Shared Flashcard Set

Details

GH Study, Design, Ethics
Ethics (T Pierce)
11
Health Care
Graduate
12/09/2010

Additional Health Care Flashcards

 


 

Cards

Term
Nuremburg code
Definition
  • most important principles
    • informed consent
    • benefits outweigh risks
    • subjects have the right to protect themselves during research
Term
basic principles of the Belmont report
Definition
  • respect for other persons via informed consent (information, comprehension, voluntary)
  • beneficience via assessing risks and benefits
  • justice via selection of subjects
Term
declaration of Helsinki
Definition
  • guides international research
  • basic principles
    • ensure informed consent
    • protect subject welfare over interest of science and society
    • assign surrogate for someone who cannot give inform consent
  • operational principles
    • research should have reasonable likelihood of benefiting people
    • studies should be subject to appropriate ethical review by properly convened committee
Term
new emphases of the Declaration of Helsinki
Definition
  • need to benefit communities where takes place
  • attention to communities that will not benefit from research
  • applying developed world standards of care to research subjects in resource poor settings
  • provide access to best proven intervention arising from a study
Term
the common rule
Definition
  • role and operation of IRB
  • required elements of research protocol and informed consent
  • general criteria for IRB review and approval
Term
dimensions of informed consent
Definition
  • competency
  • voluntary
  • knowledgeability
Term
what situations is it difficult to get informed consent: ethnographic studies
Definition
  • illiterate populations
  • vulnerable populations who engage in illicit behavior
  • populations that can be exploited after signing a document
  • people in positions of lesser authority in communities
Term
purpose of CIOMS
Definition

•Recognize local cultural values and variation in health care systems and standards

•Aims to protect vulnerable populations from exploitation

Term
surveillance vs. research
Definition
  • Surveillance:

     

    Informs public health practice
  • Research:Contributes to generalizableknowledge

Term
basic elements of ethical research practice
Definition
  • informed consent
  • confidentiality
  • minimize risk
Term
basic elements necessary for informed consent
Definition

 

 

 

 

 

 

  • Fair explanation of the purpose of the study and procedures to be followed
  • A description of risks and benefits which might reasonably be expected
  • An offer to answer inquiries concerning the procedures
  • Instruction that the person is free to withdraw consent and discontinue participation in the project at any time

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