The Elements of the Informed Consent Process

The Informed Consent Process provides information and checks for understanding all along the way. The following are elements of the informed consent process:

1. The PI or RTM must make sure the participant is clear on the difference between research and standard treatment.
2. All volunteers in research must participate in an Informed Consent Process. The IC process includes:
   • Disclosure of the research study aims
   • Procedures
   • Risks
   • Benefits
3. The PI or RTM must verify the participant's understanding of the study
4. Study participation is voluntary and potential participants must be informed of alternatives to participation.
5. The PI or RTM must represent the cost benefit ratio for the patient and society. This includes the benefits, risks, costs, and compensation. The participant makes an educated decision between participating in the study or choosing standard treatment.
6. Tell the participant the consequences of early termination of the research by the participant, investigator, or sponsor.
7. Give the participant time to talk with significant others about being in the study.
8. Give the participant time to read and reflect on the informed consent form. You may do this by introducing a waiting period between the time they receive the information and when they make a decision.
9. Encourage questions from the participant.
10. The investigator assumes responsibility for the human participant's welfare during and after the Informed Consent.