Overview of Bioethics-p.2
Bioethics-what is ethical/unethical and what are the consequences
-ethical implications of certain medical procedures
-new medicineànew consequences
-technologyànew txàconsequences the law must deal with
Bioethics usually steps in here/is it
ethical to move forward with the
new tx from the technology?
-ex: create human from stem cell-who owns the human?
-can you harvest the parts?
-is it murder?
-5 principles involved (1-5) are ethical arguments:
1)autonomy/self-determination-who’s autonomy or self-determination?-ex: I want to create a new person for my spare parts
-govt and ethicists should do nothing to impair my autonomy or self-determination
-also issues of informed consent and tort issues
-ex: gene selection when having kids
2)nothing negative should be done to one person’s body for the sole benefit to help some other person
–no harmful tx
3)beneficence- you should do everything that helps me that does not hurt/harm another person
4)utilitarian notion-do the greatest good for the greatest # of people
5)objectification-do nothing to a human that would objectify him/her
-ex: clone a human for use as body parts
Every time a new technology is created and offered as a new medical txàthese (5) principles above are called into play
The new technologies may lead to new consequences the law may not be able to deal with
Ex: who is the mom—egg donor or gestational mom?–>surrogate mother may have rights above the natural mother??
What rights do sperm donors have?
Law in place to deal with consequences- what are the arguments that can be made based on legal theory in order to argue for/against a particular medical tx?
Concerned with exploitation of the poor
Chapter 1–Introduction to Research Bioethics-p. 190
Govt Support for Research
What has happened with human experimentation to spawn bioethics?
-most historically without pt’s informed consent
-2 examples from book:
1)injection of cancer cells into healthy person to see how it grows
2)Tuskegee syphilis experiments
3)what Germans did to the Jews
-experiments done by govt and private organizations
Debate-experiment to increase knowledge-subjects historically vulnerable (prison, minorities, women, poor) and haven’t been allowed informed consent
Chapter 2—Research Involving Human Subjects-p. 198
80% of federally funded research comes through the National Institute of Health, a subsidiary of the Department of Health and Human Services
US came up with Rules to govern human experimentations:
1)Belmont Report (1979)-p.201
-series of principles
-says if govt institution receives private $$ in addition to govt $$, the private funded research must conform to govt standards
-medical malpractice vs. research:
-Medical practice-medical tx including clinical innovation
-Belmont Rule and Common Rule don’t apply—and only prohibition is malpractice law
-given primarily to treat the pt’s condition and not to gain knowledge
-don’t have to inform the pt as you would have to with research
-Research- if this and federal funding, then Belmont and Common Rule apply
-primarily to increase the body of knowledge to help future pts
-is this geared to help this particular pt? if yesàmedical practice and not researchàno Belmont of Common Rule
-is it medical tx?
-clinical trials of drugs may be practice and research
-principles: 1)respect for persons-autonomy and self-determination
-person should b
riting unless institution waives the written requirement
-problems with the Common Rule-education level of subject-informed consent may not be voluntary because don’t understand the info
-provision to allow incompetent people to have a surrogate decision maker (could be a good or bad person) to confer consent
-compensation not required and does not require that persons injured during the experiment be compensated to pay for expenses
-***subjects normally compensated for participation
Purpose-stop research abuse through 2 principles:
1)experimentation should be voluntary
2)risk/harm of experimentation should be minimized
Belmont Rule and Common Rule
Only applicable to federally funded research…not to privately funded research
-state law regulates privately funded research
An improvement, but still some acts of taking advantage of subjects (is voluntary participation and minimal risk enough today?)
Prisoner research-now very restricted to research involving ailments/problems facing the prisoner population, even if not that particular prisoner
-major criteria: are they being coerced by the prison?
Pregnant women-p. 238
-should we allow them to participate?
-should we allow child bearing age women to participate?-autonomy
-you need everyone to participate because need to know effects on all groups
**Societal issues about should vulnerable groups participate