Citi Training And Belmont Report 2023
Three principles of Belmont Report ✔️Ans - Respect for Persons
Beneficence
Justice
The Belmont Report
Principle of Beneficence ✔️Ans - MAXIMIZATION of benefits and
MINIMIZATION of risks
T/F
Belmont Report indicates it is necessary to rigorously avoid conflicts of
interest ✔️Ans - TRUE
The Belmont Report
Respect for Person ✔️Ans - Requires that subjects freely choose to
participate in research (voluntariness) and that they are adequately informed
about a study (informed consent)
The Belmont Report defines and delineates... ✔️Ans - "Practice" and
"Research"
The Belmont Report
The Principle of Justice ✔️Ans - Research benefit and burden distribution
and that selection of subjects is fair.
T/F
The Belmont report describes the necessity to effectively manage conflicts of
interest ✔️Ans - FALSE
Students in Research
The history of ethical regulations in human subjects research began with the
✔️Ans - Nuremberg Code
Nuremberg Code ✔️Ans - Human subjects research guidelines and
regulations
Year of the Nuremberg Code ✔️Ans - 1949
,Additional resources regarding IRB approval process ✔️Ans - Faculty
advisor/Research Mentor
IRB office
Human subjects research websites
What element must be included in an informed consent? ✔️Ans - All
foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require
a Determination by the IRB? ✔️Ans - If the study qualifies for EXEMPTION
Another name for the "Exempt" status ✔️Ans - the Common Rule
stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects? ✔️Ans -
Avoid using their own students in their research
Name the type of Review: Research study that involves use of educational
tests, survey, interviews, or observations of public behavior without
identifiable information. ✔️Ans - Exempt Review category 2
Name the type of review: A study involving data collected that could have an
impact on human subject's careers and it contains identifiers of the subjects.
✔️Ans - Full Board Review
Type of review that qualifies if no identification of subjects and/or their
responses would reasonably place them at risk of criminal or civil liability or
be damaging to the subjects financial standing, employability, insurability,
reputation, or be stigmatizing, unless reasonable and appropriate protections
will be implemented so that risks related to invasion of privacy and breach of
confidentiality are no greater than minimal ✔️Ans - Expedited review
Type of review: data that is collected does not meet definition of human
subjects research as stated by federal regulations. No info ABOUT human ie.
info about a business ✔️Ans - Not Human Subjects
,Federal regulations define human subjects as "living individual about whom
an investigator conducting research obtains"...? (2 components) ✔️Ans -
"1.data through intervention or interaction with the individual
2. identifiable private information"
Name the 3 responsibilities the IRB is charged with ✔️Ans - 1. Protecting
the rights and welfare of human subjects
2. Assuring that all applicable institutional policies and federal regulations
related to research with human subjects are followed
3. Reviewing subject recruitment materials and strategies
T/F
IRB's investigate scientific misconduct ✔️Ans - False
T/F
IRB's do not review manuscripts prior to submission for publication ✔️Ans
- True
DHHS
FDA ✔️Ans - Depts. IRB's review for current policies
-Department of Health and Human Services
-Food and Drug Administration
Name the study that links most directly to the establishment of the National
Research Act in 1974 and ultimately the Belmont Report and Federal
regulations for human subject protection ✔️Ans - The Public Health
Service Tuskegee Study of Untreated Syphilis in the Negro Male
The Tuskegee Study relates to which Belmont principle? ✔️Ans - The
principle of beneficence: Potential benefits justify the risks of harm
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: ✔️Ans
- Respect for persons
Belmont Report
According to the Belmont Report, the moral requirement that there be fair
outcomes in the selection of research subjects, expresses the principle of:
✔️Ans - Justice
, How is the principle of beneficence applied to a study involving human
subjects? ✔️Ans - Ensuring that risks are reasonable in relationship to
anticipated benefits.
Human subject study or not?
Developmental psychologist videotapes interactions between groups of
toddlers and their care givers to determine which intervention methods most
effectively manage aggression ✔️Ans - Yes
Human subject study or not?
The study of a list with deceased passengers ✔️Ans - No:Human subject is
a living individual
Human subject study or not?Questioning individuals to acquire data about the
number of newly diagnosed HIV cases? ✔️Ans - No: 'what' question rather
than 'who' question
Human subject study or not?
Conducting linguistic analysis of comments posted on a public blog ✔️Ans
- Not: involves neither interaction with individuals nor collecting private
identified info
Human subject study or not?
A study proposed by developmental psychologist involving interactions with
living individuals and designed to contribute to field of knowledge ✔️Ans -
Yes: humans
Human subject study?
A cognitive psychologist enrolls undergraduate students for a computer-based
study about the effect of mood on problem solving behaviors ✔️Ans - Yes:
Interacting w/ living individuals.
Human subject study or not?
Questioning a superintendent of schools to acquire data about the ethnic
composition of a school ✔️Ans - No: it is an "about what" question rather
than "about whom" question
Human subject study or not?
Three principles of Belmont Report ✔️Ans - Respect for Persons
Beneficence
Justice
The Belmont Report
Principle of Beneficence ✔️Ans - MAXIMIZATION of benefits and
MINIMIZATION of risks
T/F
Belmont Report indicates it is necessary to rigorously avoid conflicts of
interest ✔️Ans - TRUE
The Belmont Report
Respect for Person ✔️Ans - Requires that subjects freely choose to
participate in research (voluntariness) and that they are adequately informed
about a study (informed consent)
The Belmont Report defines and delineates... ✔️Ans - "Practice" and
"Research"
The Belmont Report
The Principle of Justice ✔️Ans - Research benefit and burden distribution
and that selection of subjects is fair.
T/F
The Belmont report describes the necessity to effectively manage conflicts of
interest ✔️Ans - FALSE
Students in Research
The history of ethical regulations in human subjects research began with the
✔️Ans - Nuremberg Code
Nuremberg Code ✔️Ans - Human subjects research guidelines and
regulations
Year of the Nuremberg Code ✔️Ans - 1949
,Additional resources regarding IRB approval process ✔️Ans - Faculty
advisor/Research Mentor
IRB office
Human subjects research websites
What element must be included in an informed consent? ✔️Ans - All
foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require
a Determination by the IRB? ✔️Ans - If the study qualifies for EXEMPTION
Another name for the "Exempt" status ✔️Ans - the Common Rule
stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects? ✔️Ans -
Avoid using their own students in their research
Name the type of Review: Research study that involves use of educational
tests, survey, interviews, or observations of public behavior without
identifiable information. ✔️Ans - Exempt Review category 2
Name the type of review: A study involving data collected that could have an
impact on human subject's careers and it contains identifiers of the subjects.
✔️Ans - Full Board Review
Type of review that qualifies if no identification of subjects and/or their
responses would reasonably place them at risk of criminal or civil liability or
be damaging to the subjects financial standing, employability, insurability,
reputation, or be stigmatizing, unless reasonable and appropriate protections
will be implemented so that risks related to invasion of privacy and breach of
confidentiality are no greater than minimal ✔️Ans - Expedited review
Type of review: data that is collected does not meet definition of human
subjects research as stated by federal regulations. No info ABOUT human ie.
info about a business ✔️Ans - Not Human Subjects
,Federal regulations define human subjects as "living individual about whom
an investigator conducting research obtains"...? (2 components) ✔️Ans -
"1.data through intervention or interaction with the individual
2. identifiable private information"
Name the 3 responsibilities the IRB is charged with ✔️Ans - 1. Protecting
the rights and welfare of human subjects
2. Assuring that all applicable institutional policies and federal regulations
related to research with human subjects are followed
3. Reviewing subject recruitment materials and strategies
T/F
IRB's investigate scientific misconduct ✔️Ans - False
T/F
IRB's do not review manuscripts prior to submission for publication ✔️Ans
- True
DHHS
FDA ✔️Ans - Depts. IRB's review for current policies
-Department of Health and Human Services
-Food and Drug Administration
Name the study that links most directly to the establishment of the National
Research Act in 1974 and ultimately the Belmont Report and Federal
regulations for human subject protection ✔️Ans - The Public Health
Service Tuskegee Study of Untreated Syphilis in the Negro Male
The Tuskegee Study relates to which Belmont principle? ✔️Ans - The
principle of beneficence: Potential benefits justify the risks of harm
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: ✔️Ans
- Respect for persons
Belmont Report
According to the Belmont Report, the moral requirement that there be fair
outcomes in the selection of research subjects, expresses the principle of:
✔️Ans - Justice
, How is the principle of beneficence applied to a study involving human
subjects? ✔️Ans - Ensuring that risks are reasonable in relationship to
anticipated benefits.
Human subject study or not?
Developmental psychologist videotapes interactions between groups of
toddlers and their care givers to determine which intervention methods most
effectively manage aggression ✔️Ans - Yes
Human subject study or not?
The study of a list with deceased passengers ✔️Ans - No:Human subject is
a living individual
Human subject study or not?Questioning individuals to acquire data about the
number of newly diagnosed HIV cases? ✔️Ans - No: 'what' question rather
than 'who' question
Human subject study or not?
Conducting linguistic analysis of comments posted on a public blog ✔️Ans
- Not: involves neither interaction with individuals nor collecting private
identified info
Human subject study or not?
A study proposed by developmental psychologist involving interactions with
living individuals and designed to contribute to field of knowledge ✔️Ans -
Yes: humans
Human subject study?
A cognitive psychologist enrolls undergraduate students for a computer-based
study about the effect of mood on problem solving behaviors ✔️Ans - Yes:
Interacting w/ living individuals.
Human subject study or not?
Questioning a superintendent of schools to acquire data about the ethnic
composition of a school ✔️Ans - No: it is an "about what" question rather
than "about whom" question
Human subject study or not?
