CITI (Social and Behavioral Research)
QUESTIONS AND ANSWERS ACCURATE
AND VERIFIED.
A professor at Big State University proposes to study attitudes about
obesity in Chile by giving subjects in Chile surveys to complete. Which is a
question that the Big State University IRB should ask the researcher in
order to determine if this study should be reviewed by a local Chilean IRB
or ethics committee, as well as the Big State University IRB?
Will the researchers have collaborators at the research site abroad?
The age of majority in international research is determined by the
Laws, customs, and norms in the area in which the research will be conducted.
A researcher proposes a study and wants to recruit subjects from health
care clinics in Jamaica. The survey will be conducted by the U.S.
researchers at the clinic. The nurses at the clinic will inform prospective
subjects about the availability of the research, but will not consent the
subjects nor perform any research procedures (even screening procedures).
Are the nurses engaged in the research according to federal regulations?
No, they are not engaged because they are only informing the subjects and
not consenting or performing any research procedures, or receiving or sharing
any private, identifiable information.
A researcher proposes to conduct a study at a foreign site. The research
has been determined to be exempt from the federal regulations by
institutional policy. According to federal regulations, is review required at
the foreign site?
If a proposed study qualifies for exemption, federal regulations do not
require review at the foreign site where it will be conducted.
,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.
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
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.
Which of the following examples of using the internet to conduct research
meets the federal definition of research with human subjects?
Conducting an on-line focus group with cancer survivors to determine familial
support systems. The researcher also invites subjects' significant others to be a
part of the focus group.
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.
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.
Researchers endeavoring to conduct an on-line study should consider that
there are some potential risks of harm to subjects unique to internet-based
research. One of these risks is:
Individuals may post private identifiable information about themselves on-line
without intending it to be public and available to researchers.
The peer review process can create conflicts of interest because the choice
of who reviews a potentially publishable project may show:
There may be bias by the peer reviewer as to the area of research
What is the term for management controls that are built in to a research
study (for example, independent data analysis)?
Inherent controls
A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because:
It may be difficult for the researcher to appear neutral, as the researcher may
have an interest in the research's success
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of
researchers who conducted clinical studies
An example of an individual financial COI is:
A researcher's spouse holds equity in a publicly traded pharmaceutical
company that is also the sponsor of the researcher's study.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at
the organization
During an Institutional Review Board (IRB) meeting, any IRB member who
may have a potential COI with a study under review should:
QUESTIONS AND ANSWERS ACCURATE
AND VERIFIED.
A professor at Big State University proposes to study attitudes about
obesity in Chile by giving subjects in Chile surveys to complete. Which is a
question that the Big State University IRB should ask the researcher in
order to determine if this study should be reviewed by a local Chilean IRB
or ethics committee, as well as the Big State University IRB?
Will the researchers have collaborators at the research site abroad?
The age of majority in international research is determined by the
Laws, customs, and norms in the area in which the research will be conducted.
A researcher proposes a study and wants to recruit subjects from health
care clinics in Jamaica. The survey will be conducted by the U.S.
researchers at the clinic. The nurses at the clinic will inform prospective
subjects about the availability of the research, but will not consent the
subjects nor perform any research procedures (even screening procedures).
Are the nurses engaged in the research according to federal regulations?
No, they are not engaged because they are only informing the subjects and
not consenting or performing any research procedures, or receiving or sharing
any private, identifiable information.
A researcher proposes to conduct a study at a foreign site. The research
has been determined to be exempt from the federal regulations by
institutional policy. According to federal regulations, is review required at
the foreign site?
If a proposed study qualifies for exemption, federal regulations do not
require review at the foreign site where it will be conducted.
,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.
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
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.
Which of the following examples of using the internet to conduct research
meets the federal definition of research with human subjects?
Conducting an on-line focus group with cancer survivors to determine familial
support systems. The researcher also invites subjects' significant others to be a
part of the focus group.
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.
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.
Researchers endeavoring to conduct an on-line study should consider that
there are some potential risks of harm to subjects unique to internet-based
research. One of these risks is:
Individuals may post private identifiable information about themselves on-line
without intending it to be public and available to researchers.
The peer review process can create conflicts of interest because the choice
of who reviews a potentially publishable project may show:
There may be bias by the peer reviewer as to the area of research
What is the term for management controls that are built in to a research
study (for example, independent data analysis)?
Inherent controls
A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because:
It may be difficult for the researcher to appear neutral, as the researcher may
have an interest in the research's success
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of
researchers who conducted clinical studies
An example of an individual financial COI is:
A researcher's spouse holds equity in a publicly traded pharmaceutical
company that is also the sponsor of the researcher's study.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at
the organization
During an Institutional Review Board (IRB) meeting, any IRB member who
may have a potential COI with a study under review should:
