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
Making a choice versus being a guinea pig
- Involuntary sterilization of Indian women (1960s)
- Hepatitis B vaccine in Alaska Native children (1990s)
- Fear of annihilation, genocide
- Storage of specimens
- Fear of not receiving best care (sugar pill)
- Preliminary research conducted on sacred animal (relation)