CITI questions
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
Any equity interest in a publicly held company that exceeds $50,000
According to the HHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is:
Greater than $5,000 of ownership in any single public entity/public company.
Researchers must report potential unanticipated problems that involve risks to others directly to:
Institutional Review Board (IRB)
A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children. This research would be eligible for which type of IRB review?
This research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:
Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk
To minimize potential risks of harm, a researcher conducting an on-line survey can:
Design the survey so that no direct or indirect identifiers are collected.
According to Subpart D, research with children may be eligible for exemption when:
The research involves the use of educational tests
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?
A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
All research funded by HHS
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?
An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:
Conflict of Interest
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
Designated institutional officials
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?
Designing the survey so that subjects are not forced to answer one question before going to the next.
The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:
Determined by the institution in its written policies and procedures
The specific Department of Health and Human Services (HHS) Regulations that apply to research with children are known as:
Subpart D: Additional Protections for Children Involved as Subjects in Research
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?
No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
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 DHS regulations, the researcher report this event to the IRB?
No, this does not need to be reported since it is unrelated to participation in the study.
A financial conflict of interest could involve:
Receiving stock in a company funding your 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?
The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the Internet confidentiality cannot be absolutely guaranteed.
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?
The research must pose no more than minimal risk.
