IRB Eliciting Truly Informed Consent

Principles of the Informed Consent Process

Objectives:

This module offers information for the Principal Investigator and the Research Staff on the:

• Nature and significance of the informed consent process
• Elements of the informed consent process

Introduction:
The Nature and Significance of the Informed Consent Process

Clinical research is only possible because of trust. A Research Participant cannot trust what they do not understand. When Informed Consent (IC) is done properly, the Research Participant, Principal Investigator (PI), and Research Team Members (RTM) will all have the same understanding and expectations. The video clip below shows a PI establishing the foundation of the Informed Consent process for a potential participant:

In research the unexpected can and does occur. Informed consent reduces the likelihood of participants feeling betrayed if something unexpected does occur. Research participants, the institution hosting the research, the sponsor of the research, and, in fact, the all persons engaged in the biomedical research enterprise are stakeholders in your project's IC process. They have a responsibility, along with the researchers, to ensure that a project is undertaken with a clear understanding of its importance, confidence in its methods, and integrity in its execution.

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.

This project is supported by grant number 2S07RR018153-02 from the National Institutes of Health
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