Final: Chapter 4 Flashcards
What is institutional review of research?
Exempt from review procedures; no risk
Expedited review procedures; minimal risk
Full/complete institutional review procedures –> reviewing studies using vulnerable populations, have greater than minimal risk.
When did the Nazi Medical Experiments take place?
1933-1945
What is Nuremberg Code?
(1949) consent process, protection of subjects from harms, balance of benefits and risks in a study
What is Declaration of Helsinki?
(1964, 2008) The differentiation of therapeutic research from non-therapeutic research.
What are the 3 ethical principles associated with the National Commission for the Protection of Human Subjects?
Principle of Respect for Persons
Principle of Beneficence
Principle of Justice
these may be seen in the DHH5 (Belmont Report - 1979)
What is the Principle of Respect for Persons?
autonomy –> informed consent, can withdraw, confidentially
What is the Principle of Beneficence?
Promote good –> minimize risk, assure benefits, maintain integrity of the study
What is the Principle of Justice?
Fairness –> inclusion and exclusion criteria, consent and surveys translated
what is included in the respect for persons principle?
Self-determination (participation and withdrawing)
No coercion
Full disclosure, no deception
Voluntary consent
Persons with diminished autonomy have special protections
What are persons with diminished autonomy?
Legally and mentally incompetent subjects
Neonates and children
Terminally ill subjects
People confined to an institution
Pregnant women and fetuses
is the making up of results and recording and reporting them
fabrication
manipulating research materials, equipment, or processes or changing or omitting data of results such that the research is not accurately represented in the research record
falsification
the appropriation of another person’s idea, processes, results, or words without giving appropriate credit
plagiarism
