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48 Cards in this Set
- Front
- Back
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Peter Singer |
Singer argues that the vast majority of animal experiments cannot be justified. They cost in animal suffering, while producing little to no knowledge--- and whatever knowledge they do produce we can retain it in other ways. He argues that our willingness to tolerate such experiments can be explained is our "specism". Singer also explains that many animals are more intelligent than infants and the severely retarded. |
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Research Involving the Poor |
Example) Tuskegee Syphilis Study
- Consent was never given.
- Lack of knowledge.
- They were never told the nature of the study, its risks, and the alternatives were never discussed with them. |
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Research Involving Prisoners |
Some ethicists argued that, to avoid under influence, prisoners should never be promised any substantial advantages for volunteering as research subjects. If they volunteer, they should do so for moral or humane reasons. |
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Guidelines for Children as Research Subjects |
- Permission must be given by the parents and children must give them their assent.
- An institutional review board is assigned the responsibility of considering the ages, maturity, and psychological.
- Children of the state can become participants only if the research relates to their status as wards. |
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Parental Consent |
Parents/guardians have a duty to act for the sake of the welfare of a child under their care. |
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Who is a child? |
An individual who is not capable of deciding whether its in their best interest.
Example) A 16 year old may have more aquisition of autonomy --- self direction and responsibility---- than a 30 year old. |
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What's the significance of the Tarisolf's Case? |
After the case it is now a legal duty to warn anyone in harms way even if it means breaching a patients confidentiality. |
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ECI Principle |
Equal Consideration of Other People's Interest |
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What are two conditions when you do not need consent from a patient? |
1) Minors
2) Emergency
3) Incompetent Patients |
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Why is patient confidentiality important? |
1) Ensure effective treatment.
2) Protect the patient.
3) Trust within the patient. |
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Leading justification for paternalism... |
Best interest for the patient. |
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Why did Jesse Gesler Die? Why was his death significant? |
He was the first person to undergo gene replacement surgery/therapy but ended up dying because of it. |
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Belmont Code |
Code of ethics after the Tuskegee Experiment. |
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Where do we get embryos for stem cell research? |
1) Miscarriages
2) Fertility Clinics
3) Abortions |
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Avoid tissue and organ rejection... |
Use therapeutic cloning to create stem cells that are genetically identical to the tissue/organ recipient, than use those stem cells to grow tissues or organs. |
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Alternative Sources of Stem Cells: |
1) Miscarriages
2) Parthenogenesis
3) Blastomers
4) Cell Conversion |
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Parthenogenesis |
Asexual reproduction |
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Cell Conversion |
Taking an adult cell and converting it into a stem cell. |
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Adult Stem Cells |
Undifferentiated cells in adult organism, 1 of every 1,000 human bone marrow cells is usable as a stem cell. |
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Sources of Stem Cells |
1) Fertility Clinics
2) Aborted Fetuses
3) Immortal Stem Cell Lines |
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Embryonic Stem Cells |
Undifferentiated cells in a blastocysts.
(4-5 days old, 50-150 cells, 15-20 stem cells.) |
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Legally Breach Confidentiality? |
- Protect Patient from Themselves (Suicide)
- Report a Crime.
- Protect Public Health (Health Department) |
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Why are women not as likely to be used for experiments as much as men? |
1) High level of hormones.
2) Reproductive system.
3) Caregiver of the family.
4) "Men are the same but less emotional." |
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What are the ethical considerations of clinical trials? |
Some individuals are asked to accept risk in order to develop knowledge that may not directly benefit them. |
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Are there restrictions on private funding for stem cell research? |
NO! |
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Somatic Cell vs. Germ Line Therapy |
- Somatic cell is any biological cell forming the body of an organism.
- Germ Line Therapy is the introduction of genes into reproductive cells or embryos to correct inherited genetic defects that can cause disease. |
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Gene Therapy |
the transplantation of normal genes into place of missing or defective ones in order to correct genetic disorders. |
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Adequate Disclosure of Information to a Patient: |
1) Purpose
2) Nature
3) Burdens
4) Risks
5) Alternatives |
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What is bioethics based on? |
1) Philosophy
2) Truth
3) Scientific Theory
4) Risks
5) Alternatives |
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According to the principle of utility what is the "utility" or "usefulness" of an action determined by? |
1) Consequences do not matter they're usually out of our control.
2) For action to have moral we must do it out of respect for moral law. |
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The emblem of the way in which the trust of the black patients was taken advantage of and betrayed by the biomedical establishment is what study? |
The Tuskegee Study. |
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In Phase 1 of Pre-Clinical testing why do we use healthy patients instead of ill? |
To determine the tolerance and side effects of the new drug/therapy. |
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Pre-Clinical Testing Phases |
-Phase 0: Baseline data/imaging
-Phase 1: 10-80 healthy participants to determine tolerance and side effects.
-Phase 2: 100-300 ill patients determine the safety and side effects.
-Phase 3: 1,000-3,000 ill participants to confirm safety and effectiveness, and compare to existing drugs/treatment.
- Submit test data to FDA for peer approval and review.
- Phase 4: Collect additional data after new drug has become standard.
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Federal Law on Stemcell Research |
Federal Law on using federal funds to support research that involves the destruction of embryos, but greater support for research on existing stem lines.
In other words: It is illegal to use federal funds for Stem Cell Research. |
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MI Law w/ Stem Cell Research |
MI bans the creation or destruction of human embryos for medical research. |
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Central Ethical Issue w/ Stem Cell Research |
The moral status of the source of stem cells, of human embryos. |
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Dissenting Opinion in Tarasoff (Clark):
Uphold Confidentiality |
1) Lack of privacy will deter people from seeking treatment.
2) Full patient disclosure requires trust.
3) Successful treatment requires trust. |
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Confidentiality as a Prime Faci Ethical Principle. |
Based on privacy and on public health. |
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Researching Children |
Children lack the physical, psychological, and intellectual maturity of an adult. They are not capable of giving informed consent because they do not understand the nature of research and the possible risks to themselves. But if we fail to do research on children the lack of pediatric medicine would disappear. Children are not adults and they cannot take the same dosage of medication that adults take. It can cause serious harm and damage to the child. |
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Off-Shore Research |
During the decade 1995-2005, almost half of phase III clinical trials were carried out other than the USA. The reason being is because it is difficult to get volunteers for the trials and the cost is cheaper to do it in other countries.
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What is the ethical question about Off-Shore Research? |
In poorer countries a little amount of money may seem like a lot to them. |
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What are the other "issues" with off-shore research? |
1) People are not well educated.
2) Bad diets.
3) Vulnerable.
4) Do not understand what the study can cause them and their families. |
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Placebos |
Considered essential to determine the true and effectiveness of the drug being tested. |
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Jesse Gelsinger |
Died in a clinical trial of gene therapy. |
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Medical Research |
Better understanding of the biochemical and psychological processes involved with human functioning. |
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Medical Therapy |
Aims at relieving the suffering of people and restoring them to health.
1) Cure Diseases
2) Correct Disorders
3) Bring about normal bodily functioning. |
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Informed Consent |
The patient fully understands what is being told to them by their doctor/nurse.
No pressure from doctors/family/nurses.
Never second guessing themselves. |
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Single-Blind Study |
The experimenters are the only ones who know what volunteers are going to be in the controlled group and the experimental group.
This gives the experimenter the ability to manipulate the experiment in any which way that he/she wants. |
