CITI Training Questions With All Correct Answers
Which of the following activities constitutes engagement in research?
correct answer -Obtaining informed consent and conducting research
interviews.
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?
correct answer -If a proposed study qualifies for exemption, federal
regulations do not require review at the foreign site where it will be
conducted.
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? correct answer -Will
the researchers have collaborators at the research site abroad?
What are some considerations for a U.S. researcher conducting a study in a
non-U.S. setting when obtaining informed consent from subjects? correct
answer -In addition to the consent of the research subjects, are there other
individuals or groups whose permission must be sought?
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? correct answer -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.
In most cases, a U.S. researcher affiliated with an academic institution,
proposing to conducted funded research outside of the U.S., must have the
approval of which of the following entities: correct answer -An IRB from
,both the researcher's U.S. institution and an equivalent entity within the host
country
Researchers designing studies to be conducted in host countries outside the
U.S. should: correct answer -Remember that in some populations an
individual cannot make a decision about medical care without the full
engagement of relatives, friends and those in authority in the community
Which of the following is a commonly used resource for international ethical
guidelines for human subjects research? correct answer -CIOMS
International Ethical Guidelines for Health-related Research Involving
Humans
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: correct answer -
Valid analyses of differences in intervention effects can be accomplished.
Cultural competence in research is defined as the ability of researchers to
provide high quality research that takes into account: correct answer -The
diversity of population's values, beliefs and behaviors when developing
research ideas, conducting research and exploring applicability of their
findings.
Trust and transparency are critical to successful and culturally competent
research. In the research setting, establishing trust in diverse communities
does NOT require: correct answer -Limiting public transparency and
accountability
Overcoming challenges to cultural competence in research requires that:
(Check ALL that apply) correct answer -- Investigators examine and
understand historical contexts for study populations before initiating research
study design.
- Early-phase study design should take into account race, ethnicity and
cultural factors.
- IRB membership should include representatives of large communities and
cultural groups as representatives.
, 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: correct answer -Provide a framework for use in
the resolution of ethical problems arising from research involving human
subjects.
The future of medicine is likely to be personalized to an individual's: correct
answer -Genetic make-up
A 2011 report from the conference "Dialogues on Diversifying Clinical Trials,"
sponsored by FDA's Office of Women's Health and the Society for Women's
Health Research found that: correct answer -African Americans account
for 5 percent of clinical trial participants and Hispanics 1 percent
The "Teach-back" method, when used in the consent process has been shown
to improve understanding, especially when: correct answer -Questions are
pre-imbedded in the process
The 1991 CIOMS guidelines for epidemiological studies state, that at the level
of the individual, ethics governs how one person should relate to another and
the moral claims of each member of a community, and at the level of the
community, ethics applies to how one community relates to another and
members of other groups with different cultural values. When it comes to
research, the best statement about procedures is that: correct answer -
Procedures that are unethical at one level cannot be justified merely because
they are considered ethically acceptable at the other.
A research university in California is concerned that the high number of Asian
immigrants may result in enrollments in research due to a cultural deference
to authority. The university wishes to write a policy for informed consent that
will help assure that the cultural deference to authority is addressed by
researchers. The best solution would be to include a requirement for:
correct answer -A "cooling off" period of at least one day between providing
consent information and signing the consent form
Where could student researchers and/or student subjects find additional
resources regarding the IRB approval process? Select all that apply. correct
answer -- Faculty Advisor/Research Mentor
Which of the following activities constitutes engagement in research?
correct answer -Obtaining informed consent and conducting research
interviews.
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?
correct answer -If a proposed study qualifies for exemption, federal
regulations do not require review at the foreign site where it will be
conducted.
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? correct answer -Will
the researchers have collaborators at the research site abroad?
What are some considerations for a U.S. researcher conducting a study in a
non-U.S. setting when obtaining informed consent from subjects? correct
answer -In addition to the consent of the research subjects, are there other
individuals or groups whose permission must be sought?
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? correct answer -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.
In most cases, a U.S. researcher affiliated with an academic institution,
proposing to conducted funded research outside of the U.S., must have the
approval of which of the following entities: correct answer -An IRB from
,both the researcher's U.S. institution and an equivalent entity within the host
country
Researchers designing studies to be conducted in host countries outside the
U.S. should: correct answer -Remember that in some populations an
individual cannot make a decision about medical care without the full
engagement of relatives, friends and those in authority in the community
Which of the following is a commonly used resource for international ethical
guidelines for human subjects research? correct answer -CIOMS
International Ethical Guidelines for Health-related Research Involving
Humans
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: correct answer -
Valid analyses of differences in intervention effects can be accomplished.
Cultural competence in research is defined as the ability of researchers to
provide high quality research that takes into account: correct answer -The
diversity of population's values, beliefs and behaviors when developing
research ideas, conducting research and exploring applicability of their
findings.
Trust and transparency are critical to successful and culturally competent
research. In the research setting, establishing trust in diverse communities
does NOT require: correct answer -Limiting public transparency and
accountability
Overcoming challenges to cultural competence in research requires that:
(Check ALL that apply) correct answer -- Investigators examine and
understand historical contexts for study populations before initiating research
study design.
- Early-phase study design should take into account race, ethnicity and
cultural factors.
- IRB membership should include representatives of large communities and
cultural groups as representatives.
, 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: correct answer -Provide a framework for use in
the resolution of ethical problems arising from research involving human
subjects.
The future of medicine is likely to be personalized to an individual's: correct
answer -Genetic make-up
A 2011 report from the conference "Dialogues on Diversifying Clinical Trials,"
sponsored by FDA's Office of Women's Health and the Society for Women's
Health Research found that: correct answer -African Americans account
for 5 percent of clinical trial participants and Hispanics 1 percent
The "Teach-back" method, when used in the consent process has been shown
to improve understanding, especially when: correct answer -Questions are
pre-imbedded in the process
The 1991 CIOMS guidelines for epidemiological studies state, that at the level
of the individual, ethics governs how one person should relate to another and
the moral claims of each member of a community, and at the level of the
community, ethics applies to how one community relates to another and
members of other groups with different cultural values. When it comes to
research, the best statement about procedures is that: correct answer -
Procedures that are unethical at one level cannot be justified merely because
they are considered ethically acceptable at the other.
A research university in California is concerned that the high number of Asian
immigrants may result in enrollments in research due to a cultural deference
to authority. The university wishes to write a policy for informed consent that
will help assure that the cultural deference to authority is addressed by
researchers. The best solution would be to include a requirement for:
correct answer -A "cooling off" period of at least one day between providing
consent information and signing the consent form
Where could student researchers and/or student subjects find additional
resources regarding the IRB approval process? Select all that apply. correct
answer -- Faculty Advisor/Research Mentor
