Module 13: Biomedical Ethics Author: Daniel G. Jenkins, MA Updated April 2008 This is a stand-alone module with no accompanying reading. Module Goals: After completing readings, presentations, discussions, and coursework for this module, you will be able to: Identify and explain core aspects of Biomedical ethics Apply Biomedical ethics in moral decision-making Analyze the usefulness and critique features of Biomedical ethics Synthesize Biomedical ethics with other theories in the academic study of ethics The ethical theories addressed so far have been general theories. They apply to all human beings in all circumstances. In biomedical ethics, we consider what special ethical considerations arise in the context of medicine, healthcare, and research. Biomedical ethics is important for anyone who receives any form of healthcare, as well as for healthcare professionals. The idea is that the biomedical context requires special attention if we are to apply ethical standards in the same way, not so much that there are different ethical standards in biomedicine. Why is there a need for ethics in the context of the medical and biological professions? One general answer is that any time someone wields power over another, we ought to give attention to how they employ this power, to the principles and/or virtues that guide the application of their power. Physicians and researchers need special ethical attention because their activities are outside the norm for people; special situations require special considerations – not necessarily different ethical standards, just attention to determine how to apply the same standards we apply to everyone, and perhaps more or different obligations. A more specific answer is that we ought to give special attention to ethical issues in medicine and biological research because physicians and biological researchers in the past have committed acts that most of us consider to be atrocities in the carrying out of their professional activities. Take for example the Tuskegee Syphilis Study (1932–1972), which was a clinical study, conducted around Tuskegee, Alabama, where 400 poor, mostly illiterate African American sharecroppers became part of a study on the treatment and natural history of syphilis. Told they had “bad blood” and not syphilis, they were denied treatment, even after 1947 when Penicillin became the primary effective treatment for syphilis. The study went on until 1972 when a Public Health Services worker leaked info to the press. The participants did not give informed consent. The Tuskegee Syphilis Study led to the Belmont Report and establishment of National Human Investigation Board, and the requirement for establishment of Institutional Review Boards. Also consider the Nuremberg Trials. After WWII ended the world court was established to try certain Nazi officers and officials for war crimes and crimes against humanity. Among these were the Nazi Doctors, who conducted experiments on the Jewish captives in concentration camps. These doctors used their knowledge to subject many inmates to what amounted to torture – seeing how long it takes one to die of hypothermia, determining the LD50 of certain drugs, seeing how many times one can be choked out of consciousness and resuscitated, etc. As we consider the inherently coercive effects of authority, it may be useful to remember the famous experiment on obedience conducted by psychologist Stanley Milgram. Milgram led research subjects to believe they were administering shocks to students who produced incorrect answers on a memory test. However, the subjects were not administering shocks at all. The experiment was designed to see how much electric current subjects would administer at the behest of Milgram, literally in a white coat during the experiment and insisting the subjects continue. More than half of participants were willing to administer a lethal shock at the request of the authority figure. This points to the necessity to give respect for autonomy special attention. Medical Ethics Throughout History Before we ask how ethical approaches to these professions changed following the above mentioned events, it is pertinent to ask what guided the behavior of physicians and researchers prior to these events. Historically, physicians have been guided by the Hippocratic Oath. The Hippocratic Oath dates to Greece in the 5th century BCE, though was probably not written by the physician Hippocrates, but by Pythagorean cultists using teachings of Hippocrates to establish their own group of physicians. It is also believed that the healing Temple on the Island of Cos where the Pythagoreans were was destroyed during the Christianization of Greece in the final years of the Roman Empire; if this is the case, then there was substantive differences between Christian and Hippocratic/Galenic medicine and it is not clear why a physician in the west practicing with an eye towards Christian ethics should proudly take the Hippocratic Oath, but there you have it. The Hippocratic Oath requires that a physician do what is best for the patient based on the physician’s judgment and ability, but does not require a physician to consider the patient’s judgment or preferences. Likewise, the oath pledges secrecy on the part of the physician; he may not tell the patient or anyone else the details of his craft. Hence, the patient remains uninformed and could not make a rational decision about treatment in any case. The idea that the physician knows what is best for the patient better than the patient does is known as “paternalism.” Often physicians behave paternalistically out of a belief that what is best for the patient medically is best for the patient overall. Think about your own experiences interacting with healthcare professionals. Have professionals ever behaved paternalistically towards you? Also, ask your parents and grandparents about the nature of patient-physician interactions a few decades ago. You are likely to get some interesting responses. In the 1790’s in Great Britain there was a typhoid and typhus epidemic that caused various physicians to fight amongst themselves as to who should be doing what. Thomas Percival published a volume of medical ethics in 1803 in response to this in what is known as Percival’s Code. It provides guidelines for physicians to settle disputes among themselves, but it also emphasized the duty of physicians to benefit the patient while making no mention of the rights of patients. This is the hallmark of the Hippocratic tradition. In 1848 the American Medical Association was formed in an effort to accrue superiority to one of a number of schools of thought, and to combat other forms of medical practice. The idea was to issue licenses to limit the number of people who could perform medical services for a fee, but the government did not honor this request because they didn’t see any advantage of the AMA over other medical practitioners. The AMA nevertheless established a code of ethics, in part as a gesture to indicate that they do indeed consider themselves to be a distinct profession with their own body of knowledge and their own brand of activities. This code was copied almost entirely from Percival’s code and hence was also in the Hippocratic tradition. The Nuremberg Code of 1946 is the first code of medical ethics to break with the Hippocratic Tradition, and developed in direct response to the atrocities of the Nazi doctors. Lethal research had been conducted on non-consenting persons, and it was clear that there were ethical issues to be addressed in research with human subjects. A contradiction also then seemed to be evident in the ideology of medicine – while the goal of research is to gain knowledge, not benefit the patient, the Hippocratic Oath maintains that physicians must benefit their patients. The Nuremberg code strived to resolve this issue – how can we conduct research to benefit society while still benefitting patients? By gaining informed consent from patients. The Nuremberg Code was the first document in the 2500 years since Hippocrates to make any mention of patient’s rights. A patient has the right to be informed of relevant facts and to approve or disapprove of any treatment done, either in research or traditional treatment settings. Another important difference between the Nuremberg code and previous medical ethics codes is that it was written by an international body of law and placed requirements on physicians, and was not written by physicians and bestowed upon the public. The Patient’s Bill of Rights of 1973 came from the American Hospital Association, and also breaks with Hippocratic tradition. Following complaints from patients, lawsuits, and public attention to debilitating procedures in mental hospitals such as ECT and psychosurgery, this is the first document focusing solely on the rights of patients. Again, this does not come from the AMA but from the Hospital Association. The Belmont Report is a report created by the former United States Department of Health, Education, and Welfare (which was renamed to Health and Human Services) entitled "Ethical Principles and Guidelines for the Protection of Human Subjects of Research" and is an important historical document in the field of medical ethics. The report was created on April 18, 1979 and gets its name from the Belmont Conference Center where the document was drafted. The conference center, once a part of the Smithsonian Institution, is in Elkridge, Maryland, 10 miles south of Baltimore, and is now operated by Howard Community College. The Belmont Report explains the unifying ethical principles that form the basis for the National Commission’s topic-specific reports and the regulations that incorporate its recommendations. The Belmont Report identifies three fundamental ethical principles for all human subject research – respect for persons, beneficence, and justice. Those principles remain the basis for the Health and Human Services human subject protection regulations. In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.” It was not until 1981 that the AMA changed their ethics code to reflect the liberal moral philosophy that had been gaining ground outside the medical profession. In the code published in 1981 the AMA finally acknowledges that patients have rights. When we talk of someone having rights, we cannot justify violating those rights if good consequences occur – rights cannot be violated. Something new is going on here. For the first time physicians have to listen to the patient – perhaps health or treating sickness is not their utmost concern. A Comprehensive Theory of Biomedical Ethics Simply listing guidelines for how physicians ought to behave is not compelling. In order to provide reasons for why informed consent is ethically relevant, and to explicate the role of physicians and researchers such that a definitive ethics can be derived, Beauchamp and Childress have written the “Principles of Biomedical Ethics.” Tom Beauchamp is a Professor of Philosophy and a Senior Research Scholar in Georgetown University's Kennedy Institute of Ethics. He was born in Austin, Texas. He took graduate degrees from Yale University and The Johns Hopkins University, where he received his Ph.D. in 1970. He then joined the faculty of the Philosophy Department at Georgetown University, and in the mid-70s accepted a joint appointment at the Kennedy Institute of Ethics. In 1976, he joined the staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, where he wrote the bulk of The Belmont Report (1978). James F. Childress is the Hollingsworth Professor of Ethics and Professor of Medical Education at the University of Virginia, where he directs the Institute for Practical Ethics. He served as Chair of the Department of Religious Studies, 1972-1975 and 1986-1994, as Principal of UVA's Monroe Hill College from 1988 to 1991, and as co-director of the Virginia Health Policy Center 1991-1999. In 1990 he was named Professor of the Year in the state of Virginia by the Council for the Advancement and Support of Education. Beauchamp and Childress have formulated a theory wherein health professionals and researchers behave morally inasmuch as they adhere to four principles: 1) Respect for Autonomy; 2) Nonmaleficence; 3) Beneficence; 4) Justice. Theirs is not a strictly principlist system, but is also a virtue ethics – that is, they believe that right action is constituted by striving to display certain desirable characteristics. They believe that physicians can act in accordance with the four principles by practicing the virtues that correspond to those principles: 1) Respectfulness, 2) Nonmalevolence, 3) Benevolence, 4) Fairness. We can practice these virtues by being truthful, confidential, private, and faithful. What is virtue? As we remember from Aristotle, it is character; a set of stable traits that affect or consist in a person’s judgment and action. Although we have different traits, we can cultivate those traits that are important to morality. The particular virtues that are important to a particular profession are determined through examining role responsibilities. This means more than simply studying what a professional does in fact do; it also means examining what we think they ought to do. But they believe that virtues by themselves are not enough; we also need principles, a set of rules that provide a standard for our moral deliberations. The lack of such principles was one of the failings of Aristotelian virtue ethics. Principles express the values underlying morality and give us rules by which we can maintain these values; ways we can do or refrain from doing those things that are congruent with our values. Without principles, virtue is not efficacious; it lacks direction, it is merely a good will without the knowledge of how to guide its application. Without virtue, we merely have principles that fail to impress themselves upon us. We have no reason for following principles without virtue. For Beauchamp and Childress, for a health care professional to be ethical he must first be virtuous, and he must use his virtue to act in a manner congruent with principles. To respect autonomy is to acknowledge a person’s right to hold views, make choices, and take actions based on personal values and beliefs. Respecting autonomy requires respectful action, not just respectful attitude. In the context of healthcare it requires more than mere noninterference. It requires an obligation to build up and maintain others’ capacity for autonomous choice while helping to allay fears and other conditions that destroy or disrupt autonomous actions. What about competence? Competency refers to the ability to perform a certain task. We have varying competencies. None of us are competent to diagnose or treat ourselves; that’s why we go to the Dr. But we can be competent to make a decision about what treatment to receive if we are informed in the healthcare context. In order to be competent to make decisions, we must be able to do the following: 1) Express or communicate a preference or choice; 2) Understand one’s situation and its consequences; 3) Understand relevant information; 4) Give rational reasons (rational does not mean factual but it should mean non-delusional; if I want to refrain from getting a blood transfusion I can say I believe I will go to hell when I die, but saying that I fear the creature from Alien will pop out of my chest is not acceptable); 5) Give risk/benefit related reasons; 6) Ability to make a decision. If a person is competent they may give informed consent. What does informed consent consist in? There are 5 elements of informed consent: 1) Competence; 2) disclosure; 3) understanding; 4) voluntariness and 5) consent. Disclosure can be inhibited by the physician’s ulterior motives. Understanding can be polluted by false beliefs (we may understand information but not accept it as true). Voluntariness can be denied through offering unfair incentives, or through coercion. Defining coercion can be a problem (see Robert Nozick). Are we ultimately always coerced in some fashion by the man in the white coat? Nonmaleficence. Do no harm. But how? We cant say not to kill, because what about physician assisted suicide or advance directives? We cant say we should always treat, because there are situations in which it would be wrong not to treat, and also those in which it would be wrong to treat. What about withholding or withdrawing treatment for nonpayment? What about actively treating versus sustaining? How should we determine who to give scarce resources to? While we may not know exactly what doing no harm consists in, we know when something has gone wrong – 1) there must be an obligation/duty on the part of the professional; 2) the professional must fail/breach that duty; 3) the affected party must experience harm; 4) the harm must be caused by breach of duty. Also, harm is always thought to exist when autonomy is violated. There is no sharp break demarcating where nonmaleficence ends and beneficence begins, but beneficence places more requirements on professionals because they must actively pursue client welfare instead of merely refraining from harming them. “Positive beneficence” requires agents to provide benefits. “Utility” requires agents to balance benefits and drawbacks to produce best overall results. Professionals must protect and defend the rights of others. Remove conditions that will cause harm to others. Help persons with disabilities. Rescue persons in danger. Many physicians see the requirement to be beneficent to mean that they ought to be paternalistic, but we know that beneficence is fostered to the extent that autonomy is fostered. Justice of course refers to fairness, desert (what is deserved), and entitlement. Justice refers to fair, equitable, and appropriate treatment in light of what is owed to people. Distributive justice refers to the fair and equitable distribution of rights and responsibilities in society. In medicine, this means fair distribution of resources, such as the attention of professionals, medication, hospital beds, procedures (time on machines). How do we determine who gets access to care? Aristotle’s formal principle of equality states that equals ought to be treated equally and unequals ought not to be treated the same. Great. How do we know who is equal? Should we give each person an equal share? Give to each person according to need? Effort? Contribution? Merit? Money? And anyway don’t we believe that unequals in these respects are still deserving of care and rights? The issue of justice is relevant to discussions of our health insurance system, and to discussions of who should be the first to receive care in hospitals. Norman Daniels gives us one method by which we might allocate healthcare resources, and he derives his theory through extending Rawlsian notions of justice to healthcare management. Daniels has established the “fair opportunity rule:” no persons ought to receive social benefits on the basis of undeserved advantageous properties (because no person is responsible for having these properties) and that no persons ought to be denied social benefits on the basis of undeserved disadvantageous properties (because they also are not responsible for these properties). The idea is that properties distributed by the lotteries of social and biological life do not provide morally acceptable grounds for discrimination between persons if they are not properties which people have a fair chance to acquire or overcome. Money is a result of the natural and social lotteries inasmuch as the distribution of wealth is determined by the distribution of talent in free market economies. This factors into the distribution of healthcare by mandating that the disadvantaged have the most access to care, as they are the most likely to be immensely disadvantaged by being sick. In this sense, it is one aim of healthcare to foster the Rawlsian notion of Justice as Fairness. If the subject interests you further, consult Beauchamp and Childress’ Principles of Biomedical Ethics, 5th edition.