Module 3 Flashcards
Ethical Issues in Research
Why are ethics discussed?
- It is part of responsible and accountable scientific inquiry.
- It balances the pursuit of knowledge and the well-being of individuals/society
When did the Nazi Germany experiment happen?
During WWII
What happened to the prisoners of the Nazi Germany experiment? (Give examples)
They were tested without an objective. (Mass sterilization, twin experiments, freezing, high altitude, gangrene [dead tissue disease], malaria, mustard gas and seawater [drinking])
What did the Nazi Germany experiment lead to?
Nuremberg Code of 1947
What does the Nuremberg Code of 1947 state?
- Must have voluntary consent
- Results must benefit society
- Based on sound rational
- Avoids harm (mental and physical)
- Benefits outweigh risks
- The subject can stop whenever
- Must be qualified
- Must stop the study if it causes harm
When did The Declaration of Helsinki become published and what is it focused on?
Established in 1964; More focused on clinical research compared to Nuremberg Code of 1947
What does The Declaration of Helsinki state?
Research protocols should be reviewed by an independent committee.
When did the Tuskegee Syphilis Study start and when was it exposed?
1932 and 1972
What was wrong with the Tuskegee Syphilis Study?
- No informed consent
- Told they were being treated
- No treatment after a cure was discovered
How was the Tuskegee Syphilis Study ruled?
- Unethically justified
- Results were NOT greater than risks
What was a direct result of the Tuskegee Syphilis Study?
The Belmont Report
What does the Belmont Report deal with?
Human Subjects
What are the three basic principles of the Belmont Report?
- Respect for Persons
- Beneficence
- Justice
What does respect for persons mean?
- Right to decide
- Cannot be coerced
- Right to know EVERYTHING
- Individuals with mental barriers are protected
What does beneficence mean?
- Do no harm
- should NOT be at a disadvantage after the study
- Studies can be uncomfortable, but not harmful
- If there is a “best” option, everyone gets it
What does justice mean?
- Right to fair treatment
- Right to privacy
- All benefits should be shared
What is confidentiality in relation to the Belmont Report - Justice?
The researcher knows you, but no one can access your data.
What is anonymity in relation to the Belmont Report - Justice?
Your data cannot be traced back to your name. (The researcher does not know who you are)
What happened in the Minnesota Starvation Study?
- Young men who objected to the war were studied (they volunteered)
- The study was a year long
Describe what happened during each section of the Minnesota Starvation Study.
- First 3 months = Stabilized to correct weight
- Next 3 months = Severe Caloric Restrictions ( lost 25% of their weight)
- Last 3 months = Recovery
Who was studied in the Willowbrook Hepatitis Study and what was done to them?
- Children from the Willowbrook State School for special education
- They were infected with live hepatitis to develop a vaccine
Why did parents give consent for the Willowbrook Hepatitis Study?
It guaranteed their child would get into a facility.
How did researchers justify the Willowbrook Hepatitis Study and what were the results?
- Most of the children would get the disease anyway and they assumed the vaccine would outweigh the harm
- Discovering type A and type B hepatitis
What happened to Henrietta Lacks?
- She had Cervical Cancer
- She was admitted to John Hopkins
- Her cervical tissues were removed for samples and then kept for research without her permission
Describe Henrietta Lacks’ cells.
- The cells would continue to produce
- This helped for cures and research purposes
- Known as HeLa cells
What research did the HeLa cells help with?
- Polio Vaccine
- Cancer research
- AIDS research
What types of questions were raised because of what happened to Henrietta Lacks?
- Informed Consent
- Autonoym and Privacy
- Exploitation
What does the institutional board of review do?
They are the process of getting studies and research approved
What does research training mean?
- Everyone must go through training
- Everyone must be qualified
- CITI Training
Describe informed Consent
- 82 pages long
- Fair explanation of procedures
- Description of risks and discomforts
- Disclosure of appropriate alternative procedures
- Offer to answer any inquiries
- Instruction that the participant is free to leave at any time
What should participants expect?
- Right to privacy and non-participation
- Right to remain anonymous
- Right to confidentiality (HIPPA)
- Right to experimenter’s responsibility
Who is considered vulnerable participants?
- Pregnant women and fetuses
- Minors
- Prisoners
- Persons with diminished mental capacity
- Persons educationally or economically disadvantaged
What is the definition of a vulnerable participant?
Any individual who cannot fully consent to participate in a research study and may be at higher risk of exploitation in research
What does The Guide for the Care and Use of Labor advocate?
- The design and performance of procedures based on relevance to animal health, advancement of knowledge, or good of society
- Use of appropriate species, quality, and number of animals
- avoidance/minimalization of discomfort, distress, and pain concerning the sound of silence
- Appropriate sedation, analgesia, or anesthesia
- Establishment of experimental end points
- animal husbandry must be directed and performed by a qualified person
- Experimentation on live animals only by or under the supervision of of qualified and experienced person
