The Informaed Consent Process
The Informaed Consent Process

What does the informed consent process include?

The potential participant must understand all the information.

  • Statement that the study involves research
    • Purpose of the study
    • Clarify how long participants are involved in the study
    • Describe the procedures
    • Identify any procedures that are experimental
  • Describe the possible risks or discomfort to participant.
  • Describe the possible benefits to the participant or others.
  • Explain alternatives available other than taking part in the study.
  • Describe privacy and confidentiality protections.
  • For those studies with higher risk, describe the medical treatment and rewards.
  • Clarify who to contact with questions /concerns.
  • Reassure that taking part is voluntary.
  • The participant can withdraw from the study at any time with no risk of penalties

Insufficient Informed Consent
Making a choice versus being a guinea pig

  • Involuntary sterilization of Indian women (1960s)
  • Hepatitis B vaccine in Alaska Native children (1990s)

Examples of Cultural Concerns & Clinical Trials

  • Fear of annihilation, genocide
  • Storage of specimens
  • Fear of not receiving best care (sugar pill)
  • Preliminary research conducted on sacred animal (relation)

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