When children or minors (<18 years of age) are involved in research, the regulations require the assent of the child or minor and the permission of the parents or guardians, in place of the consent of the subjects.
While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research: (1) does not involve interventions likely to be of benefit to the subjects; and (2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others.
Legally authorized representatives are individuals authorized under applicable Maryland state law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research
The IRB must determine for each protocol – depending on such factors as the nature of the research and the age, status, and condition of the proposed subjects – whether all or some are capable of assenting to participation.
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: