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

To document that the research participant has voluntarily agreed to participate in the study, the research participant must:A. Pass a test of comprehension.B. Meet with the institution's Institutional Review Board (IRB).C. Sign and date the Informed Consent Form.D. All of the above.

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

Study participant recruitment cannot begin until the IRB has approved the:A. Informed Consent form.B. Protocol.C. Advertisements.D. All of the above.

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

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