Bioethics Exam 3

Nazi Medical Experiments

• Conducted on concentration camp prisoners

• Focused on military and ideological objectives

The Nuremberg Code

• Outlined 10 principles for conducting ethical research

• Non-binding

Declaration of Helsinki

• Built on Nuremberg Code

• Non-binding

• For all physicians worldwide

Tuskegee Syphilis Study

• No informed consent

• Studied the long-term effect of leaving syphilis untreated

Willowbrook Hepatitis Study

• Researchers intentionally infected disabled children with hepatitis

• Led to Belmont Report and development of Institutional Review Boards (IRBs)

The Belmont Report

• Provides the philosophical basis for “The Common Rule”, which governs human subjects research

• Includes respect for persons, beneficence, and justice

Institutional Review Boards (IRBs)

Committee that reviews and monitors research involving human subjects

Necessary Conditions

Mandatory requirement - If A is necessary for B and A doesn’t occur/isn’t true, B can’t occur.

Sufficient Conditions

On its own is enough to fulfill a requirement

Emmanuel et al.’s 7 Requirements for Ethical Research

1. Value

2. Scientific Validity

3. Fair Subject Selection

4. Favorable Risk - Benefit Ratio

5. Independent Review

6. Informed Consent

7. Respect for Enrolled Subjects

Vulnerability (in the context of subject selection for research)

Vulnerable populations were enrolled in research not because they expected to benefit from the research, but because they were convenient to study

Animal Research Ethics

Explores value-laden aspects of relationships between humans and non-human animals.

Anthropomorphism

Unwarranted attribution of human characteristics to non-human animals

Speciesism

Making judgements of moral status on the morally irrelevant factor of species membership

Reasons For Using Animals in Research

• Reduces risk to humans

• In vivo studies

• Determine potential pharmacological action of investigational drugs and adverse effects in humans

• Gain insight to veterinary applications

• Increase biological knowledge about different species

Degrees of Severity of Pain/Suffering

• Extreme - Intense pain, suffering, distress

• Severe - severe pain, continuous suffering, significant fear, severe impairment

• Moderate - Medium short-term or long-term slight

• Mild - slight short term pain or impairment

• Non-recovery - Suffering prevented during procedure but there may be slight distress pre-procedure

• None

3 R’s of Animal Research

Replace, reduce, refine

Pros/Cons of Using Different Animals in Research

• Chimpanzees/Rhesus Macaque - Most like humans, Expensive to obtain/take care of, difficult to control, require significant socialization and intellectual stimulation

• Pigs and Sheep - Organs are similar, potential for gene editing/xenotransplantation

• Dogs and Cats - Easy to obtain, complex mammals,

• Mice and Rats - Inexpensive, short life span

Organ Transplantation

Process of moving a vital organ from one person to another

The Two Main Questions in Transplant Ethics

1. How are we going to fix the organ shortage?

2. How are we going to allocate organs in the meantime?

Transplant Evaluation Process Decision Points

1. Hospital decides they are willing to transplant patient, put on waitlist

2. National waitlist sends out transplant offers to specific patients

3. Patient accepts or denies organ offer

OPTN’s Values Regarding Allocation in Organ Transplantation

Utility, justice, respect for persons

Living Donor Transplantation

Living donors can donate a kidney, or part of their liver, 97% of donations are direct - to someone they know

Coercion

• Donors can back out at any moment

• Advocate checks with both teams for signs of coercion

• Each team has separate medical teams

Directed vs. Non-Directed Transplantation

Directed is to someone the donor specifies, non-directed is to anyone

Individual-level Harms vs. Community Harms

• Individual-level harms are direct injuries and rights violations to a person

• Community harms are social stigmatization of a group, inequity, or systemic risk

Community-Based Participatory Research

• Community members act as partners, not just participants

• Share a role in defining research questions, guiding the process, and interpreting results

Limitations of the Belmont Report

Lack specificity, outdated scope

Differences Between Public Health Ethics and Clinical Ethics

Childress et al.’s 5 Justificatory Principles

Nudges

Equality vs. Equity

Mill’s Harm Principle

Health Equity

Algorithmic Bias

Artificial Intelligence

Precision Medicine

Concerns about AI Use in Medicine