Securing a Certificate of Confidentiality
  • In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations
  • 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
  • An investigator obtains consent from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes
  • Data are made anonymous by
No more than minimal risk and the research activities fall within regulatory categories identified as eligible
  • A waiver of the requirement for documentation of informed consent may be granted when
  • As part of the consent process, the federal regulations require researchers to
  • According to federal regulations, the expedited review process may be used when the study procedures pose
  • According to the federal regulations, research is eligible for exemption, if
Prisioners
  • An investigator obtains consent from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes
  • As part of the consent process, the federal regulations require researchers to
  • 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
  • In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations
Involve local leadership in recruitment
  • As part of the consent process, the federal regulations require researchers to
  • Data are made anonymous by
  • A recommended recruitment strategy for older adult subjects is
  • Continuing review of an approved and ongoing protocol
A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified
  • 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)
  • Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct
  • A 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 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 researcher will not be interacting/intervening with subjects and the data has no identifiers
  • 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
  • According to the federal regulations, research is eligible for exemption, if
  • A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects
  • 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
The research falls into one of six categories of research activity described in the regulations
  • According to federal regulations, the expedited review process may be used when the study procedures pose
  • According to the federal regulations, research is eligible for exemption, if
  • Clinicians find it difficult to care for older adults because
  • A waiver of the requirement for documentation of informed consent may be granted when
There was neither a violation of privacy nor a breach of confidentiality
  • A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects
  • As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true
  • 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
  • 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
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 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
  • 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)
  • 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
  • As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true
Must occur within 12 months of the approval date
  • Data are made anonymous by
  • A recommended recruitment strategy for older adult subjects is
  • Clinicians find it difficult to care for older adults because
  • Continuing review of an approved and ongoing protocol
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
  • When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct
  • A 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
  • 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
  • Regulations require that IRB membership include
A breach of confidentiality
  • 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
  • A 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
  • An investigator obtains consent from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes
  • 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
The researcher cannot control what participants repeat about others outside the group
  • When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct
  • A 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
  • Regulations require that IRB membership include
  • A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects
Destroying all identifiers connected to the data
  • A recommended recruitment strategy for older adult subjects is
  • Continuing review of an approved and ongoing protocol
  • 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
  • Data are made anonymous by
children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons
  • A waiver of the requirement for documentation of informed consent may be granted when
  • Federal regulations require that additional safeguards have been included in a study to protect the rights and welfare of these subjects
  • Legally Authorized Representatives (LARs) should be involved in the consent process when
  • According to federal regulations, the expedited review process may be used when the study procedures pose
Prospective subjects are assessed and determined to lack capacity to make consent decisions
  • As part of the consent process, the federal regulations require researchers to
  • A waiver of the requirement for documentation of informed consent may be granted when
  • Legally Authorized Representatives (LARs) should be involved in the consent process when
  • According to the federal regulations, research is eligible for exemption, if
Members with sensitivity to community attitudes
  • Regulations require that IRB membership include
  • Continuing review of an approved and ongoing protocol
  • When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct
  • A 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
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