Test 10 Flashcards
What was the Nuremberg Code?
This set of directives established the basic principles that must be observed in order to satisfy moral, ethical, and legal concepts in the conduct of human subject research
what are the 3 ethical principles identified in the Belmont Report?
- Respect for persons
- Beneficence
- Justice
What is an autonomous person?
A person capable of deliberation about personal goals and of acting under the direction of such deliberation
What do you do when there is diminished autonomy?
Give additional protections
What is coercion?
Influencing an individual’s decision about whether or not to do something by using explicit or implied threats (loss of good standing in a job, poor grades, etc.).
What are the two principles of beneficence?
- Do no harm
2. Maximize possible benefits and minimize possible harms
What are the major principles of justice?
The burdens and benefits of research should be fairly distributed among individuals, groups, societies, etc.
What is the definition of a human subject?
A living individual about whom an investigator conducting research obtains
- Data through intervention or interaction with the individual
- Identifiable private information
What is the definition of research?
A systematic investigation designed to develop or contribute to generalizable knowledge
What subjects require additional protections?
Individuals with diminished autonomy
What is mean by a vulnerable subject?
Pregnant women, Human fetuses and neonates, Prisoners, Children, Mentally disabled, Economically and/or educationally disadvantaged
What general questions must be addressed in a research application?
- Risk to the subjects
- Adequacy of protection against these risks
- Potential benefits of the research to the subjects and others
- Importance of the knowledge gained or to be gained
What is exempt research?
Research that is exempt from requirements described in the HHS regulations including IRB oversight
What is meant by respect for persons?
- Individuals should be treated as autonomous agents
2. Persons with diminished autonomy are entitled to additional protections
What are the three fundamental aspects of informed consent?
- Voluntariness
- Comprehension
- Discolsure
When do you get informed consent?
At enrollment and throughout the study
what language is used in informed consent?
Language that is understandable to the subject
What is meant by a waiver of informed consent?
The institutional review board (IRB) waives or alters some or all of the required elements of informed consent
What is meant by practicability?
Not just time and cost restraints
How is informed consent documented?
Written form that either contains all of the required elements or a short form that states that all of the required elements have been presented orally
Can informed consent be waived?
Yes
What is meant by diminished autonomy?
Age, cognitive impairment, illness, and treatments
How do you obtain informed consent from someone with diminished autonomy?
Legally authorized representatives provide voluntary informed consent for individuals with diminished capacity to participate in research
How do you obtain informed consent from a child?
You can’t?
What is assent?
Affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent
Why are prisoners considered vulnerable persons?
They may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research
What is meant by community consultation?
Obtaining informed consent from a community as a whole through meetings with large groups of community representatives or community leaders
What are the 3 guiding practical applications for informed consent?
- Give their consent freely and voluntarily
- Have the decisional capacity to understand the information presented to them
- Be provided with complete information about the study in order to make an informed decision
What are the two principles of beneficence?
- Do no harm
2. Maximize possible benefits and minimize possible harms
What is the definition of a risk?
The probability that a certain harm will occur
What is the definition of minimal risk?
That the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
Who is responsible for protecting participants from risk?
Investigators, Institutional Review Boards, and other members of the research team
What is a benefit?
A contribution of generalizable knowledge about diseases disorders, public health concerns, etc., to society