Question 1A 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? 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 research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors. The new research would need full review by a convened IRB because children are a protected population. 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.Question 2The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research. True FalseQuestion 3According to federal regulations, “children” are defined as: Persons who are under 18 years of age. Persons who are under 21 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 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.Question 4Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? Federal regulations do not require the documentation of minors' assent. Parents must approve written documentation. Documentation is required unless waived by an IRB. To protect minors documentation is always required.Question 5The 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

According to federal regulations, the expedited review process may be used when the study procedures pose: Any level of risk, but all the subjects are adults. More than minimal risk, but the study replicates previously approved research. No more than minimal risk and the research activities fall within regulatory categories identified as eligible. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.

Explain the process of obtaining informed consent for minor child participants

If the REB determines that the targeted population and prospective participants have the capacity to decide for themselves to participate in this study, must the REB also require that the researcher seek the authorization of a parent or authorized third party prior to the participation of minors in this context?

Question 1A 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 students must be offered an optional classroom activity. Parents must be notified that the study is taking place. An independent consultant must approve the waiver. The research must pose no more than minimal risk.Question 2According to Subpart D, research with children may be eligible for exemption under Category 2 when: The children will be interviewed by the researcher. The children will be asked to complete a survey The research with children will involve participant observation with researcher interaction. The research involves the use of educational testsQuestion 3The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research. True FalseQuestion 4According to federal regulations, “children” are defined as: 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 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 are under 21 years of age.Question 5The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: All research that is more than minimal risk All research funded by HHS All research involving children All research funded by any federal agency

As part of the consent process, the federal regulations require researchers to: Recommend that potential subjects discuss their decision to participate with family members. Provide potential subjects with information at the appropriate reading comprehension level. Describe penalties that may be imposed for non-participation. Provide a list of the IRB members who reviewed the protocol.