Ishibashi: Research Ethics Flashcards
Despite the tortuous/unethical means of early clinical research, what was beneficial about these experiments?
Important knowledge was gained (i.e. most of what we know about the effects of hypothermia was discovered during this time)
What was the Tuskegee study? What were problems with this study?
Purpose: to record the natural history of syphilis, and in the hopes of justifying treatment programs for African Americans.
Conducted without informed consent
They did not receive adequate treatment needed to cure their illness.
Participants never given a choice to quit the study.
The study was meant to last for 6 months, but continued for 40 years.
Even when PCN became the drug of choice for syphilis in 1947, the participants were not offered the drug.
What was one result of the radiation experiments and uranium toxicity incidences in the US in the mid 1900’s?
Ex: Government knew that miners were exposed to high levels of radon, but failed to act/warn them.
a legacy of mistrust of the government
Set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners
Nuremberg Code
What happened at the Willowbrook State School following the establishment of the Nuremberg Code?
mentally retarded children were exposed to hepatitis in an attempt to track the development of the viral infection
What was administered in 1964 to establish the following:
Duty of physician in medical research: promote and safeguard the health of the people and protect life, privacy and dignity of the human subject.
Well-being of the human subject takes precedence over the interests of science and society.
There are vulnerable populations that need special protection.
Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements.
Declaration of Helsinki
T/F: According to the Helsinki Principles, minors participating in studies must give assent in addition to consent from their parents.
True
What was the turn-out of the Tuskegee study?
The study was deemed to be ethically unjustified. It finally came to an end, but 28 men had died, 100 others died due to syphilis related complications, 40 wives had been infected, etc.
What came out of the National Commission, and became a key document in human research ethics regulations?
the Belmont Report
3 principles of the Belmont Report?
Respect for persons
Beneficence
Justice
What’s this?
Individuals’ autonomy should be respected
Persons with diminished autonomy are entitled to protection.
In research involving human subjects
Subjects enter into research voluntarily and with adequate information.
Respect for persons
What’s this?
Physicians have an obligation to secure their subjects well-being
“Do no harm”
Maximize possible benefits and minimize possible harms
Investigators are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from research investigation.
Beneficence
What is this?
Selection of research subjects to protect vulnerable groups.
Avoid providing advantages only to the wealthy
Avoid use of subjects unlikely to benefit in subsequent applications of the research.
Justice
In conformed consent, how much information is needed?
Standard of the “reasonable volunteer” - give as much info such that the participant can decide whether they wish to participate in the furthering of knowledge
