What is Informed Consent?
The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116, and the documentation of informed consent must comply with 45 CFR 46.117.
Informed consent is a process that does not end with a signed document. It is a process by which persons are educated about your project so that they can make a truly voluntary decision to participate. Therefore, any conversation about the project and any documents used in the project must be presented in “lay language.” To ensure that the reading level of the document is appropriate for the audience, please go to our readability guide (PDF).
The informed consent document serves as one mechanism to document an individual’s consent.
What should my consent form contain?
Please see the University’s informed consent templates.
The informed consent document should contain:
- The title of the study
- A non-technical description of
- the reason for doing the study
- what the participant is likely to experience while in the study
- the expected time commitment
- any known risks that the participant is likely to experience
- any known benefits that the participant is likely to experience
- how confidentiality of records and data will be maintained
- An indication that the participant is a volunteer and can withdraw at any time
- Contact information for the Principal Investigator(s) should a participant need to ask questions about the study
- Contact information for the IRB Chair should a participant have a question about his/her rights
- A checklist so that a participant may opt out of being audio or video taped if they so choose
- A checklist so that a participant may opt out of allowing the investigator to use his/her data in future studies
- A signature line for the participant
- A signature line for the investigator who provided the study information to the participant
- For students only: a signature line for the faculty sponsor
- The final, approved document must be printed on departmental letterhead
Who should be listed on consent forms?
- The participant’s name (space should be included for the participant to write their name)
- The investigator who provided the study information to the participant
- For student investigators only: the faculty sponsor
- The IRB Chair
Who should sign as the investigator on the consent form?
- The investigator who provided the study information to the participant