Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Breach of confidentiality, loss of autonomy, and study procedures
Study procedures, breach of confidentiality, and loss of employment
Invasion of privacy, adverse reaction to study drug, and discrimination
Invasion of privacy, breach of confidentiality, and study procedures
Answer: Invasion of privacy, breach of confidentiality, and study procedures
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IRB
- Researchers must report potential unanticipated problems that involve risks to others directly to:
- A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?
- Researchers must report potential unanticipated problems that involve risks to others directly to:
- A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (i.e., the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?
- According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:
- The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
- The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:
- A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on DHS regulations, the researcher report this event to the IRB?
- According to federal regulations, "children" are defined as:
- A 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?
- According to Subpart D, research with children may be eligible for exemption when:
- A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims and the IRB chair agrees that the study is exempt from IRB review. This decision:
- A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children. This research would be eligible for which type of IRB review?
- Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?
- A 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 specific Department of Health and Human Services (HHS) Regulations that apply to research with children are known as:
- A sociologist wants to study a culture that occurs in some women's prisons: "state families," in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is:
- A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:
- Which example of research with prisoners would be allowable under the regulations?
- A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of getting employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:
- A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:
- A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
- Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
- In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?
- When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
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