CITI Training Review Human Subjects
Research questions with answers.
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
Parental Permission using this example: A therapist at a free university clinic treats elementary school
children with behavior problems who are referred by a social service agency. She is also a doctoral
candidate who proposes using data she has and will collect about the children for a case-based research
project. ANS -The parents of the children might feel pressure to give permission to the therapist to use
their children's data so that she will continue to provide services to their children
Exculpatory Language ANS -Language which waives or appears to waive any of the subject's legal rights
or releases or appears to release those conducting the research from liability for negligence.
Research questions with answers.
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
Parental Permission using this example: A therapist at a free university clinic treats elementary school
children with behavior problems who are referred by a social service agency. She is also a doctoral
candidate who proposes using data she has and will collect about the children for a case-based research
project. ANS -The parents of the children might feel pressure to give permission to the therapist to use
their children's data so that she will continue to provide services to their children
Exculpatory Language ANS -Language which waives or appears to waive any of the subject's legal rights
or releases or appears to release those conducting the research from liability for negligence.
