IRB Basics Flashcards
Ethics and human subject protections; from week 6
What is the purpose of an IRB?
Review research and ensure the rights and welfare of human subjects involved in research are adequately protected
Name five historical events related to the need for an IRB
- Nazi War Crimes (1940s)
- US Human Radiation experiments (1944-1974)
- The Jewish Chronic Disease Hospital Study (1963)
- The Willowbrook Study (1956-1971)
- Stanford Prison Experiment ( 1971)
The Nazi experiments triggered which ethical milestone?
Nuremberg Code 1947
The Tuskegee Syphilis Study triggered which ethical milestone?
National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research 1974
What two works were established by the National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research?
- Belmont Report (1978)
- Common Rule (1991)
The following are key elements of which ethical milestone:
* Voluntary consent
* Anticipate scientific benefits
* Benefits must outweigh risks
* Perform animal experiments first
* Avoid suffering
The Nuremberg Code
The following are key elements of which ethical milestone:
* No intentional death or disability
* Do no harm
* Subjects can withdraw at any time
* Investigators must be qualified
* Research will stop if harm occurs
The Nuremberg Code
Describe the events regarding Henrietta Lacks (1951)
Cells were harvested without permission
Cells were cultured and created first human immortal cell line
Describe the events of the Jewish Chronic Disease Hospital Study (1963)
Patients were injected with live cancer cells
Consent did not include any discussion on the injection of cancer cells
Describe the events of the Willowbrook Study (1956-1971)
“Mentally defective” children were injected with Hepatitis
Parents were coerced into agreeing in order to have their children admitted
Who was responsible for the Tuskagee Syphilis Study (1932-1972)?
Government run project by the US Public Health Service with Tuskagee University
In the Tuskagee Syphilis Study (1932-1972), what was communicated to subjects?
Hundreds of impoverished black sharecroppers were told they were being treated for “bad blood”
By 1947, what was the standard treatment for syphilis?
What treatment was given to those in the Tuskegee Syphilis Study (1932-1972)?
Standard treatment for syphilis was penicillin
Scientists withheld and prevented access to treatment for study subjects
What led to the termination of the Tuskegee Syphilis Study (1932-1972)?
What was the result of this study?
1972 a leak results in study termination
Led to Belmont Report (1976) and development of IRBs
The historical disclosure of the Tuskegee study in 1972 is correlated with…
increases in medical mistrust
How did the Tuskegee study affect life expectancy for black men?
Life expectancy at age 45 for black men fell by up to 1.4 years
This accounts for approximately 35% of the 1980 life expectancy gap between black and white men
The principles of the Belmont Report govern…
all research supported by the U.S. Government
What are the three basic principles of the Belmont Report?
- Respect for persons
- Beneficence
- Justice
What are some aspects of respect for persons?
- Treat individuals as autonomous agents
- Do not use people as a means to an end
- Allow people to choose for themselves
- Provide extra protections to those with diminished autonomy (ie. prisoners, children, cognitively impaired, etc)
The two general rules formulated from the principle of beneficence are:
- Do no harm
- Maximize possible benefits and minimize risks
What are two aspects of justice?
- Treat people fairly
- Fair sharing of burdens and benefits of the research
An injustice occurs when…
- benefits to which a person is entitled are denied without good reason, or
- burdens are imposed unduly
What are two rules derived from the idea of respect?
- Informed consent process
- Respect for privacy
What are three rules derived form the idea of beneficence?
- Good research design
- Competent investigators/researchers
- Favorable risk-benefit analysis
What is a rule derived from the idea of justice?
Equitable selections of subjects
What is the purpose of the Common Rule (1981)?
Describe processes and regulations
Ethics and morality takes “back-burner” and is addressed in the Belmont Report
Name three regulations put in place by the Common Rule (1981)
- Federal Policy for the Protection of Human Subjects
- FDA-regulated clinical investigations
- Responsibility of IRBs that review FDA-regulated clinical investigations
What are three risk categories?
- Exempt
- Expedited
- Full board
A study that is in the exempt risk category does not mean…
exempt from submitting/review
A study that is in the expedited risk category is reviewed by…
the IRB Chair or a qualified IRB member
Which risk category has greater than minimal risk?
What are some examples?
Full board
ie. illegal activities, most prisoner studies, invasive procedures
How are studies approved or denied in the full board risk category?
Studies are discussed during a full board meeting
A vote is taken to approve or deny
Only a full board can deny approval (rarely happens)
What are some examples of exempt studies?
Surveys/interview/focus groups with adults collecting non-sensitive data
Benign behavioral interventions with adults
What are some examples of expedited studies?
Research with drug and device products that is exempt from FDA IND and IDE regulations
ie. Non-invasive collection of saliva, hair, nails, teeth, skin swab, sputum, etc.
In an expedited study, what must be considered when involving venous or fingerstick blood collection?
Frequency, amount, and subject
Risks must be minimal
What are three components of informed consent?
- Information
- Comprehension
- Voluntariness
With informed consent, voluntariness requires…
conditions free of coercion and undue influence
When can there be a waiver of informed consent and HIPAA?
- Retrospective chart review
- Collection of leftover tissue usually discarded
