Bioethics Midterm

define: ethics

THE STUDY OF MORALITY

Systematic & philosophical examination of your morals.

why is it right, can I justify it, does it hold up under scrutiny, and how should it guide action in complex situations?

define: bioethics

ethical study of issues in healthcare, biomedical research, and related fields.

APPLIED ETHICS to various aspects of healthcare: medical treatment, research, public health, healthcare policy, etc

define: morality

Varies across time and cultures.

Your own sense of right and wrong. Shaped by your upbringing, culture, religion, lived experience, and conscience.

moral absolutism vs. moral relativism

moral absolutism: there is always one right answer to any ethical question

moral relativism: morality is relative (ie culture or historical period) and that no standpointis uniquely privilege over all others

moral reasoning

Collaborating in reasoning together about moral dilemma situations

moral theories

Articulating the meaning of important moral concepts and connect them to moral theories

moral dilemmas

Reproducing the vignettes of classic thought experiments in moral philosophy and use them as heuristics to illustrate moral concepts and discuss new moral dilemmas

normative ethics

"what general principles or frameworks should guide our actions?"

provides saif principles/frameworks that applied fields like bioethics can use.

______ support ______ in moral arguments

premises, conclusions

theory: consequentialism

An ethical theory that judges whether or not something is right by its outcome.

‘Does this action lead to good outcomes?’

theory: deontology

An ethical theory that uses universal rules to distinguish right from wrong.

Sometimes “Deontology” is called “Deontological ethics” or “Kantianism”

“Lying is wrong no matter what’

theory: utilitarianism

The most ethical choice is the one that will produce the greatest good for the greatest number

Jeremy Bentham

theory: virtue ethics

highlights character.

“Does Batman want to be the kind of person who takes his enemies’ lives?”

theory: natural law theory

good moral action can not be reduced to following a checklist or producing good outcomes.

Natural Law Theory says that right and wrong can be discovered by looking at what is natural, rational, and fulfilling for human beings.

~"Some things are just naturally right or wrong. Human reason can figure out what they are.”

theory: contractarianism

Assumes individuals can benefit from cooperating with one another

theory: ethics of care

values emotional responsiveness, empathy, and care as important ethical considerations, as opposed to conventional bioethics that often neglects the importance of emotions and relationships.

4 Principles of Bioethics (Beauchamp & Childress) are…

Respect for Autonomy, Nonmaleficence, Beneficence, Justice

. Respect for Autonomy: liberty-no controlling influences, agency-self-initiated intentional action

. Nonmaleficence: do no harm

. Beneficence: do good

. Justice: treated according to what is fair, due, or owed.

The Nuremberg Trials / Nuremberg Code

. trial: individuals can be persecuted under international law for crimes against humanity even if they were just following orders

. code: from trials; a set of ethical guidelines for medical research involving human subjects. focused on subjects’ rights

used for nazi officials in holocaust

Hippocratic Oath

. do no harm

. foundational text in medical ethics, outlining the obligations and responsibilities of physicians, emphasizing patient care, confidentiality, and avoiding harm

Declaration of Helsinki

focuses on obligations of the physician-investigator to research subjects. still did not have an global enforcement mechanism...

Institutional Review Board (IRB)

committee that reviews research involving human participants to ensure it is ethical and that participants’ rights and welfare are protected.

Historical Abuse: U.S. Public Health Service Untreated Syphilis Study @ Tuskegee

low-income black men from alabama were told they were recieving treatment for “bad blood” but were given a placebo. even after penicillin was discovered they were not given it.

Historical Abuse: Guatemala Syphilis Experiments

american researchers infected prisoners (with $100 bribe), sex workers (without consent), and other individuals (orphanages and psychiatric hospitals) with syphilis and gonorrhea, and left without treating them.

Historical Abuse: Radiation Experiments

. human subjects were intentionally exposed to ionizing radiation without their knowledge or informed consent. prisoners, pregnant women, and children.

Historical Abuse: Willowbrook Experiments

Purposely infected developmentally delayed children at Willowbrook Mental Hospital with hepatitis to examine its effects in the body, parents consented but were pressured

vulnerable populations

Children, prisoners, pregnant women, mentally disabled persons, and economically or educational disadvantaged persons

What policy activities/regulations followed U.S. Public Health Service Untreated Syphilis Study at Tuskegee?

National Research Act: formalized a process to oversee human subject research and authorized the NIH & FDA to develop human research regulations.

Belmont Report: respect for persons (informed consent), beneficence, justice

Common Rule: set of regulations that applies to all research involving human subjects conducted or supported by the federal government. IRB requirements, informed consent, assurances of compliance

informed consent, broad consent

Informed consent: give all the information subject needs to make a free and knowledgeable decision about whether to participate in research or treatment

Broad consent: type of informed consent, allows researchers to ask for your permission once to use your data or samples in multiple future studies, rather than asking again each time a new study begins.


capacity, comprehension, voluntariness, authorization

HeLa case info (legality, NIH guidance, what happened)

what happened: took a sample of Henrietta Lacks's cancerous tissue without her knowledge or consent. distributed the cells to researchers around the world.

legal at the time?: technically yes, this was before the national research act

NIH guidance on sharing sequence data: family acknowledgement

What qualifies as human subject research?

living and identifiable

Consequences of improperly reporting or IRB approval for human subject research?

. Research may be retracted from publication

• Institution risks losing its federal research

authorization

• Investigator may be barred from receiving

federal funding

• Legal liability in cases involving harm to

participants

Can common rule be revised?

Yes

What are some legal obligations to protect human subjects?

any information, biological or reported, if it can be linked to an identifiable individual is human subject research

What are the ethics of ancient DNA research?

as long as its not identifiable and the individual died a long time ago

define eugenics and its assumptions

“perfect people” some traits are better than others.

Assumes a hierarchy of people determined by genetics.

Assumes hereditary component of less desirable traits.

who was eugenics coined by?

Francis Galton (1883)

Eugenics was supported by…

major U.S. institutions, in popular press, and was a defining idea of the 20th century

eugenics connection to IQ tests?

prove that some peeople are genetically “feeble-minded”, intelligence is hereditary

eugenics connection to “Fitter Family” contests?

perfect families, ranked higher than others, should be allowed to reproduce

eugenics connection to Human Betterment League?

forced sterilization of individuals deemed "unfit" or "feebleminded"

eugenics connection to Jukes Family case?

followed a family tree of criminals, argued that bad deeds are hereditary

positive vs. negative eugenics

positive: breeding for advantage (“fitter family” contests)

negative: eliminating undesirables (forced sterilization)

Which state was first to legalize the first compulsary sterilization law in the U.S.?

Indiana

How many people were sterilized in the USA between the 1920s-1970s?

64k

Which state led the nation with the most sterilizations?

California, 20k

Buck v. Bell (1927)

carrie buck was deemed feebleminded, her mother was in an asylum and they said her child was deemed feebleminded too at 7 months. she was the first to be sterilized in virginia.

landmark decision; effectively legitimized eugenic sterilization laws across the United States

HAS NOT BEEN overturned

The desire to restrict immigration (immigration act 1924) is proposed to support…

the eugenics movement in the U.S.

What was the U.S.’s eugenics influence on Nazi Germany & Aktion T4?

Nazi Germany: sterilization practices.

Aktion T4: campaign of mass murder (“mercy killing”) by involuntary euthanasia in Nazi Germany. “Life unworthy of life”

What happened to the eugenics movement after the holocaust?

. public opinion shift of eugenics (making it more toxic than desirable)

. there was still continued sterilization practices post-WWII.

what was hypothesized to drive eugenics thinking after ww2?

population control, welfare policy, state institutes (psychiatry and prisons)

who did eugenicists target 20th century? what did this align with?

. Latinxs (forced sterilization of 1/3 of women in Puerto Rico),

. Native Americans (Indian Health Services),

. African Americans,

. poor whites and people with disabilities

. aligned with discriminatory immigration legislation and Civil Rights/Welfare Rights

why did eugenics sterlization decline in the 1970s?

exposure, four principles of bioethics, rise of civil rights movements

restorative vs. reparative justice

restorative: SYSTEMIC; HEAL RELATIONSHIPS. repairing the harm caused by criminal behavior through a process involving the victim, the offender, and the community. Reconcile and restore relationships, rather than focusing solely on punishment (criminal justice system)

reparative: RESTORE TANGIBLE LOSSES. making amends for harm done, primarily through compensation or restitution to victims.

why does eugenics fail scientifically?

• complex traits are polygenic; controlled by multiple different genes impossible to “breed out”

• selective breeding makes a population less diverse

• environment matters more than genes

• what constitutes an “ideal population?”

genetic determinism

Implies that knowing someone's genome tells you who they will become

is race a social construct?

yes, humans are very similar in DNA (99.9% identical)

techno-eugenics

•Refers to the use of advanced biological and reproductive technologies to select, screen, or modify the genetic characteristics of future people.

•Pursuing goals that are structurally continuous with historical eugenics, but through technological means and individual market choices rather than state coercion.

definition and ethics of preimplantation genetic testing (PGT)

definition: technique used during in vitro fertilization (IVF) to screen embryos for genetic abnormalities before they are implanted in the uterus.

“It’s one thing to screen for conditions like Type 1 diabetes; it’s quite another to go looking for the embryo deemed most likely to clear six feet and test into the Ivy League.”

concept of pronatalism

declining fertility in “developed” countries; we must have “genetically superior” babies (that can be engineered)

what is DNA fingerprinting?

RFLP analysis

Discovers that each human being had unique DNA, except in the case of identical twins.

focus on specific, unique regions of DNA that show much person-to-person variability,

DNA typing becomes not simply a method for exclusion or inclusion, but a means of absolute identification.

What are short tandem repeats (STRs), and why are they useful for fingerprinting?

An STR is a region in the genome that has multiple copies, in tandem, of a short sequence

Variable Number of Tandem Repeats (VNTRs)

unique to individuals

DNA fingerprinting can help with ______ and _______

. matching (like paternity testing)
. exoneration of a suspect using DNA

Why do we need standards to ensure confidence in testing results?

false positives put innocents in jail

OJ case

watershed moment leading to increased public awareness, improved forensic practices, and broader acceptance of DNA evidence in courts

CODIS pros and cons

PROS

1. Controlled access to database of DNA profiles

2. Fast, cheap, easy assay to develop DNA profile

3. Simple hit/no hit results

4. Hit is generated in ~30% of searches.

5. broadens the ability to identify a suspect, more so than DNA fingerprinting

CONS

1. No investigative direction if no hit.

2. Assay fails for degraded samples

Maryland v King Supreme Court case

buccal swab to harvest an arrestee's DNA is comparable to fingerprinting

forensic genetic genealogy (FGG)

ancestry data bases when CODIS fails

surreptitious DNA collection

the unexpected or incidental gathering of DNA evidence that proves useful in criminal investigations or solving cases.

GINA: Genetic Information Privacy Act: Imposes restrictions on the collection, use, and sharing of genetic information. This includes prohibitions on collecting a person’s genetic information without their explicit consent, making it illegal to surreptitiously collect DNA, such as by taking a toothbrush from someone's trash to extract DNA without their knowledge

what are the concerns over the use for “Snapshot” technology to provide leads vs evidence?

exacerbate racial profiling among law enforcement agencies and infringe on privacy; wrongful accusations

somatic vs. germline

Somatic (non-heritable) (fetus, adult, baby, etc) vs. Germline (HHGE-Heritable Human Genome

Editing) (heritable) (sperm/egg)

CRISPR-Cas9

A tool with “considerable potential” to edit the genome with ease. cut and repair.

inexpensive and easy to experiment with.

accurate and safer and more accessible than gene editing devices that came before.

limiting the frequency of genes in the population can…

use alternative screening (vs. editing) options, like letting couples know they have the recessive allele or using technology like preimplantation IVF.

2018 germline editing of twins to prevent HIV: justified? reactions? criticisms?

was it scientifically and ethically justified? Public and scientific reaction before/after the announcement

Understand the criticisms: safety, efficacy, consensus, is it a necessity

Criticized for skipping safety tests and failing to follow proper procedures when recruiting participants—on top of using germline editing.

germline-edited embryos to produce a pregnancy: legality

Germline editing and implantation to give birth to an edited child is not permitted clinically in any country (due to unresolved safety, ethical, and policy issues).

although germline editing research can be supported with non-federal funds, that germline-edited embryos to produce a pregnancy has no pathway to FDA approval.

based on NASEM reports (2017, 2023) and WHO that there is support for additional research and dialogue (not a hard ‘no’ to germline editing).

disability rights critique to gene editing (e.g., editing for deafness or autism)

•Editing out disability-related traits can send a message that people with those traits are less valuable or should not exist.

•Gene editing may focus too much on "fixing bodies" instead of improving inclusion.

•Selecting against disabilities may resemble past eugenics movements, raising fears about who decides which lives are worth living.

•Disability communities emphasize the need for their voices in decisions about genetic technologies that affect them.

unlike germlineiediting, somatic editing…

has over 20 years of regulated research and some FDA-approved applications

first crispr medicine?

Victoria Gray’s sickle cell trial (CRISPR approved by FDA) casgevy

off-target effects

cuts can happen outside of target genes, causing unwanted effects and changes to DNA

challenges with prenatal somatic genome editing

legal blocks, off target effects, unintentional germline transmission

Evaluation criteria for FDA

safe and effective, and requires a preclinical testing phase

Goal is to establish the desired activity and safety of the drug or therapy before testing in humans.

• Experiments may be done in tissue culture and/or animal models

• Development of methods for manufacturing and formulating the drug on a commercial scale

• Intellectual property analysis

how many phases of clinical trial? how many make it past phase 1?

3; 10%

define human dignity using Kantian Deontology, Natural Law Theory, and Capabilities Approach

The idea that every person has inherent worth simply by being human, and must be treated with respect, care, and moral consideration, regardless of their condition, status, or capacity.

kantian (deontology): humans have inherent worth because they are rational beings

natural law theory: image of god. dignity is grounded in shared human life, nothing else

capabilities approach: Human dignity is grounded in the ability of every person to flourish, function, and exercise central human capabilities

human dignity and human rights

human dignity is the moral foundation and that human rights are the legal and ethical structures built upon it

Universal Declaration of Human Rights (UDHR)

. declaration, not legally binding

•Serves as a moral and political standard for all nations

•First global consensus on human dignity and rights after WWII

. universal, inalienable, and indivisible rights that serve as a moral and legal basis for promoting and protecting human dignity, equality, and justice.

. possessed by all individuals by virtue of their humanity.

. envisioned as a foundational document that would articulate shared values to guide international law, national constitutions, and social progress.

what 2 covenants did UDHR give rise to?

. International Covenant for Civil and Political Rights

. International Covenant on Economical, Social and Cultural Rights

egalitarianism

moral commitment that people are fundamentally equal and deserve equal rights, opportunities, and status

distributive justice

Seeks to ensure fair and equitable distribution of resources. How should a society actually allocate rights, opportunities, wealth, and burdens among its members?

veil of ignorance

proposes that when designing a society's rules, people should be unaware of their own, or anyone else's, future social status, class, gender, race, or talents, ensuring impartiality and fairness.

environmental ethics: why is it relevant to bioethics?

social determinants of health

medical ethics vs. public health ethics

Public health considers economic, social, and environmental factors that influence health at a community.

Medical ethics often concentrates on direct patient care issues.

environmental justice & environmental racism

A form of systemic racism where communities of color are disproportionately burdened with environmental hazards (e.g., living near toxic waste sites, breathing polluted air), leading to worsened health outcomes.

The fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to environmental laws, regulations, and policies.

social determinants of health (SDOH) , SDOH hubs , how does this apply to flint water crisis?

Health is More Than Healthcare: social factors such as income, education, and environment impact health outcomes.

Health disparities are not random; they are patterned by social structures like racism, classism, and historical injustices.

Requires interventions beyond healthcare: e.g. minimum wage, education access, housing laws, etc.

Flint switched its water supply to the Flint River to cut costs. The water was not properly treated, leading to lead contamination. The crisis was not random or natural

SDOH Hubs are designed to address non-medical factors influencing health, such as housing, education, and food security. connect individuals to community resources

anthropocentrism

humans only hold moral standing

sentientism

only sentient beings hold moral standing

biocentrism

all living things hold moral standing

ecocentrism

the entire environment, living and non-living, holds moral standing

aldo leopold’s land ethic

emphasized the need for humans to recognize their ethical responsibility towards the land, to understand the interconnectedness of ecosystems, to act as responsible stewards, to promote a conservation ethic, and to shift from an anthropocentric perspective

animal welfare act of 1970

sets standards for the humane care and treatment of animals in the U.S

pet stealing for experiment: response

covers six species: dogs, cats, nonhuman primates, guinea pigs, hamsters, and rabbits

intergenerational justice

The ethical obligation to consider the rights and health of future generations when making decisions today. Especially important in areas like pollution control, biodiversity conservation, and climate change mitigation.