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BCMB 461: Bioethics & Cancer

with jeffrey pannekoek (jpanneko@utk.edu)

Cancer

Research

Informed Consent

Decision-Making

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Introduction to Bioethics

April 2021

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Foundations of Bioethics

(Ancient) History

“Wherever the art of medicine is loved, there is also a love of humanity.”

― Hippocrates

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Modern History through Cases 1.0

Karen Quinlan and the Right-to-Die

"In 1975, Karen Quinlan had a “respiratory arrest.” She was resuscitated and left in what was initially described in the records as a coma. Later it was determined she was vegetative. Karen's parents asked that her mechanical ventilator be removed so that she might die, and the doctors refused. In the legal documents, the doctors indicated that they thought removing life-sustaining treatment was the equivalent of murder; they felt they had an inherent duty to protect life and specifically to keep Ms. Quinlan alive.”

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Contemporary medical ethics began to emerge in the 1960s and 70s. Changes in society and medicine, away from paternalism and toward a model based on personal autonomy, prompted by particular questions in the ethics community: What is the meaning of life? How does medicine relate to this? How should we conceptualize the end of life? How does this translate to our duties regarding end of life care?

We are now seeing a shift from an atomistic model that focuses on the individual, toward one of social contextualization. Here, the patient’s relationships and social environment become more central aspects to consider. In this US in particular, this shift was also affected by a series of highly influential court cases.

Slide text adapted from Robert L. Fine’s “From Quinlan to Schiavo: medical, ethical, and legal issues in severe brain injury.” See the source for more information about the Quinlan case and other key medical ethics cases: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1255938/

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Modern History through Cases 2.0

The Tuskegee Study

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“The Tuskegee Study is perhaps the most enduring wound in American health science. Known officially as the Tuskegee Study of Untreated Syphilis in the Negro Male, the 40-year experiment run by Public Health Service officials followed 600 rural black men in Alabama with syphilis over the course of their lives, refusing to tell patients their diagnosis, refusing to treat them for the debilitating disease, and actively denying some of them treatment. Whistleblowers brought an end to the incredibly unethical study in 1972, finally prompting the development of what would become modern medical ethics. But the lives of those black men and many of their families were mostly ruined; many men died from complications of syphilis, and several of their wives and children contracted the disease.”

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“The 1972 disclosure made the system less abusive, and led to reforms such as the Belmont Report [see below] that established medical ethics and protections for disadvantaged people.” “The Belmont Report is one of the leading works concerning ethics and health care research. Its primary purpose is to protect subjects and participants in clinical trials or research studies. This report consists of 3 principles: beneficence, justice, and respect for persons.”

Tuskegee information adapted from Vann R. Newkirk II’s “A Generation of Bad Blood“ in The Atlantic (2016): https://www.theatlantic.com/politics/archive/2016/06/tuskegee-study-medical-distrust-research/487439/

Belmont Report information adapted from J.M. Sims’: “A brief review of the Belmont report: https://pubmed.ncbi.nlm.nih.gov/20543620/

CDC webpage about the Tuskegee study: https://www.cdc.gov/tuskegee/timeline.htm

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Why Ethics (Committees)?

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Hospitals are moral communities, in two senses. First, a moral community is one whose members are bound to each other by a set of commonly-held ethical commitments and whose purpose is something more than mere self-interest. Second, a morally-sound community is one that fosters high moral standards. In moral communities, moral uncertainty and moral conflict are acknowledged and resolved, and moral distress is reduced. There are a variety of moral problems that can arise in the medical community, including moral conflict: (two or more people have different views about what is right or wrong about a situation in which they are involved), moral dilemma (competing moral obligations; feeling that every course of action is ethically problematic, moral distress (feeling blocked or prevented from doing something you feel is right (or forced to do something you feel is wrong); moral uncertainty (a sense of moral unease; feeling that something is morally wrong about a situation, but not being able to explain what it is).

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The Principles of Biomedical Ethics

Autonomy

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Beneficence

Nonmaleficence

Justice

Literally: “self-rule” or “self-legislation,” from the Greek auto (self) and nomos (rule or law).

The obligation to promote the well-being of others – particularly those who have been entrusted into your care.

Primum non nocere: “Above all, do no harm.”

Justice requires that benefits, burdens, and resources should be distributed fairly and equitably.

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Virtues of Biomedical Ethics

Compassion

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Discernment

Trustworthiness

Integrity

Conscientiousness

This character trait combines an attitude of active regard for others’ welfare with an imaginative responsiveness to others’ suffering.

The trait of discernment constitutes clear insight or sounds situational judgment.

To be trustworthy is to merit the confidence and credibility of others. It involves a variety of other virtues and attitudes (honesty, transparency, etc.)

Willingness to stand by and act on principles, even when there is a risk. i.e. remaining principled “when push comes to shove.”

Conscientiousness is the knowledge of when and how to compromise. Balance to integrity.

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Narrative Ethics

The Role of Narrative

Narratives helps us break out of the traditional view of persons as being ideally rational minds. Rather, it allows for the acknowledgement of power dynamics, the importance of relationships, and how these can influence decision-making.

In narrative ethics, principles are implicit in the backdrop, rather than the primary ethical tools. A focus on principles to the exclusion of narrative produces a stunted often momentary ethical picture, and can prompt premature closure.

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Informed Consent and Decision-Making

April 2021

Part 1b of 2

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Informed Consent

(Ancient) History

“To think well and to consent to obey someone giving good advice are the same thing.”

― Herodotus

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Modern History through Cases 1.0

Schloendorff v. New York Hospital (1914)

“In January 1908, Mary Schloendorff ... was admitted to New York Hospital [where] the house physician diagnosed a fibroid tumor. The visiting physician recommended surgery, which Schloendorff adamantly declined. She consented to an examination under ether anesthesia. During the procedure, the doctors performed surgery to remove the tumor. Afterwards, Schloendorff developed gangrene in the left arm, ultimately leading to the amputation of some fingers. Schloendorff blamed the surgery, and filed suit.”

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Modern History through Cases 2.0

Salgo v. Leland Stanford Jr. University Board of Trustees (1957)

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“Martin Salgo ... awoke paralyzed after aortography, having never been informed that such a risk existed.”

“The decision held that failure to disclose risks and alternatives was cause for legal action on its own, reaching further than a case of battery.”

Informed consent: provide “all the information needed to make an intelligent decision, such information including the harms, benefits, risks and alternatives of the proposed procedure.”

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This case provides (one of) the first iteration of informed consent.

“The court determined that “a physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment.” This new type of consent focused on whether the doctor had provided the patient with all the information needed to make an intelligent decision, such information including the harms, benefits, risks and alternatives of the proposed procedure. Such disclosure went much beyond the disclosure that was required to defeat a battery claim, which simply involved information about the nature of the procedure.”

Adapted from Dougland Green and Ronal MacKenzie’s “Nuances of Informed Consent:” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2504103/

And from Michelle Wandler’s “The History of the Informed Consent Requirement:” https://dash.harvard.edu/handle/1/8852197

The case: https://law.justia.com/cases/california/court-of-appeal/2d/154/560.html

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Modern History through Cases 3.0

Natanson v. Kline (1960)

“Irma Natanson suffered severely disabling burns as a result of cobalt irradiation for breast cancer in spite of having been told that there were no risks associated with this treatment.”

“The court held the medical profession responsible for a standard of disclosure of risks that a reasonable practitioner would provide a patient.”

Canterbury v. Spence (1972)

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“Jerry Canterbury was partially paralyzed after thoracic spine surgery. His claim that he had not been informed that such a risk existed was confirmed in testimony by his surgeon.”

“Practitioners [were now required] to disclose the risks that a reasonable patient would want to know.

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Elements of Informed Consent

Nature of Treatment

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Alternatives

Relevant Risks

Assess Understanding

Acceptance by Patient

What does the treatment or procedure involve? What does the recovery looks like?

What are other potential courses of action? What do they look like in terms of risks, benefits, uncertainties? Why would we favor one over the other?

What are the possible risks involved in the treatment or procedure, and how likely are they to occur? How might these be responded to? What are the realistic benefits of the treatment or procedure?

Does the patient understand the nature of the treatment, its affect on their health and situation, and the way it relates to their own values and relationships?

The patient must, in light of the information above, freely agree to undergo the treatment or procedure.

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There are important exceptions to the requirement for informed consent, including: emergency situations (when a patient’s condition is emergent, and they are unable to provide themselves, and no one is available to make decisions on their behalf), waiver (a patient might waive the provision of information, perhaps when they prefer not to know the details of a procedure), designation of a decision-maker by a competent patient (usually delegated to a spouse or close family as a group, out of preference, or anticipated necessity), or lack of medical decision-making capacity (next section).

Note that the fourth element of informed consent is the assessment of understanding. Understanding is central in a patient’s capacity for decision-making. That is to say, if this assessment shows that a patient does not fully understand the information that is provided to them, this also shows that they have diminished capacity for decision-making, at least for the particular decision presently under consideration.

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Decision-Making

Choice, Understanding, Appreciation, and Reasoning

“We deliberate about what is in our power.”

― Aristotle

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Decision-Making Capacity … QUIZ!

Question 1

“Decision-making capacity” is synonymous to “competency.”

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Decision-Making Capacity … QUIZ!

Question 1

“Decision-making capacity” is synonymous to “competency.”

Answer

April 2021

TRUE and FALSE

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Decision-Making Capacity … QUIZ!

Question 2

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Decision-making capacity is all or nothing. i.e. either a patient has capacity to make any and all decisions for themselves, or they do not have this capacity for any decision.

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Decision-Making Capacity … QUIZ!

Answer

Generally FALSE

Question 2

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Decision-making capacity is all or nothing. i.e. either a patient has capacity to make any and all decisions for themselves, or they do not have this capacity for any decision.

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Decision-Making Capacity … QUIZ!

Question 3

All patients with serious psychiatric illness lack capacity.

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Decision-Making Capacity … QUIZ!

Question 3

All patients with serious psychiatric illness lack capacity.

Answer

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FALSE

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Decision-Making Defined

Expressing a Choice

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Understanding

Appreciation

Reasoning

The ability to state a decision (nearly a prerequisite for decision-making).

The ability to state the meaning of the relevant information (e.g. diagnosis, risks and benefits of a treatment or procedure, indications, and options of care). A good prima facie indicator of capacity.

The ability to explain how information applies to to the patient and their situation; how it may affect them and their life (a measure of the authenticity of the decision).

The ability to compare information and infer consequences from choices, and develop a rationale for the decision (no arbitrary decision).

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Quick Case Studies

Case 1: Simone

Case 1: A female patient, 58, is being assessed for capacity. She is well oriented and able to communicate clearly that she wanted to go home, and not to an extended care facility of any kind. Although ill, she values life and certainly has no desire to die. She is unable to go from a reclining to a sitting position unassisted; she can’t feed herself; she can’t walk; and when she’s asked about these things, she has no plan as to how she would do those things at home.

Case 2: Ben

April 2021

A male patient, 62, is being assessed for capacity. He has been in an accident and not recovering well. He is ready for discharge, but adamantly refuses a skilled nursing facility and said he would go home. His mental status was not so good: his thinking was cloudy and he wasn’t firmly oriented, but on the subject of placement he was clear and invariable: “I’ve lived a rough life. I drink too much, smoke too much, and get in trouble with the law. I’ve lived by my own lights and I don’t intend to be put away in no old-folks home. I’ll go to my house. My brother lives across the road and he and his wife will help me some. I know I could die and I ain’t going to die in no damn hospital. If I die in my bed or on my porch that’s fine with me.”

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Surrogate Decision-Making

Tennessee Law

In the case of a patient who lacks capacity, has not appointed an agent, has not designated a surrogate, and does not have a guardian, or whose agent, surrogate, or guardian is not reasonably available, the patient's surrogate shall be identified by the supervising health care provider and documented in the current clinical record of the institution or institutions at which the patient is then receiving health care.
The patient's surrogate shall be an adult who has exhibited special care and concern for the patient, who is familiar with the patient's personal values, who is reasonably available, and who is willing to serve. No person who is the subject of a protective order or other court order that directs that person to avoid contact with the patient shall be eligible to serve as the patient's surrogate.
Consideration may be given, in order of descending preference for service as a surrogate, to:

The patient's spouse, adult child, parent, ….

If none of the individuals eligible to act as a surrogate under this subsection (c) are reasonably available, the designated physician may make health care decisions for the patient after the designated physician either: Consults with and obtains the recommendations of an institution's ethics mechanism; or obtains concurrence from a second physician who is not directly involved in the patient's health care.

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Research Ethics and Case Studies

April 2021

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Research Ethics

Tom Regan

“‘Research Ethics’ refer to the process of critically reflecting on ethical questions that researchers face, in their capacity as researchers”

― Tom Regan

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The Faces of Research Ethics

Academic Ethics

April 2021

Science Ethics

Animal Ethics

Biomedical Ethics

Data collection, plagiarism, ownership, etc.

Method, reproducibility, science as value free, etc.

Animal pain, welfare, costs and benefits of animal models, etc.

Informed Consent, paternalism, dignity of risk, etc.

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Moral Issues in RDM & Research

Informed Consent

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Dignity of Risk

Nudging

Paternalism

Justice

Placebo

Autonomy, understanding and appreciation of risks/benefits, quantity?

The freedom and ability to decide on a path that carries greater risks.

Decision-influencing through subtleties of presentation and language.

A kind of objectification, where the subject’s agency is undermined.

Distribution of resources, anti-racism, reparations, benefit-for-risk

Withholding of potentially effective medication, integrity, confidentiality, etc.

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Regan’s Example

Case: Hilda

“In Europe a woman named Hilda was near death from a rare type of cancer. There was one drug that doctors thought might save her. It was a form of radium that a druggist in the same town had recently discovered. The drug was not expensive to make, but the druggist was charging ten times what the drug cost to make. He paid $200 for the radium and charged $2,000 for a small dose of the drug. Hilda's husband, Heinz, went to everyone he knew to borrow the money, but he could only get about $1,000. He told the druggist that his wife was dying, and asked him to sell it cheaper or let him pay later. But the druggist said, "No, I have worked very hard and sacrificed a great deal to discover this drug. It is my property. I have a moral right to it, protected by law, and another moral right to decide what to do with it. And what I want to do is make as much money as I can so I can make my life more enjoyable. I am not running a public charity." So Heinz got desperate and began to think about breaking into the man's store to steal the drug.” (Regan 3)

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Case Evaluation Questions

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What are the morally relevant facts of the case.

- Stakeholders and their stakes.

Which (if any) concepts need to be clarified before we can make our best ethical judgment or decision?

- Evaluative or normative ideas/claims/concepts.

Is anyone behaving in a virtuous manner? If so, who? How?
Is anyone behaving viciously? If so, who? How?
Are any nondiscretionary duties involved? If so, who has them?
Are any discretionary duties involved? If so, who has them?
Are any special duties involved?

- Duties of care or professional norms? Who and to whom?

Are any duties of justice involved? If so, who has what rights? Against whom?
Are any duties of utility involved? If so, who will be affected? By whom? How much?

Do any of the duties involved conflict with one another? If so, which ones? How?
Has someone acted in supererogatory manner? If so, who? How?
Is someone being asked to act in a supererogatory manner? If so, who? By whom?
Taking all the relevant considerations into account, what do we think should be done? What would be right? What, wrong?
What reasons can we give to support our answers to the questions asked in (13)?
What are the implications of applying the Bad Consequences Test to the answer we favor? Can we continue to favor this answer, given these implications?
What are the implications of applying the Universalization Test to the answer we favor? Can we continue to favor this answer, given these implications?

Adopted from Tom Regan’s “Research Ethics: an Introduction”

From Tom Regan’s “Research Ethics: an Introduction” (on Canvas). Note that Regan is a Kantian/duty ethicist, but he tries to fold in the other views (consequences, virtues, relationships, etc.).

These questions are a tool for case analysis. They are not themselves the solution to any case. They are meant to help pick up on the morally relevant features of the situation, and guide our thinking and ultimate decision-making. It is not an algorithm.

Quick Glossary:

- Non-discretionary duties: Equal duties we have to all. e.g. honesty, respect. Includes duties of justice, which we do not owe equally, but depend on oppression and vulnerable populations.

- Discretionary duties: General duty, but their particulars are up to us. e.g. charity.

- Special duties: Care ethics or relational duties and professional ethics, for instance the special duty to protect children, or the professional duty keep information confidential.

- Duties of Utility: How our actions affect the lives of others (a utilitarian concern).

- Supererogation: Good but beyond duty.

- Ethical Hypotheses: Formulation of a proposed course of action.

- Bad consequences Test: If Everyone acts the same in a similar situation, would the consequences be acceptable?

- Universalization Test: If everyone acts the same in a similar situation, would we judge them the same (consistency)?

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CASES

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Bioethics

Concluding

“Many of the moral decisions we need to ponder will not be life or death, career break-or-make situations; our daily life is full of “little” questions. … When thinking about how to follow through on our ethical decisions, it is important to factor in the toll the decision will take. … Maybe we should add the question, “How will I follow through and live with my decision?” to our list” (Regan 12).

A method for answering moral questions does not issue in a single correct response, but is about how we approach moral questions. Science produces “wrong” answers all the time, but we put our faith in the process and method. And it’s the same for ethics. We develop processes that get us to better questions and better answers (paraphrased from Regan addendum 12).

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End of Part 2

Thanks, Everyone! (Questions/comments: jpanneko@utk.edu)

Cancer

Research

Informed Consent

Decision-Making