Modules

The COI management plan aims to:

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:

An example of an individual financial COI is:

The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?

A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.

The FDA regulations governing disclosure of individual COIs require:

An example of an institutional COI is:

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

The Belmont principle of beneficence requires that:

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:

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

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:

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

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

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

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

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

Continuing review of an approved and ongoing protocol

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

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

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

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:

The primary purpose of a Certificate of Confidentiality is to:

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

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 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:

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

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

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

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)?

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?

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?

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

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:

A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on DHHS regulations, should the researcher report this event 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. 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?

NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability?

Which is true of inducements in research?

Subjects with a serious illness may be at risk for exploitation since they may be desperate for a possible cure. This is an example of

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections:

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of

Which is an example of a situation where deferential vulnerability might be a factor?

In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: