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- 40 BC first ethical code - described: Importance of sharing, beneficience, non-maleficience, confidentiality, caution against invasive procedures, honesty and devotion |
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-in concentration camps -research on prevention of malaria, typhus, weapon development, fighting strength, human survivability -codes are needed |
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- 1st international code of ethics adopted after Nuremburg trials - Informed consent, Scientific Validity of proposed study, reponsible/medically qualified managemnt - review system and exceptions not stated |
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Second Sino-Japanese Way and WWII |
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- local branch of the Japanese Army Epidemic Prevention Research Laboratory -Subjects called "logs of wood" |
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Military Research in the US in 1940's |
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- 1941 President Franklin Roosevelt est. Office of Scientific research and development - studied/developed therapies for pathogens and developed biological/chemical warfare ie anthrax/mustard gas - Prisons and mental institution people |
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Military research 1940's justification |
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Soldiers are fighting enemies, compelled to risk death; researchers fightint diseases to help win victory - ppl can help by testing vaccine |
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WMA, The Declaration of Helsinki 1964 |
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- informed consent, exceptions for sick people/incompetent persons (proxy consent) -for both therapeutic and non -less restrictive, percieved more as a guide - amendment 1975: research projects should be reviewed by a specially appointed ind committee prior to initiation |
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Human Radiation Experiments 1945-1970's |
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- Manhattan project conducted studies on the effect of nuclear radiation on humans; injected with plutonium or uranium nitrate w/out IC - Albuquergue Tribune ran article "The Plutonium Experiment" |
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Government Standards for Human Experiments until the 1950's |
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- no unified regulation - Nuremburg code drew little attention because so strict - Human radiation experiments classified until late 1980's |
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-Free samples of thalidomide distributed in Europe, seemed to be safe, said to prevent seizures, as a sedative, soothe morning sickness -Birth defects reported all over -Happened because current rule by Fed food, drug and cosmetic act: medication must be safe but proof of efficacy not required and "investigational" use of drug prior to approval was allowed |
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Kefauver-Harris Amendments 1962 |
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- the drug amendments -included proof of efficacy requirement |
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-chimpanzee to human kidney transplant at Tulane University -researchers claimed they recieved IC but not peer review |
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Jewish Chronic Disease Hospital Case 1963 |
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-injected elderly patients with live cancer cells without their consent and w/out peer review |
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Willowbrook Hepatitus Study 1963-66 |
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- inmates at Willowbrook State School for mentally retarded children injected with live virus preparations -Manipulative language used on parents -individual interviews for informed consent soon after became required for participation |
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Tuskagee Syphilis Study 1932-1972 |
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-399 African American males with syphilis observed w/out being treated to observe syphilis from the beginning of the disease until death - led to National Research Act |
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National Research Act 1974 |
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- Institutional Review Board system legislated (IRB) -Est. National Commission for the Protection of Human subjects of Biomedical and Behavioral Research |
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Institutional Review Board |
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Definition
approves, requires to modify, or disapproves research projects by investigating 1) if risks for human subjects are minimized 2) if risks are tolerable in view of the expected social/individual benefits 3) if no-coerced, fully informed consent obtained 4) subjects confidentiality 5) human rights |
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- issued by National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1) Respect for persons- IC 2) beneficience- assessing risks and benefits 3) Justice-consider fair procedures and outcomes in the selection of reseach subjects |
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- Informed consent - Exceptions - International Review Board - Common rule |
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- obtaining/documenting of IC and IRB requirement - considerations for research using especially vunerable subjects -applied to most research invovling human subjects sponsored by the fed |
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IC in Medical treatment (therapeutic IC) |
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a patient must be informed of, and fully understand, his medical condition and the medical treatments/procedures proposed to him, and to decide and consent to recieve those treatments /procedures |
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IC in Biomedical Research (Research IC) |
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For a research subject/participant to be informed of, and fully understand, the biomedical research/experiment that will be done to him, and to decide and consent to participate in that research and experiement |
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Research Informed Consent- three goals |
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Definition
1) developing new effective therapies, technologies, or other devices that may (hopefully) benefit people including the subjetcs involved 2) promotes scientific knowledge that will eventually benfit future patients 3) for scientists to publish research papers |
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Possible Exceptions from the Doctrine of Informed Consent |
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Definition
- incompetent persons-proxy consent - double-blind randomized placebo controlled clinical trials in which study becomes meaningless if all participants know exactly what will be done to them -epidemic or large scale population study -research using biological samples, researchers cannot precisely describe how far samples used |
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encouraging "talented" people to reproduce |
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discouraging or preventing "unfavorable" people to reproduce |
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non-coercive, non-totalitarian, Personal reproductive "choice" |
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- respect for pluralism vs. power game - "mid-level" principles vs. random choice on each occasion or dead end |
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Egoism - Thomas Hobbes Natural Condition and Human Nature |
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Definition
1. Natural Condition: one's mind contains no sense of morality nor are there social rules guiding 2. Human Nature: equality in physical/mental abilities, equality of hope in attaining one's ends |
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Hobbe's Theory The Rights of Nature and the Law of Nature |
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"The Rights of Nature": liberty that one will take any measure to preserve one's own life Law of Nature: a self-regulatory rule that prudent persons would stipulate in the natural condition |
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Fundamental Law: one ought to endeavor to attain peace,as far as one has the hope of obtaining it 2nd law: one ought to give up part of one's liberty to realize peace/defend oneself; ought to be content w/ limited liberty 3rd Law: ought to perform covenants one makes with others |
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Definition
- competition, distrust, glory=war of everyone against everyone
- determined to set up/maintain morality
- Basic view of humans: egoistic beings with some ability of rational reasoning
- view of morality: one observers morality because it will ultimately be in one's own interest
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- Inquiry in the "reason" that all humans share
Two Assumtions: 1) every human endowed with the faculty called reason 2) an individual must develop this faculty of reason |
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Kant's "universal" principle and reason |
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- a principal which is not whimsical/transient but applies to all similar situations
- not dictated by others/comes out of own will
- humans have reason and because of that they too should be perfected through trial and error
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desire: spur of the moment, often motivated by one's non-rational behavior duty: universal because it dictates what one ought to do every time their in similar situation/ not dictated by others |
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Kant's Supreme Moral Principals : Formula of Universal Law and Formula of an End in Itself |
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Formula of Universal Law: act in a way that could also be constituted as a universal law Formula of an End in itself: when working with another do it out of a sense of duty never merely as a means to something else |
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People should not be motivated by happiness but the happiness of others; respecting others in encouraging their happiness |
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- a morally right action is one that will bring about maximum good for the maximum amount of people affected
- thoery determines future actions only
- inaction is considered an action
- what one ought to go depends on consequences of feasible alternatives
- the better the consequence=more ethical. morally right act is one that maximizes happiness
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method applied to the rightness or wrongness of each individual action |
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used to determine general rules for morally right actions |
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justifies certain general rules for ordinary use; decides particular action when a person has time to do so or in case of conflict |
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Average Utilitarianism vs Total Utilitarianism |
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Av: maximizes average of people's happiness Total: Maximizes sum total of people's happiness or satisfaction |
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Five Features of Utilitarianism |
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1. Consequentialism: considers consequences to determine rightness 2. Pleasure: The ultimate good in pleasure and nothing else 3. Reductionism of "public good": public good is made up of the good for each individual and of nothin else 4. Impartial Consideration for all parties affected 5. Maximization principle |
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Common Misundertanding of Utilitarianism |
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Definition
1. confusion with egoism (they're not scheming) 2. narrow interpretaion of pleasure 3. confusion with retrospective judgement 4. narror interpretation of consequences (include what affects other people) 5. not majority vs. minority but alternatives vs. consequences 6. "greater good" not about social good or nation's good but people's happiness |
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John Rawl's Critique of Utilitarianism |
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1. the basic liberties and basic rights of each person override the sum of people's overall happiness 2. A balance of interests among different individuals is impossible |
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- A hypothetical situation where all natural/social contingencies are eliminated
- naturally egoistic persons with a purpose to set up society without any info about themselves [veil of ignorance]
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- people know the basic info about people (differences, limited resources, sim needs, equal in ability) - don't know social status or generation - people will make rational decisions based on the maximin rule; choose the alternative with the least worst consequences |
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Rawl's Two Principles of Justice |
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First: each person is to have an equal right to the most extensive basic liberty compatible with a similar liberty for others Second: social and economic inequalities are to be to everyone's advantage - to max the expectations of those most disadvantaged (diff principle) -attached to positions and offices open to all (equal opportunity principle) |
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Basic claims of Virtue Ethics |
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- virtue: character trait that can be cultivated; more important than individual actions - not concerned with duty or what is "right" but with what is truthful or honest - an action is right if it is what an agent with a VIRTUOUS CHARACTER would do |
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philosophical analyses of moral terms and judgements |
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Term
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the main function is to describe what it is, or what it is like. One can explain its meaning by indicating a corresponding object thus its meaing is expected to be objective in the sense that it is understood by everyone in the same way |
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the main function is to recommend or to prescribe something. Such a recommendation or prescription reflects a preference or a value-judgement of the person uttering the statement |
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4 Principles of Biomedical Ethics |
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Definition
- Respect for Autonomy
- Beneficience
- Non-maleficience
- Justice
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4 Principles of Research Ethics |
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- Knowledge
- Necessity
- Benefit
- Consent
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4 Shared values for the Responsible Conduct of Research |
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- Honesty
- Accuracy
- Efficiency
- Objectivity
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- Comlusory Sterilization Law, IN - Immigration Restricition Act - Legislation Concerning Marriage Restrictions |
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