Glossary of Terms

Informed Consent Form (ICF)

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Clinical Trials

A summary of information provided to the patient (and/ or their legal representative(s)) that is used as a guide for the verbal explanation of the study’s potential risk and benefits. ICF is an ongoing process, as the trial progresses new benefits, risk and side effects might necessitate the researchers to inform participants.

ICF documents can vary in length and complexity, they should contain information such as:

  • The nature, purpose, and duration of the study
  • Voluntary participation
  • Confidentiality of records
  • Benefits to the participants  
  • Contact for possible questions
  • Reasonably, foreseeable risk and discomforts
  • Confidentiality of records
  • For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained