THEO 353 - Notes

o Should we get consent for a “no CPR” order? o When should you report a colleague’s error? o Should we hide medication in a patient’s food? o When should you follow the advance directive of a patient with anorexia? o Should those who can pay be able to jump the cue? o Is the institution undermining the values of its staff? o Is the research done in a clinical setting respecting the dignity of the research subject? o Should our healthcare system offer genetic testing for late-onset diseases that cannot be treated? o Should our society promote physician assisted death? o Is it part of a physician’s duty to kill his/her patient? o Should government provide funds on human enhancement therapy? Historical Background to Bioethics - Problem or a dilemma always underlies ethical questions - Emergence of discipline in the 1960’s - Born from challenges posed by scientific and technological breakthroughs and “loss” of traditional authority - Bioethics emerged out of this authority vacuum - Cases that caused ethical concern and research in medicine: o ‘The decide who lives, who dies’  In 1962, first dialysis machines were introduced in the US. 1 out of 50 were chosen to go on the dialysis machine. The criteria involved age, gender, marital status, number of dependents, income, net worth, emotional stability, educational background, occupation, past performance and future potential, references  Biases in the criteria o Henry Beecher, “ethics and clinical research”  Wrote about 50 examples of ethics within clinical research using human subjects o First human heart transplant, 1967  Dr. Barnard removed a heart of a 25-year-old woman and placed it into a 55-year-old man  Questions emerged about the criteria used to pronounce the death of donors, as there was none yet to decide the death of beating heart donors - Prominent Canadian cases o 1980 decision in Reibl v. Hughes  Moved the standard of patient consent, what would the reasonable patient need to know in order to make a decision o The Matter of Stephen Dawson 1983  Ethical significance of accurate medical information in life and death decisions, and the ethics of proxy decision making o The 1986 Case of Eve

o What is a good life?  Aristotle believes it is to reach happiness (eudaimonia) o Human flourishing → Acting virtuously o Virtue requires practice and commitment o Ethical action involves discerning and promoting the proper ends or goals  How things “work”  Discerning their inner structure  Observing their own path of development  Acting to promote their flourishing  In virtue-based ethics, acting ethically requires:  Interiorizing good values  Learning good habits  Developing good character  Cultivating virtues o For Aristotle, virtue means:  A cultivated habit  A formation of character  A type of habitual dedication that enables us and directs us  To be attentive to the good  To care for it  To understand it  To act in an informed and responsible way - The golden mean o Middle way between extremes of excess and defiency o Aristotle, virtue is not associated with momentary passion, rather states of chatacter finding expression in purpose and action o Virtue is deliberate and involved appropriate emotional responses o The intermediate depends on the situation, not an exact science o Lack of virtue = Cowardice, stinginess o Virtue = Courage, generosity o Excess virtue = Recklessness, lavishness - What should I do? o Virtue ethics refers to one’s character o What promotes the development of virtue throughout a person’s life o Strengths:  Insistence on careful reflection  Balanced outcome  Recognize the limitations of human acting  Promotes development of virtue throughout person’s life - Limitations o Strangers must rely on rules and obligations, not character evaluation o Evaluating one’s character seems trivial when faced with immediate, challenging decisions o Insufficiency of virtue – good people with good intentions can perform wrong actions

Consequence-Based Ethics - John Stuart Mill (1806-1873) - Utilitarian ethics or theological ethics - Humans naturally tend to pursue personal happiness o However, social life requires common action - Obligation: o Pursue the greatest good for the greatest number - Utilitarian ethics o Utilitarian ethics judges the moral worth of actions in terms of the consequences of those actions  Point of reference – consequence of an action  If the consequence of an action is the source drawn on to make a decision at an individual level, the criterion is happiness  If the end result promotes happiness, then it is good  The ethical act is what brings about happiness  Ethics has to do with personal preference o “He is clueless about what is happening in the country, but he is much happier since he stopped watching the news” o Utilitarianism is an expression of personal preference  Individual action is right if it increases happiness more than unhappiness o Cost-benefit analysis  What will it cost?  What is the benefit?  Does the benefit outweigh the cost? o What should I do?  What is wanted?  What most satisfies one’s desire?  How efficiently can I get it?  The good is what maximizes the satisfaction of personal desire or social goals o Limitations  Who determines the good?  How is the good decided?  Majority interests outweigh minority – tends to exclude most vulnerable  Sometimes horrible actions can lead to positive results  For example, does murdering a brutal dictator justify murder? Care-Based Ethics - Carol Gilligan (b. 1936) & Nel Noddings (b.1929) - Most contemporary ethical tradition - Feminist thinkers o Focused on female ways of moral knowing - Women operate out of a different set of values - Relationship-based reasoning

o Clinicians can identify when the follicles are large enough to administer another hormone which releases the egg o Chance of conception at this time is greatly increased if a couple has intercourse - Manipulation of the eggs, sperm, and embryos outside the body o IVF is used in a range of circumstances to assist with conception, but is most often the only means of achieving pregnancy for a woman whose fallopian tubes are blocked  If multiple embryos develop, they can be frozen for later use o During the preparation phase involved in IVF, is it possible, through preimplantation genetic diagnosis or PGD to:  Test for disease-related genes or chromosomal abnormalities  Identify gender of the embryo  Reduce the risk or avoid transmission of a genetic disease when:  A couple themselves have a genetic disease  There is a family history of a genetic disease that can be passed on o The issue of gender selection may occur to reduce:  Risk of transmission of a genetic disorder linked to an X chromosome  i.e., muscular dystrophy  A condition that occurs more frequently in one gender  In these scenarios, embryos are chosen based on the wishes of the parents o Somatic cell nuclear transfer cloning (SCNT)  Highly controversial and experimental procedure that is not yet used as ART  Could eventually be used to assist infertile couples  SCNT refers to:  Transfers of the nucleus of a somatic cell (non-germ cell or non-reproductive cell) into an egg from which the nucleus has been removed (the nucleus or genetic material from a human cell is inserted into a denucleated human egg)  Consists of transferring nuclei from a person’s somatic cell into donated human or even animal unfertilized eggs from which the nuclei have been removed  These reconstructed eggs could be stimulated with electricity to develop into a embryo and be implanted into a woman’s uterus producing a cloned individual  The first cloned animal occurred in 1997 - Methods aimed at migration of gametes or embryos into a woman’s body o Artificial insemination  Insertion of a male partner’s semen through the female’s cervix and into the uterus at or just before the time of ovulation  This process can also use a donor’s semen (anonymous or not) o GIFT (gamete intrafallopian transfer):

 With contraception, having children became a choice and many women and couples decide not to have children o Regardless, for those who desire to have children who are genetically related, IVF offers hope even if there is no guarantee the procedure will result in a live birth - Benefits: reproductive liberty o Another benefit is the reproductive freedom of individuals  Individuals and couples have the right to have genetically related children  Governments should promote this  Canada: more restrictions on ART than in the U.S.  Largely an unregulated free market in the U.S.  Assisted Human Reproduction Act (AHR Act) (2004) o Prohibits paying a surrogate mother and purchasing sperm and ova from a donor o Section 12: opened the possibility of some form of reimbursement of expenditures incurred by surrogate mothers and gamete donors and reimbursement for loss of work-related income for surrogate mothers - Burdens o There are five aspects of ART that raise concern and thus come under the category of ‘burden’ o Commodification of human reproduction  There is objection “to ART on the grounds that it undermines dignity of human beings and human reproduction because it promotes the commodification of human biological material”  There is “considerable evidence of commercial transactions in Canada for both surrogacy and human eggs, and yet … research reveals that there has only been one conviction in the last ten years  United States:  Relative free market approach to ART  Canada:  Lack of rigorous oversight of existing regulations  Each raise concerns about the commodification of human reproduction  When individuals engage in a commercial pre-conception arrangement where:  A child: product sold by the surrogate  Purchased by a commissioning individual or couple  This is a business transaction  Reproduction and children: “objects” to be purchased with all the potential hazards that follow  If one reduces reproduction to a business transaction, raises concern of “product” not meeting specifications of “buyers” o Financial costs  Significant infertility treatment happens below the radar  Physicians who provide the service are often also business owners

 The “conventional” notion of family is difficult to define  Does ART pose a danger or a threat to a child’s self identity or its sense of belonging:  What will be the long-term consequences of these new configurations? o Donor sperm and donor eggs raises questions about the very meaning of family, parents, and children - How do we understand these designations in an age of reproductive technology? Theological and Ethical Reflection - In exploring the issue of assisted reproductive technologies, women figure prominently in this bioethical issue because women’s lives are deeply impacted in the area of reproduction o When one considers the lived experience of women, we are confronted with both the benefits and limitations of ART o Exploring the ART through the lens of nonmaleficence and beneficence, as well as autonomy and justice there are a spectrum of views o Some views reproductive technologies as a new means of devaluing women, rendering them “expendable in the procreative process” - The history of women’s experience in relation to reproduction has been a history of both great pain and great joy, of great oppression and great fulfilment - It is not possible to evaluate or reflect theologically or ethically on ART without taking into consideration the concrete experience of women - The good is always concrete, it is not something waiting to be found in some future insight - It is something to be created in the concrete experience of women and men who seek assistance in reproduction - It is difficult to make sweeping ethical judgements on ART - One might consider ART against the framework of the three levels of the good to understand the potential good and the potential harm - Women and men who seek ART desire deeply to have a child genetically related to both, but if that is not possible, then a child who is genetically related to at least one of them - Desire to have a child can go as far as: o Having both egg and sperm donors so that child is not genetically related to either, but will still be their child to nurture and raise o ART is a means to fulfilling this ‘good’ at the first level - The good of society in general is promoted by: o The importance of reproduction, of bringing children into the world who will grow into good citizens o Having more control over reproduction allows for more choices about lifestyle, and more autonomous individuals  This impacts women as a group who contribute considerably to the social good

o Sixteen (16) doctors were found guilty of “willing participation in the systematic torture, mutilation, and killing of prisoners in experiments”, Seven were executed - Tuskegee Syphilis Experiment: 1932-1972 o The Tuskegee syphilis experiment has had a far-reaching impact on much more than just the health of men involved o The “legacy of Tuskegee” is that many African-Americans distrust white doctors and the government: o In 1990, a survey found:  10% of African Americans believed that the U.S. government created AIDS as a plot to exterminate blacks  20% could not rule out the possibility that this might be true o The men in the experiment were told they were being treated for “bad blood” when, in fact:  They were only observed to watch the progression of the disease  In 1932, there was no complete cure for syphilis, but there were treatment programs that were known to help:  These treatments were withheld from the participants, or given in doses so small as to be ineffective o Bismuth o Neo arsphenamine o Mercury o Even when penicillin was discovered in the 1940s, participants in the Tuskegee syphilis trials were never told or treated o They were actively prevented from receiving treatment so that doctors could continue to watch the progress - Henrietta Lacks o Born Loretta Pleasant in Roanoke, Virginia on August 1, 1920 o Mother died when she was only 4 years old o Married her cousin, David “Day” Lacks with whom she had 5 children o The couple moved to Maryland o On January 29, 1951, she went to the John Hopkins Hospital because of abdominal pain  Diagnosed with cervical cancer and received radiation treatment  During her treatment, doctors removed two cervical samples without her knowledge  She died at John Hopkins on October 4, 1951 at age 31 o The cells taken from Henrietta Lack’s tumor flourished  Most cells survived for only a few days  First human cells that could be grown indefinitely in a laboratory  Amazingly durable  Researcher Dr. George Otto Gey isolated and multiplied a specific cell, creating a cell line  Named the sample “HeLa”

o The cells derived from Henrietta Lacks’ tumor revolutionized medical research:  Vaccine for polio was developed through use of HeLa cells  Tens of thousands of patents resulted  Her family learned about the HeLa cells in the 1970s, but received no answers to their inquiries  In 1998, the British Broadcasting Corporation screened a documentary about Henrietta Lacks  In 2010, Rebecca Skloot published The Immortal Life of Henrietta Lacks o Henry Beecher’s 1966 article published in the New England Journal of Medicine, “Ethics and Clinical Research”  In 1966, Henry Beecher published an important paper reporting a variety of abuses of human subjects in medical research at major universities and medical centers in the United States  Ethical abuses in research came from reputable medical institutions  Harvard Medical School  National Institutes of Health Clinical Center  His article triggered discussions and debate within the medical field and beyond  Importance and practicality of obtaining consent from research subjects or surrogates if the subjects could not provide consent for themselves  His courage in challenging research abuses led to better oversight and protection of human subjects in research studies o Ethics violations cited include:  Treatment withheld despite proven efficacy  Continuing studies despite evidence of toxicity  Administration of toxic substances to improve understanding of disease  Experimental surgical techniques tested on healthy patients  Infants exposed to high doses of x-rays for dubious purposes  Use of subjects without their consent - Biotrial (France, 2016) o Research violations continue to occur in our present-day o Recent example:  Drug BIA 10-2474 was being tested by Biotrial, a pharmaceutical company in Rennes, France  Drug would be effective in treating certain neurological diseases  June 2015 – January 2019  One of the healthy volunteers was declared “brain dead” o “Volunteer 2508” experienced headaches and blurry vision after receiving multiple, high doses of BIA 10-2474 o Hospitalized in the early evening and stayed in the hospital overnight o Other healthy volunteers were given high doses of the drugs without Biotrial staff finding out what happened to volunteer 2508

o Later that day, volunteer 2508 was declared brain-dead o Four other healthy volunteers were hospitalized when they also became ill  Two ended up with long-term neurological damage o Oversights identified:  The testing should have stopped until the condition of volunteer 2508 was known  Additional healthy volunteers were administered the drug after volunteer 2508 was hospitalized - Willow brook state school hepatitis study o Mentally disabled children were deliberately infected with hepatitis so researchers could test gamma globulin as a treatment  Some parents were coerced into consenting to let their children infected  Could not get their children into the state school unless they agreed  Researchers justified deliberate infection justified deliberate infection by arguing that children in that school would come down with hepatitis anyway - Jewish chronic disease hospital study o Researchers deliberately injected chronically ill patients with live cancer cells without document informed consent  Patients had given oral consent  Patients were in no mental state to give truly informed consent - West Lost Angeles veterans’ affairs medical center o Department of veterans’ affairs ordered all research involving animal and human subjects to stop o Hospitals and clinics of the veterans affairs medical center o Alleged that patients with cognitive disabilities were deliberately taken off their medicines so that researchers could study their symptoms o Others were given drugs that intentionally made their symptoms worse so that researchers could observe the symptoms as they occurred - Roger Poisson (1994) o Incident involving a Canadian researcher  Roger Poisson, Professor of surgery at the University of Montreal  Member of the National Surgical Adjuvant Breast and Bowel Project (NSABP)  A joint U.S. and Canadian research effort  Since 1958 has conducted studies on some of the most effective treatments for breast cancer o In 1994, the U.S. Office of Research Integrity found:  For nearly a decade, Poisson had enrolled patients who were not eligible for trials and falsified or fabricated their medical records to cover up their ineligibility  Two sets of patient books in Poisson’s lab, one marked ‘true’ and another labelled ‘false’

 Women were part of trials that established that lumpectomy plus radiation was at effective as mastectomy in lowering risk of recurrent breast cancer  Other studies have since confirmed the benefits of lumpectomy combined with radiation  Misrepresentation caused many who underwent the procedure to question whether they had made the right decision Normative Texts - Research on human subjects has been going on for hundreds of years - Awareness of ethical concerns has a history well before the Second World War - Atrocities that were committed by German physicians in World War II o Gave rise to the first effort at articulating directives that went beyond national borders - Nuremburg code (1947) o Following the Nuremburg Trials, the inhumane and atrocious experiments carried out by German doctors on behalf of the Nazis led to the development of the Nuremberg Code in 1947  The Nuremberg Code was the first international code of research ethics  Mandated that research involving human beings must follow 10 basic directives  1. The voluntary consent of the human subject is absolutely essential o Legal capacity to give consent o Able to exercise free power of choice without coercion or deceit o Have sufficient knowledge and comprehension of the elements of the subject matter involved as to understand and make an enlightened decision  The benefits  The risks  2. The experiment must yield fruitful results for the good of society that could not be obtained in any other manner and is not random and unnecessary in nature  3. Animal experimentation should precede human experimentation  4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury  5. No experiment should be conducted if there is reason to believe it will lead to injury or death  6. The degree of risk to subjects should never exceed the humanitarian importance of the problem to be solved by the experiment  7. Risk to participants should be minimized through proper preparations

 8. The experiment should be conducted only by scientifically qualified persons  9. Participants should always be at liberty to withdraw from the experiments  The scientists in charge must be prepared to terminate the experiment at any stage, if there is cause to believe continuing is likely to result in injury, disability, or death to the research subject - The Helsinki declaration (1964) o While the Nuremberg Code was an important development in regulating ethical research, it clearly was not enough to prevent tragedies like Tuskegee  The Helsinki Declaration was another key historical moment in regulating research on human beings  It was developed by the World Medical Association in 1964 in Helsinki, Finland  An elaboration of Nuremberg Code, with a focus on biomedical research o The 1975 revision of the Helsinki Declaration  Introduced the concept of independent oversight committees to review the ethics of research  In Canada, these are “Research Ethics Boards” or at Concordia University, it is the “Human Research Ethics Committee”  It has been formally revised 5 times between 1964 and 2000  The most recent revision takes into account debates over differing standards applied to research conducted in wealthy and less developed countries  Helsinki allowed for proxy consent from individuals who were unable to give informed consent to research  The Helsinki Declaration stipulates that:  No one group of society should disproportionately bear the costs of, or reap the benefits of, research  Any research participant should receive the best treatment available  “In any medical study, every patient – including those of a control group, if any – should be assured of the best proven diagnostic and therapeutic method.”  “The populations in which the research is carried out [must] stand to benefit from the results of the research”  Anti-retroviral therapy trials in Africa have shown how transnational research poses new challenges to the principles of ethical research  In the wake of the HIV-AIDS epidemic: o Poor countries have been used to test new drug therapies because medical trials in such countries are much cheaper than medical trials in wealthy, developed countries

o People participating in medical research in poor countries have not been given the same treatments as patients in wealthy countries  They also have not benefited to the same extent from the development of new drug therapies to treat HIV transmission - The Belmont Report (1978) o In 1974, partly in response to:  The scandal of the Tuskegee syphilis experiment and to provide a succinct description of the mandate for review of research involving human subjects:  The U.S. Congress established the National commission for the Protection of Human Subjects of Biomedical and Behavioral Research o The commission released a series of reports that provided the “official” positions necessary to create uniformity in American policies on the various complex legal and ethical issues  The committee’s primary position relied on the three principles:  1. Beneficence  2. Justice  3. Autonomy - Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2014) o In Canada, the federal research funding agencies are:  The Canadian Institutes of Health Research (CIHR)  The Natural Sciences and Engineering Research Council of Canada (NSERC)  The Social Sciences and Humanities Council of Canada (SSHRC) o These agencies developed a joint policy regarding ethical conduct in research involving human subjects:  The Tri-Council Policy Statement reflects to commitment of the three agencies in promoting ethical conduct in research involving humans  The TCPS aims to promote fruitful and ethical research o 8 guiding principles:  1. Respect for human dignity  Protect human subjects o Bodily o Psychologically o Culturally  The “cardinal principle”  2. Respect for free and informed consent  Freely (without coercion or pressure) consent to research  Understand the implications of the research  Free to withdraw from the research whenever they choose  3. Respect for vulnerable persons

 Calls for greater vigilance o Abuse o Exploitation o Discrimination  4. Respect for privacy and confidentiality  5. Respect for justice and inclusiveness  Independent review of research programs  Considerations regarding the research subjects  6. Balancing harms and benefits  7. Minimizing harm  Unnecessary risk for research subjects must be avoided  Importance of the research must be ensured  8. Maximizing benefit in that the research must benefit others o These 8 principles are incorporated into 3 ‘core principles’:  Respect for others  Concern for welfare  Concern for justice Principles - The Belmont Report and the TCPS2 both identify three key principles o Belmont (1978)  Respect for persons  Beneficence  Justice o TSPS2 (2014)  Respect for persons  Concern for welfare  Justice - Respect for persons o Typically framed as an issue of autonomy and of informed consent o Two key concerns:  The dignity of the human subject must be respected above all other values including the potential benefit of the research to society  Autonomy includes the participant’s relationship to their family and the community  Also includes a commitment to accountability and transparency in the ethical conduct of research  Special care must be taken when working with individuals who have reduced autonomy: o Children o Mentally incapacitated adults, prisoners, employees - Concern for welfare o Harms can be physical or psychological o Can involve a risk to a person’s privacy and to their well-being o Goal:

 Maximize the benefits both to the participant and society at large  If there is a conflict, the participant’s benefit must always take precedence over society’s benefit o Welfare also means:  Minimizing risks as far as possible  To anticipate a reasonable risk-benefit ratio - Justice o Justice refers to treating people:  Fairly  Equitably  With equal respect and concern  Equally distributing the benefits and burdens o “Vulnerability is often caused by limited decision-making capacity, or limited access to social goods, such as rights, opportunities, and power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women, prisoners, those with mental health issues, and those with diminished capacity for self-determination” Research Ethics Boards - Purpose o REBs are mandated by their institution to assess whether the research proposals they review are ethically acceptable according to TCPS 2 o At Concordia, the University Human Research Ethics Committee must review all protocols of research involving human subjects that are intended to be carried out by Concordia researchers (faculty and students) o Researchers are obligated so submit a protocol when their research involves working with human subjects - Structure o The mandate of the REB is to protect the rights and well-being of research participants o According to the TCPS, the minimal composition of the REB is:  Two members with relevant research expertise  One ethicist  One member with relevant legal expertise  One community member o The configuration of REBs varies dramatically across Canada  5 members – basic minimum, some REBs have many more  This multidisciplinary flavour of REBs allows for a balance of expertise and provides a broad range of positions concerning a research program – these positions can cause conflict  Each position is a source of information that helps us understand more deeply and deepen our level of reflection Week 5 – Organ Donation Organs are a Scarce Resource

- Strong commitment in Canada to promote organ and tissue donation o A valued medical procedure that most think promotes the good both individually and socially o Yet, Canada has one of the lowest rates of organs donors among developed nations - Remarkably, Canadian transplant methods are among the most sophisticated o Employ superior innovative tools to procure and use the most body parts - Only 15 per 1 million of those who die in hospitals donated o Compared to 34 per 1 million in Spain and 26 per 1 million in the United States - There is a critical shortage of organs for transplantation o In 2014, there were 592 deceased organ donors and 553 living donors  A living donor provides a single organ, but a deceased organ donor can provide up to eight  Living donors are usually related to the recipient (although not always) o 2,346 transplants in Canada  1,430 kidney transplants (61% of transplants)  537 liver transplants  161 heart transplants  226 lung transplants  79 pancreas transplants o 4,514 people waiting  77% (3,476) were waiting for a kidney transplant  11% (45) were waiting for a liver transplant  75 patients were waiting for an islet cell transplant - Organs are a scarce resource o Funding will not substantially change this situation except in education programs o Education will help in providing valuable information that Canadian citizens need to know and understand in order to make an informed choice about donating their organs either while living or when deceased Shifts in Procurement - Donation after cardio-circulatory death (DCD) was the criteria for procuring organs o When a potential donor’s heart and breathing stopped and they had given informed consent, organs could be procured - Prior to respirators and modern critical care in the mid-20 th century, cessation of cardio-respiratory function was the only criterion for determining death - In 1968, the understanding of death shifted to brain death based on neurological criteria - In 1969, the Harvard Ad Hoc Committee proposed adopting neurological criteria for determining death - Neurological criteria became widely adopted - Organs from “brain-dead” donors had much better success rates than the soon abandoned “non-heart-beating donors” (NHBD) or cardo-circulatory death methods

- Programs in Europe and the United States have returned to DCD in the last 10-20 years to meet increasing demands for organs o In Canada, DCD was adopted in 2006 after a 32-year-old woman named Sarah Beth Therian died of a heart arrhythmia  Her parents followed her wishes and asked the hospital to consider her organs under the “new protocol called DCD”  Therian became the first Canadian in four decades to donate organs after cardiac death o In 2016, one third of all donors are DCD - Clarifications about DCD o There is an important difference between the current DCD proposals and the original DCD  It is a new category of controlled donors o There are two types of non-heart-beading donors (NHBD):  1. Uncontrolled  Dead on arrival (DOA) or unsuccessful CPR in the emergency room  2. Controlled  Following planned treatment withdrawal o The new category of controlled donors raises some questions:  Why has it become an important category?  What are the ethical ramifications? o The return to DCD is the result of several factors:  Dying patients and families requesting to donate  Organs from NHBD had improved graft function  Canada was falling behind other countries due to fewer donations after cardiac death  The demand for solid organs exceeds the supply  Agencies looked for ways to expand the supply by relaxing the rules and the criteria o For all these reasons, we see the emergence of “expanded criteria donors”, and DCD is one type Major Ethical Issues in Organ and Tissue Donation - DCD raises several ethical issues - We will consider these first and then look at some general issues after. The ethical issues raised by DCD are: o Pre-mortem interventions  In the ‘controlled’ type of non-heart-beating donation, organ donation discussions should occur only after a patient or substitute decision maker (SDM) has decided that it is no longer in the patient’s best interest to continue life-sustaining interventions  Invasive pre-mortem interventions such as blood tests, bronchoscopies and insertion of a central line are used to maximize the success of the retrieval and transplantation

 While the patient or SDM has opted to stop all medical intervention, there may be medical interventions for a different reason  This scenario presents the prospect of invasive medical procedures being inflicted on the body of the dying person for someone else’s benefit  There is also the possibility such interventions will hasten the patient’s death  The question needing asking from an ethical perspective is this: are the post-mortem interventions consistent with providing overall benefit for the patient? o Conflict of interest  In relation to DCD, there are two possible conflicts of interest:  1. First, the potential ‘controlled’ donor’s end of life care may be jeopardized because of their donor status o “It can be difficult not to manage patients as potential donors rather than as dying patients”  2. Second, therapeutic interventions might be held back to protect the organs o For example, a patient might not be given enough sedation before withdrawing life-sustaining machines o The sole purpose of this is to avoid hastening death before preparation for organ retrieval is completed  The main point is the separation of treatment of the patient (for the patient’s benefit) from procurement of the patient’s organs (for the potential recipient’s benefit) o Are DCD donors dead?  “DCD protocols are controversial because some physicians and bioethicists have questioned whether donors are really dead at the time organ recovery begins”  We come to a question that we discuss more detail in lesson 11: what is death?  Death has become more difficult to define in an age where bodies can be kept alive almost indefinitely  This question is important because there is a tension between starting procurement as quickly as possible and allowing enough time to make sure the donor is dead  When a potential donor’s cardiorespiratory functions cease, it must be irreversible either because the cessation of the heartbeat could not be reversed with intervention (i.e., CPR) or because it will not be reversed due to a decision  Yet, if reversibility is possible, is the person really dead?  Currently most hospitals follow the so-called “5-minute rule” o The procurement team must wait 5 minutes after the heart stops before organs are removed o The ethical debate revolves around the concern that waiting 5 minutes does not ensure the patient is dead

and the potential for the brain to ‘come back to life’ exists