Informed consent requires that research staff and participants should be given appropriate (a) information about the research (b) in a comprehensible manner (c) without duress or inappropriate inducement. The information should include: the research procedure, the purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the participant the opportunity to ask questions and to withdraw at any time from the research. Where a person is not receiving treatment but is a pure volunteer, the standard of disclosure may be expected to be higher. The extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the participants should understand clearly the range of risk and the voluntary nature of participation. Comprehension entails that the manner and context in which information is conveyed is as important as the information itself. For example, presenting information too quickly or in a format that is confusing may adversely affect a participant's ability to make an informed choice. Because a participant's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the participant’s capacities. Investigators are responsible for ascertaining that the participant has comprehended the information. Special provision may need to be made when comprehension is severely limited – for example, by conditions of immaturity or mental disability (e.g., infants and young children or those with mentally disabilities). Participants must have the opportunity to choose to the extent they are able, whether or not to participate in research. This situation also requires seeking the permission of other parties in order to protect the participants from harm and represent their best interests. Voluntariness requires that a participant make their decision without duress or other undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the participant is especially vulnerable. Unjustifiable pressures usually occur when persons in positions of authority or commanding influence – especially where possible sanctions are involved – urge a course of action for a participant. The story portrayed in The Immortal Life of Henrietta Lacks points to several important bioethical issues, including informed consent, medical records privacy, and communication with tissue donors and research participants. Johns Hopkins, and researchers and bioethicists worldwide, have learned a great deal from examination of these issues. Though the collection and use of Henrietta Lacks’ cells in research was an acceptable and legal practice in the 1950s, such a practice would not happen today without the patient’s consent. We are deeply committed to ensuring the appropriate protection and care of medical information related to Henrietta Lacks and her family. In 2013, Johns Hopkins worked with members of the family and the National Institutes of Health (NIH) to help broker an agreement that requires scientists to receive permission to use Henrietta Lacks’ genetic blueprint, or to use HeLa cells in NIH funded research. The committee tasked with deciding who can use HeLa cells now includes two members of the Lacks family. The medical research community has also made significant strides in improving research practices, in part thanks to the lessons learned from Henrietta Lacks’ story. The table below demonstrates the significant shift in biomedical practices between the time when Henrietta Lacks was treated and today. Author: Thomas R. McCormick, D.Min., Senior Lecturer Emeritus, Dept. Bioethics and Humanities, School of Medicine, University of Washington The place of principles in bioethics Ethical choices, both minor and major, confront us everyday in the provision of health care for persons with diverse values living in a pluralistic and multicultural society. In the face of such diversity, where can we find moral action guides when there is confusion or conflict about what ought to be done? Such guidelines would need to be broadly acceptable among the religious and the nonreligious and for persons across many different cultures. Due to the many variables that exist in the context of clinical cases as well as the fact that in health care there are several ethical principles that seem to be applicable in many situations these principles are not considered absolutes, but serve as powerful action guides in clinical medicine. Some of the principles of medical ethics have been in use for centuries. For example, in the 4th century BCE, Hippocrates, a physician-philosopher, directed physicians “to help and do no harm” (Epidemics, 1780). Similarly, considerations of respect for persons and for justice have been present in the development of societies from the earliest times. However, specifically in regard to ethical decisions in medicine, in 1979 Tom Beauchamp and James Childress published the first edition of Principles of Biomedical Ethics, now in its seventh edition (2013), popularizing the use of principlism in efforts to resolve ethical issues in clinical medicine. In that same year, three principles of respect for persons, beneficence, and justice were identified as guidelines for responsible research using human subjects in the Belmont Report (1979). Thus, in both clinical medicine and in scientific research it is generally held that these principles can be applied, even in unique circumstances, to provide guidance in discovering our moral duties within that situation. How do principles "apply" to a certain case? Intuitively, principles in current usage in health care ethics seem to be of self-evident value and of clear application. For example, the notion that the physician "ought not to harm" any patient is on its face convincing to most people. Or, the idea that the physician should develop a care plan designed to provide the most "benefit" to the patient in terms of other competing alternatives, seems both rational and self-evident. Further, before implementing the medical care plan, it is now commonly accepted that the patient must be given an opportunity to make an informed choice about his or her care. Finally, medical benefits should be dispensed fairly, so that people with similar needs and in similar circumstances will be treated with fairness, an important concept in the light of scarce resources such as solid organs, bone marrow, expensive diagnostics, procedures and medications. The four principles referred to here are non-hierarchical, meaning no one principle routinely “trumps” another. One might argue that we are required to take all of the above principles into account when they are applicable to the clinical case under consideration. Yet, when two or more principles apply, we may find that they are in conflict. For example, consider a patient diagnosed with an acutely infected appendix. Our medical goal should be to provide the greatest benefit to the patient, an indication for immediate surgery. On the other hand, surgery and general anesthesia carry some small degree of risk to an otherwise healthy patient, and we are under an obligation "not to harm" the patient. Our rational calculus holds that the patient is in far greater danger from harm from a ruptured appendix if we do not act, than from the surgical procedure and anesthesia if we proceed quickly to surgery. Further, we are willing to put this working hypothesis to the test of rational discourse, believing that other persons acting on a rational basis will agree. Thus, the weighing and balancing of potential risks and benefits becomes an essential component of the reasoning process in applying the principles. In other words, in the face of no other competing claims, we have a duty to uphold each of these principles (a prima facie duty). However, in the actual situation, we must balance the demands of these principles by determining which carries more weight in the particular case. Moral philosopher, W.D. Ross, claims that prima facie duties are always binding unless they are in conflict with stronger or more stringent duties. A moral person's actual dutyis determined by weighing and balancing all competing prima facie duties in any particular case (Frankena, 1973). Since principles are empty of content the application of the principle comes into focus through understanding the unique features and facts that provide the context for the case. Therefore, obtaining the relevant and accurate facts is an essential component of this approach to decision making. What are the major principles of medical ethics? Four commonly accepted principles of health care ethics, excerpted from Beauchamp and Childress (2008), include the:
1. Respect for Autonomy Case 1 Discussion 2. The Principle of Nonmaleficence Case 2 Discussion
(Beauchamp & Childress, 1994, p. 207) The reader may apply these four criteria to the case above, and find that the principle of double effect applies and the four conditions are not violated by the prescribed treatment plan. 3. The Principle of Beneficence It is sometimes held that nonmaleficence is a constant duty, that is, one ought never to harm another individual, whereas beneficence is a limited duty. A physician has a duty to seek the benefit of any or all of her patients, however, a physician may also choose whom to admit into his or her practice, and does not have a strict duty to benefit patients not acknowledged in the panel. This duty becomes complex if two patients appeal for treatment at the same moment. Some criteria of urgency of need might be used, or some principle of first come first served, to decide who should be helped at the moment. Case 3 Discussion 4. The Principle of Justice It is generally held that persons who are equals should qualify for equal treatment. This is borne out in the application of Medicare, which is available to all persons over the age of 65 years. This category of persons is equal with respect to this one factor, their age, but the criteria chosen says nothing about need or other noteworthy factors about the persons in this category. In fact, our society uses a variety of factors as criteria for distributive justice, including the following:
(Beauchamp & Childress, 1994, p. 330) John Rawls (1999) and others claim that many of the inequalities we experience are a result of a "natural lottery" or a "social lottery" for which the affected individual is not to blame, therefore, society ought to help even the playing field by providing resources to help overcome the disadvantaged situation. One of the most controversial issues in modern health care is the question pertaining to "who has the right to health care?" Or, stated another way, perhaps as a society we want to be beneficent and fair and provide some decent minimum level of health care for all citizens, regardless of ability to pay. Medicaid is also a program that is designed to help fund health care for those at the poverty level. Yet, in times of recession, thousands of families below the poverty level have been purged from the Medicaid rolls as a cost saving maneuver. The principle of justice is a strong motivation toward the reform of our health care system so that the needs of the entire population are taken into account. The demands of the principle of justice must apply at the bedside of individual patients but also systemically in the laws and policies of society that govern the access of a population to health care. Much work remains to be done in this arena. Summary and critique The four principles currently operant in health care ethics had a long history in the common morality of our society even before becoming widely popular as moral action guides in medical ethics over the past forty-plus years through the work of ethicists such as Beauchamp and Childress. In the face of morally ambiguous situations in health care the nuances of their usage have been refined through countless applications. Some bioethicists, such as Bernard Gert and colleagues (1997), argue that with the exception of nonmaleficence, the principles are flawed as moral action guides as they are so nonspecific, appearing to simply remind the decision maker of considerations that should be taken into account. Indeed, Beauchamp and Childress do not claim that principlism provides a general moral theory, but rather, they affirm the usefulness of these principles in reflecting on moral problems and in moving to an ethical resolution. Gert also charges that principlism fails to distinguish between moral rules and moral ideals and, as mentioned earlier, that there is no agreed upon method for resolving conflicts when two different principles conflict about what ought to be done. He asserts that his own approach, common morality, appealing to rational reflection and open to transparency and publicity is a more useful approach (Gert, Culver & Clouser, 1997). Further, bioethicst Albert Jonsen and colleagues (2010) claim in their work that in order to rigorously apply these principles in clinical situations their applicability must start with the context of a given case. (See Bioethics Tools).. This article is intended to be a brief introduction to the use of ethical principles in health care ethics. Students of clinical ethics will find additional information and deeper analysis in the suggested readings below. References Beauchamp T, Childress J. Principles of Biomedical Ethics, 7th Edition. New York: Oxford University Press, 2013. Frankena, WK. Ethics, 2nd Edition. Englewood Cliffs, NJ: Prentice-Hall, 1973. Hippocrates. The history of epidemics. Samuel Farr (trans.) London: T. Cadell, 1780. Jonsen A, Siegler M, Winslade W. Ethics, 7th Edition.New York: McGraw-Hill Medical, 2010. McCormick, TR. Ethical issues inherent to Jehovah’s Witnesses. Perioperative Nursing Clinics 2008;3(3): 253-259. Rawls J. A Theory of Justice. Cambridge, MA: Harvard University Press, 1999. Related Discussion Topics/Links Informed Consent, Parental Decision Making, Withholding or Withdrawing Life-Sustaining Treatment, Bioethics Tools Thomas R. McCormick, D Min Faculty, Bioethics & Humanities University of Washington |