exam i: ch4 Flashcards
tuskegee syphilis study
unethical study that gave poor african american men syphilis to study, did not treat
willowbrook study
unethical study where mentally ill children were given hepatitis
jewish chronic disease hospital study
unethical study in which cancerous cells were injected into pts who did not have cancer without their consent
belmont report
law made after unethical research that made clear the guidelines of how to maintain ethical standards
3 principles of the belmont report
- beneficence (should be good, promote good)
- respect of persons (autonomy)
- justice (whatever comes out should benefit the community and all)
nuremberg code 1949
brought informed voluntary consent; made sure studies were credible with qualified researchers
declaration of helsinki 1964
brought therapeutic and nontherapeutic research
national commission for the protection of human subject of biomedical and behavioral research 1978
belmont report was created
scientific/research misconduct
the fabrication, falsification, or plagiarism in processing, performing, or reviewing research or in reporting results
- ex - lack of disclosure of data
therapeutic research
came from declaration of helsinki; results may benefit participants and the whole community
non-therapeutic research
came from declaration of helsinki; generates knowledge for science; no expected benefit for the participants
what are the goals of common rule/code of federal regulation
enhance protection of participants and decrease admin burden of regulating research
common rule/code of federal regulations
purpose is to protect the rights and welfare of human participants involved in research
health insurance portability and accountability act (HIPAA)
implemented to protect private health info
what are the 5 human rights
- right to self determination (make own decision)
- right to privacy (hipaa)
- right to anonymity and confidentiality (pt stays anonymous)
- right to fair treatment (prevents coercion)
- right to protection from discomfort or harm
self determination
idea that humans are autonomous agents with freedom to conduct their lives as they choose
3 ways to violate self-determination
coercion, covert data collection, deception
coercion
way of violating self determination; forcing someone to be in the study
covert data collection
way of violating self determination; subjects unaware that study is taking place
deception
way of violating self determination; misinforming subjects about the study
vulnerable population
people with diminished autonomy
what are examples of vulnerable populations
Legally and mentally incompetent ppl
Neonates, children
Terminally ill
Ppl confined to institution
Pregnant women + fetus
breach of confidentiality
unauthorized access to raw data
disclose
provide all details necessary for subjects to know
comprehend
understanding of subject
competence
ability of subject to understand AND make necessary decisions
institutional review board (IRB)
“gatekeepers” of research; board has to look at your study and give you permission to do it or not
3 functions of the IRB
- protection of rights and welfare
- voluntary informed consent
- benefits exceed risks
3 levels if IRB review of research
exempt, expedited, full
exempt
research on regular educational strategies, data does not ID subject, public benefit programs, taste/food quality eval
expedited
collection of bodily items and ID data, moderate exercise by healthy volunteers, behavior without stress
full
reviewing studies using vulnerable populations, have greater than minimal risk
what is the nurse’s role in ethical research
critical appraisal of ethical aspects of published studies and research conducted in clinical agencies
what type of sampling is good for outcomes research
heterogenous samples
what are the parts of informed conset
disclose, comprehend, competence, voluntary agreement
protected health research
data generated and collected for research that can be linked to an individual person
plagiarism
using the words or ideas of another person without citing the reference or otherwise giving that person credit
