Human Subjects Research and Ethics Part 1

A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of:

A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of:

A medical record is an example of:

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

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:

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

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

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

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

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

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:

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

The primary purpose of a Certificate of Confidentiality is to:

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:

If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:

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 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 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 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:

Data are made anonymous by

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 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?

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?

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 researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements is true?

According to Subpart D, research with children may be eligible for exemption under Category 2 when:

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?

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?

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?

Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?

Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?

To minimize potential risks of harm, a researcher conducting an on-line survey can:

The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool?

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

Researchers must report potential unanticipated problems that involve risks to others directly to the:

Trust and transparency are critical to successful and culturally competent research. In the research setting, establishing trust in diverse communities does NOT require:

Overcoming challenges to cultural competence in research requires that: (Check ALL that apply)

Cultural competence in research is defined as the ability of researchers to provide high quality research that takes into account:

NIH has set forth guidelines on the inclusion of women and members of minority groups and their subpopulations in biomedical and behavioral human subject research. This inclusion is to ensure that:

In 1979, the National Commission for the Protection of Humans Subjects of Biomedical and Behavioral Research developed ethical principles and guidelines for the protection of human subjects for research. The purpose of these guidelines was to:

What are student administrative data?

A researcher is conducting a study of students with special needs in a local school. The study requires the analysis of identifiable student performance data from the past five years. The researcher plans to publish the study results in a peer-reviewed journal and presenting them at conferences. This research could potentially help thousands of young students. Which of the following is true?

Which of the following statements is true?

Which of the following is a risk associated with a small cell size?

A researcher is conducting a study of four graduate students enrolled in a unique university program. The foundation supporting the study wants a report that provides summary information about the students' outcomes, including their grades and survey responses. What would be the least risky option?

The use of prisoners in research is a concern under the Belmont principle of Justice because:

Issued in 1974, 45 CFR 46 raised to regulatory status

Informed consent is considered an application of which Belmont principle?

Which of the following is included in the Nuremberg Code:

Which of the following brought increased public attention to the problems with the IRB system?

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

How long is an investigator required to keep consent documents, IRB correspondence, and research records?

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?