CVB Professional Development Flashcards
Describe the Jewish Chronic Disease Hospital Study (1963)
At the Jewish Chronic Disease Hospital in New York, live cancer cells were injected into chronically ill and debilitated patients who were told they were recieving a skin test.
The purpose of the study was to learn more about the human immune system’s response to cancer
Describe the “Expedited” IRB review category
- Minimal risk, identifiable, more personal information than exempt category
- Reviewed in the office except for vulnerable populations
- If the expeditied reviewer does not approve, the study must go to the full board
What are the basic ethical principles and applications of the Belmont Report?
Ethical principles
- Respect for persons/patient autonomy
- Beneficience
- Justice
Applications
- Informed consent
- Assessment of Risks and Benefits
- Selection of Subject
Which “Regulatory Unit” would be involved in grant submission?
The OSR - Office of Sponsored Rsearch
Describe the “exempt” IRB review category
- Minimal Risk
- Belmont Principles still apply
- Does not apply to FDA regulated research unless it falls under emergency use
What are the 5 roles of the investigator/study team member in obtaining informed consent?
- Ensure that the participant understands all the information
- Facilitate participant’s decision without coercion or undue influence
- Use the most current version of the ICF document
- Answer all the participant’s questions
- Give the participant a copy of the signed ICF document (ensure that it is signed by both parties)
The National Research Act of 1974 was enacted in response to which unethical research study?
The Syphilis Study at Tuskegee (among others)
The Belmont Report was drafted in reaction to which unethical research study?
The Syphilis Study at Tuskegee (among others)
What study prompted the protection of pregnant women and fetuses under the common law?
The study of thalidomide and DES (Diethylsetilbestrol)
Which groups constitute “vulnerable populations” under the…
Belmont Report?
Common Rule?
Belmont Report
- Racial minorities
- The economically disadvantaged
- The very sick
- The institutionalized
Common Rule
- Pregnant women
- Fetuses
- Neonates
- Children
What is an IRB?
An Institutional Review Board is a committe established to review research involving human subjects
What are the 3 basic principles stated in the Belmont Report?
-
Respect for Persons
- Recognizing the autonomy and dignity of individuals
- Recognizing the need to protect those with diminished autonomy
- Voluntariness is important
-
Beneficence
- Obligation to protect persons from harm by maximizing benefits and minimizing risks
- Especially vulnerable populations
-
Justice
- Fair distribution of the benefits and burdens of research
- No populations of convenience
- Equal accessiblity to research
What does the Nuremberg Code state?
The voluntary consent of the human subjects is absolutely essential
What are the general steps for IRB submission at Northwestern?
- PI submits new application
-
IRB analyst pre-review
- Modifications may be required for formal review
- Assigned to reviewer or panel
- Changes may be requested
-
If approval criteria are met…
-
Goes on to post-approval
- Modifications
- Continuing Review
- Reportable new information
-
Goes on to post-approval
What is the significance of the Tuskegee study?
Black male prisoners were subjected to untreated Syphilis for 40 years as part of a research study
This eventually led to the Belmont report, which gives extra protections from research studies to racial minorities, prisoners, the very sick, and the intitutionalized
Describe the “full board” IRB review category
- Minimal risk research that is NOT in the exempt or expedited category
- Research that is more than minimal risk
- Certain research with vulnerable populations
- Children
- Pregnant women
- Prisoners
List the 3 IRB review categories
Exempt
Expedited
Full Board
Informed consent and the ability to consent fall under which principle of the Belmont Report?
Respect for Persons
If a request for an expedited IRB review is not approved by the expedited reviewer, what happens to the study?
It goes to the full board
What kind of FDA regulated research would fall under the “exempt” IRB review category?
Emergency Use
Describe the Willowbrook Study (1963-1966)
At the Willowbrook State School for “mentally defective persons,” studies were conducted to learn more about the transmission and treamtent of hepatitis
- All subjects were children
- Only children whose parents gave consent for participation were admitted to Willowbrook: coercion
- They were deliberately infected with hepatitis by…
- Ingesting stools of infected persons
- Recieving injections of purified virus preparations
What does the Nuremburg Code (1947) establish?
10 directives for human experimentation
It was the first international code of research ethics
The Nuremburg Code was written in response to what?
Nazi Medical War Crimes
Which populations are considered “vulnerable to coercion or undue” influence, according to the IRB lecture?
- Children
- Prisoners
- Individuals with impaired decision-making capacity
- Economically or educationally disadvantaged persons
Note:
- Under the Belmont Report
- Racial minorities
- The conomically disadvantaged
- The very sick
- The institutionalized
- Under the Common Rule
- Pregnant women
- Fetuses
- Neonates
Which “Regulatory Unit” woudl be important in animal studies?
The IACUC - Institutional Animal Care and Use Committee
“Selecting subjects equally” and “sharing benefits and burdens of research between subjects equally” fall under which principles of the Belmont Report?
Justice
What are the 4 major roles of the IRB (Institutional Review Board)
- Reviews and approves research projects involving human subjects or identifiable private information obtained from human subjects
- Assists investigators in planning and conducting experiments in accord with the highest scientific, humane, and ethical principles and in conformity with relevant laws, regulations, and policies
- Liaison between investigators and the federal government
- Safeguards rights and welfare of human subjects
Which “Regualtory Unit” would be relevant to studying recombinant DNA or stem cells?
The IBC - Institutional Biosafety Committee
For IRB approval, what must be done in a study that uses deception?
Participants are fully debriefed if deception is used
“Do not harm” and “Maximize benefit” fall under which principle of the Belmont Report?
Beneficence
Which groups constitute “vulnerable populations” under the…
Belmont Report?
Common Rule?
Belmont Report
- Racial minorities
- The economically disadvantaged
- The very sick
- The institutionalized
Common Rule
- Pregnant women
- Fetuses
- Neonates
- Children
Describe the Syphilis Study at Tuskegee
~600 African-American men were the subjects of a study of the natural history of untreated syphilis
- They were recruited without informed consent
- They were told they were recieving “special treatments”
- They were not treated with the known treatment for syphilis
What “regulatory unit” is relevant to human research?
The IRB - institutional review board
What is the purpose of an IRB?
To ensure that all human subject research is conducted in accordance wiht federal, institutional, and ethical guidelines
