Use of Human Subjects in Research  

Federalwide Assurance  

Research Protocol Format

The usual format for a regular research protocol submitted by the Protocol Director (PD) to an IRB includes:

• A description of the proposed research activity.
  
  
• A discussion of the human subjects protection issues which addresses, at a minimum:
  
  
  • The risks to subjects
    
    
  • All procedures that are experimental
    
    
  • The anticipated benefits to subjects, if any.
    
    
• Subject selection, recruitment procedures, and the anticipated number of subjects.
  
  
• The proposed consent document and process to be used.
  
  
• Appropriate additional safeguards if potentially vulnerable subjects are to be enrolled. Potentially vulnerable subjects include the elderly, prisoners, children, cognitively impaired people, or people who are economically or educationally disadvantaged.