Children are persons who have not attained the legal age to consent to treatments or procedures involved in the research; the legal age of consent in Florida is 18 years of age. Otherwise, the individual is considered a minor (or child) unless they qualify as an emancipated minor.
A legal guardian (including natural or adoptive parents who currently hold parental rights) must consent for the minor in Florida. Generally, foster parents may NOT consent for treatment or research participation for children.
For minors enrolled in a study, consent must be sought immediately from the individual when they turn 18 or otherwise reach the age of majority through emancipation.
If you have any questions on who can consent for a minor, the HSRO recommends you contact the University of Miami, Office of General Counsel at 305-284-2700 gc.receptionist@miami.edu.
MANDATED REPORTING
Some study activities may result in researchers becoming aware of abuse or neglect of human subjects; this awareness may result during or from interactions or interventions with human subjects, or from disclosure by study subjects. Where abuse or neglect reporting is mandated by law or professional standards, the incident must be reported to the appropriate authorities. In Florida, FIU researchers may be considered mandatory reporters, and must follow applicable law for reporting abuse or neglect. See FIU Policy #140.130, Mandatory Reporting of Child Abuse, Abandonment and Neglect on the FIU Policies and Procedures Library for reporting obligations and how to report.
PARENTAL PERMISSION
Florida law requires parental permission before a minor can be included in human subject research, unless the minor’s involvement is limited to a record review, such as a medical chart review.
Research that is no greater than minimal risk OR greater than minimal risk but with prospect of direct benefit requires:
- Permission from at least one parent/guardian
- Assent of the child (if child is 7 or older)
Research that involves more than minimal risk and presents the prospect of no direct benefit to the individual subjects or research not otherwise approvable requires:
- Permission from both parents/guardians
- Assent of the child (if child is 7 or older)
DOCUMENTING ASSENT
The PI is responsible for determining whether the subject is capable of being involved in the assent process and must be appropriate for the age ranges and levels of mental development for the subjects to be enrolled. Although age is used as the primary criteria in determining an appropriate means of obtaining assent, factors such as literacy and mental development must also be considered.
If minors are not capable of assent, there should be an explanation of why they will not assent.
We generally recommend that children 7 years of age or older are assented using our assent template.
Depending on the age range of the minors to be involved, two different assent forms at different reading comprehension levels may be appropriate (e.g., one assent form written for young children ages 7-12 years old, and one assent form written for minors ages 13-17 years old).
More information on obtaining assent can be found in our Investigator’s Manual under section 7.10 Obtaining and Documenting Assent.
THINGS TO CONSIDER
- Is the participation of children as research subjects justified?
- Are personnel involved in the research knowledgeable about and sensitive to the physical and psychological needs of the children and their families?
- Will assent be obtained from minors? If so, is it from all minors or only some of them? If only some of them or none of them, have you explained why?
- Will minors enrolled in this study reach 18 years of age while in the study? If so, is the plan and process for obtaining their consent to continue before their study participation ends described?
