The Informed Consent Process
Choosing to participate in a clinical research study is an
important personal decision. Informed consent is just one part
of a larger process designed to help safeguard people who are
interested in participating in a clinical study.
What is informed consent?
Informed consent is the process of learning the key
facts about a clinical study before deciding whether or not to
participate. This process continues throughout the study as a
way of providing information to participants.
What information does it cover?
If you think you may be interested in participating
in a clinical study, an informed consent document will be
presented to you. This document includes detailed information
about the study, including but not limited to the following:
- Objective or purpose of the study
- Study duration
- Required procedures
- Risks and potential benefits
- Key contacts
What happens next?
After reading through the document and discussing its
contents with the study doctor or staff, it is up to you to
decide if you want to sign the document and participate in the
study. The informed consent document is not a contract – even if
you sign the document, you are free to leave the study at any
time.