CITI IRB (Conflicts of Interest & Basics of Info Security);CITI training questions and answers complete,100% verified and updated
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CITI IRB
CITI IRB (Conflicts of Interest & Basics of Info Security);CITI training questions and answers complete,100% verified and updated
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 n...
CITI IRB (Conflicts of Interest & Basics of Info
Security);CITI training questions and answers 2023-2024
complete,100% verified and updated
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
During an Institutional Review Board (IRB) meeting, an IRB member who may
have a potential COI with a study under review should:
Disclose their potential COI and may answer questions, but recuse themselves from
voting
The COI management plan aims to:
Provide procedures or extras steps to be taken to minimize the risk of bias when a COI
is disclosed
What is the term for management controls that are build in to a research study
(for example, independent data analysis)?
Inherent controls
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.
No later than the time of proposal submission
An example of a COI is:
An industry sponsor pays for the construction of a new research laboratory at the
organization
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers
who conducted clinical studies.
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
Which of these is generally not a good practice with respect to oral
communications (that is, talking) in organizations like healthcare facilities?
Use of full names in public areas or on intercom/paging systems, because there is no
security issue with identifying persons in public areas and using full names helps avoid
misidentification.
Which of these is not a good practice for physical security?
To preserve good customer relations, visitors are generally allowed access to all areas
of a facility unless it appears they are doing something suspicious.
Which of these is not generally a good practice for fax machine use?
Sensitive faxes -- inbound or outbound -- are left sitting in or around the machine.
Security measures are sometimes described as a combination of physical,
technical, and administrative (PTA) safeguards. Which of these would be
considered a technical safeguard?
,Measures including device data encryption, anti-malware software, and communications
encryption.
Which of these is not generally a good practice for telephone use?
Using voicemail systems and answering machines that do not require a password or
PIN for access.
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 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.
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.
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.
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.
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 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.
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.
,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.
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.
What procedures must be described in an agreement called an "assurance of
compliance" with OHRP?
procedures in place that ensure that subjects will be protected in a manner
commensurate with the Common Rule, including review by an independent committee
comparable to an IRB.
What are some considerations for a U.S researcher conducting a study in a non-
U.S. setting when obtaining informed consent from subjects?
In addition to the consent of the research subjects, are there other individuals or groups
whose permission must be sought?
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 researcher have collaborators at the research site abroad?
A Researcher proposes to conduct a study at a foreign site that 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.
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
availably 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 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
availably 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 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 researcher have collaborators at the research site abroad?
Which of the following is the LEAST important activity when protecting human
subjects in international research?
Assessing transportation conditions
What procedures must be described in an agreement called an "assurance of
compliance" with OHRP?
Procedures in place that ensure that subjects will be protected in a manner
commensurate with the Common Rule, including review by an independent committee
comparable to an IRB.
What are some considerations for a U.S. researcher conducting a study in a non-
U.S. setting when obtaining informed consent from subjects?
In addition to the consent of the research subjects, are there other individuals or groups
whose permission must be sought
Which of the following activities constitutes engagement in research?
Obtaining informed consent and conducting research interviews.
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.
The University of Scranton IRB or its designated reviewers must review all
research involving
Both simple anonymous surveys and class assignments outside of class
A Departmental Review Board (DRB) can review
Form A and B
Which type of research cannot be submitted on Form A
No risk experiment
Which type of research must be submitted on Form B - no risk beyond everyday
life and
Both recording participant identity and experimental procedures
Which type of research must be submitted on Form C
Both research involving children and risk beyond everyday life
To speed up the approval process, an IRB administer can be the sole reviewer of
__ proposals.
Form A
Which of the following is the general guideline that IACUCs use to evaluate the
potential pain of a procedure conducted with animals?
Any procedure that causes pain or distress in human beings may cause pain or distress
in other animals.
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