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
Question
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
Solution
Question 1: Before an IRB could waive parental permission, the research must pose no more than minimal risk.
Question 2: Research with children may be eligible for exemption under Category 2 when the research involves the use of educational tests.
Question 3: True, the 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.
Question 4: According 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 will be conducted.
Question 5: The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to all research involving children.
Similar Questions
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.
A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct? If it is the best interests of the community that the children participate in the study, parental permission is optional. The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn't have to ask the parents for permission. The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes. The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.
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.
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
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?
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