Research Ethics Flashcards
What are these:
nuremberg code
helsiniki declaration of the world medical association
belmont report
ethical principles guiding research
What does bad blood mean?
syphilis anemia and fatigue
What was the tuskegee study?
the messed up study about syphilis that was supposed to last 6 months but lasted 40 years and didnt treat the subjects with care to save them even though they could
what happened at the concentration camps?
everything horrible ever. Here are just a few: Bone, muscle and nerve transplantation Sulfonamide experiments Immunization and treatment of malaria Sea water experiments mustard gas poison hypothermia
Tell me about past radiation experiments?
without consent were done on vulnerable individuasl (cancer patients, pregnant women, children, prisoners and military personnel.)
What did the nurembreg code give us?
directives for human experimentation
What does the nuremberg code stipulate?
- the voluntary consent of the human subject is absolutely essential!
- must yield fruitful results fro the good of society
- designed and based on animal experimentation and natural history disease
- conducted to avoid unnecessary physical/mental suffering
- not conducted if a prior reason to believe that death or disabling injury will occur.
- Risk should not exceed that determined by the humanitarian importance of the problem to be solved.
- Protections made to protect subject from even remote possibility of injury, disability or death.
- Conducted only by scientifically qualified persons
- subjects can leave if they wat
- The scientist in charge must be prepared to terminate at any stage if he has “probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the subject.”
What is this:
Legal capacity
Able to exercise free power of choice
Without force, fraud, deceit, duress, constraint or coersion
Sufficient knowledge and understanding
Prior to consenting should be made aware of the nature, duration, and purpose of the experiment, the methods and means, all inconveniences and hazards to be expected, and effects upon health that may come from participation
A nuremberg directive stipulating that the voluntary consent of the human subject is absolutely essential!
What happeed at willowbrook state school in NY?
gave mental retarded children hepatitis
What does the declaration of helsinki say?
- researchers must protect life, privacy and dignity of patient
- well being of human sub. takes precedence over interests of science and society
- vulnerable pops need special protec (eco or med disadvabtaged, those that cant give consent, those that are under duress, those who will no benefit, those whom research is combined with care)
- look at ethical, legal, regulatory requirements here ad i other countries
- no national, ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects
- research protocols need to be reviewed by an ethical committee
Can a parent consent for a child?
only if the child has consented as well.
What is this:
the boundaries between biomedical and behavioral research and routine practice of medicine
assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects
guidelines for the selection of human subjects for participation in research
the nature and definition of informed consent in research settings.
The national commission directives
What is this:
Review of proposed research by an IRB
Informed consent
Fair selection of subjects
Based on respect for persons, beneficence,justice
the belmont report
What principle is 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 principle is 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 principle is this:
Who ought to receive benefits of research and bear its burdens?
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
How can you apply the principles of justice, beneficence and respect for persons?
informed consent
risk/benefit assessment
fair selection of subjects
What are the three requirements for an an adequate consent process?
information, comprehension, voluntariness
When is an IRB required?
for federally funded research, for research that will be submitted to FDA, for all researchers at university
Who is andrew wakefield?
he lied and said that vaccines cause autism, now a bunch of people are getting mumps and measles cuz hes an idiot.
He was hired by a lawyer to basically be corrupt and then illegally and unethically made children undergo a bunch of invasive tests, and then that jerk face patented a measle vaccine after saying that it was causing autism!!!!!! AND he fabricated a ton of data. Then he got is because the courts found him SUPER guilty!
