• most important principles
  • informed consent
  • benefits outweigh risks
  • subjects have the right to protect themselves during research

• respect for other persons via informed consent (information, comprehension, voluntary)
• beneficience via assessing risks and benefits
• justice via selection of subjects

• 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

• 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

• role and operation of IRB
• required elements of research protocol and informed consent
• general criteria for IRB review and approval

• competency
• voluntary
• knowledgeability

• 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

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

•Aims to protect vulnerable populations from exploitation

• Surveillance:

   

  Informs public health practice

• Research:Contributes to generalizableknowledge

• informed consent
• confidentiality
• minimize risk

• 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