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:

Click on the picture above to view the video.

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.