What is Informed Consent?
Before you take part in any research study, a researcher must give you information about the study, what will be asked of you throughout the process, and any potential risks and benefits. You must then voluntarily agree to become a participant in the study. This is called the informed consent process.
During the informed consent process, you will meet with a member of the research team who will talk with you about the study. He or she will describe what you will do or what will happen to you during the study, your rights, and potential risks and benefits. The researcher will answer any questions you have, and may ask you some questions to be sure you understand the information.
You will be given a document to take home that contains all the information the researcher tells you.
At the end of the meeting, if you agree to participate, you will be asked to sign a form indicating you understand the study and agree to participate. Your signature only means that you agree to participate. It is not a waiver of responsibility for the researcher or the research team. You are not signing away your right to sue, and you are not obligated to stay in the study until it is completed. You can withdraw from the study at any time.
You, as an informed decision maker, are your own best protection when it comes to making smart decisions about participating in research. This section is designed to give you the information and resources you need to make an informed decision.
Watch the video to learn more about what Informed Consent means in reference to a research study.
10 Key Elements of the Informed Consent Process
During the informed consent process, there are some key elements you will always be given and that you should make sure you understand. These key elements should be discussed during your meeting with the research team member and included in the informed consent document you receive.
Purpose of the study
Why you were asked to join the study
Who is conducting the study (names of the institution and researchers)
Possible or anticipated risks
Potential benefits
What you will be doing during the study
What incentives, if any, there are for volunteering
Information about who you can contact during the study if you have any questions or concerns
Statement that participation is voluntary and that if you join the study, you can quit at any time
Privacy and Confidentiality
View the sample informed consent document below to learn more about the key elements. Please note that though the forms look different from each other and are for different types of studies, they each contain all of the key elements.
Section includes the following key elements:
- 1: Purpose of the study
- 2: Why you were asked to join the study
- 3: Who is conducting the study (names of the institution and researchers)
Section includes the following key element:
- 4: Possible or anticipated risks
Section includes the following key element:
- 5: Potential benefits
Section includes the following key elements:
- 6: What you will be doing during the study
- 7: What incentives, if any, there are for volunteering
Section includes the following key element:
- 8: Information about who you can contact during the study if you have any questions or concerns
Section includes the following key element:
- 9: Statement that participation is voluntary and that if you join the study, you can quit at any time
Section includes the following key element:
- 10: Privacy and Confidentiality
Important Question
How would you want the informed consent conversation to take place? Taking the document home to share with family? Seeing a video? Having a family member present?
