Establishing open dialog with sponsors and security of study records
Data are made anonymous by
-Destroying all identifiers connected to the data.
-Requiring all members of the research team to sign confidentiality agreements.
-Keeping the key linking names to responses in a secure location.
-Reporting data in aggregate form in publications resulting from the research.
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?
-Using data encryption for stored files.
-Securing a Certificate of Confidentiality.
-Waiving documentation of consent.
-Using pseudonyms in research reports.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
-If group members know each other confidentiality is not an issue.
-Using pseudonyms in reports removes the concern about any confidences shared in the group.
-The researcher cannot control what participants repeat about others outside the group.
-If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.
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?
-There was neither a violation of privacy nor a breach of confidentiality
-The subjects’ privacy has been violated.
-Confidentiality of the data has been breached
-There was both a violation of privacy and a breach of confidentiality.
Which of the following constitutes both a breach of a 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 researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.
-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.
-A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.
-In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
An investigator is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children’s first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:
-Not an excessive incentive.
-Of high quality.
An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:
The survey instrument is standardized.
Confidentiality of the prisoners’ health status is maintained.
All prisoners receive HIV testing.
A medical doctor serves as co-investigator.
Which of the following statements about prison research is true?
Participation in research can be considered during parole hearings.
Researchers may study the effects of privilege upgrades awarded by the prison.
It is permissible for risks to be higher than those that would be accepted by non-prisoners.
The regulations prohibit compensating prisoners.
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:
Approve this project but submit it for federal review.
Approve this project since the risk appears to be no more than minimal.
Not approve this project because the prisoners are merely a population of convenience for the student.
Approve this project since the superintendent is the ultimate authority on what happens in his facility.
Which of the following statements most accurately describes the requirement for the documentation of minors’ assent to participate in research?
Parents must approve written documentation.
To protect minors documentation is always required.
Documentation is required unless waived by an IRB.
Federal regulations do not require the documentation of minors’ assent.
According to Subpart D, research with children may be eligible for exemption when:
The research involves the use of educational tests
The children will be interviewed by the researcher.
The research with children will involve participant observation with researcher interaction.
The children will be asked to complete a survey
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?
Parents must be notified that the study is taking place.
The students must be offered an optional classroom activity.
An independent consultant must approve the waiver.
The research must pose no more than minimal risk.
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?
The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population.
The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors.
Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
The new research would need full review by a convened IRB because children are a protected population.
Parental notification, in lieu of active parental permission, is allowed when:
The researcher anticipates a low response rate.
An IRB has approved a waiver of the requirement for parental permission.
The researcher has conducted a similar study at another institution.
The superintendent of schools and the principals have approved the study.
According to Subpart D, which of the following research activities with children would qualify for an exemption?
Observation of public behavior when the researcher participates in the activities being observed.
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