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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