Quiz 1 Answers

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

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

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

Officials of the institution may overrule an IRB approval.

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


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

The research falls into one of eight categories of research activity described in the regulations.

5.) Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB

Must occur within 12 months of the approval date

Experience emotional or psychological distress.

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

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

8.) Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Invasion of privacy, breach of confidentiality, and study procedures

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

Risks are specific to time, situation, and culture.

10.) The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure.

11.) 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 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.

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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.

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.

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

Provide potential subjects with information at the appropriate reading comprehension level.

16.) 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?

Securing a Certificate of Confidentiality

17.) 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 faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

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18.) Data are made anonymous by

Destroying all identifiers connected to the data.

19.) When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

The researcher cannot control what participants repeat about others outside the group.

20.) 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.


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