IRB Flashcards
Who approves and monitors research that involves animals?
IACUC
Who approves and monitors research that involves Biohazards and Recombinant DNA?
Biohazards and Recombinant DNA committee
Who approves and monitors research involving a radioisotope?
Radiation safety committee
Who approves and monitors research involving a controlled substance?
University office of Research and Compliance Officer
Who approves and monitors research involving humans?
The IRB
IRB is…?
An ethics committee composed of scientists and non-scientists. It is charged with the responsibility of reviewing and overseeing human subjects research conducted under the aegis of the university
A project must be both what to require IRB review?
BOTH research and involve human subjects
Criteria for IRB approval
Risks are minimized Risks are reasonable Subject selection is equitable Informed consent is sought and documented Data monitored Privacy protected Safeguards
The 3 basic ethical principles that should govern human research
Respect for persons
Beneficence
Justice
Explain what it means for risks to subjects are minimized
Using procedures which are consistent with sound research design and which do not unnecessarily expose to risk
Whenever appropriate by using procedures already being performed on the subjects for diagnostic or treatment purposes
What are the 2 aspects of Beneficence?
Do no harm
Maximize benefits and minimize possible harms
What are the 2 dimensions of risk?
Magnitude of harm
Probability of harm
What are the 5 types of risk?
Physical Psychological Social Legal Economic
Identify aspects of informed consent
Legal capacity
Exercise free power of choice
Sufficient knowledge and comprehension
What should be made known to the experimental subjects?
The nature, duration, purpose, methods, means, inconveniences and hazards
The duty and responsibility for ascertaining the quality of consent rests upon who?
Each individual who initiates, directs, or engages in the experiment
No informed consent, oral or written may include any…?
Exculpatory language
What legal rights might be infringed by exculpatory language?
- Property rights
- Right to compensation for injuries
- Right to sue
Simplifying the consent form is known as?
Executive summary
What is special about case reports?
They do not strictly meet the criteria of research
Investigations designed to develop or contribute to generalizable knowledge
Research
