Children or minors are considered a vulnerable research population because their intellectual and emotional capacities are limited and they are legally incompetent to give valid consent. Special procedures and considerations are required by the Federal regulations for the review of research involving children or minors. Children or minors are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
In the state of Maryland, individuals are adults and of legal age (released from parental authority), when one attains the age of 18 years. Children or minors are those individuals who have not attained the age of eighteen years.
In almost all cases, written consent from a parent or legal guardian must be obtained if the research involves children or minors under the age of 18. In certain cases, the requirement for parental consent can be waived.
Documentation of assent is required for participants between the ages 7 and 18 years of age unless the participant is incapable, either decisionally or emotionally, of being reasonably consulted about participating. The protocol application submitted for review will provide the IRB the procedures for interacting with and the process for obtaining assent. The protocol will also describe how parents are informed and permission documented if participants are under age 7. Depending on the research, an investigator may use an oral script in very simple language appropriate for children. This assent form provides a simplified version of the elements of informed consent at a level appropriate to the child’s or minor’s age, maturity and condition, of the procedure(s) to be used, their meaning to the child or minor in terms of discomfort and inconvenience, and the general purpose of the research. As mentioned above, if your project has an approved waiver of consent, the IRB will expect you to document how and when consent was obtained.
The consent form (for parents/guardians) and assent form (for children or minors) must be prepared as two separate documents. NOTE: Participants older than 7 but under the age of 18 will need to complete an Assent form; a separate parental consent form is required for these participants providing parental permission to participate.
Consent forms are provided to participants at the time the consent conversation begins by the person actually administering consent, attesting to the informed consent conversation. The UMBC Office of Research Protections and Compliance assigns an IRB protocol number as well a “valid through” (or “end”) date indicating the end of the IRB approval period; this will appear at the bottom of all pages of the UMBC assent form.
Obtaining and documenting informed consent is required for all participants in a research project. As a general rule, investigators must:
- Provide “key information” to participants essential to decision making;
- Present informed consent information in sufficient detail and in a way that helps with participant comprehension, not just running down a list of risks and procedures;
- Provide a copy of the consent form to the participant and/or legal representative;
- Keep a copy of the consent form for the approved protocol file
- Seek consent only if the potential participant has the decisional capacity to give consent; if not, consent must be obtained by a legal representative;
- Obtain parental permission for minor participants;
- Provide sufficient opportunity to the potential participant or legal representative to consider whether or not to participate;
- Ensure that the possibility of coercion or undue influence is absent;
- Enhance each participant’s comprehension of the information; and
- Utilize a consent form appropriate to the age level.
Choose the below to submit with your IRB application:
Child or Minor assent template