due to system error and not by the mother. Basically, maintaining the integrity of the family is essential and medical staff must consider family support at all stages, especially in such circumstances.

Indeed, an important ethical point in this case is the necessity of offering an honest apology. It is not always as simple as saying: “We are sorry”. The way of informing the parents is a sensitive issue and there is an urgent need for training healthcare providers in sensitive interpersonal relationships and related skills to facilitate honest and proper communication with the patient’s family ( 20 ).

Forensic medicine aspect

Laws and regulations related to patient safety, which may vary based on the legislation system of each country, should encourage the disclosure of medical errors while supporting the implementation of the ethical imperatives of patient safety. In general, based on the medical law, the patient who is a victim of negligence is supposed to be fairly compensated. In addition, these rules provide possibilities for promotion of transparency and open communications in all levels. Reaching this goal requires regarding all stakeholders in the healthcare system ( 21 ).

In the mentioned case, some questions could be raised. Either the falling was in the presence of the mother or not. If it was in her presence, the hypothesis is that she dropped the baby intentionally. However, if there is no sign of any apparent trauma, it seems there was no specific hurtful force or he fell from his mother’s arms, and it shows the mother’s lack of experience.

Accordingly, it should be considered that maternal postpartum sleepiness is one of the major risk factors for falling of newborns. Half of all newborn falling incidents in hospitals have occurred while the mother was holding the infant in a hospital bed. Therefore, recognizing the risks of neonatal falling during mother–baby care situations and teaching the mothers is a major nursing responsibility ( 22 ).

If the mother is incapable of taking care of the hospitalized baby, she should be under supervision of the care team and should be educated. Furthermore, notifying the father is an appropriate act if the complaint was raised by the father.

The main task of the physician or nurse after a detailed examination and treatment is the detailed registration and description of all events without any assumptions. If the examinations found evidence of neglect, it would be a completely different discussion and calling the social services would be absolutely necessary.

The question might also be raised that “if nothing happened to the child and we did all the assessments to insure his health, are we obligated to inform the parents?”

There is an obligation to inform the patient or the family about every unwanted event in healthcare settings. The idea that there is no need to disclose errors which did not affect the patient is based on the traditional stance of the law. Furthermore, today, it is well known that such disclosures will enhance patients’ trust to healthcare professionals while making them aware of that which is going on around them. In addition, through this approach, healthcare professionals can respect the patients’ autonomy and dignity ( 21 , 23 ).

Despite increased attention toward the quality of health care services, there are still numerous threats to patient safety in healthcare settings. Since patient safety is multidimensional and grounded in ethical and legal imperatives, both ethical and legal challenges should be taken into account.

Reaching the ultimate goal of the healthcare system, which is to ensure quality and safety of the services, requires structured policies and processes to foster the safety settings based on mutual trust. This can be facilitated by encouraging multidisciplinary collaboration for the transparent reporting of medical errors and also active participation of the patients and their families in detecting medical errors. Furthermore, the provision of emotional support and legal protection of the staffs by the organization is essential to encourage voluntary reporting of incidents.

Moreover, training and emphasizing on the professional code of ethics can be effective on deepening the understanding of and belief in the moral foundations of patient safety.

Conflict of interest

The authors declare that there is no conflict of interest.

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  • Published: 02 February 2021

Patient privacy and autonomy: a comparative analysis of cases of ethical dilemmas in China and the United States

  • Hui Zhang 1 , 2   na1 ,
  • Hongmei Zhang 3   na1 ,
  • Zhenxiang Zhang 1 &
  • Yuming Wang   ORCID: orcid.org/0000-0003-0497-055X 4  

BMC Medical Ethics volume  22 , Article number:  8 ( 2021 ) Cite this article

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Respect for patients’ autonomy is usually considered to be an important ethical principle in Western countries; privacy is one of the implications of such respect. Healthcare professionals frequently encounter ethical dilemmas during their practice. The past few decades have seen an increased use of courts to resolve intractable ethical dilemmas across both the developed and the developing world. However, Chinese and American bioethics differ largely due to the influence of Chinese Confucianism and Western religions, respectively, and there is a dearth of comparative studies that explore cases of ethical dilemmas between China and the United States.

This paper discusses four typical cases with significant social impact. First, it compares two cases concerning patient privacy: the “Shihezi University Hospital Case”, in which a patient was used as a clinical teaching object without her permission, and the “New York-Presbyterian Hospital Case”, in which the hospital allowed the filming of a patient’s treatment without his consent. Second, it compares two cases regarding patient autonomy and potentially life-saving medical procedures: the “Case of Ms. L”, concerning a cohabitant’s refusal to sign a consent form for a pregnant woman’s caesarean, and the “Case of Mrs. V”, concerning a hospital’s insistence upon a blood transfusion for a dissenting patient. This paper introduces the supporting and opposing views for each case and discusses their social impact. It then compares and analyses the differences between China and the United States from cultural and legislative perspectives.

Conclusions

Ethical dilemmas have often occurred in China due to the late development of bioethics. However, the presence of bioethics earlier in the US than in China has not spared the US of ethical dilemmas. This paper highlights lessons and inspiration from the cases for healthcare professionals and introduces readers to the role and weight of privacy and autonomy in China and in the US from the perspectives of different cultures, religions and laws.

Peer Review reports

By the 1970s, with the joint promotion of technology and humanity, bioethics became a global phenomenon. It emerged in the United States [ 1 ], across Europe [ 2 ], and in China due to the “reform and opening-up” policy [ 3 ]. Bioethics is an emerging discipline that uses a variety of ethical approaches to study the philosophical, social, and legal issues arising in medicine and the life sciences in an interdisciplinary and cross-cultural context. It is intended to provide clinicians with a comprehensive framework for understanding the moral aspects of medicine [ 4 ].

Despite there has been controversies and challenges in relation to the four principles of bioethics—respect for autonomy, non-maleficence, beneficence, and justice—respect for the patient’s autonomy is usually considered to be an important principle in Western countries [ 5 , 6 ]. To respect the autonomy of agents represents an acknowledgement of their right to hold views, make choices, and take actions based on their values and beliefs [ 7 ]. Invasion or infringement of privacy actively undermines individuals’ sense of self; therefore, privacy and confidentiality are important aspects of respecting people’s autonomy [ 8 , 9 ]. Privacy contributes to the preservation of a sense of reverence and dignity; hence, it is vital for establishing and maintaining a respectful and effective clinical relationship [ 10 , 11 ].

In Western society, moral precepts have their origins in both religion and philosophy [ 12 ]. The predominant religion of America—Christianity—is based on the idea that God (or some deity) reveals insights about life and its true meaning, prescribing clear and unambiguous rules that must be followed. Law shares four elements with religion: ritual, tradition, authority and universality. These four elements connect the legal order to beliefs in an ultimate, transcendent reality. Law provides religion with its social dimension while religion gives law its spirit and direction, as well as the sanctity it needs to command respect [ 13 ].

Conversely, traditional Chinese ethics focus on the responsibility of a person to work for the good of others [ 14 ]. The interdependence of family and community define the greater morals and social meanings in society, which overrides the concept of autonomy [ 15 ]. According to Confucianism, ethics is based on humanism; therefore, it does not include peremptory standards, codes, or norms that restrain people’s conduct. It encourages people to judge “right and wrong” based on their nous. Thus, unlike Western societies, it is difficult to find statutory moral codes in China.

Healthcare professionals frequently encounter situations that involve medical ethical principles leading to ethical dilemmas [ 16 , 17 ]. In the past few decades, the use of courts, to resolve intractable ethical dilemmas, has increased across both developed and developing countries [ 18 , 19 , 20 , 21 ]. Despite the growing volume of literature exploring patient privacy and autonomy, there is a dearth of comparative studies that explore cases of ethical dilemmas between China and the United States. Consequently, the aim of this study is to bridge this gap and to consider the role and weight of patient privacy and autonomy from an intercultural and legislative perspective between the two countries.

As mentioned above, this study aimed to conduct a comparative analysis of cases involving ethical dilemmas—from China and the United States—to understand the importance of patient privacy and autonomy. Four representative empirical cases (two from China and two from the US) are presented, with an analysis of the supporting and opposing views for each case. All names used in the cases were replaced with pseudonyms or initials, and the following sub-sections include illustrations of the cases.

Case 1: Shihezi University Hospital case

On September 15, 2000, A Jing, a 22-year-old unmarried patient, went to the First Affiliated Hospital of the Medical College of Shihezi University in Xinjiang for an abortion. When she laid on the bed undressed waiting for examination, the physician, Dr. A, abruptly summoned more than 20 people wearing white coats into the room. A Jing felt so embarrassed and ashamed that she asked the physician to make them leave, but the physician responded that it did not matter and that they were all interns. Then, Dr. A proceeded to explain the names of private body parts, early pregnancy symptoms, and examination procedures to the interns, a process which took about 5 min. A Jing was indignant and decided to protect her rights and interests through the legal system. On October 8, A Jing filed a lawsuit against the hospital in the People’s Court of Shihezi City, asking for an apology and compensation of RMB 10,000 (around $1200) for the mental distress that she had to endure. The court held a private hearing of the case on October 27 [ 22 ], and decided in favour of the plaintiff.

Arguments presented in favour of the hospital were as follows: first, bedside clinical teaching is an essential component of medical education [ 23 ]; training medical students is both a responsibility and a legal obligation of teaching hospitals. The majority of hospitals in China believed that patients automatically consented to serving as bedside clinical “teaching material” for trainees by seeking care at teaching hospitals. This notion led to the belief that informed consent was unnecessary. Second, medical students are not unnecessary personnel, but are both interns and future physicians; therefore, clinical teaching aims to educate the next generation of healthcare professionals rather than intentionally inflict harm upon the subject. Third, bedside teaching is required because it improves medical students’ skills, which benefits future patients. In Chinese culture, public interest outweighs personal interest, thus, patient altruism supersedes individual privacy, which is why it may be overridden in favour of bedside teaching.

Conversely, compelling arguments were also presented against the hospital. First, the obligation to teach legally binds the health administration offices, hospital, and medical students; however, this does not include patients. Hospitals and patients have equal legal status, sharing a fiduciary relationship that is contractual in nature. Therefore, patients are not obliged to cooperate with or participate in clinical teaching. Second, the involvement of students during an intimate examination of patients requires the patients’ explicit permission [ 24 ]. Conducting teaching activities after the patient has expressed their discontent and failing to obtain their informed consent for the same is a direct violation of the patient’s autonomy and privacy. Third, only physicians are professionally expected to keep the information that patients provide them or that they obtain during their professional interaction with patients confidential. Medical students do not have the professional qualifications to do the same; therefore, blurring the distinction between medical students and physicians is incorrect.

This was the first lawsuit in China in which a hospital was sued for causing mental anguish to a patient because her permission was not obtained during clinical teaching. This sparked a heated societal discussion and raised patients’ consciousness regarding safeguarding their rights. Since then, there have been additional cases of patients defending their privacy across China. At that time, there was no concept of privacy rights or penalty clauses in China’s law. The right of privacy was protected by the right of reputation indirectly; the court considered acting on the violation of privacy only if the plaintiff’s reputation was also violated or affected. The main reason that many patients’ privacy rights have been arbitrarily violated is due to inadequate legislation. Case 1 (in 2000) and a series of subsequent cases led to legislative reform. In 2002, China started to review the draft Tort Liability Law, which was finally enforced on July 1, 2010. In China’s legislative history, the concept of “privacy right” was established for the first time in the Tort Liability Law, and came to be seen as an independent right of personality. Disclosing other people’s privacy, even if it does not infringe upon their reputation, constitutes infringement. Consequently, health management departments have accelerated their procedures on the protection of patient privacy. Medical institutions have been working toward making suitable adjustments to modify their infrastructures and regulations as well as to provide humanistic medical training to staff and interns.

Case 2: NewYork-Presbyterian case

In August of 2012, Mrs. C, a 75-year-old woman, saw a medical documentary filmed by The American Broadcasting Company (ABC) called “NY Med”. She recognized Dr. B, a surgeon who had tried to save her husband’s life 16 months prior. In the documentary, the surgeon was treating a man injured in a car accident. Although the image was blurred, the man could be heard in the episode. Mrs. C recognized that the man was her husband, Mr. C. In 2013, Mr. C’s family sued ABC, New York-Presbyterian (NYP) and Dr. B for violation of patient privacy. After 3 years of litigation, on April 21, 2016, the Department of Health and Human Services’ Office for Civil Rights (OCR) announced a $2.2 million settlement agreement with NYP [ 25 ].

The arguments that were presented in favour of the hospital follow. First, NYP decided to take part in the reality series to help educate the public about the challenges faced by medical professionals and the complexities of medical care. Second, ABC claimed that the medical documentary inspired people to go to medical school, to seek treatment they otherwise would not have known about, or to become organ donors, and because “NY Med” was produced by its news division, it was protected by the First Amendment. Third, ABC blurred the victim’s face and used voice alteration software to obscure any potential identifying information; therefore, the hospital’s duty to avoid disclosing personal information was not breached [ 26 , 27 ].

The cogent countervailing arguments included the following. First, all of the intimate details of a person’s health are supposed to be shared only with the patient and whoever else they designate, however, the crew was allowed to film Mr. C’s treatment at the hospital and broadcast the moments leading up to his death, without the patient’s or his family’s permission. Second, patients and their families are vulnerable, and the TV show caused Mr. C’s family emotional distress and psychological harm. Medical ethicists and groups such as the American Medical Association worry that such shows exploit the suffering of patients for public consumption. Third, although the hospitals and doctors did not receive money in return for allowing the filming of their procedures, but they did benefit in the form of free publicity [ 27 , 28 ].

Consequently, litigation has pushed for stricter regulations. It was decided that it is not sufficient to film patients and then obtain consent to broadcast the material, nor is it permissible to use blurring, pixilation, or voice alteration to mask the identities of patients whose consent has not been obtained. In addition, NYP initiated a corrective action plan to update policies and procedures and to develop workforce training. It also had to be monitored by OCR for two years to ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA) obligations while it continued to provide care for patients [ 25 ].

China versus the United States from a cultural perspective

As a common phenomenon, privacy exists in various cultures. In ancient times, people covered their bodies with leaves and hides, suggesting that the earliest understanding of privacy related to the private parts of the body. In Case 1, the patient sued the hospital because of an invasion related to her private body parts. It indicated that consciousness of patient privacy was slow to evolve and that the concept of patient privacy was relatively weak in China. The term “privacy” was translated from English and introduced to mainland China after the 1980s. The translation of “privacy” in Chinese is yinsi —the word yin means “hide” and the word si means “private” or “privacy” and has long been used as an antonym to gong (public) and guan (official). Historically speaking, China has always treated individuality with suspicion and has advocated for collectivism and cohesion for centuries. Common people regard mutual care and assistance as a symbol of unity and harmony, and believe that privacy is primarily associated with internal secrets or scandals related to personal reputation. Most people think that if their private matters becomes public, their reputation will be tarnished. Thus, the term “privacy” has a negative connotation. It represents a scenario in which the focus on individual ownership of private information is bleak and shielding one’s reputation in the community is more prominent [ 29 ].

On the contrary, American culture takes greater pride in individual accomplishments and enjoys more personal freedoms and privacy than collectivist cultures. Merriam-Webster defines privacy as “the state or condition of being free from being observed or disturbed by other people; the state of being free from public attention”. This definition is broader than the concept of privacy in Chinese culture. The right to privacy is considered a fundamental right in a free society; it is a notion that runs deep in American culture, and is to be both respected and defended.

China versus the United States from a legislative perspective

The famous article published in the Harvard Law Review in 1890 by Warren and Brandeis on the “Right to be let alone” marked the birth of privacy protection in the US [ 30 ]. In 1965, the Supreme Court case Griswold v. Connecticut established the right to privacy as a constitutional doctrine [ 31 ]. A variety of laws have worked in tandem to allow Americans to stand up for their privacy rights, such as the Family Educational Rights and Privacy Act of 1974, the Americans with Disabilities Act of 1990, and the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Since its enactment (a period of over two decades), HIPAA has been extremely successful in accomplishing its primary objective: making patients feel safe giving their physicians and other treating clinicians sensitive information while permitting reasonable information flows for treatment, operations, research, and public health purposes [ 32 ].

In China, the legal protection of privacy rights started late; from the 1980s to 2010, privacy protection was included in the right of reputation protection in China. On July 1, 2010, China’s Tort Liability Law came into effect, which for the first time explicitly stipulated that there is a “right of privacy” in China. The formal recognition and protection of privacy rights in the Tort Liability Law has brought about great changes in legal practice; privacy right has been shifted into an independent reason of tort. Nevertheless, the definition of the right of privacy was not clearly defined, and proper operation of the law requires further elaboration. Meanwhile, as society develops and technology advances, people’s privacy content also expands. On May 28, 2020, the third session of the 13th National People’s Congress passed the Civil Code. Privacy is here defined for the first time, and it is defined as a natural person’s sphere of life protected from interference, where a person should be left in peace, as well as the sphere of information and actions that individuals do not want to be of public domain and hence not shared with other people. This was the first law that was defined as a “code” that enriches the connotation of privacy and the scope of applicable protection [ 33 ].

Case 3: the case of Ms. L

On November 21, 2007, Ms. L, a 22-year-old woman who was in her ninth month of pregnancy, was sent to Beijing Chaoyang Hospital by her cohabiter, Mr. X. The physicians suggested an immediate caesarean operation because the patient had developed severe pneumonia. However, Mr. X insisted for a normal delivery stating that Ms. L just had a cold. The hospital learned that the pair was suffering economic hardships; consequently, they offered to perform the operation free of charge. Ms. L went into a coma because her situation had worsened, thus, her partner Mr. X was asked to sign the surgery consent form. Doctors had spent three hours explaining the situation and persuading Mr. X, but he ultimately wrote “refuse the caesarean section, and bear the consequences” on the form. Ms. L and the unborn child both died despite continuous efforts to save them. On January 24, 2008, Ms. L’s parents filed a civil lawsuit against the hospital. In December 2009, the Court of First Instance ruled that Chaoyang Hospital had not caused any infringement, and the hospital decided to give the plaintiff 100,000 yuan (around $14,500) on humanitarian grounds. However, the plaintiff refused to accept this judgment and lodged a second appeal. On April 28, 2010, the Court of Second Instance dismissed the appeal and upheld the original judgment [ 34 ].

Arguments presented against the hospital are as follows. First, respecting the sanctity of life should be paramount and the physicians’ actions violated the right to life. They did not follow Article 24 of the Law of Medical Practitioners, which states that emergency measures should be taken for diagnosis and treatment of patients in critical condition. Second, Article 33 of the Administrative Regulations on Medical Institutions stipulates that in cases of special circumstance, the physician shall propose a medical plan and implement it after obtaining the approval of the leader or authorized personnel of the medical institution. Third, Article 33 of the Regulations on the Handling of Medical Accidents clearly stipulates that emergency measures undertaken to save the life of critically ill patients, but that cause adverse consequences, shall not be regarded as medical malpractice, thus, physicians should have performed the surgery without obtaining informed consent from the patient or her cohabitant.

Conversely, the hospital presented the following arguments. First, the physicians had taken emergency measures apart from surgery; they had urgently asked the superior department for instructions to operate without the family’s signature. In addition, because it was difficult for ordinary people to understand Mr. X’s behaviour, the hospital had invited the director of the neurology department to assess his mental state. The police were also contacted to search for Ms. L’s family members with whom she had been disconnected for years. Second, Article 33 of the Administrative Regulations on Medical Institutions clearly stipulates that the hospital must obtain the consent of the patient and the signature of their family members or legal acquaintance before an operation. The regulation of “special circumstances” in Article 33 is vague; some scholars believe that it refers primarily to patients whose identity is not known, or who have no family members or source of income. Third, the physician–patient relationship is a civil legal relationship. According to Article 4 of the General Principles of Civil Law, civil activities should comply with the principle of voluntariness; therefore, because Mr. X’s signature expressing his explicitly disagreement with the operation, if doctors forced to the caesarean, the hospital will bear legal liability in case of an accident during the surgery.

This case caused a furore amongst the media and the public. While most netizens believed that Mr. X should be held responsible for the tragedy, nearly all official media insisted that the hospital should have treated the patient without consent. Additionally, many scholars proposed to amend the relevant laws and regulations. At the end of 2007, the emergency disposal rights of medical institutions were written in the draft of the Tort Liability Law. Article 56 of the Tort Liability Law (2010) officially stated, “if the opinions of patients or their close relatives cannot be obtained due to emergency situations such as rescuing patients in critical condition, corresponding medical measures can be adopted immediately with the approval of the leader or authorized person of the medical institution”. Some legal professionals termed it the “Mr. X clause”.

Case 4: the case of Mrs. V

On August 27, 1994, a pregnant woman, Mrs. V, gave birth to a healthy baby at the Stamford Hospital in Connecticut, US, but she endured heavy bleeding due to placenta residue. A blood transfusion was proposed to save her life; however, Mrs. V and her husband refused the procedure because it was against their religious beliefs. Before undergoing any procedure, she executed a release requesting that no blood or its derivatives be administered to her during her hospitalization, Mrs. V’s husband also signed the release. Despite the fact that Mrs. V would die without blood transfusions, she and her husband maintained their decision. Her obstetrician, Dr. C, tried dilation, curettage, and other alternatives that did not require blood transfusion, but her condition continued to deteriorate. On August 28 at 2 a.m., Dr. C submitted a request to the court regarding Mrs. V’s case, which resulted in the trial court eventually permitting the hospital to administer blood transfusions. Mrs. V was then given blood transfusions and recovered from the complication, but she appealed to the Appellate Court contesting the trial court’s judgment. On April 9, 1996, the Supreme Court of Connecticut ruled that Stamford Hospital violated Mrs. V’s right of self-determination [ 35 , 36 ].

The arguments in favour of the hospital are as follows. First, although Mrs. V’s refusal to undergo blood transfusions was clearly in keeping with the legal right of bodily self-determination, Mrs. V’s attending and other hospital physicians believed that they had exhausted all non-transfusion alternatives. Based on reasonable medical certainty, it was essential that she receive blood transfusions to survive. Second, Mrs. V was young, previously healthy, and had a favourable chance of recovery from the complication; therefore, the physicians’ ethical code did not permit them to stand by idly and allow her to die. The hospital had an interest in ensuring that the ethical integrity of the medical profession remained intact. Third, the trial court, relying on the state’s interests in preserving life and protecting innocent third parties such as the baby, granted the injunction.

Arguments presented against the hospital are as follows. First, physicians should respect the decisions made by informed and competent patients. The hospital’s repudiation of the releases signed by Mrs. V constituted a breach of the hospital’s contractual duty to her. Second, practitioners of Jehovah’s Witnesses believe that although a blood transfusion might save their corporeal life, it will deprive them of eternal salvation. Therefore, a non-consensual blood transfusion is a gross physical violation as well as a violation of the individual’s values. Third, when the court request was filed by Dr. C, Mrs. V was no longer pregnant. Consequently, while concern for the long-term welfare of the baby is certainly commendable, Mrs. V’s decision to refuse a blood transfusion posed no risk to the baby’s physical health.

The issue presented in this case was of public importance, as the appeal had a significant impact on more than 23,000 Jehovah’s Witnesses residing in Connecticut at that time [ 35 ]. In this case, the Connecticut Supreme Court provided further judicial support to the right to self-determination. It was the first time that the Connecticut Supreme Court held that a medical patient, whose life was in danger but who could be cured by a simple and relatively routine treatment, had the right to refuse that treatment [ 36 ].

The ancient Chinese Empire was a society characterized by class, patriarchy, and paternalism [ 37 ]. Chinese cultural and moral traditions shaped by Confucianism are customarily described as communitarian, familial, and patriarchal, emphasizing the importance of family, community, and state, rather than the individual. Family is the core of Chinese culture. In ancient Chinese society, the family, which is bound by blood ties, participated in social and economic activities as a basic unit. In Chinese culture, the merits of group belonging include enhancing the sense of obligation, deepening feelings, and promoting harmony among family members. Group autonomy and shared decision-making can promote these merits. Chinese culture encourages people to protect patients from mental stress and to avoid negative topics, such as informing patients of potential risks prior to surgery or telling a cancer patient the truth. In addition, patients in China may prefer to rely on their family for life care and economic support. Hence, the importance of protecting patients from mental stress and fulfilling family members’ familial obligations exceeds respect for patient autonomy. The consent of a patient’s family substitutes the principle of informed consent and autonomy of patients in Chinese medical practice.

In striking contrast to China, the concept of autonomy is a manifestation of Western culture, which emphasizes individualism. Self-determination is paramount in the liberal Western tradition that advocates for the importance of individual freedom and choice [ 38 ]. Moreover, unlike most of the population in China, which holds no religious belief, such beliefs are deeply respected in the US and play an important role in shaping a person’s value system and provide meaning in their life [ 39 ]. Consequently, the United States applies a patient-centred approach, wherein physicians are required to discuss information relevant to patients’ decisions to facilitate their autonomy [ 40 ]. Advance directives or appropriate surrogates are consulted to make decisions only when patients lack the capacity to make informed decisions.

Schloendorff v. Society of New York Hospitals (1914) is widely regarded as a landmark in the history of informed consent and sets a precedent for bioethical autonomy [ 41 ]. The decades since the 1950s have seen an increased emphasis on the patient’s right to accept or decline recommended treatments [ 40 ]. The American Hospital Association published the Patient Bill of Rights in 1972, which focused on improving standards for respecting patients admitted to hospitals. In 1990, the US Congress passed the Patient Self-Determination Act to inform patients of their rights to decide their own medical care and to ensure that these rights are communicated to them by the health care provider.

In 2016, Taiwan passed the Patient Autonomy Act, the first law in Asia that focused on the patients’ right of autonomy. Mainland China does not have a law protecting patient autonomy; instead, it regulates informed consent and autonomy issues through specific laws, such as the Tort Liability Law, Law of Medical Practitioners, and the Administrative Regulations on Medical Institutions. These laws and regulations stipulate that informed consent forms required for medical procedures and treatments (such as surgeries) can be signed either by patients or by their relatives. However, many problems exist in the current legal system, such as the dispersion and generalization of laws, and the unification of different subjects. The Civil Code, which took effect on January 1, 2021, will provide a legislative reference for patients’ informed consent and autonomy mentioned in the clauses of tort liabilities [ 33 ].

Ethical dilemmas in China have often occurred due to the late development of bioethics in the country. However, the presence of earlier bioethics in the US has not freed the country of ethical dilemmas. Culture and religion mould people’s beliefs, values, expectations about health, the physician–patient relationship, the style of decision-making and the country’s legislation. Regarding privacy, in Case 1, private body parts were infringed upon and the compensation was minimal; in Case 2, digitally altered images and sound were made public and the fine was immense. Regarding autonomy, in Case 3, the subject of informed consent was the patient’s family. The hospital did not perform the surgery due to her family’s refusal, and the patient died, however, it was ruled that the hospital had not caused any infringement. In Case 4, the subject of informed consent was the patient. The hospital prescribed a blood transfusion which the patient rejected; the patient survived, but it was ruled that the hospital violated the patient’s right of self-determination. The extent to which privacy and autonomy were valued and enforced by the courts differed in China and the United States. A comparative analysis of the cases referenced provides insight to understanding the practice of bioethics from both an intercultural and a legislative perspective.

Because China has a profound cultural tradition, the tension between international ethical norms and local culture must be handled with care. On the one hand, for autonomy, the core and essence of ethical standards of informed consent must be adhered to, while the relevant methods and processes can be altered according to cultural backgrounds and/or specific situations. On the other hand, for privacy, positive values and beliefs must be respected and sustained, while obsolete concepts that have exerted negative influences must be discarded. In terms of protecting patients’ rights and handling ethical problems, Western countries have a more developed system than China; therefore, owing to their practical experience, they can serve as a legislative reference for China to develop a more advanced concept of bioethics that incorporates modern features to meet future requirements.

Availability of data and materials

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Abbreviations

NewYork-Presbyterian

The American Broadcasting Company

Office for Civil Rights

Health Insurance Portability and Accountability Act

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Hui Zhang and Hongmei Zhang are joint first authors

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School of Nursing and Health, Zhengzhou University, No. 101, Science Avenue, Zhengzhou, 450001, Henan, China

Hui Zhang & Zhenxiang Zhang

Department of Scientific Research and Discipline Construction, Henan Provincial People’s Hospital and the People’s Hospital of Zhengzhou University, Zhengzhou, 450003, Henan, China

Nursing Department, Henan Provincial People’s Hospital and the People’s Hospital of Zhengzhou University, Zhengzhou, 450003, Henan, China

Hongmei Zhang

Clinical Research Centre, Henan Provincial People’s Hospital and the People’s Hospital of Zhengzhou University, No. 7, Weiwu Road, Zhengzhou, 450003, Henan, China

Yuming Wang

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Zhang, H., Zhang, H., Zhang, Z. et al. Patient privacy and autonomy: a comparative analysis of cases of ethical dilemmas in China and the United States. BMC Med Ethics 22 , 8 (2021). https://doi.org/10.1186/s12910-021-00579-6

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Montgomery and informed consent: where are we now?

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  • Peer review
  • Sarah W Chan , chancellor’s fellow 1 ,
  • Ed Tulloch , MBChB student 2 ,
  • E Sarah Cooper , consultant obstetrician 3 ,
  • Andrew Smith , QC 4 ,
  • Wojtek Wojcik , consultant liaison psychiatrist 5 ,
  • Jane E Norman , professor of maternal and fetal health and director of Tommy’s Centre for Maternal and Fetal Health 6
  • 1 Usher Institute for Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK
  • 2 Edinburgh Medical School, University of Edinburgh
  • 3 Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh
  • 4 Compass Chambers , Edinburgh
  • 5 Department of Psychological Medicine, Royal Infirmary of Edinburgh
  • 6 MRC Centre for Reproductive Health, University of Edinburgh
  • Correspondence to: SW Chan sarah.chan{at}ed.ac.uk
  • Accepted 5 May 2017

The Montgomery case in 2015 was a landmark for informed consent in the UK. Two years on, Sarah Chan and colleagues discuss the consequences for practising doctors

The Montgomery v Lanarkshire case of March 2015 1 drew fresh attention to informed consent. Nadine Montgomery, a woman with diabetes and of small stature, delivered her son vaginally; he experienced complications owing to shoulder dystocia, resulting in hypoxic insult with consequent cerebral palsy. Her obstetrician had not disclosed the increased risk of this complication in vaginal delivery, despite Montgomery asking if the baby’s size was a potential problem. Montgomery sued for negligence, arguing that, if she had known of the increased risk, she would have requested a caesarean section. The Supreme Court of the UK announced judgment in her favour in March 2015. The ruling overturned a previous decision by the House of Lords, 2 which had been law since at least the mid 1980s. 3 It established that, rather than being a matter for clinical judgment to be assessed by professional medical opinion, a patient should be told whatever they want to know, not what the doctor thinks they should be told.

Many organisations (in particular the General Medical Council, who intervened to make submissions in the case) said that the Montgomery decision had simply enabled UK law to catch up with current GMC guidance; others hailed it “the most important UK judgment on informed consent for 30 years.” 4 Doctors have expressed their concerns about its potentially radical effects on patient care and clinical practice. 5 We held a public debate in 2015, including doctors, lawyers, and medical students, which showed renewed tension between the professional discretion of doctors and patients’ choices 6 ; indeed, the verdict has been characterised as supporting patient autonomy over medical paternalism. 3 7 8 9 But what are the implications for doctors’ practice and their legal liability? Two years after the Supreme Court’s decision, we examine the effects of the Montgomery ruling on clinical and medicolegal practice.

Response to the ruling

Some clinicians said that retrospective application of the judgment could “open the floodgates” for claims in relation to doctors’ past actions. 10 Others thought that the Montgomery ruling was unlikely to have this effect, however “excited the claimant law firms might become initially.” 11 Legal opinions were reserved, describing the ruling as “the belated obituary, not the death knell, of medical paternalism.” 12 Some argued that the standard imposed by the Montgomery decision merely reflected good practice as already specified by the GMC 13 and would make little practical difference to clinicians. 8 Nevertheless, the concern generated by the ruling might affect doctors’ behaviour and other potential cases. Others have raised questions about the implications for the legal treatment of clinical judgment, suggesting that it represents “a radical move away from English law’s traditional respect for clinical expertise.” 9

Doctors at the coalface have received little official direction on how their practice should change in light of the ruling. We have heard anecdotally that some hospitals are in the process of updating their procedures on informed consent, but few have completed this. Although the Medical Defence Union and the Medical Protection Society have each issued statements and updated their guidance, as have some royal colleges (such as the Royal College of Surgeons), other bodies such as the GMC and the Royal College of Obstetricians and Gynaecologists (RCOG) have yet to do so.

RCOG’s difficulty in providing guidance perhaps reflects the unique nature of obstetrics—essentially helping two patients through a normal and inevitable physiological process. A further challenge is that the risks of birth can change dramatically and quickly, making detailed discussion and informed decision making difficult. These “emergencies” might be exempt from the Montgomery ruling, depending on their nature and timing, but complications of labour (such as sudden and profound fetal distress or major maternal haemorrhage) are not, even though, as was noted in the judgment, choices about management of labour cannot generally be deferred. GMC guidance says that the consenting process is not a snapshot but an ongoing process. Planning for labour emergencies is essential, so that the doctor and patient can discuss the patient’s wishes if an emergency should arise.

RCOG has proposed pilot programmes to identify what resources women, clinicians, and health services need to comply with the Montgomery ruling. Training and educational materials must be fit for purpose. Obstetricians urgently need guidance.

Legal consequences for doctors

The Montgomery decision redefined the standard for informed consent and disclosure. Previously, the Bolam test 14 in England and the Hunter v Hanley test 15 in Scotland were used to determine what should be disclosed. These tests ask whether a doctor’s conduct would be supported by a responsible body of clinicians. The Bolam test was affirmed in Sidaway v Bethlem Royal Hospital Governors and others, 2 although the ruling was not unanimous, with judges placing different weight on the patient’s right to make informed treatment decisions versus the doctor’s professional judgment in disclosing information. The Montgomery case firmly rejected the application of Bolam to consent, establishing a duty of care to warn of material risks. The test of materiality defined in the Montgomery ruling was whether “a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.” 1 The solicitor representing Montgomery spoke of the decision as having “modernised the law on consent and introduced a patient focused test to UK law.” 16

Retrospective cases

Constitutionally, the Supreme Court cannot make new law; it can only state what, in theory, the law has always been. Doctors may have been treating patients as they understood the law to be, as in the Sidaway case, but the Supreme Court has told us that this was wrong 3 and that anyone who practised according to Sidaway was also wrong.

In practical terms, the ruling should apply at least back to 1999, when Montgomery saw her obstetrician. Guidance in effect at that time from the GMC, 17 BMA, 18 NHS, and the Scottish Office 19 supported a doctor’s duty to disclose relevant information and risks. So the Montgomery principles have been known—or should have been known—by doctors for many years.

Since the Montgomery ruling, several attempts have been made to introduce a consent based claim to cases that were under way before the decision. One such attempt in Scotland has, so far, been unsuccessful. 20 Two English cases have allowed consent claims to be added after the Montgomery decision. 21 22 Some cases have succeeded on a Montgomery basis 23 ; we (AA) understand that others have settled before litigation ever started or was concluded, as the claims were unanswerable in the light of Montgomery . We (ESC) have noticed that a considerable proportion of cases of obstetric negligence raised since Montgomery involve consent in addition to standard complaints of substandard care. These issues are not always pursued, but obstetric litigation practice has noticeably changed, making professional training and clarity with respect to guidelines an even higher priority.

Subsequent cases

Looking at some of the cases in which the Montgomery ruling has been considered tells us about its interpretation to date. In Spencer v Hillingdon NHS Trust (April 2015) 23 the patient had bilateral pulmonary emboli after a hernia operation. He did not seek treatment immediately because he had not been advised of the risk of deep vein thrombosis or pulmonary embolism or of symptoms that might indicate these. The judge considered the Montgomery ruling and found that failure to inform the patient was a breach of the duty of care.

Shaw v Kovac (October 2015) 24 concerned a patient who died in 2007 after a transaortic valve implantation, which was then still the subject of clinical trials and not fully approved. The claimant’s argument sought to use the Montgomery ruling to ground a claim for damages for the loss of life without informed consent. The court rejected this, holding that the Montgomery ruling did not create a right to informed consent as an independent cause of action, but simply set a new legal standard for the duty to disclose.

In Mrs A v East Kent Hospitals University NHS Foundation Trust (April 2015), 25 the claimant’s baby, who was conceived using intracytoplasmic sperm injection, had a chromosomal abnormality. The claimant alleged that the trust was negligent in failing to advise of this possibility. The court applied the Montgomery test and decided that the risk was not material, because neither a reasonable patient nor the patient herself would have attached significance to it. Thus, although the test is focused on patients, doctors are not liable for every omission of disclosure to which a patient later objects.” 25

Clinical concerns and ethical arguments

Some doctors feared that more stringent disclosure requirements would risk overwhelming patients with information, causing distress or leading them to make poor decisions, while doctors’ time would be taken up with lengthy explanations, creating a drain on healthcare resources. Information overload is unlikely given that information should be tailored to the patient. But doctors must judge what is appropriate for each patient and how their exercise of judgment might be assessed by the courts. The doctor might think that disclosure of certain information could lead the patient to a decision that is not in their best interests, as was true for the Montgomery case. But the ethical and legal position is clear: doctors must not withhold information simply because they disagree with the decision the patient is likely to make if given that information.

Making sure that patients understand all the information they need to make a decision will inevitably take longer. But allocation of health resources should be tackled systematically rather than individually. Healthcare policy should cover, for example, which treatments should be available and how consent procedures should be handled. 17 The doctor’s duty is simply to treat patients according to their interests, which might include being given more information than usual.

A second concern was that the ruling would encourage “defensive medicine,” shifting the focus from helping the patient to protecting the doctor. But doctors should have already been following GMC guidance, which highlights the importance of communication. 13

Finally, doctors criticised the focus of patient autonomy over medical paternalism. But this is a false dichotomy—the idea of a fully autonomous patient making choices completely independent of the doctor’s input does not reflect the complex reality of medical decision making, nor does the caricature of a paternalistic doctor riding roughshod over patients’ objections.

Patients are not always aware of the facts of their treatment after consent related discussions, 26 and they are influenced by the way in which information is presented (the “framing effect”). 27 But the difficulties of conveying information about treatment and risks should not be taken to indicate that patients are incapable of understanding medical information or that patient autonomy in decision making is meaningless. Rather it shows that the communication process has a strong influence on how patients understand, remember, and evaluate information—all of which are essential to informed consent. The doctor’s role is to ensure that relevant information is presented to enable the patient to use it meaningfully.

Conclusions

The Montgomery case was framed as a clash of values—patient autonomy versus medical paternalism. In reality, medical decision making involves a nuanced negotiation of information. Today’s patients can expect a more active and informed role in treatment decisions, with a corresponding shift in emphasis on various values, including autonomy, in medical ethics.

The full implications of the case are undoubtedly still unknown, but Montgomery has clear relevance for medical law and ethics. Legally, consent law has been clarified and aligns with current GMC guidance, and the Montgomery test has already been applied in several cases. Ethically, it clarifies the existing shift towards a more cooperative approach in the consultation room. The Montgomery ruling has not radically changed the process of consent; it has simply given appropriate recognition to patients as decision makers.

Contributors and sources: The authors were organisers (ET, WW, JEN) and participants (SWC, AS, ESC) of an event in the Edinburgh Medical Debates series on the ethical and legal impact of the Montgomery case. 6 ET is a medical student at the University of Edinburgh and was primarily responsible for research and initial drafting of the manuscript; SWC is a researcher in bioethics and was responsible for subsequent drafting, critical revisions, ethical analysis, and part of the legal research; ESC, WW, and JEN are clinicians and were responsible for conceiving the idea for the manuscript, critical revisions, and obstetric medicolegal advice; AS is a barrister and QC in both Scotland and England, specialising in medical negligence, and was responsible for legal advice, analysis, and critical revisions. All authors approved the submission of the manuscript. SWC and JEN are the guarantors.

Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following interests: AS represented the GMC in the Supreme Court in the Montgomery case. All other authors have nothing to declare.

Provenance and peer review: Not commissioned; externally peer reviewed

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .

  • ↵ Montgomery v Lanarkshire Health Board [2015] SC 11 [2015] 1 AC 1430.
  • ↵ Sidaway v Board of Governors of the Bethlem Royal Hospital and others [1985] 871 AC.
  • ↵ Heywood R. RIP Sidaway: patient-oriented disclosure—a standard worth waiting for? Montgomery v Lanarkshire Health Board[2015] UKSC 11. Med Law Rev 2015 ; 23 : 455 - 66 . doi:10.1093/medlaw/fwv024 pmid:26023076 . OpenUrl
  • ↵ Dyer C. Doctors should not cherry pick what information to give patients, court rules. BMJ 2015 ; 350 : h1414 . doi:10.1136/bmj.h1414 pmid:25769489 . OpenUrl
  • ↵ Sundar S. New law on consent will overload seriously ill patients. BMJ 2015 ; 350 : h1787 . doi:10.1136/bmj.h1787 pmid:25851299 . OpenUrl
  • ↵ University of Edinburgh. Patient consent: do doctors really know best? https://youtu.be/lCwOYz_uJLc .
  • ↵ Edozien LC. UK law on consent finally embraces the prudent patient standard. BMJ 2015 ; 350 : h2877 . doi:10.1136/bmj.h2877 pmid:26023049 . OpenUrl
  • ↵ Farrell AM, Brazier M. Not so new directions in the law of consent? Examining Montgomery v Lanarkshire Health Board. J Med Ethics 2016 ; 42 : 85 - 8 . doi:10.1136/medethics-2015-102861 pmid:26685149 . OpenUrl
  • ↵ Montgomery J, Montgomery E. Montgomery on informed consent: an inexpert decision? J Med Ethics 2016 ; 42 : 89 - 94 . doi:10.1136/medethics-2015-102862 pmid:26811487 . OpenUrl
  • ↵ Sundar S. Case based laws are turning into “emperors new clothes.”[electronic response to Sokol DK. Update on the UK law on consent] BMJ http://www.bmj.com/content/350/bmj.h1481/rr-23 .
  • ↵ Weston A. Consent down under. Br Dent J 2015 ; 219 : 304 . doi:10.1038/sj.bdj.2015.764 pmid:26450228 . OpenUrl
  • ↵ Foster C. The last word on consent? New Law J 2015 ; 165 : 1 . OpenUrl
  • ↵ Sokol DK. Update on the UK law on consent. BMJ 2015 ; 350 : h1481 . doi:10.1136/bmj.h1481 pmid:25779588 . OpenUrl
  • ↵ Bolam v Friern Hospital Management Committee [1957] 1 WLR 582.
  • ↵ Hunter v Hanley 1955 SC 200.
  • ↵ Tyler F. Supreme Court decision changes doctor-patient relationship forever. Balfour and Manson, 2015 .
  • ↵ General Medical Council. Good Medical Practice. 1995 .
  • ↵ British Medical Association. The Handbook of Medical Ethics. British Medical Association, 1981 .
  • ↵ Scottish Office. The Patient’s Charter: What Users Think. 1992. Scottish Office, 1993 .
  • ↵ Clark v Greater Glasgow Health Board [2016] CSOH 25. A further judgment was issued in this case on appeal which refused the amendment. It is understood that an application to appeal to the Supreme Court is being presented and if allowed, some of the issues raised in this article may be further discussed.
  • ↵ Jones v Royal Wolverhampton NHS Trust [2015] EWHC 2154 (QB).
  • ↵ Georgiev v Kings College Hospital NHS Foundation Trust [2016] EWHC 104 (QB).
  • ↵ Spencer v Hillingdon Hospital NHS Trust [2015] EWHC 1058 (QB).
  • ↵ Shaw v Kovac [2015] EWHC 3335 (QB).
  • ↵ Mrs A v East Kent Hospitals University NHS Foundation Trust [2015] EWHC 1038 (QB).
  • ↵ Byrne DJ, Napier A, Cuschieri A. How informed is signed consent? Br Med J (Clin Res Ed) 1988 ; 296 : 839 - 40 . doi:10.1136/bmj.296.6625.839 pmid:3130937 . OpenUrl
  • ↵ McNeil BJ, Pauker SG, Sox HC Jr, , Tversky A. On the elicitation of preferences for alternative therapies. N Engl J Med 1982 ; 306 : 1259 - 62 . doi:10.1056/NEJM198205273062103 pmid:7070445 . OpenUrl

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The Tuskegee Syphilis Study

This is one of six cases from Michael Pritchard and Theodore Golding's instructor guide, " Ethics in the Science Classroom ." that provide background and some discussion guidelines around the historical Tuskegee Syphilis Study.

Categories Illustrated by This Case:  Issues related to experimentation on human subjects.

1. Introduction

Although experimentation on human subjects has long been understood to be fraught with serious ethical concerns, little was done to develop national and international guidelines and regulations with regard to such research until the end of World War II. Populations that were frequently victimized by involuntary or coerced participation in potentially dangerous experiments included prisoners and insane asylum inmates. Due to popular recognition of the need to test new medical treatments, defenders of the rights of such powerless individuals found little political interest in outlawing these practices. However, the atrocities committed by Nazi doctors in the name of medical experimentation, as revealed during the Nuremberg war crimes trials, raised international consciousness about the need for an acceptable code for medical research.

The result was the promulgation in 1947 of the Nuremberg Code. This document was drafted by an international panel of experts on medical research, human rights, and ethics. It focused on the requirement for voluntary consent of the human subject and the weighing of the anticipated potential humanitarian benefits of a proposed experiment against the risks to the participant. The Code served as the initial model for those few public and private research and professional organizations that voluntary chose to adopt guidelines or rules for research involving human subjects.

In the ensuing years occasional media publicity called attention to continuing questionable biomedical and behavioral research practices. In 1972 the Tuskegee Syphilis Study, described in the case study below, became a cause celebre due to the thorough and dramatic Associate Press story written by reporter Jean Heller. Congressional hearings took place in 1973 and the following year Congress passed legislation creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commissioners included prominent experts and scholars in the fields of medicine, psychology, civil rights, the law, ethics and religion. In 1979 they published Ethical Principles and Guidelines for the Protection of Human Subjects of Research, which is commonly referred to as "The Belmont Report." This document presents a well-developed ethical framework for the exploration of the issues associated with the use of human beings as the subjects of research. More comprehensive than the Nuremberg Code, it defined the boundary between accepted therapeutic practice and experimental research, and proposed the following three basic principles to guide in the evaluation of the ethics of research involving human subjects.

  • Respect for Persons  - This principle incorporates the convictions that individual research subjects should be treated as autonomous agents, and that persons with diminished autonomy (such as prisoners or inmates of mental institutions) are entitled to protection.
  • Beneficence  - Research involving human subjects should do no intentional harm, while maximizing possible benefits and minimizing possible harms, both to the individuals involved and to society at large.
  • Justice  - Attention needs to be paid to the equitable distribution within human society of benefits and burdens of research involving human subjects. In particular, those participants chosen for such research should not be inequitably selected from groups unlikely to benefit from the work.

The Belmont report has greatly influenced the codes and regulations regarding human subjects research that have since been established in the United States by federal and many state governments, universities, professional organizations and by private research institutions, as well as similar codes and regulations elsewhere in the world.

2.  Background

Syphilis was a widespread but poorly-understood disease until shortly after the turn of the century. Two of the principal steps forward were the isolation of the bacterium associated with syphilis in 1905, and shortly thereafter, the development of the Wasserman reaction to detect the presence of syphilis through a blood test.

Still, much about the disease and its progress remained unknown. Due to this lack of understanding many cases were incorrectly diagnosed as syphilis, while in other cases patients who would now be recognized as victims of the disease were missed. As the etiology of the disease was better understood, it became increasingly urgent to understand its long-term effects. The early treatments that predated the discovery of penicillin involving the use of such poisons as arsenic and mercury were dangerous, and sometimes even fatal. Thus, it was vital to learn about the likelihood that the disease itself would result in serious physical or mental disability in order to make sure that the potential benefits of treatment exceeded the risks.

One long-term study had been carried out in Oslo, Norway. This had been a retrospective study, going over the past case histories of syphilis victims then undergoing treatment, and had been undertaken on an exclusively white population.

In the early 1930s, the U.S. Public Health Service (PHS) began a program aimed at controlling venereal disease in the rural South. The Julius Rosenwald Fund - a philanthropic organization that was interested in promoting the welfare of African-Americans, provided the funds for a two-year demonstration study in Macon County, Alabama where 82% of the residents were African-Americans, most of whom lived in poverty and had never seen a doctor. A principal aim of this study was to determine the incidence of the disease in the local population, while training both white and African-American physicians and nurses in its treatment. When the results revealed that 36% of the Macon County African-Americans had syphilis, which was far higher than the national rate, the Rosenwald Fund, concerned about the racial implications of this finding, refused requests to support a follow-up project.

The discovery of the fact that the incidence of the disease was higher among African-Americans than among whites was attributed by some to social and economic factors, but by others to a possible difference in susceptibility between whites and non-whites. Indeed one Public Health Service consultant, Dr Joseph E. Moore of Johns Hopkins University School of medicine proposed that "Syphilis in the negro is in many respects a different disease from syphilis in whites. "

3. The Case

In 1932 the PHS decided to proceed with a follow-up study in Macon County. Unlike the project supported by the Rosenwald Fund, the specific goal of the new study was to examine the progression of untreated syphilis in Afro-Americans. Permission was obtained for the use of the excellent medical facilities at the teaching hospital of the Tuskegee Institute and human subjects were recruited by spreading the word among Black people in the county that volunteers would be given free tests for "bad blood," a term used locally to refer to a wide variety of ailments. Thus began what evolved into "The Tuskegee Study of Untreated Syphilis in the Negro Male," a project that would continue for forty years. The subject group was composed of 616 Afro-American men, 412 of whom had been diagnosed as having syphilis, and 204 controls.

The participants were never explained the true nature of the study. Not only were the syphilitics among them not treated for the disease -- a key aspect of the study design that was retained even after 1943 when penicillin became available as a safe, highly effective cure -- but those few who recognized their condition and attempted to seek help from PHS syphilis treament clinics were prevented from doing so.

Eunice Rivers, an Afro-American PHS nurse assigned to monitor the study, soon became a highly trusted authority figure within the subject community. She was largely responsible for assuring the cooperation of the participants throughout the duration of the study. She was aware of the goals and requirements of the study, including the failure to fully inform the participants of their condition and to deny treatment for syphilis. It was her firm conviction that the men in the study were better off because they received superior medical care for ailments other than syphilis than the vast majority of Afro-Americans in Macon County.

The nature of the Study was certainly not withheld from the nation's medical community. Many venereal disease experts were specifically contacted for advice and opinions. Most of them expressed support for the project. In 1965, 33 years after the Study's initiation, Dr. Irwin Schatz became the first medical professional to formally object to the Study on moral grounds. The PHS simply ignored his complaint. The following year, Peter Buxtin, a venereal disease investigator for the PHS began a prolonged questioning of the morality of the Study. A panel of prominent physicians was convened by the PHS in 1969 to review the Tuskegee study. The panel included neither Afro-Americans nor medical ethicists. Ignoring the fact that it clearly violated the human experimentation guidelines adopted by the PHS in 1966, the panel's recommendation that the Study continue without significant modification was accepted.

By 1972, Buxtin had resigned from the PHS and entered law school. Still bothered by the failure of the agency to take his objections seriously, he contacted the Associated Press, which assigned reporter Jean Heller to the story. On July 25, 1972 the results of her journalist investigation of the Tuskegee Study of Untreated Syphilis in the Negro Male were published. The response to Heller's revelations was broad-based public outrage, which finally brought the Study to an immediate end.

4. Readings  and Resources 

A good, detailed case study of the Tuskegee Syphilis Project, with background material and suggestions about teaching the case, written for undergraduate college students is:

  • "Bad Blood - A Case Study of the Tuskegee Syphilis", by Ann W . Fourtner, Charles R. Fourtner, and Clyde F. Herreid, Journal of College Science Teaching , March/April 1994, pp 277-285.

An excellent dramatization of the Tuskegee Syphilis Study story, available as a 60-minute video recording is:

  • "The Deadly Deception," a Nova video written, produced and directed by Denisce Di Anni, WGBH Boston, 1993 production. [This video is owned by many libraries and is currently distributed by Films for the Humanities and Sciences, P.O. Box 205, Princeton, NJ 08543-2053.]

For a medical report on the Study summarizing the first thirty years of subject observation see:

  • "The Tuskegee Study of Untreated Syphilis: the 30 th year of observation," by D.H. Rockwell et al., Arch. Intern. Med. , 144, pp 792-798, 1964.

Recent books about the Tuskegee Study include:

  • The Tuskegee Syphilis Study , by Fred D. Gray (Montgomery, AL: Black Belt Press, 1998).
  • Bad Blood. The Tuskegee Experiment , by J. H. Jones (: Free Press, 1993).

For more information on the ethics of experimentation on human subjects read:

  • "The Belmont Report," by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, OPPR Reports, NIH, PHS, HHS , April , 1979.
  • The Nazi Doctors and the Nuremberg Code , by G. Annas and M. Grodin, (New York: Oxford University Press, 1992).

For a report on recent revelations concerning unethical experiments that exposed many human subjects to nuclear radiation see:

  • "Radiation: Balancing the Record," by Charles C. Mann, Science , 263, pp 470-473, January 28, 1994.

For an excellent treatment of the history of syphilis, which raises many other interesting questions about the nature of scientific research see:

  • Genesis and Development of a Scientific Fact , by Ludwick Fleck, (Chicago: University of Chicago Press, 1979).

5. The  Issues

Significant questions of ethics and values raised by this case:

  • An explicit requirement of the Tuskegee study was that the subjects not receive available treatment for a debilitating disease, a clear violation of normal medical practice. Would any study involving human subjects that violated normal medical practice necessarily be unethical?
  • The Tuskegee victims were not informed -- in fact they were deliberately misinformed -- about the nature of the study in which they were participants. A basic guideline for human subject research, specified in both the Nuremberg Code and the Belmont Report is the requirement of informed consent. What would have constituted informed consent in the case of the Tuskegee Study? If such informed consent had been obtained from the subjects, would this remove all questions about whether the Study was ethical?
  • In what sense were the premises and the practices of the Tuskegee study racist? An important question to explore when examining accusations of human rights violations or of prejudicial behavior is whether the standards being applied are those of the time the action took place, and if not, whether this should affect any judgement about the ethics of the situation. (Conforming to official social standards does not necessarily imply that you are behaving in an ethical manner. Most people would consider the medical experiments of the Nazi Doctors to be unethical even though they conformed to the principles spelled out in the Nazi ideology imposed on Germany by the Third Reich.)
  • Eunice Rivers, the African-American nurse who played a vital role by befriending the Tuskegee Study participants and assuring their cooperation has justified her support for the project in terms of the fact that the attention that she and the other medical staff gave to the men was more than a non-enrolled, poor, Macon County resident was likely to receive. If you had been in her place, do you think you would have come to the same conclusion with regard to the ethical choices available to you.
  • Ordinarily, one would not think of the media as the proper instrument for enforcing public morality. They had that role here, but should they have?
  • The political reaction to the Tuskegee revelations was largely responsible for establishing the committee that wrote the Belmont report, which set guidelines for experimentation on human subjects. These guidelines have been the basis for regulations, usually enforced by human subjects research panels, at most public and private institutions that conduct such research. Is this likely to assure that all future research on human subjects will be conducted in a manner that raises no ethical concerns?
  • The Belmont Report proposes three criteria for the evaluation of human subjects research, respect for persons , beneficence and justice , as described above in the introductory section. In what ways does the Tuskegee Study fail to conform to each of these criteria.
  • In experiments on infants, it is obviously impossible to obtain the informed consent of the subject. This is also true in experiments on senile individuals. Does this mean that ethical considerations preclude using such subjects in any experiment?

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  • Volume 36, Issue 11
  • A case study from the perspective of medical ethics: refusal of treatment in an ambulance
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  • Hasan Erbay 1 ,
  • Sultan Alan 2 ,
  • Selim Kadıoğlu 1
  • 1 Department of Deontology and History of Medicine, Cukurova University, Adana, Turkey
  • 2 Cukurova University Adana Health High School, Department of Midwifery, Adana, Turkey
  • Correspondence to Dr Hasan Erbay, Cukurova University, Department of Deontology and History of Medicine Balcali Kampusu 01330 Yuregir, Adana, Turkey; hasanerbay{at}yahoo.com

This paper will examine a sample case encountered by ambulance staff in the context of the basic principles of medical ethics.

An accident takes place on an intercity highway. Ambulance staff pick up the injured driver and medical intervention is initiated. The driver suffers from a severe stomach ache, which is also affecting his back. Evaluating the patient, the ambulance doctor suspects that he might be experiencing internal bleeding. For this reason, venous access, in the doctor's opinion, should be achieved and the patient should be quickly started on an intravenous serum.

The patient, however, who has so far kept his silence, objects to the administration of the serum. The day this is taking place is within the month of Ramadan and the patient is fasting. The patient states that he is fasting and that his fast will be broken and his religious practice disrupted in the event that the serum is administered. The ambulance doctor informs him that his condition is life-threatening and that the serum must be administered immediately. The patient now takes a more vehement stand. ‘If I am to die, I want to die while I am fasting. Today is Friday and I have always wanted to die on such a holy day,’ he says.

The ambulance physician has little time to decide. How should the patient be treated? Which type of behaviour will create the least erosion of his values?

  • Quality/value of life
  • informed consent
  • right to refuse treatment
  • moral and religious aspects

https://doi.org/10.1136/jme.2010.035600

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Introduction

In Turkey, the official medical emergency dispatch system that manages health calls and the dispatching of ambulances is the hotline ‘112’. This study will examine an incident between a patient who is making a decision and ambulance staff to render this patient emergency medical intervention, from the perspective of medical ethics.

On Friday, 26 September 2008, an accident occurs on the intercity highway. Onlookers call 112. According to the information they supply, there is one injured person involved in the accident. The 112 control centre dispatches the closest ambulance team to the scene of the accident. 1 The injured person is the driver of the vehicle, travelling alone. The driver has been removed from the vehicle with the help of persons from passing cars and he is conscious. Having arrived at the scene, the 112 ambulance staff pick up the injured driver and medical intervention is initiated.

The injured man has a severe stomach ache that he can feel in his back. He describes the pain as intermittent, surrounding his waist like a belt. Apart from some small scratches on his face, there is no active bleeding. There is also no visible bleeding in the abdomen. A physical examination indicates that the patient's blood pressure is low (100/60 mmHg), his pulse is weak and his ECG is normal. After about 5 min, his blood pressure is measured again and seen to be even lower (80/50 mmHg). The patient's respiration is troubled. However, listening to lung sounds indicates that both lungs are equally participating in respiration. The patient asks to have the cervical collar removed because it affects his breathing. The ambulance physician making the evaluation, suspects that the patient might be experiencing intra-abdominal bleeding. Because blood loss is suspected, the patient must quickly be administered serum by venous access. The healthcare team starts to make preparations for the administration of the serum.

The patient, however, who has so far kept his silence and watched the procedures, not being very involved and in fact absorbed in his own pain, suddenly objects to the administration of the serum. The day this is taking place is within the Islamic holy month of Ramadan and the patient is fasting. 2 The patient states that his fast will be broken and his religious practice disrupted in the event that the serum is administered. The ambulance staff member informs him that his condition is life-threatening and that the serum must be administered. The patient now takes a more vehement stand. ‘If I am to die, I want to die while I am fasting. Today is Friday and I have always wanted to die on such a holy day,’ he says. The ambulance team tries to make a quick assessment about whether this decision of the patient is a conscious one and whether the patient is aware of its possible consequences.

The ambulance physician has little time to decide what to do. The patient is rapidly losing blood. The blood loss must be urgently replaced with the serum. Yet the patient does not accept this.

Analysing the matter from a religious perspective is outside the scope of this paper. It would be useful, however, to examine the religious assertions that the patient has made in refusing medical treatment.

The ultimate decisions about life and death are not simply medical decisions. 3 The use of religious references in refusing medical treatment is not a phenomenon that has been newly encountered. There have been many instances of ethical and legal discussions related, for example, adherents of Jehovah's Witnesses. 4 5 Living and wishing to shape their lives according to religious teachings are of course matters related to people's personal preferences and more important, constitute one of the foremost of human rights. 6 Also, it is expected that physicians should respect a competent patient's right to accept or refuse treatment. 7 Just as they plan their lives, individuals may wish to plan for their deaths or processes of death according to specific points of reference. What is important at this juncture is whether the teaching or philosophy used as a reference point has been in fact correctly perceived. The rightness or wrongness of applications arising from such perceptions, however, does not depend only on the teaching that has become the point of reference. More determining are the reasons set forth by the implementer of such doctrines. Just as physicians should aim to provide relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more clearly and rationally. 8

As a matter of fact, differences of implementation have caused the emergence of many different denominations in Islam. There are different school thoughts in Islam and discussions here, are made from Sunni, Hanafi perspective. It is also a fact that, because of the existence of different interpretations, an individual who accepts a particular religious teaching as a point of reference may find him/herself brought into a situation that is unacceptable according to that same religious teaching.

This is the type of situation that is being studied here. The injured person has a religious point of reference for the end of life, but due to his own interpretation, falls into a situation that is in fact not approved by that same religious point of reference. Within the framework of the religious teachings of Islam, the faith has anointed the human being as the most noble among creatures, attaching great importance to human life and insistently recommending medical treatment. 9 Fasting in Islam constitutes conscious abstinence from eating, drinking and sexual intercourse, from dawn to sunset. 2 According to many Islamic scholars, the fasting believer who must be administered a serum will suffer a break of his/her fast, but one that does not require atonement, only a kaza prayer of compensation. 10 ( Kaza in Islamic terminology means to allow postponement of a religious duty to another time in certain conditions.) This is because what is at issue here is a human life. There are many situations in which it is considered acceptable to break a fast, times at which facility is rendered to the practice of fasting. Also according to Islam, the treatment of the individual in the life to come is believed will be determined by his/her actions on earth. No connection is made with the time or place of his/her death. 10 On the other hand, in the meaning of a hadith, there are two pleasures in fasting: breaking the fast and the convergence to Allah. 11 The injured man could have taken reference the hadith himself. Moreover, Islamic teaching has developed various algorithms to deal with decision-making processes in medical emergencies. 12 Islamic doctrine is based on a reverence for life and accepts that refusing to be treated is a serious sin 13 ; Islam has certainly prohibited suicide. In the light of all of this, the conclusion that can be drawn in the religious context of this case is that the individual here is exaggerating the implications of the religious point of reference, jumping to conclusions that are not in fact sanctioned by the religion and which are only subjective interpretations.

As mentioned at the beginning, the purpose of this article is not to analyse the case from a religious point of view. What is being attempted above is to show the error in the behaviour of the individual, who is acting from the perspective of a particular religious standpoint, by offering reference to sources of knowledge accepted by the same religion. Again, what is important here is whether or not the belief guiding the individual in his behaviour can in fact be evaluated within the framework of individual autonomy. The question of whether a point of religious reference is being rightfully used or how it is being used is completely the subject of theological discussion. What is being reviewed here is the autonomy of a patient in making use of a reference to a religious doctrine, even though the relevant teaching has been misinterpreted.

In today's pluralistic society, universal agreement on moral issues between physicians and patients is no longer possible. 14 Traditional medical ethics regards the wellbeing and interests of the patient as a primary value. In the present case, the patient has been carried to the ambulance and bleeding has been stopped. Verbal communication with the patient has been continuous to achieve the patient's psychological comfort. The injured person has been informed of what is happening, which medical procedures are to be performed, which hospital he will be transported to, and so on. It has been observed that these explanations have been understood by the patient, who has given verbal reactions and made comments in response. The ambulance team has made every effort to provide the patient with the best care that conditions in the ambulance permits.

Respect for autonomy

Respect for persons is widely regarded as the fundamental basis of any ethics involving human beings. 15 The most effective method of achieving individual autonomy is through the practice of obtaining informed consent. Informed consent constitutes the acceptance of a patient of the diagnosis and treatment methods to which he/she will be subjected, along with their benefits and possible undesired results, based on the information received regarding other alternative methods and their structural and outcome-related characteristics. Medical procedures that are undertaken without the patient's consent have no ethical or legal foundation. It is obvious that no medical intervention can be forced upon an individual exhibiting mental competence and free will who opposes that intervention. The problem that appears in this context is more an issue of what is to be done in the event the patient has impaired consciousness or has lost his/her decision-making competence. Closest family members are usually considered the first choice as surrogates because it is assumed that they know the patient best and that they have the wishes and best interests of the patient as a top priority. 16 But, this is not possible in this case.

In the present case, two elements—competence and consent—must be examined in order to make a decision about the patient's autonomy. The communication the health team achieved with the injured party may be a guide in this analysis. The ambulance staff made every effort to set up a line of effective communication with the injured individual. The patient responded to questions with rational and conscious answers as to how the accident happened, where he was coming from and where he was going, what his occupation was, and so on. He remembered how he was removed from the vehicle. The conclusion at which the emergency medical team arrived after all of this was that the patient was conscious and competent enough to be aware of the consequences of his actions.

The principle of autonomy, outside of the exceptions recognised by law, encompasses all medical situations, including emergencies, where informed consent is required. 17 Consent implies the patient's acceptance of the medical procedure to be undertaken after having been provided with accurate, simple and comprehensible information about that procedure. The medico-legal contexts with regard to capacity to consent may vary in different countries but the capacity to consent remains an important ethical and legal aspect of patient care in all settings. 18 In the present case, the patient gave his consent to many medical procedures. He permitted the medical staff to place and fix him on the gurney, measure his blood pressure, fit him with a neck brace, put dressing on the bleeding parts of his body and administer oxygen via nasal tubing. The sole objection of the injured individual where he did not consent to the procedure was towards the attempt to administer serum. The patient connected his refusal to consent with his own interpretation of religious practice. When he was reminded of the stance of religious laws in situations like this, the patient stated that he did not accept such an interpretation. At this point, it could be seen that the patient was able to consciously provide grounds for his objection. It should be noted also that there is no institution can be urgent consulted in such cases by telephone or otherwise in Turkey.

In the context of respect for autonomy, another matter concerning medical staff and patient relations that must be analysed is the fixing or immobilisation of a patient on a gurney. An ambulance is a vehicle that speeds through traffic. Fixing the patient onto the stretcher with a safety belt is a requirement geared to prevent the patient from being jostled from side to side as he/she lies on the stretcher inside the ambulance. How can there be a reference to autonomy when the patient is tied down to a stretcher in this way? Is it not possible to say that a person in that position, surrounded by uniformed personnel, in an environment which is foreign to him/her and in a situation to which he/she has not given consent, is in a sense only partially autonomous? Physically tying the patient to the gurney, although an action that is performed for the benefit of the patient is a procedure that restricts the patient's autonomy.

Medical decisions that physicians must make in the name of the patient should not be grounds for ignoring a patient's autonomy. However beneficial a medical decision may be for a patient, this decision must not be taken without respecting the patient's autonomy. There is a conflict between autonomy and beneficence for ambulance crew. Emergency cases where speedy medical decisions are crucial are generally regarded as situations where physicians and other healthcare providers, in their desire to benefit the patient, will frequently ignore the principle of respect for patient autonomy. Society's expectation from organisations that provide emergency medical care is a paternalistic approach where the emergency medical staff eases the pain of suffering persons, thus performing, in other words, an act of benevolence. There is always the preconceived belief that the person in need of the emergency healthcare will consent to the procedures. It is when the patient voices an objection that from that point on, autonomy and respect for autonomy comes to the fore as issues.

According to a study on this subject, while patients are less likely to reject a medical intervention, healthcare professionals adopt the view that patients have the right to refuse a procedure and express more respect towards a patient's autonomy than patients themselves. 19 It is indeed seen that healthcare providers are more sensitive than patients themselves to the rights of patients to refuse medical treatment in Turkey. To the contrary, according to another study, doctors believe patient wishes and values are important, but other considerations are often equally or more important. This suggests that patient autonomy does not guide physicians' decisions as much as is often recommended in the ethics literature. 20 In the present case, it is seen that while continuing their medical intervention, the emergency staff did not ignore the patient's right to object to the procedures. Analysing the reasons for the objection was not among their duties. The job of the emergency staff in this case was to establish whether or not the patient was making a conscious decision. In other words, their task was to determine the level of the patient's competence and to provide him with accurate information. If physicians are to promote autonomy, if they are to respect patients as persons, if they are to help patients to choose and do what there is good reason to do, they should care more about the rationality of their patients' beliefs. 8

In the case in question, the injured person has adopted a religious teaching as a point of reference for himself. Everyone has the right to expect respect for his/her moral and cultural values and religious and philosophical beliefs. 6 From the perspective of ethical values, a human being has the right to make a decision concerning his own physical person. In this case, however, a problem has arisen because the religious teaching has been exaggerated or misinterpreted. The same religious teaching exhibits a paternalistic approach that closely resembles the approach adopted in the context of emergency medical care. Islamic tenets teach that life is sacred and can only be ended by the will of God (Allah) and any other kind of death wish or actual death is accepted as the grave sin of suicide.

What is important in solving the ethical conflicts encountered in medical applications is to find the path that provides the least sacrifice of values, or in other words, the path that most conserves and protects values. In the case at hand, the members of the emergency healthcare team have found themselves in a conflict between the principle of acting in the best interests of the patient and the moral obligation of respecting the patient's autonomy. A deeper analysis of the situation reveals that the conflict is exacerbated when the obligation of not harming the patient is also considered. The answer to the question ‘should an action (or lack of action) that risks the life of an injured person be attempted in the interest of exhibiting respect for the patient's autonomy?’ is crucial to the approach to this dilemma.

The emergency medical professionals in this case have chosen to act in accordance with the principle of protecting the patient's best interests as a priority. Continuing to examine the case from the perspective of the ethical dilemma presented here, the medical staff applied an intravenous cannula after obtaining the patient's consent. The cannula is a plastic device used for flexible venous access. Although the cannula was applied to the patient, no fluid was infused. Thus, the ambulance staff respected the decision and therefore the autonomy of the patient. Their objective in attaching the cannula was not to connect the serum when the patient lost consciousness but to be prepared to find an appropriate venous route should the injured person later change his mind about the administration of the serum. If this had not been done, finding an appropriate vein to infuse the serum would present a medical challenge as time passed and the patient then changed his mind about receiving the medication.

The injured party did not lose consciousness before reaching the hospital and was delivered to the hospital fully conscious. The case was one that presented a number of ethical issues for the emergency medical team. The difficulties were exacerbated because the entire event transpired within about 15 min. The ambulance team thus found itself in the position of having to make a series of medical decisions in the space of a short period of time and the case has been described here as an attempt to emphasise how important it is for ambulance staff to be knowledgeable and aware of ethical concepts and approaches. It is important to improve communication and decision-making skills in ethically and culturally problematic situations.

  • ↵ Case Records Journal of the Emergency and Disaster Health Services Directorate . No: 16695. Kahramanmaraş, 2008 .
  • ↵ Qur'an 2:183–7, Sura Al-Baqara.
  • ↵ Universal Declaration of Human Rights, Article 18. United Nations General Assembly Decision No:217 A(III). 10 : 1948 .
  • ↵ Malta Declaration on Hunger Strikers, World Medical Assembly, 43rd World Medical Congress . http://www.wma.net/en/30publications/10policies/c8/index.html (accessed 17 Apr 2010).
  • Savulescu J ,
  • ↵ Sunan al-Tirmidhi, v2, Hadith number: 2038.
  • ↵ İSAM . Islamic rules . Istanbul : Publication of the Foundation for Religious Affairs , 1999 .
  • ↵ Sahih-i Buhari, Savm, 9.
  • ↵ Qur'an 4:29, Sura An-Nisa.
  • Pellegrino ED
  • Hartman KM ,
  • Fassassi S ,
  • Bianchi Y ,
  • Stiefel F ,
  • Lawrence RE ,

Competing interests None.

Provenance and peer review Not commissioned; externally peer reviewed.

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  • Office of Inspector General - fraud reporting This site includes information on reporting fraud.
  • Office of Inspector General – U.S. Department of Health and Human Services This site contains healthcare fraud and abuse control program reports.
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Medical Ethics case study

The following case study is an example of the kind of dilemma that we discuss on the course, and was the basis for an assignment question.

Sandra, an exceptionally bright and articulate 13 year old, is found to have a cancerous tumour in one eye. The tumour is growing rapidly. Surgery is required and the surgeons believe it likely that a blood transfusion will be required during the operation. Sandra’s parents make it clear to you that they are unwilling to give their consent to any procedure which involves giving her blood products. Initially, Sandra agrees with them, even though you explain to her the risks involved. However, later on, when you and your colleagues are alone with Sandra, she tells you that she’s really very scared of dying and would like you to do whatever you think is best. What should you do, and what ethical considerations should inform your decision ?  

Most interesting ethical questions involve conflict between the demands of two (or more) commonly-held moral values.  In this case, the conflict is between the duty of the medical team to preserve life and promote recovery, the duty to respect the instructions of the parents, who have explicitly refused to consent to the use of blood products, and (perhaps) a duty to Sandra to pay attention to her wishes. If the parents did consent, or if Sandra's well-being would not be affected by withholding blood products, then there would not be a dilemma.

One response to this problem is just to follow whatever guidelines are laid down by the relevant authorities. Although there are legal guidelines and procedures for this kind of situation (and medical law is an integral part of our course), the mere fact of their existence isn’t enough to show that they are the right guidelines and procedures. And this is the ethical question that we really want an answer to: what are the right guidelines for situations such as this? The fact that they are legal guidelines might be an argument for following them - most people think that we have a duty to obey the law- and we might think that it is better for everyone to follow the ethical guidelines than for individuals to ignore them at will.  But this will not settle the argument about what ought to be done, about what the guidelines ought to be.

One apparently attractive option in this case is to argue that Sandra - although only 13 - is very articulate, very bright, and has a maturity beyond her years that would allow healthcare professionals to consider her consent to be more important than that of her parents – it’s her life, after all.  This would enable the medical team to use blood products if they are needed to save her life, and this seems to present a neat way out of the problem. The duty to save life is met, the duty to obtain and follow consent is met.  The parents were overruled, but they can have no real complaint since Sandra is obviously able to make her own decisions.

However….

What if the situation was slightly different? What if it was Sandra who thought that using blood products was morally wrong, and her parents who were so scared of losing their daughter that they were prepared to consent to the use of blood products, even though she objected? If Sandra's consent is allowed to overrule her parent's view in the first case because she is very bright and very mature, surely we ought also to be prepared to let her refusal to override her parents’ consent in the second case, otherwise we could be accused of being inconsistent.

One possible response to this objection would be to say that being prepared to risk death rather than receive blood products would be a sign that Sandra was not mature enough to make such a decision, as she obviously doesn't really understand death. But if we say that, we’ll have to say in the first case that her parents don’t really understand death either. A response like this could be criticised for being paternalist, or dismissive, or intolerant of other cultures and belief systems; and that doesn’t seem ethically satisfactory at all.

There is no ready, simple answer to this very difficult dilemma.  Working out what to do in a case like this can take all the moral thoughtfulness and sensitivity and reasonableness that we can muster.  We can increase our sensitivity, sharpen our moral reasoning skills, by thinking hard about such cases, and the moral theories which underlie our responses to them, in a context of academic inquiry and discussion.  This is what our MA course aims to provide.

Welcome to Ethics at Keele!

EU AI Act: first regulation on artificial intelligence

The use of artificial intelligence in the EU will be regulated by the AI Act, the world’s first comprehensive AI law. Find out how it will protect you.

A man faces a computer generated figure with programming language in the background

As part of its digital strategy , the EU wants to regulate artificial intelligence (AI) to ensure better conditions for the development and use of this innovative technology. AI can create many benefits , such as better healthcare; safer and cleaner transport; more efficient manufacturing; and cheaper and more sustainable energy.

In April 2021, the European Commission proposed the first EU regulatory framework for AI. It says that AI systems that can be used in different applications are analysed and classified according to the risk they pose to users. The different risk levels will mean more or less regulation. Once approved, these will be the world’s first rules on AI.

Learn more about what artificial intelligence is and how it is used

What Parliament wants in AI legislation

Parliament’s priority is to make sure that AI systems used in the EU are safe, transparent, traceable, non-discriminatory and environmentally friendly. AI systems should be overseen by people, rather than by automation, to prevent harmful outcomes.

Parliament also wants to establish a technology-neutral, uniform definition for AI that could be applied to future AI systems.

Learn more about Parliament’s work on AI and its vision for AI’s future

AI Act: different rules for different risk levels

The new rules establish obligations for providers and users depending on the level of risk from artificial intelligence. While many AI systems pose minimal risk, they need to be assessed.

Unacceptable risk

Unacceptable risk AI systems are systems considered a threat to people and will be banned. They include:

  • Cognitive behavioural manipulation of people or specific vulnerable groups: for example voice-activated toys that encourage dangerous behaviour in children
  • Social scoring: classifying people based on behaviour, socio-economic status or personal characteristics
  • Biometric identification and categorisation of people
  • Real-time and remote biometric identification systems, such as facial recognition

Some exceptions may be allowed for law enforcement purposes. “Real-time” remote biometric identification systems will be allowed in a limited number of serious cases, while “post” remote biometric identification systems, where identification occurs after a significant delay, will be allowed to prosecute serious crimes and only after court approval.

AI systems that negatively affect safety or fundamental rights will be considered high risk and will be divided into two categories:

1) AI systems that are used in products falling under the EU’s product safety legislation . This includes toys, aviation, cars, medical devices and lifts.

2) AI systems falling into specific areas that will have to be registered in an EU database:

  • Management and operation of critical infrastructure
  • Education and vocational training
  • Employment, worker management and access to self-employment
  • Access to and enjoyment of essential private services and public services and benefits
  • Law enforcement
  • Migration, asylum and border control management
  • Assistance in legal interpretation and application of the law.

All high-risk AI systems will be assessed before being put on the market and also throughout their lifecycle.

General purpose and generative AI

Generative AI, like ChatGPT, would have to comply with transparency requirements:

  • Disclosing that the content was generated by AI
  • Designing the model to prevent it from generating illegal content
  • Publishing summaries of copyrighted data used for training

High-impact general-purpose AI models that might pose systemic risk, such as the more advanced AI model GPT-4, would have to undergo thorough evaluations and any serious incidents would have to be reported to the European Commission.

Limited risk

Limited risk AI systems should comply with minimal transparency requirements that would allow users to make informed decisions. After interacting with the applications, the user can then decide whether they want to continue using it. Users should be made aware when they are interacting with AI. This includes AI systems that generate or manipulate image, audio or video content, for example deepfakes.

On December 9 2023, Parliament reached a provisional agreement with the Council on the AI act . The agreed text will now have to be formally adopted by both Parliament and Council to become EU law. Before all MEPs have their say on the agreement, Parliament’s internal market and civil liberties committees will vote on it.

More on the EU’s digital measures

  • Cryptocurrency dangers and the benefits of EU legislation
  • Fighting cybercrime: new EU cybersecurity laws explained
  • Boosting data sharing in the EU: what are the benefits?
  • EU Digital Markets Act and Digital Services Act
  • Five ways the European Parliament wants to protect online gamers
  • Artificial Intelligence Act

Related articles

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This section features overview and background articles for the general public. Press releases and materials for news media are available in the news section .

IMAGES

  1. Medical Law and Ethics: A Problem-Based Approach, 1st Edition by

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  3. Medical Law and Medical Ethics by Nils Hoppe (English) Paperback Book

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  6. Medical law and ethics by Bonnie F. Fremgen

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VIDEO

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  5. Damien's Case Study (Medical Billing Opportunity)

  6. principles of medical ethics part 2

COMMENTS

  1. Cases in Medical Ethics: Student-Led Discussions

    Case 1: A woman enters the emergency room with stomach pain. She undergoes a CT scan and is diagnosed with an abdominal aortic aneurysm, a weakening in the wall of the aorta which causes it to stretch and bulge (this is very similar to what led to John Ritter's death).

  2. Cases

    Jan 2024 Why Competency Frameworks Are Insufficiently Nuanced for Health Equity Teaching and Assessment Zareen Zaidi, MD, PhD, Daniele Ölveczky, MD, MS, Nicole A. Perez, PhD, Paolo C. Martin, PhD, Andres Fernandez, MD, MSEd, Philicia Duncan, MD, and Hannah L. Anderson, MBA

  3. List of medical ethics cases

    List of medical ethics cases - Wikipedia List of medical ethics cases Some cases have been remarkable for starting broad discussion and for setting precedent in medical ethics . Research Termination of mechanical ventilation and life support Withholding life-prolonging medical treatment Informed consent to medical treatment

  4. The top 10 most-read medical ethics articles in 2021

    Each month, the AMA Journal of Ethics® ( @JournalofEthics) gathers insights from physicians and other experts to explore issues in medical ethics that are highly relevant to doctors in practice and the future physicians now in medical schools, as well as the other health professionals who constitute the health care team. Ethics in Health Care

  5. PDF 100 Cases in Clinical Ethics and Law, Second Edition

    Case 4: Virtue Ethics 7 Case 5: Casuistry 9 Case 6: Narrative Ethics 11 Case 7: Rights and Duties 13 Section 2 Ethics and Law in Clinical Practice: How to Deal with an Ethical Dilemma in Clinical Practice 15 Section 3 Ethics and Law in Clinical Practice: Beginning of Life 17 Case 8: In Vitro Fertilisation 17 Case 9: Same-Sex Parenting 21

  6. Principles of Clinical Ethics and Their Application to Practice

    Ethics is an inherent and inseparable part of clinical medicine [ 1] as the physician has an ethical obligation (i) to benefit the patient, (ii) to avoid or minimize harm, and to (iii) respect the values and preferences of the patient. Are physicians equipped to fulfill this ethical obligation and can their ethical skills be improved?

  7. Ethical and legal aspects of patient's safety: a clinical case report

    In this regard, a falling incident case of a 12-day-old newborn was raised in the monthly ethics round in the Children's Medical Center of Tehran University of Medical Sciences, Iran, and the ethical and legal dimensions of patient safety were discussed by experts in various fields.

  8. Fundamentals of Medical Ethics

    Because addressing issues in medical ethics often requires multidisciplinary expertise — in philosophy, biomedical research, clinical practice, law, policy, and communication, among other fields ...

  9. Patient privacy and autonomy: a comparative ...

    By the 1970s, with the joint promotion of technology and humanity, bioethics became a global phenomenon. It emerged in the United States [], across Europe [], and in China due to the "reform and opening-up" policy [].Bioethics is an emerging discipline that uses a variety of ethical approaches to study the philosophical, social, and legal issues arising in medicine and the life sciences in ...

  10. Montgomery and informed consent: where are we now?

    Today's patients can expect a more active and informed role in treatment decisions, with a corresponding shift in emphasis on various values, including autonomy, in medical ethics. The full implications of the case are undoubtedly still unknown, but Montgomery has clear relevance for medical law and ethics. Legally, consent law has been ...

  11. Browse Medical Ethics General

    Browse Medical Ethics General Filter Showing 1-20 of 1865 results Newest Perspective VOL. 390 No. 5, Feb 01, 2024 Recognizing Historical Injustices in Medicine and the Journal: Explaining...

  12. Journal of Law, Medicine & Ethics

    The Journal of Law, Medicine & Ethics (JLME) is a leading peer-reviewed journal for research at the intersection of law, health policy, ethics, and medicine. Read by more than 4,500 health care professionals, JLME is the authoritative source for health law teachers, practitioners, policy makers, risk managers, and anyone else concerned with the ...

  13. The relationship between medical law and good medical ethics

    In the UK, medical ethics and law are often thought of and taught together, but while 'good medical ethics' is often reflected in law-the need to obtain a patient's adequately informed consent, for example—this is not necessarily the case. Sometimes medical ethics is more demanding than law; at other times, perhaps counterintuitively, the law appears to ask more of doctors than does ...

  14. What Should Clinicians Do When a Patient's ...

    Abstract ESP | 中文 Language and cultural barriers can impede communication between patients and clinicians, exacerbating health inequity. Additional complications can arise when family members, intending to protect their loved ones, ask clinicians to lie or not disclose to patients their diagnoses, prognoses, or intervention options.

  15. Clinical Ethics Committee Case 15: A case study in surgical consent

    This case study is published with permission from Mr X. Google Scholar. 4. Blazeby J (Professor of Surgery, University of Bristol), May 2011 and Whistance R (NIHR Doctoral Research Fellow, University of Bristol), April 2011, Personal communication. ... (Keele), an MA in Medical Ethics and Law (Keele) and a PhD in Ethics (Keele). The subject of ...

  16. The Tuskegee Syphilis Study

    1. Introduction Although experimentation on human subjects has long been understood to be fraught with serious ethical concerns, little was done to develop national and international guidelines and regulations with regard to such research until the end of World War II.

  17. A case study from the perspective of medical ethics: refusal of

    This paper will examine a sample case encountered by ambulance staff in the context of the basic principles of medical ethics. An accident takes place on an intercity highway. Ambulance staff pick up the injured driver and medical intervention is initiated. The driver suffers from a severe stomach ache, which is also affecting his back. Evaluating the patient, the ambulance doctor suspects ...

  18. Clinical Ethics and Case Studies

    Medical Law, Ethics and Bioethics for the Health Professions by Marcia A. Lewis; Carol D. Tamparo Now in its 6th Edition, this groundbreaking book continues to champion the "Have a Care" approach, while also providing readers with the strong ethical and legal foundation that enables them to better serve their clients. Clearly written and ...

  19. RasGuides: *School of Health Sciences*: Medical Law & Ethics

    ISBN: 9780813347356. Publication Date: 2012. The Case of Terri Schiavo by Kenneth W. Goodman. Call Number: eBooks from EBSCO. ISBN: 9780199748594. Publication Date: 2009-10-29. The Case of Terri Schiavo assembles a team of first-hand participants and content experts to provide thoughtful and nuanced analyses.

  20. Medical Ethics case study

    Medical Ethics case study. The following case study is an example of the kind of dilemma that we discuss on the course, and was the basis for an assignment question. Sandra, an exceptionally bright and articulate 13 year old, is found to have a cancerous tumour in one eye. The tumour is growing rapidly. Surgery is required and the surgeons ...

  21. Medical Law & Ethics

    Medical Law & Ethic terms - Chapter 2 Learn with flashcards, games, and more — for free. ... Medical Law & Ethics ~Chapter 2~ Test 2. 52 terms. ragan21. Preview. 2024 Module 91.6 & 91.7 - Standard IV & V. Teacher 31 terms. ... also called common law, case law is based on decisions made by judges. CHECKS AND BALANCES.

  22. EU AI Act: first regulation on artificial intelligence

    Law enforcement; Migration, asylum and border control management; Assistance in legal interpretation and application of the law. All high-risk AI systems will be assessed before being put on the market and also throughout their lifecycle. General purpose and generative AI. Generative AI, like ChatGPT, would have to comply with transparency ...