Mastering CITI IRB – A Comprehensive
Study Guide for Research Ethics
Which of the following studies would need IRB approval? - Studies collecting
identifiable information about living individuals.
Identify one way faculty researchers can possibly avoid undue influence of student
subjects? - Avoid recruiting their own students in the research
Under the U.S. Department of Health and Human Services (HHS) and U.S. Food
and Drug Administration (FDA) regulations, what is the Institutional Review Board
(IRB) charged with? Select all that apply. - - Protecting the rights and welfare of
human subjects.- Assuring that researchers follow all applicable institutional policies
and federal regulations related to research with human subjects.- Reviewing subject
recruitment materials and strategies.
Where could student researchers and/or student subjects find additional resources
regarding the IRB approval process? Select all that apply. - - Faculty
Advisor/Research Mentor
- IRB Office
In the U.S., the first federal regulations for human subjects research began in 1981
with the codification of the ________. - Common Rule
Which of the following is an example of how the principle of beneficence can be
applied to a study employing human subjects? - Determining that the study has a
maximization of benefits and a minimization of risks.
Which of the following are the three principles discussed in the Belmont Report? -
Respect for Persons, Beneficence, Justice
The Belmont Report's principle of respect for persons incorporates at least two
ethical convictions: first, that individuals should be treated as autonomous agents,
and second, that: - Persons with diminished autonomy are entitled to protection.
Your informed consent form must describe _______. - All foreseeable risks and
discomforts.
A student plans on interviewing 15 principals in neighboring high schools. The
student plans to collect data about the personal experiences the principals have had
with disruptive students, including the types of disciplinary actions that were taken
(including decisions they may have personally made) and their feelings or thoughts
regarding whether those actions were appropriate. The research data collected could
have an impact on the principals' careers. The student will collect identifiers. This
study would be subject to which type of review? - Convened Review
The Belmont principle of beneficence requires that: - Risks to subjects are
reasonable in relation to anticipated benefits.
, An example cited in the Belmont Report (The National Commission 1979) stated that
"During the 19th and early 20th centuries the burdens of serving as research
subjects fell largely upon poor ward patients, while the benefits of improved medical
care flowed primarily to private patients." This is an example of a violation of which
Belmont principle? - Justice
According to the Belmont Report, the requirement that the benefits and burdens of
the research are equitably distributed, expresses the principle of: - Justice
A study was submitted to the IRB designed to evaluate the effect of background
noise on an individual's ability to concentrate and answer questions. The IRB
approved the study and consent form. The consent form includes all the required
information. The use of a consent form is an example of the Belmont principle of: -
Respect for persons
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: - Respect for persons
A medical record is an example of: - Private information
A researcher is interested in assessing risk-taking by individuals. The researcher is
sitting on a bench near a busy four-way stop intersection. She plans on recording the
number of bike riders wearing a safety helmet and whether they stop at the
intersection before proceeding in order to correlate use of safety apparel with risk-
taking. This collection of information is an example of: - Public behavior
According to the federal regulations, human subjects are living individuals about
whom an investigator conducting research obtains information through interaction or
intervention with the individual, and uses, studies, or analyzes the information; or: -
Obtains, uses, studies, analyzes, or generates identifiable private information.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? - A cognitive psychologist enrolls
undergraduate students for a computer-based study about the effect of mood on
problem-solving behaviors.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? - An experiment is proposed on the
relationship between gender-related stereotypes in math and the subsequent
performance by males and females on math tests.
Which of the following statements about the relationship between an institution and
the institution's IRB(s) is correct? - Officials of the institution may overrule an IRB
approval.
According to the federal regulations, research is eligible for exemption, if: - The
research falls into one of eight categories of research activity described in the
regulations.
Study Guide for Research Ethics
Which of the following studies would need IRB approval? - Studies collecting
identifiable information about living individuals.
Identify one way faculty researchers can possibly avoid undue influence of student
subjects? - Avoid recruiting their own students in the research
Under the U.S. Department of Health and Human Services (HHS) and U.S. Food
and Drug Administration (FDA) regulations, what is the Institutional Review Board
(IRB) charged with? Select all that apply. - - Protecting the rights and welfare of
human subjects.- Assuring that researchers follow all applicable institutional policies
and federal regulations related to research with human subjects.- Reviewing subject
recruitment materials and strategies.
Where could student researchers and/or student subjects find additional resources
regarding the IRB approval process? Select all that apply. - - Faculty
Advisor/Research Mentor
- IRB Office
In the U.S., the first federal regulations for human subjects research began in 1981
with the codification of the ________. - Common Rule
Which of the following is an example of how the principle of beneficence can be
applied to a study employing human subjects? - Determining that the study has a
maximization of benefits and a minimization of risks.
Which of the following are the three principles discussed in the Belmont Report? -
Respect for Persons, Beneficence, Justice
The Belmont Report's principle of respect for persons incorporates at least two
ethical convictions: first, that individuals should be treated as autonomous agents,
and second, that: - Persons with diminished autonomy are entitled to protection.
Your informed consent form must describe _______. - All foreseeable risks and
discomforts.
A student plans on interviewing 15 principals in neighboring high schools. The
student plans to collect data about the personal experiences the principals have had
with disruptive students, including the types of disciplinary actions that were taken
(including decisions they may have personally made) and their feelings or thoughts
regarding whether those actions were appropriate. The research data collected could
have an impact on the principals' careers. The student will collect identifiers. This
study would be subject to which type of review? - Convened Review
The Belmont principle of beneficence requires that: - Risks to subjects are
reasonable in relation to anticipated benefits.
, An example cited in the Belmont Report (The National Commission 1979) stated that
"During the 19th and early 20th centuries the burdens of serving as research
subjects fell largely upon poor ward patients, while the benefits of improved medical
care flowed primarily to private patients." This is an example of a violation of which
Belmont principle? - Justice
According to the Belmont Report, the requirement that the benefits and burdens of
the research are equitably distributed, expresses the principle of: - Justice
A study was submitted to the IRB designed to evaluate the effect of background
noise on an individual's ability to concentrate and answer questions. The IRB
approved the study and consent form. The consent form includes all the required
information. The use of a consent form is an example of the Belmont principle of: -
Respect for persons
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: - Respect for persons
A medical record is an example of: - Private information
A researcher is interested in assessing risk-taking by individuals. The researcher is
sitting on a bench near a busy four-way stop intersection. She plans on recording the
number of bike riders wearing a safety helmet and whether they stop at the
intersection before proceeding in order to correlate use of safety apparel with risk-
taking. This collection of information is an example of: - Public behavior
According to the federal regulations, human subjects are living individuals about
whom an investigator conducting research obtains information through interaction or
intervention with the individual, and uses, studies, or analyzes the information; or: -
Obtains, uses, studies, analyzes, or generates identifiable private information.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? - A cognitive psychologist enrolls
undergraduate students for a computer-based study about the effect of mood on
problem-solving behaviors.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? - An experiment is proposed on the
relationship between gender-related stereotypes in math and the subsequent
performance by males and females on math tests.
Which of the following statements about the relationship between an institution and
the institution's IRB(s) is correct? - Officials of the institution may overrule an IRB
approval.
According to the federal regulations, research is eligible for exemption, if: - The
research falls into one of eight categories of research activity described in the
regulations.
