When writing the consent form, do not copy and paste your grant or proposal procedures into the consent form. The consent form is meant to inform participants about what is being asked of them in the simplest terms possible. Please do not copy and paste lengthy methodology from a proposal or grant application into the consent form.
The reading level of a consent form should be at a 6th - 8th grade reading level, or higher depending on the study population. Avoid scientific / technical terms and define or spell out all abbreviations and acronyms. Tip: always ask yourself what would you say if you were explaining your research study to a family member.
You can determine the reading level of your consent form using different programs available such as Microsoft Word’s built in feature or AI tools.
Not all studies required a signed written consent form. Choose the most appropriate consent process for your study. If you think your study does not require a signed consent, you must provide the IRB with a justification as to why this requirement should be waived. A wavier of signature and waiver of consent are not the same thing. Waiving consent is only granted in cases where the research involves (1) no more than minimal risk to the subjects, (2) it would be impracticable (not possible) to conduct the research without the waiver, (3) the research involves the use of identifiable private information or biospecimens, and it would be impracticable (not possible) to conduct the research without the use of the identifiable information or biospecimens, and (4) the waiver will not adversely affect the rights and welfare of the participants.
The FAU IRB does not recognize the use of “passive” or “opt out” consent in research.
Children cannot legally consent for themselves. Therefore, informing them about the study and asking them to agree to participate is called an assent process. Only parents or guardians can give permission for a child to participate in research, unless the IRB waives this requirement. However, even if a parent agrees, if the child refuses to assent, the researcher generally should not enroll the child in the study.
In most cases, minors between ages 7 and 17 can give their written assent to participate in research. An assent must be tailored to the emotional and educational level of the child. Short, simple sentences and friendly, conversational language is preferred. For very young children, such as those under age 7, a verbal assent script that describes what will be said to the child may be more appropriate.
If you plan to recruit participants who do not speak English, you will need to translate the written consent document to obtain effective informed consent. However, since the IRB may request changes, please wait until after the IRB has approved the English version of the consent document before seeking translation services. If you are using a verbal consent process, you still need to provide a translated version of the script that will be spoken to the participant. See Policy 10.3.4, “International Research” for more information on engaging non-English speaking participants.
Guidance on obtaining effective informed consent or assent are available on the Toolkit for Researchers under Education.