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Human Subjects - SBE CITI Test Answers

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A: The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided.
B: A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs.
C: An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.
D: A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

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Answer: A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

EXPLANATION: The study in the 4th grade classrooms about the relationship between the time of day reading is taught and reading comprehension does meet the definition of research with human subjects. The study is designed to contribute to generalizable knowledge about student performance and the research question can only be answered using a systematic investigation. Information collected by the play ground designer does not involve any information about human subjects even though it does involve interaction between the designer and school staff. An analysis of aggregate data doesn't involve interactions with living individuals nor the collection of private identifiable data. An economic feasibility study will gather information from people with relevant information and expertise but does not meet the definition of research with human subjects, because the intention of the study is to answer "about what" questions rather than "about whom" questions.

According to the federal regulations, research is eligible for exemption, if:

A: All the subjects are adults and the risk is minimal.
B: The investigator is experienced in the field of inquiry.
C: Participation in the research will involve 10 minutes or less of the subjects' time.
D: The research falls into one of six categories of research activity described in the regulations.

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Answer: The research falls into one of six categories of research activity described in the regulations.

A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?

A: The IRB will review this study because it includes human subjects and is considered research.
B: The IRB will not review this study because it does not involve an investigational new device.
C: The IRB will not review this study because it is not research as defined by the federal regulations.
D: The IRB will not review this study because it does not include human subjects as defined by the federal regulations.

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Answer: The IRB will not review this study because it is not research as defined by the federal regulations.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A: A researcher conducts a comparison of the comments made in a publicly available blog and the blogger's comments on a similar topic in a weekly magazine.
B: A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches.
C: A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.
D: Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques.

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Answer: A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A: A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the U.S. between 1820-1845 to track the numbers of immigrants from certain ethnic groups.
B: A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.
C: A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS.
D: A researcher conducts a linguistic study of comments posted on a local public blog.

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Answer: B: A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.

EXPLANATION: The study of passenger lists is a study of individuals who are no longer living. A human subject is a living individual. Questioning individuals to acquire data about the number of newly diagnosed HIV cases is asking "about what" questions rather than "about whom" questions. Conducting a linguistic analysis of comments posted on a public blog involves neither interaction with individuals nor collecting private identified information and thus does not meet the definition of research with human subjects. The study proposed by the developmental psychologist does meet the definition of research with human subjects. It involves interactions with living individuals and is designed to contribute to a field of knowledge.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A: A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department.
B: An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
C: A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university.
D: An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership.

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Answer: B: An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. EXPLANATION: In the study of the effects of evoking stereotypes on subsequent performance, the researcher has a research question and will be manipulating the behavior of individuals. An in-house study conducted with the intention of improving a department's mentoring programs is not research with human subjects, but rather program improvement. Receiving data with no identifiers is not research with human subjects because there is no interaction or intervention with a living human being and no collection of private identifiable data. In addition, creating a report for a membership organization does not involve a research question, as defined by the federal regulations, so it too is not research with human subjects.

Census data (the final report as published by the Census Bureau) is an example of:

A: Private behavior
B: Public information
C: Private information.
D: Public behavior.

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Answer: B: Public information

EXPLANATION: Census data is a public source of data, and an individual could not reasonably expect it would not be made public.

According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:

A. De-identified private information.
B. Observations of public behavior.
C. Identifiable public information.
D. Identifiable private information.

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Answer: Identifiable private information.

According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:


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ANSWER: Obtains, uses, studies, analyzes, or generates identifiable private information.

EXPLANATION: In order to meet the definition of research with human subjects a researcher must obtain data about a living individual through interaction or intervention or, alternatively, obtain individually identifiable private information. If a researcher obtains public information or de-identified information about individuals, and has not interacted or intervened with the individuals, those individuals are not considered human subjects for the purposes of the research.

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

A. Adults with decisional impairments
B. The elderly
C. Students
D. Prisoners

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Answer Prisoners

EXPLANATION: Prisoners are provided additional protections in the HHS regulations. The HHS regulations do not have specific additional protections for the elderly, for students, or for persons whose decision-making capabilities are impaired. Researchers may consider and the IRB may require additional safeguards for these populations.

According to federal regulations, the expedited review process may be used when the study procedures pose:

A: No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
B: A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.
C: More than minimal risk, but the study replicates previously approved research.
D: Any level of risk, but all the subjects are adults.

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Answer: No more than minimal risk and the research activities fall within regulatory categories identified as eligible

Continuing review of an approved and ongoing protocol

A: Must be conducted by a convened IRB.
B: Is limited to review of unanticipated problems.
C: Must occur within 12 months of the approval date.
D: Is not required unless additional risks have been identified.

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Answer: Must occur within 12 months of the approval date.

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

A: Institutional priorities take precedence over all IRB determinations.
B: Department chairs can overturn an IRB disapproval.
C: Officials of the institution may overturn an IRB disapproval.
D: Officials of the institution may overrule an IRB approval.

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Answer: officials of the institution may overrule an IRB approval.

What statement about risks in social and behavioral sciences research is most accurate:

A: Anonymizing data effectively manages the risk of creating emotional distress.
B: Risks are specific to time, situation, and culture.
C: There are never any risks.
D: If a study offers potential benefits, it is not necessary to minimize risks.

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Answer: Risks are specific to time, situation, and culture.

EXPLANATION: Research in the social and behavioral sciences sometimes does pose risks to subjects. Risks can be time, situation, and context specific. What may be a socially sensitive issue or topic at a given time and/or place may not be so at another time and/or place. The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur. Risks must always be minimized to the extent possible, regardless of the potential for benefit.

Identify the example of when situation and time are key to assessing risk of harm in a research study:

A: A study on the efficacy of a behavioral intervention for smoking cessation involves both adults and teenagers
B: Asking women if they have had an abortion
C: Research on the prevalence of HIV-infected individuals in communities
D: A survey about sexually transmitted diseases

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Asking women if they have had an abortion

A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:

A: Solely by the probability of expected harm.
B: Both the magnitude (or severity) and the probability (or likelihood) of harm.
C: Neither the magnitude or probability of harm.
D: Solely by the magnitude or severity of expected harm.

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Both the magnitude (or severity) and the probability (or likelihood) of harm.

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: 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.
B: 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.
C: The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes.
D: If it is the best interests of the community that the children participate in the study, parental permission is optional.

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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.

IRB continuing review of an approved protocol must:

A: Include copies of all signed consent forms
B: Occur at least annually
C: Must be conducted by a convened IRB
D: Must occur only when the level of risk changes

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Answer: Occur at least annually.

Additional safeguards that may be included in a social and behavioral study may include:

A: Remove all direct identifiers from the data as soon as possible.
B: Requiring a legally authorized representative to provide signed consent for an incapacitated subject.
C: Frequent monitoring of the subject’s heart through ECG after administration of the study drug.
D: Requiring pregnancy tests before administration of the study drug

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Remove all direct identifiers from the data as soon as possible.

EXPLANATION: When a possible disclosure of subjects' responses is the primary source of potential harm, collecting data anonymously may provide the best protection and removing direct identifiers is an additional safeguard. The other responses are additional safeguards, but refer to studies that may involve investigational drugs or are biomedical and not social behavioral.

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