question
According to federal regulations, the expedited review process may be used when the study procedures pose:
answer
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
question
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?
answer
Officials of the institution may overrule an IRB approval.
question
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?
answer
Prisoners
question
According to the federal regulations, research is eligible for exemption, if:
answer
The research falls into one of eight categories of research activity described in the regulations.
question
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB
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Must occur within 12 months of the approval date
question
A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:
answer
Experience emotional or psychological distress.
question
Additional safeguards that may be included in a social and behavioral study may include:
answer
Remove all direct identifiers from the data as soon as possible.
question
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
answer
Invasion of privacy, breach of confidentiality, and study procedures
question
What statement about risks in social and behavioral sciences research is most accurate:
answer
Risks are specific to time, situation, and culture.
question
The primary purpose of a Certificate of Confidentiality is to:
answer
Protect identifiable research information from compelled disclosure.
question
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?
answer
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
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?
answer
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
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:
answer
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
A waiver of the requirement for documentation of informed consent may be granted when:
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The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
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As part of the consent process, the federal regulations require researchers to
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Provide potential subjects with information at the appropriate reading comprehension level.
question
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?
answer
Securing a Certificate of Confidentiality
question
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)?
answer
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.
question
Data are made anonymous by
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Destroying all identifiers connected to the data.
question
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
answer
The researcher cannot control what participants repeat about others outside the group.
question
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?
answer
There was neither a violation of privacy nor a breach of confidentiality.
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