• scientific design and conduct of the study. The Ethics Committee should consider the design of the research to the extent that it impacts the safety of the participants.
  
  - Are procedures consistent with appropriate research design? 
  - Is the researcher qualified to conduct the research? 
  
  It is recommended that the research be reviewed by a scientific review committee prior to Ethics Committee submission. The scientific committee reviews the technical or scientific aspects of the study. 
  
  
• recruitment of research participants. The Ethics Committee should examine the materials and methods by which participants will be recruited.
  
  - Are the recruitment methods appropriate for the research  
    setting and the subject population?
  - Are there appropriate safeguards in place to protect vulnerable 
    populations?
  
  
• community considerations. The research should address a local need or problem and must be designed with an understanding of the community in which a study will take place. The Ethics Committee must assess the impact of the research on the community.
  
  - How will the community benefit from the research? 
  - How will community members be included in the design of the 
    study? 
  
  
• care and protection of research participants. The Ethics Committee must examine the impact of the research on the participants.
  
  - Are adequate measures in place to provide for the well-being of 
    the participant during and, if appropriate, after the study? 
  - How is the study being monitored to ensure the safety of 
    research participants?
  
  
• informed consent. All codes and guidelines require individual informed consent.
  
  - Are participants adequately informed about the study, the 
    voluntary nature of their participation, and their right to end their 
    participation at any time? 
  - How is informed consent documented?
  
  
• confidentiality issues. The Ethics Committee must review the steps taken by the research team to protect the confidentiality of participants. In some research, the greatest risk could well be a breach of that confidentiality.
  
  - Are adequate measures in place to protect confidentiality?
  - Will participants be at risk if confidentiality is broken?

Only when all these questions have been answered should the Ethics Committee grant approval.