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100
Why are human/animal research NOW regulated?
What is past experiences involving the ill treatment of individuals and animals
100
Due to the past treatment of humans and animals during the 20th century, what code and declaration was created for protection?
What is Nuremberg code (1947) Declaration of Helsinki (1964 and 2002) Based on Radiation Testing (1950s -60s), and Syphilis studies (1950s-60s)
100
What is Name one of the five key components to the Nuremberg Code (1947)?
One of the following: a. voluntary consent of the human subject, b. the experiment should be expected to yield fruitful results, c. all unnecessary physical and mental suffering/injury should be avoided, and d. experiments should not be conducted when there is reason to believe death/disabling risks occur
100
What was created in 1974 as the initial Federal regulation regarding use of human subjects in research?
What is The National Commission for the Protection of Human Subjects
100
In 1991, what common set of regulations for the protection of human subjects was created?
What is "Common Rule."
200
What specific types of subjects are addressed in the “Common Rule?” (name 3)
What is: Pregnant Women, Human Fetuses, Neonates, Prisoners, and Children
200
How does the common rule define research
What is Systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
200
What two categories that qualify some humans to be exempt from formal documentation when researching them? (name 2)
What is a. research in established/commonly accepted educational settings B. researching using educational tests
200
Who determines whether research is exempt?
Who is the IRB
200
How many members must be part of an IRB Board?
What is five.
300
Provide the 3 main principles of the Belmont Report (1979)
What is a. respect for persons, b. beneficence (greater benefit than risk), and c. justice
300
What does FWA stand for?
What is Federal-wide Assurance.
300
What should subjects know about the proposed research and their protection before they enroll as subjects? (Name 4)
What is a. length of experiment, b. risks involved, c. benefits, d. testing involved, and e. withdrawal information
300
Name one type of experiment with which humans should not be allowed to enroll.
What is when there is no benefit or there is not an opportunity to withdrawal completely
300
Name ONE of the regulatory acts.
What is a. 1966 Animal Welfare Act (1970, 1976, 1985,1990) b. 1985 Health Research Extension Act, Sec 495
400
Name at least two organizations presiding over the regulation of animal care facilities.
What is A. USDA B. PHS Policy on Humane Care and Use of Laboratory Animals C. Guide for the Care and Use of Laboratory Animals Guide (latest revision 1996) & (OLAW- Office of Laboratory Animal Welfare) D. USDA E. Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) F. Institutional Animal Care and Use Committee (IACUC)
400
What are the 3 R’s of the IACUC (Institutional Animal Care and Use Committee)?
What is a. replacement b. reduction c. refinement
400
What is the basic website where US Government Principles for the Utilization and Care of Vertebrate Animals May be found regarding Testing, Research, and Training?
400
What animals would be inappropriate to use in laboratory research settings? (Give two animals or two situations and explain)
What is a. Animals that cannot be appropriately housed, b. If the laboratory would cause the animal pain or stress animals where the proper number cannot be obtained or housing requires growth in different environments when the same procedure will be performed and compared, c. Situations where risks of having the animal outweigh the benefits, d. Costly, e. Endangered species, and/or f. Unapproved animals
400
What should be done for animals that will suffer severe or chronic pain or distress that cannot be relieved?
What is to painlessly kill them.
500
If questions arise regarding exemption after the project is started, who should be contacted?
What is the Institutional Animal Care and Use Committee (IACUC) for that Organization.
500
Free
What is Free
500
What type of model should be considered when there is a high risk vs. benefit ratio for a human?
What is an Animal Model, or Non-animal Model
500
Free
What is Free
500
Where can training and compliance information be found for researchers affiliated with Marshall University?