These guidelines and sample consent form are intended for researchers who need assistance in creating a Consent Form for research involving human participants. If you have questions about your form or any part of the IRB process, please feel free to contact the IRB Chair.
According to the Belmont Report, informed consent which adheres to the moral principle of respect for persons contains three elements: information, comprehension, and voluntariness.
It is important for researchers to remember that consent is an ongoing process. It is not merely a form that must be signed. Researchers must take pains to ensure that participants understand what they are agreeing to and understand their rights, particularly their right to withdraw from participation without consequence, throughout all stages of the research project.
Participants must be given sufficient information—usually in a consent form—with which to decide whether or not to participate. A good consent form should answer the following questions for the participant in clear, easy-to-understand language.
- What is the purpose of this study? What happens to the results of the study?
- Who is being invited to take part in this study?
- What will happen during this study and how long will it take?
- What are the risks to me of participating in this study?
- What are the anticipated benefits (to me) of participating in this study?
- Who will see the information I give?
- Do I have a choice to be in the study?
- What if I have questions?
- What if I want to stop being in the study?
Incomplete disclosure may be justified only if it is clear that: (1) the goals of the research cannot be accomplished if full disclosure is made; (2) the undisclosed risks are minimal; and (3) when appropriate, subjects will be debriefed and provided the research results. The IRB makes final determinations about the acceptability of incomplete disclosure in any given research protocol.
Participants must be able to comprehend the information that is given to them. Researchers are encouraged to use a document readability tool to ensure that their consent form is written at an appropriate “grade level.” It is recommended that consent forms for the general public be written at a level no higher than 6-8th grade. Participants must be given an opportunity to ask questions and receive answers.
Consent to participate must be voluntarily given. The conditions under which an agreement to participate is made must be free from coercion and undue influence. Researchers should be sensitive to differences in power dynamics when recruiting participants (e.g., professor-student, employer-employee, upperclass-lowerclass student).