CITI Training Review: Human Subjects
Research
Example of how the principle of beneficence is applied to a study involving
human subjects ✔️Ans - Ensuring that the risks are reasonable in
relationship to anticipated benefits
Harvard "Tastes, Ties, and Time (T3)" (2006-2009) Study involves this
primary ethical violation ✔️Ans - The researcher's failure to protect
research subjects from deductive disclosure (primary ethical violation)
"The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro
Male" Study ✔️Ans - The study most directly linked to the establishment
of the "National Research Act" (1974) and ultimately the "Belmont Report and
Federal Regulations for Human Subject Protection"
The Belmont principle of Beneficence ✔️Ans - Requires that: potential
benefits justify the risks of harm
The Belmont principle of Justice ✔️Ans - Moral Requirement that: there
be fair outcomes in the selection of research subjects
Identifiable Private Information (according to Federal regulations) ✔️Ans
- Data obtained by an investigator about human subjects/living human beings
through interaction/intervention with an individual
Example of a study that meets the definition of research with human subjects
(according to Federal regulations) ✔️Ans - 1 - A developmental
psychologist videotapes interactions between groups of toddlers and their
care givers to determine which intervention methods most effectively manage
aggression.
2 - A study of twenty 4th grade classrooms in which researchers ask the
school to systematically vary the time of day reading is taught, and collect
weekly assessments of reading comprehension for each child over a three-
month period.
, 3 - An experiment is proposed on the relationship between gender-related
stereotypes in math and the subsequent performance by males and females
on math tests.
4 - A cognitive psychologist enrolls undergraduate students for a computer-
based study about the effect of mood on problem solving behaviors.
Example of Public Information ✔️Ans - Census data (final report as
published by the Census Bureau)
Example of Private Information ✔️Ans - A medical record
Example of a study the IRB will not review because it is not research (as
defined by the Federal regulations) ✔️Ans - A professor at Big State
University is writing a biography about Bill Gates and conducting oral
histories with all of Bill Gates' friends, family members, and business
acquaintances. The researcher submits the research proposal to the
institution's IRB
A subject in a clinical trial experiences a serious, unanticipated adverse drug
experience. The investigator should proceed, with respect to the IRB, after the
discovery of the adverse event occurrence by: ✔️Ans - Reporting the
adverse drug experience in a timely manner, in keeping with the IRB's policies
and procedures, using the forms or the mechanism provided by the IRB
An investigator is required to keep consent documents, IRB correspondence,
and research records for: ✔️Ans - A minimum of 3 years after completion
of the study
Expedited review or a new, proposed study may be used by the IRB if:
✔️Ans - - the study involves no more than minimal risks
- AND meets one of the allowable categories of expedited review (specified in
Federal regulations)
Amendments involving changes to IRB approved protocols do NOT need prior
IRB approval if: ✔️Ans - The changes must be immediately implemented
for the health and well-being of the subject
IRB Continuing Review of an approved protocol must occur: ✔️Ans - at
LEAST anually
Research
Example of how the principle of beneficence is applied to a study involving
human subjects ✔️Ans - Ensuring that the risks are reasonable in
relationship to anticipated benefits
Harvard "Tastes, Ties, and Time (T3)" (2006-2009) Study involves this
primary ethical violation ✔️Ans - The researcher's failure to protect
research subjects from deductive disclosure (primary ethical violation)
"The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro
Male" Study ✔️Ans - The study most directly linked to the establishment
of the "National Research Act" (1974) and ultimately the "Belmont Report and
Federal Regulations for Human Subject Protection"
The Belmont principle of Beneficence ✔️Ans - Requires that: potential
benefits justify the risks of harm
The Belmont principle of Justice ✔️Ans - Moral Requirement that: there
be fair outcomes in the selection of research subjects
Identifiable Private Information (according to Federal regulations) ✔️Ans
- Data obtained by an investigator about human subjects/living human beings
through interaction/intervention with an individual
Example of a study that meets the definition of research with human subjects
(according to Federal regulations) ✔️Ans - 1 - A developmental
psychologist videotapes interactions between groups of toddlers and their
care givers to determine which intervention methods most effectively manage
aggression.
2 - A study of twenty 4th grade classrooms in which researchers ask the
school to systematically vary the time of day reading is taught, and collect
weekly assessments of reading comprehension for each child over a three-
month period.
, 3 - An experiment is proposed on the relationship between gender-related
stereotypes in math and the subsequent performance by males and females
on math tests.
4 - A cognitive psychologist enrolls undergraduate students for a computer-
based study about the effect of mood on problem solving behaviors.
Example of Public Information ✔️Ans - Census data (final report as
published by the Census Bureau)
Example of Private Information ✔️Ans - A medical record
Example of a study the IRB will not review because it is not research (as
defined by the Federal regulations) ✔️Ans - A professor at Big State
University is writing a biography about Bill Gates and conducting oral
histories with all of Bill Gates' friends, family members, and business
acquaintances. The researcher submits the research proposal to the
institution's IRB
A subject in a clinical trial experiences a serious, unanticipated adverse drug
experience. The investigator should proceed, with respect to the IRB, after the
discovery of the adverse event occurrence by: ✔️Ans - Reporting the
adverse drug experience in a timely manner, in keeping with the IRB's policies
and procedures, using the forms or the mechanism provided by the IRB
An investigator is required to keep consent documents, IRB correspondence,
and research records for: ✔️Ans - A minimum of 3 years after completion
of the study
Expedited review or a new, proposed study may be used by the IRB if:
✔️Ans - - the study involves no more than minimal risks
- AND meets one of the allowable categories of expedited review (specified in
Federal regulations)
Amendments involving changes to IRB approved protocols do NOT need prior
IRB approval if: ✔️Ans - The changes must be immediately implemented
for the health and well-being of the subject
IRB Continuing Review of an approved protocol must occur: ✔️Ans - at
LEAST anually
