Requirements for Approval of Human Subject Research

The Code of Federal Regulations outlines the procedure and the standards for review of protocols. Research will not be approved unless:

• risks to subjects are minimized;
  
• risks to subjects are reasonable in relation to anticipated benefits;
  
• selection of subjects is equitable;
  
• informed consent is adequate and appropriately documented;
  
• where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects;
  
• where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data; and
  
• appropriate safeguards have been included to protect vulnerable subjects.

The Forms section includes the information to be submitted as a protocol.

Investigator and Faculty Advisor Responsibilities