Special considerations apply to research involving children who are wards of the state. Investigators should contact the IRB staff or the Office of Compliance if they need further guidance.
Parental Consent for Children to Participate in Research (California Education Code 51513) Generally speaking, no test, questionnaire, survey, or examination containing any questions about the pupil's personal beliefs or practices in sex, family life, morality, and religion, or any questions about the pupil's parents' or guardians' beliefs and practices in sex, family life, morality, and religion, shall be administered to any pupil in kindergarten or grades 1 to 12, inclusive, unless the parent or guardian of the pupil is notified in writing that this test, questionnaire, survey, or examination is to be administered and the parent or guardian of the pupil gives written permission for the pupil to take this test, questionnaire, survey, or examination.
Waiver of Parental or Guardian Consent However, the IRB will often consider a request for a waiver or partial waiver of parental permission for minimal risk research to be conducted in a classroom. Research is ordinarily not suitable for a waiver of parental permission if it involves any of the following issues:
Parental political affiliations or beliefs;
Mental or psychological problems;
Sexual behavior or attitudes;
Illegal, antisocial, or self-incriminating behavior;
Appraisals of other individuals with whom the minor has a familial relationship;
Relationships legally recognized as privileged (lawyers, doctors, clergy); and
Religious affiliations or beliefs.
If the IRB waives the requirement for parental permission, it may devise an alternative mechanism to protect the child participants (e.g., appoint a qualified child advocate). Research regulated by the FDA is not eligible for waiver of parental permission, except for the use of an FDA test article meeting the emergency exception.
Exceptions to the General Rule:
Chapter 10: California Laws That Apply to Human Subjects Research USC HSPP Policies and Procedures
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