Term
| Nurenberg; voluntary, informed consent; animal |
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Definition
| Due to WWII medical abuse in Nazi experiments with prisoners conducted without their knowledge or consent the _____________Code was written. Two major principles include ______________ and that ____________ experiments precede research on human subjects. |
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Term
respect for persons - requires subjects to enter into the research voluntarily and with clear understanding of its purposes.
beneficence - ensuring that individual subjects are protected from harm during research and that benefits extend to society at a large.
justice - research does not exploit disadvantaged groups, assures that benefits of research are made available to all. |
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Definition
| What are the 3 Basic ethical principles put forth in the 1979 Belmont Report and what does each require? |
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Term
| Peer review; written proof |
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Definition
| NIH & FDA revised investigator guidelines and produced The Institutional Guide to DHEW Policy on Protection of Human subjects. This required __________ _________ of proposed studies of human subjects and ________ ______________ of informed consent |
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Term
risks to subjects must be reasonable in comparison to benefits or importance of knowledge obtained. Scientific merit.
-minimize risks
-equitable selection of subjects
-informed consent obtained and documented
-privacy and confidentiality ensured
-continuous data monitoring
-additional safeguards for vulnerable subjects like children |
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Definition
| To be covered in class. What are critera used in the assessment of a protocol by the Institutional Review Board? |
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Term
-Children: need parental permission and assent from child
-fetuses: need permission from both parents in most circumstances
-prisoners: requires additional protection to prevent coercion
-cognitively impaired persons: many need permission from guardian, other legally authorized representative |
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Definition
| To be covered in class: Vulnerable populations include: |
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Term
| analyses of existing biological specimens, clinical trials, treatment outcome studies. |
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Definition
| Choose one or two of these examples of human subjects research that you might participate in during your proposed career. analyses of existing biological specimens chart reviews clinical trials cognitive and perceptual experiments evaluations of social or educational programs interviews and focus groups surveys and questionnaires treatment outcome studies |
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Term
-Societal Benefit: advancement of knowledge, benefit to humans and animals
-Non-maleficence |
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Definition
| To be covered in class: NASA's "Ethical Care and Use of Animals" proposes 3 principles for all animal use in research. One principle is Respect for Life. List the other two. |
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Term
institutional - animal care and use committee (IACUC)
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Definition
| At UCI, All research involving animals must be approved by the |
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Term
1) review and inspect the animal program every 6 months
2) review concerns involving animals use
3) investigate issues of non-compliance
4) report to regulatory agencies |
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Definition
| To be covered in class: It is the responsibility of the Institutional Animal Care and Use Committee to 1) 2) 3) 4) |
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Term
unnecesesary duplication of experiments
adequacy of training personnel
appropriate sedation, analgesia, anesthesia
conduct of multiple major surgeries
post-procedural care
euthanasia method
alternatives - painful procedures
safety of working environment for personnel |
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Definition
| An animal care protocol must consider the rationale and purpose of the use of animals and a justification for the species and number of animals. Other considerations include: |
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Term
replacement: cell culture, computer simulation, selection of animals lower on the phylogenic tree
refinement: analyses, anesthesia, improved techniques
reduction: experimental design, statistical technique, tissue sharing |
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Definition
| To minimize the use of animals, in planning experiments investigators are asked to use Reduction, Refinement and Replacement. Give an example of each. |
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Term
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Definition
| As an undergraduate researcher, what are your ethical obligations? |
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