Research with Children - SBE

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: All research funded by HHS All research involving children All research funded by any federal agency All research that is more than minimal risk

All research funded by HHS

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? Documentation is required unless waived by an IRB. Parents must approve written documentation. Federal regulations do not require the documentation of minors' assent. To protect minors documentation is always required.

Federal regulations do not require the documentation of minors' assent.

According to federal regulations, "children" are defined as: Persons who are under 21 years of age. Persons who are under 18 years of age. Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research was approved.

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.

A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission? The research must pose no more than minimal risk. An independent consultant must approve the waiver. Parents must be notified that the study is taking place. The students must be offered an optional classroom activity.

The research must pose no more than minimal risk.

A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate? Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review. The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population. The new research would need full review by a convened IRB because children are a protected population. The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors.

Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.