Do you need to obtain consent and/or assent?
Human subjects must provide informed consent to participate in your research. If your study subjects are children (6-18 years of age) assent also must be obtained.
The
researcher has a legal and ethical obligation to ensure that prospective study
participants have sufficient knowledge and understand all aspects of the
research prior to obtaining informed consent. This means the prospective
research participant must be able to make an informed decision as to whether or
not to participate in research. Valid informed consent should be obtained by
using a simple, but complete consent form written at an appropriate educational level for the participant
population. As part of the process for obtaining informed consent, each element
of consent should be carefully and simply explained to the prospective
participant. In addition, the researcher should periodically assess the prospective
participant's understanding by asking appropriate questions. The researcher
bears full responsibility for obtaining valid informed consent from the
participant.
Investigators
should be sensitive to the possible need of an interpreter/translator for
participants who do not speak English as a first language or who are hearing
impaired. Follow the Process for Obtaining Informed Consent, and make sure that you have included all of the components required in the consent form. This link explains each of these components.
The
requirements for informed consent are less rigorous for Exempt reviews and for
research that poses “less than minimal risk” as opposed to “minimal risk or greater.”
Legally,
children cannot give consent on their own behalf. The consent of their parent(s) or legal guardian is required
before children can participate in research projects. In addition to obtaining parental/legal guardian consent,
researchers must also obtain assent of children between the ages of 5 and 18. If a subject is age 5 or younger, consent from a parental/legal guardian is required. Click here for the procedures for obtaining parental/legal guardian consent and assent of children to participate in research.