Additional Protections for Children
Any reference to 112f or 112x forms predates ORahs (Office of Research Application for the use of Human Subjects). ORahs is the only application for Human Subjects use. The information is still correct as it applies to ORahs.
- Claim of Exemption
- Research involving survey or interview procedures - does not apply to research where the subject population includes children.
- Research involving the observation of public behavior - applies with the condition that the investigator does not participate in the activities being observed.
- Informed Consent
- The investigator must obtain the child's assent to participate in the proposed research. If the investigator finds a child or group of children incapable of giving assent, the investigator must request a waiver of this requirement and provide justification of this waiver in the Application for Approval of Activity Involving the Use of Human Subjects (UCSB/ORDA Form 112f).
- The investigator must obtain permission from the parent/guardian of the child and for research that involves more than minimal risk, permission must be obtained from both parents. Exceptions to this requirement pertain only when one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the child.
- The requirement for obtaining permission from a parent may be waived if the subjects are not protected by this requirement (for example, neglected or abused children), provided that the investigator documents for the HSC that an alternative form of protection has been sought (e.g. permission from a legally authorized representative).
- Documentation of Informed Consent
- If an investigator is required to obtain a child's assent, (s)he must describe in the Application for Approval of Activity Involving Human Subjects (UCSB/ORDA form 112f) how and if the assent should be documented.
- Investigators seeking waiver of the requirement to document a child's assent should give justification for this request.
- Risk/Benefit Ratio
- For research that involves more than minimal risk of harm to the subjects, the investigator must assure the Human Subjects Committee that the amount of benefit clearly outweighs the amount of risk.
- Children who are wards of state or any other agency, institution, or entity can be involved in research that includes more than minimal risk without direct benefit to the individual subjects only if the research is related to the child's status as a ward, or if the research is conducted in schools, camps, hospitals, or institutions in which the majority of the children are not wards.