What, then, constitutes the new material for this emerging age in bioethics? We suggest that it is interprofessional ethics. Consider that there might be an ethics for pediatrics as well as an ethics for nursingâwhat is one to do if they are in conflict?
Â
Shall we train our doctors and our nurses to believe that different courses of action are the right ones, leading to interprofessional conflict? Should we let the more powerful or well-funded disciplines always have the last say as to what is the best course of treatment, a recipe guaranteed to lead to moral distress for those who feel disempowered?
Â
How, practically, does the team move forward? If the team intubates the patient, will this lead to a general devaluing of patient preferences in medical decision-making, for example, seeing geriatric patients as just too uninformed to be allowed to make important life-and-death decisions? And will that, in turn, undermine the input of nurses who accept the charge of being patient advocates, and create moral distress?
Â
What is needed, in other words, is an articulation of sets of interprofessional and dialogical principles, values, and practices that encourage genuine teamwork by all members of health care teams. The purpose is to be more patient-centered and to have all team members be more consciously aware that both the quality of health care and the satisfaction of patients will improve if they all share the same patient-centered ethics.
Â
What is emerging in the field of bioethics is consistent with larger trends in the education of health professionals. In 1978, the World Health Organization first indicated that interprofessional education is an important component in the education of health professionals.
Â
The question is, what might an interprofessional approach to ethics look like? In simple terms, we can identify three ways to attempt to frame an answer.
Â
1. What are the ethically relevant features of the situation? An answer will require a thoughtful assessment of prior commitmentsâthose agreements that create duties and obligations typically tied to important relationships, including familial ones, professional roles, and group memberships. A special class of obligations arises from rights that are typically assigned priority over other commitments. Are there any rights claims being made, or can you identify any? Or is there a common good or greater good that can be identified? This first question is a test of your ability to see the situation from all points of view. The next question gets to the core issue of ethical claims and regard for others. It is a test of your ethical sensitivity and imagination. To adequately answer these
questions, one must be able to use your imagination to develop empathy, kindness, compassion.
Â
2. What is at stake for all of those involved and for those who might be affected? This question requires an impartial stance so that our own personal interests do not get in the way of making a sound ethical judgment. You must put aside your own potential gains and losses in favor of a sensitive rendering of the possible effects on othersânot just the others named in the situation but all others who
might be affected by the action taken or avoided. This is known as the ethical point of view; it requires empathy to fully understand and appreciate the interests of others, especially of the socially and economically vulnerable, who are often overlooked. Now that you have identified the ethical nature of the problem with these first two questions, it is time to clarify the situation.
There are limitations that can prevent you from being able to choose to act ethically.
3. Are there limits to the ethical responsibilities of those in the situation? Is there a single best action or stance that can be freely chosen? Or are the available choices constrained by external factors or an inability to see beyond oneâs own interest? Is the situation itself a product of unjust procedures or rules that fail to treat people with equal concern and respect? Is coercion present? This
step is a test of your analytical and problem-solving skills, higher-level skills more like critical thinking than like factual knowledge retrieval. It tests the ability to recognize, confront and resolve subtle background assumptions that can obscure the ethical issues. At this point, you have made some judgment about what should be done. One last test is in order.
Â
4. If the chosen action were to be generally observed, would the consequences and possible side effects still be reasonably acceptable to all those affected? This is a final test to ensure that the stakes mentioned in question 3 have been weighed from an ethical point of view. It ensures that the fairness of actions to others is given a central role in ethical judgment. This helps focus on your sense of obligations and responsibilities towards others, your personal attitude and willingness to assume responsibility and take some leadership. Test 4 is a check of your integrity, professionalism, and character.
Â
Finally, attention needs to be given to improving the prospects for ethical action generally by addressing the institutional context and its contribution to unfairness and unjustifiable unequal treatment.
Â
5. What are the implications of this situation for the justness of the institutions involved? Do commitments and roles or rules and procedures need to be changed to protect the welfare or capacities of others for future ethical action? This is sometimes called organizational ethics, wherein a case brings to our attention a systematic problem with our system, organization, or policies and procedures. If the system somehow inhibits your ability to do what is right, you must then consider addressing those problems, trying to improve the system without endangering your effectiveness to work within it.
Sometimes a professional can pass the first four tests but be stymied (or think they are stymied) by the place where he or she works. This can lead to moral distress, a topic on which there is a large literature, mostly from nursing. Nurses often feel that they do not have the power or authority to change something they consider dangerous to patients or otherwise unethical. However, professionals
from any field can feel burnout and moral distress from feeling as if they are being overworked and that their opinions are not respected by the hospital or health care system that employs them. Increasingly, we see the same concerns about moral distress voiced by physicians, as health care systems become larger and more centrally controlled. To really succeed in any job, you must learn when and how you can contribute to improving the system and how not to be demoralized by moral distress when you canâtâ a test of your resilience.
Â
Now we can offer a model of how to approach an ethical problem and produce an ethical argument, that is, make a well justified or sound recommendation in a case analysis, for an essay on a test or for a paper in a course.
1. What are the facts? What more do you need to know? Good ethics begins with good facts: First collect all the pertinent scientific, clinical, and population data; then the perspective of all stakeholders, whether they are neighborhood residents, patients, or research participants. You can only accurately and fairly identify the ethical issues after this process. If there is important information lacking, identify what else you need to know before making any judgments. Then (and only then) you should identify the ethical issues.
Here casuistry or narrative ethics can play an essential role in describing an ethical process for case analysis (âcasuistryâ is derived from âcasesâ). To do it well requires attention to details, sensitivity to seek out and listen to people who may be marginalized, and is more âbottom-upâ than mere âlogical deductionâ from either mid-level Principles or general theories like Kantâs Categorical Imperative (which, it must be added, was never the suggested approach of Beauchamp and Childress).
2. What are the ethical issues? Identify the ethical issues and outline all the options: Identify every reasonable alternative course of action, and the most likely outcome of each. (This is where one sees the value of Utilitarianism; one cannot ignore the consequences of the choicesâthe consequences of your acts count.) Some choices may only address one issue, or even make other issues worse. So
try to address all of the issues you identified. Identifying only one issue or optionusually indicates a weakness in the analysis. Sometimes each person involved in the case has a different recommendation on how to resolve the issue.
3. What are the arguments? How do the various principles (or theories) apply? Construct ethical arguments: Outline the pros and cons for each option you identified, using the Principles outlined above, as well as experience from previous cases, applicable Professional Codes of Ethics and Statements (âwhite papers,â guidelines) from recognized professional organizations, hospital or state or federal
policies, state and federal laws, and international organizations like the World Health Organization. All of these can be sources of helpful conceptual frameworks that contribute to the sophistication of the reasoning process and its ethical content.
Â
4. What is the best choice? Present and defend one decision: Use your judgment to determine the ethically best option, i.e. answer the questions âWhat is the best thing to do?â or âWhat are your obligations, as a professional and as a citizen?â Consider which choice seems to be supported by the most principles and policies; likewise which option will satisfy the most stakeholders (or the persons with the most at stake), or if one person (or profession) has more right to be the decision-maker. Just as a math or chemistry teacher wonât take an answer without showing your work, since it might just be a lucky guess, the same is true for ethics. You must explain why you made the choice you have made. Different principles can lead to different decisions, and good judgment (practical wisdom, phronesis) can depend on your level of experience, imagination, critical thinking, and problem solving.
5. How will you proceed? Recommend a course of action, anticipate arguments against it, discuss what it might take to negotiate a resolution and build a consensus, and document the plan. Acting with integrity and idealism is the goal, rather than expediency. Donât be reticent; keep in mind that taking no action has the same effect as giving tacit approval of the status quo. In this final step, strength of character (e.g. the courage to raise controversial issues in a risk-averse organization) can become an important factor.
Â
Case 1: The Limitations of Electronic Health Records (EHRs), Decision-Support, and Financial Conflicts of Interest
Relevant Professions: Health Informatics, Medicine, Nursing
Issues: The limitations of EMRs, and Conflict of interest.
Why this is important: The recent push for widespread adoption of Health Informatics raises significant concerns related to the safety and oversight of electronic health records (EHRs) and HIT (health information technology).
The Case: This year Hope Hospital spent Fifty Million Dollars ($50,000,000) to acquire Protogram, an electronic health record (EHR). Protogram t has a full featured suite of patient care and decision making tools including clinical decision support (CDS), drug-drug interaction checker, and computerized physician order entry (CPOE). This system was designed by Judy Green, Owner of Protogram Software, LLC and member of Hopeâs Board of Directors.
As the Chief Informatics Officer of the hospital you feel confident that this new system will improve overall patient care, however you have become concerned with reports from the medical staff that there is an issue with the drug-drug interaction checker. This issue only arises when one particular combination of drugs are prescribed. These two medications should not be prescribed together as they cause severe adverse reactions in patients up to and including death. The EHR should alert users to this potentially deadly combination at the time the medication is ordered but the system seems to only catch and alert users 95 % of the time. You have alerted Judy, the board, the employed physicians and hospital staff to this issue on numerous occasions and Judy has indicated that they are aware of the issue and are working to fix it. Six (6) months have gone by and still no update has been released. The hospital has had too many âclose callsâ to count, as physicians become more and more reliant on CDS and the drug-drug interaction functionality of the EHR.
Â
Today, the Hopeâs CEO stopped by your office to inform you that the hospitalâs board has approved the purchase and donation of Protogram t to non-hospital based primary care providers who have regular and courtesy privileges at the Hospital. During your discussion with the CEO on this issue you mention that you think this is a bad idea since a software fix has not been released, and even if the hospital alerted the PCPs to the issue it would not prevent future events from occurring. Upon hearing this, the CEO states that, due to the confidentiality provisions of the software agreement, the hospital cannot inform anyone other than hospital employees or the vendor of any issues related to the software. Additionally, the CEO states that failure to abide by the confidentiality provision will nullify the agreement with Protagram and subject the hospital to a costly lawsuit (costing between forty and seventy million dollars), cause significant issues with the hospitalâs board, and the termination of any employee(s) who released the information.
Questions:
1. What should the hospital CEO do?
2. Should the hospitalâs potential financial liabilities offset the potential harms to patients, even if the harms arenât likely to occur? How much say should belong to the CFO rather than the CEO?
3. What should you, the Chief Informatics Officer say to the CEO and do you have an obligation to report this to the Board?
Â
Case 2: Preserving Privacy and Confidentiality with Electronic Health Records
Â
Relevant Professions: Health Informatics, Medicine, Nursing, Clinical Psychology, Social Work
Â
Issues: The tension between patient safety and patient privacy and the role technology plays in meeting your professional obligations to each of these; data segmentation; psychiatric history.
Why this is important: The recent push for patient centered HIT applications raises significant concerns related to the safety and oversight of such systems.
The case: Boogle, a global software company and large internet search website recently released PHR Vault, a software platform that allows patients to download their medical information into a personal health record (PHR) and electronically share that information with health providers who use an electronic health record (EHR) that is connected to the local health information exchange (HIE). This
information is provided seamlessly to the provider and is automatically inserted into the providerâs EHR. Boogle recently released an update to PHR Vault that allows patients to choose which PHR data they would like to share with specific healthcare providers.
Â
Mary-Lou Smith a 40 year old female patient, recently came to your office to be seen for depression. Her regular PCP (primary care physician) is a medical school classmate of yours. Mary-Lou is the Executive Vice President of Excel Energy, a Fortune 100 company. During the visit she mentions that she does not want the reason for the visit recorded in her chart since a diagnosis of depression could threaten her job. You determine that she does, in fact, suffer from depression and prescribe Zoloft. Mary-Lou forbids you from disclosing the visit to any other providers, pays cash, and does not use her health insurance to cover the cost of the visit. Furthermore, she gets her Zoloft filled at a local independently owned pharmacy paying cash.
Recently, it has come to your attention that Mary-Lou didnât tell her regular PCP that she is taking Zoloft and has set up her PHR to prevent sharing this information with him. You are concerned that failure to share this information may be detrimental to her health and cause a potential adverse reaction to any drugs that are subsequently prescribed by her PCP.
Questions:
1. How do you balance a patientâs privacy needs with your duty to ensure their health and safety?
2. What is the proper role of technology and is there ever risk introduced by overreliance on technology?
3. There is a long tradition of keeping patientâs psychiatric care in a separate file to protect their privacy. Should HIT allow this to continue, in the name of patientâs rights, or should the technology be used to improve communication between providers and insurance companies?
Â
Case 3: Privacy in the Age of Patient-Driven Websites
Relevant Professions: Health Informatics, Medicine, Biomedical Sciences
Issues: Privacy and Technology.
Why this is important: The recent push for widespread adoption of health informatics raises significant concerns related to the privacy and security of health information.
The Case: Having become disillusioned with your research job at big pharma you take a job at a local research institution dedicated to the research and cure of rare diseases. After starting your new job you learn of a new website, âPatients Like Youâ, where individuals with rare diseases can share personal and clinical information with others in an attempt to improve the lives of similarly situated people. To facilitate this exchange of information, âPatients Like Youâ has created a platform for collecting and sharing outcome-based data with other patients. You have heard that many patients with rare conditions use the website to talk to each other and exchange information about the various available treatments. Upon creating a member account, users agree to the terms of the siteâs privacy
statement which grants the site the unrestricted ability to use the data in the research and treatment of the disease. Having seen that the site currently has 10,000 members sharing data on the disease you are researching, you contact it to see if they will provide you with a list of local physicians who are treating this patient population to ascertain whether they might want to participate in an upcoming research trial. âPatients Like Youâ informs you that while they cannot provide you with a list of local physicians, they can provide you with detailed patient data (including personally identifiable information) on the 10,000 patients for a small fee of $100.00 per patient.
Questions:
1. In what situation would it be appropriate for you to receive the data held by âPatients Like Youâ?
2. Does it matter that the site is charging for the data?
3. Would the situation be different if the patient expressly authorized the site to provide the data to anyone requesting the information? Does checking a box on the website legally suffice as âexpressly authorizingâ? And should it?
4. Is there anything you would want to know before recommending a decision?
Â
Case 4: Workplace Wellness Programs and Health Disparities
Relevant Professions: Medicine, Nursing, Public Health
Issues: Health promotion in the workplace; Health disparities.
Why this is important: The Affordable Care Act contains provisions incentivizing employers to adopt workplace wellness programs however, to what extent should an employer be involved in the health of its workforce?
The case: Obesity, hypertension, and diabetes have reached epidemic proportions throughout the United States. The Affordable Care Act (ACA) recognizes the impact these epidemics have on rising health care costs and includes provisions to incentivize healthy behaviors through workplace wellness programs. Although the Health Insurance Portability and Accountability Act (HIPAA) of 1996 prohibits charging subscribers a higher premium based on health status, it is legal to give premium discounts or rebates to those who adhere to programs of health promotion and disease prevention. You are the medical director for a Fortune 500 company and the board of directors has requested that you design a wellness program that would ultimately reduce the incidence of obesity and diabetes among the companyâs 30,000 employees. The first thing you did was analyze the demographic information for your urban work force. The results were revealing but not unexpected: those employees who earned less than $40,000 a year had significantly worse health than those who earned more than $40,000 a year. The data was further bifurcated for the lowest wage earners. As expected, health care spending was proportionate to these findings.
Questions:
1. What is the best way to incentivize your workforce to adopt and maintain healthy lifestyles without overtly singling out your low wage earners?
2. Some executive âgold plansâ include not just gym memberships, but personal trainers. Should you add that to your low wage earnersâ benefits?
3. What are the benefits and burdens for companies who choose to intervene in the health of their employees?
Â
Case 5: Conducting Human Subject Research Abroad: Whose Standards?
Â
Relevant Professions: Biomedical Science, Translational Science, Medicine, Public Health
Issue: Protection of Human Subjects.
Why this is important: Increasingly biomedical research is being conducted in developing (resource poor) countries. No matter where you live, you may have an opportunity to be involved in research in other countries.
The case: Aragen, a UK-based company has developed a vaccine against HIV that appears promising. Animal studies were very successful. Phase I and phase II trials demonstrated that the vaccine was remarkably safe and it produced significant antibody levels in essentially all of the volunteers. The company now wishes to begin phase III trials in Guatemala where previous surveillance studies revealed a very high incidence of HIV. Such a study could be completed in two years. The Guatemalan government has expressed interest in having the study conducted and begins negotiations with Aragen. The vaccine, which is specifically directed against
the strain in the Guatemalan population, will be provided free by Aragen. The company will cover the cost of conducting the study, which will be carried out by the Guatemala Vaccine Institute. In addition to the study costs, the company will provide all the laboratory equipment necessary to conduct the studies, ten computers for the Institute, and two vehicles to visit the study sites. The company agrees that if the vaccine proves effective it will be given free of charge to the affected population of the city at no cost to the country for five years. In designing the Phase III study the sponsor Aragen proposes a randomized double blind prospective study with one group receiving the test vaccine and the other group receiving a placebo. All potential participants will be tested for HIV prior to being enrolled in the study. If they are HIV + they will be referred to one of the municipal hospitals of the Guatemala Corporation. Further, any research subject who converts to HIV + during the study will be randomizedâhalf will be referred to one of the Municipal Corporation hospitals to be treated by the standard method in Guatemala, which does not include retroviral drugs, including AZT, or any protease inhibitors. The other half will not be told of their HIV status to measure whether the vaccine has any impact on the disease as suggested by animal models. If there is any change in the standard therapy recommended by the government, any previous or future seroconvert or will be switched to this therapy. Due to the AIDS epidemic, the Guatemalan government has proposed making the vaccine mandatory, however, once enrolled the subjects can withdraw at any time. The Municipal Corporation will continue to provide treatment for the patientâs lifetime.
Questions:
1. When, if ever, can the cost difference of conducting studies in developing countries be ethically justified?
2. What are the ethical standards for conducting research? Are they the same in all countries? Should a study like this meet the standards of the U.S. or Guatemala or both?
3. You are the chairman of an IRB in a developing county tasked with evaluating this protocol. What questions would you ask? Do you need any additional information? What would you advise and why?
Â
Case 6: Authorship and Clinical Equipoise
Relevant Professions: Medicine and Biomedical Science
Issues: Authorship, Placebo controlled studies, Children in research, Financial conflict of interest, Research in developing (resource poor) countries, and Identifying when parents are being coerced to give consent.
Why this is important: One of the most common complaints among researchers has to do with who gets (or doesnât get) authorship credits of a paper. Secondly, in randomized clinical trials it is assumed that there is clinical equipoise; that one intervention isnât better than the other.
The case: Dr. Stanford is a scientist who has been conducting research for the past ten years on genetic defects in the biosynthesis of biopterin, the absence of which leads to a severe type of phenylketonuria (PKU). Most forms of PKU are effectively treated through diet, but not in this instance. Left untreated, this genetic defect leads to cognitive disability and motor neuron disease. Dr. Stanford has found a method by which synthetic biopterin can be efficiently transported across the blood brain barrier in laboratory rats. He contacted his universityâs patent office immediately after the discovery 4 years ago. At that same time he contacted Dr. Peterson, an esteemed pediatric neurologist at the university to ensure that his research would be transferable to her patient population. Dr. Peterson fully endorsed Dr. Stanfordâs research and told him that she would like to collaborate. Dr. Stanford prepared a manuscript documenting his laboratory findings and sent it to Dr. Peterson for review. Dr. Peterson was upset that she wasnât listed as a co-author. Drs. Stanford and Peterson recently concluded a Phase I trial of the drug in Honduras and Mexico and are currently working on a multi-centered Phase II protocol. Additionally, they have formed a spin-off company with the biotechnology firm DDX which will hopefully produce and market the new drug once it receives FDA approval. The Phase II protocol (double-blinded placebo-controlled)
will include Dr. Petersonâs patient population. Dr. Peterson is privy to information about the drug thus, she wants to give her patients the study drug and somehow arrange to give a placebo to a colleagueâs patients. She approaches Dr. Stanford with this arrangement.
Questions:
1. What is the ethical standard that defines who should be listed as an author of a paper? The International Committee of Medical Journal Editors (ICMJE) has published guidelines for authorship.
2. How should patients be recruited for a new study? Can a doctor leading the study recruit her own patients, and what protections should be built into such a study protocol?
3. Is it ethical for the researchers to own a company (or stock in a company) that will make money if the research proves successful?
4. When, (if ever) is a placebo controlled study ethical when studying a serious disease with irreversible consequences for children?
Â
Case 7: When Professional Identity Conflicts with Research
Relevant Professions: Medicine, Biomedical Sciences and Nursing
Issue: Nurses as patient advocates; Executing research protocols; Alternative and complementary medicine.
Why this is important: Principal Investigatorâs responsibility to a research protocol may conflict with the normal fiduciary duty to the patientâs best interest. Nursing staff taking care of a patient may also be caught in this bind, even though they are not involved in the research.
The case: Dr. Fellmann is a neuroscientist who has been studying acute anxiety in primates. He has developed a combined therapy using benzodiazepine and a newly developed, fast-acting anxiolytic agent called AA-1202. Use of the combined therapy in primates has been so successful that it was patented. Dr. Fellmann is collaborating with a cardiac surgeon, Dr. Earl, because they believe that this combined therapy might be beneficial for patients who are about to undergo surgery. They recently concluded a Phase 1 study testing its safety and a multi-center Phase 2 clinical trial has been approved by the Universityâs IRB.
The Phase 2 clinical trial is a double-blind, placebo-controlled protocol that will include two different dosages of the combined therapy. They will recruit patients who are scheduled for cardiac surgery. As part of the protocol, patients are admitted the afternoon prior to surgery and are given the study drug or placebo at 7:00 P.M. Vital signs and pain levels are monitored hourly. All subjects are administered an anxiety scale instrument at the time the drug is administered as well the next morning. One of the floor nurses, Ms. Patel, has a great deal of experience with surgical patients. She has worked the cardiac pre-op. floor for 15 years and frequently uses a
mindfulness meditation technique to ease patientsâ fears prior to surgery. Clinical experience has taught her that patients who use this technique seem to be less anxious prior to their surgical procedures. One evening, Dr. Earl noticed that Ms. Patel was teaching this technique to one of his patients who as scheduled for cardiac surgery in the morning and who was enrolled in the Phase 2 trial. Dr. Earl asks to see Ms. Patel in the hall where he explains that since this patient was enrolled in the clinical trial for the pre-surgical anti-anxiety medication she should refrain from using the meditation technique.
Â
Questions:
1. Do you think Dr. Earl is justified in asking Ms. Patel to refrain from using a mindfulness meditation technique with the patients enrolled in the clinical trial? Why or why not?
2. Nurse Patel has an obligation to offer help her patients. Does she have a similar obligation to follow the orders of an attending physician?
3. How should you rectify the conflict at hand?