Human research ethics Flashcards
What does the Nuremberg code say?
-for human research:
1) voluntary
2) informed
3) prospective consent form
4) subjects with legal capacity
What does the Declaration of Helsinki say?
Requires independent review of protocols, allows for surrogate consent, and requires stricter standards for non-therapeutic research.
What is the Belmont report?
-main report that protects US human subjects of research
-Describes several core ethical commitments to be used in establishing federal regulatory guidelines
=informed consent, Risk-benefit ratio, fair selection of subjects
What is research defined as?
a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
What is a human subject defined as?
a living individual about whom an investigator conducting research obtains Data through intervention or interaction with the individual, or Identifiable private information
Informed consent requirements are ________ extensive in research than in clinical practice.
more
Who’s consent is needed for pediatric research?
- pediatric ASSENT
- parental PERMISSION
What is minimal risk?
harm or discomfort not greater than that “ordinarily encountered in daily life or during routine physical or psychological examinations or tests”
-difficult to assess, very subjective
Which of the following most accurately describes the primary role of an institutional review board (IRB)?
A. Protect the institution from liability
B. Protect the physician from liability
C. Ensure the ethical and humane treatment of human subjects in experimentation
D. Ensure the study is scientifically accurate
E. Ensure that the study is financially feasible for the institutions
C. Ensure the ethical and humane treatment of human subjects in experimentation
(T/F) According to the Office of Human Research Protections (OHRP), the research use of biological specimens constitutes research involving human subjects.
F
**probs gonna change soon
