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Question 1A 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? 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. 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. If it is the best interests of the community that the children participate in the study, parental permission is optional.Question 2A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for. In the event of any distress you may have related to this research, you will be given access to appropriate resources. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.Question 3A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance. A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects' attention on the material. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.Question 4A waiver of the requirement for documentation of informed consent may be granted when: Potential subjects might find some of the research questions embarrassing, personal, or intrusive. The investigator has no convenient place to store signed consent forms separate from the research data. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. The subjects are literate in their own language; however, they do not read, write, or speak English.Question 5As part of the consent process, the federal regulations require researchers to: Provide a list of the IRB members who reviewed the protocol. Recommend that potential subjects discuss their decision to participate with family members. Describe penalties that may be imposed for non-participation. Provide potential subjects with information at the appropriate reading comprehension level.

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Question 1A 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? 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. 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. If it is the best interests of the community that the children participate in the study, parental permission is optional.Question 2A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for. In the event of any distress you may have related to this research, you will be given access to appropriate resources. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.Question 3A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance. A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects' attention on the material. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.Question 4A waiver of the requirement for documentation of informed consent may be granted when: Potential subjects might find some of the research questions embarrassing, personal, or intrusive. The investigator has no convenient place to store signed consent forms separate from the research data. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. The subjects are literate in their own language; however, they do not read, write, or speak English.Question 5As part of the consent process, the federal regulations require researchers to: Provide a list of the IRB members who reviewed the protocol. Recommend that potential subjects discuss their decision to participate with family members. Describe penalties that may be imposed for non-participation. Provide potential subjects with information at the appropriate reading comprehension level.

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Question 1: The correct statement about parental permission is "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."

Question 2: The statement in a consent form that is an example of exculpatory language is "Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries."

Question 3: It would NOT be appropriate to provide subjects with information about missing elements of consent in "A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team."

Question 4: A waiver of the requirement for documentation of informed consent may be granted when "The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality."

Question 5: As part of the consent process, the federal regulations require researchers to "Provide potential subjects with information at the appropriate reading comprehension level."

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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

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