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.

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is limited to review of unanticipated problems. Is not required unless additional risks have been identified. Must occur within 12 months of the approval date. Must be conducted by a convened IRB.

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

What information should be provided to an IRB for review at the initiation of a study?

When is it necessary to obtain IRB approval for a user study?Group of answer choiceswhen conducting online or mail studieswhen using data from a publicly available source like a newspaper or magazinewhen the results are used only in a class but won't be publishedwhen the data obtained is about individuals who are not livingall of these require IRB approval

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.