CITI Training Review: Human Subjects Research
1. Example of how the principle of beneficence is applied to a study
involving human subjects: Ensuring that the risks are reasonable in
relationship to antici- pated benefits
2. Harvard "Tastes, Ties, and Time (T3)" (2006-2009) Study involves this pri-
mary ethical violation: The researcher's failure to protect research
subjects from deductive disclosure (primary ethical violation)
3. "The Public Health Service Tuskegee Study of Untreated Syphilis in the
Negro Male" Study: 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"
4. The Belmont principle of Beneficence: Requires that: potential benefits
justify the risks of harm
5. The Belmont principle of Justice: Moral Requirement that: there be
fair out- comes in the selection of research subjects
6. Identifiable Private Information (according to Federal regulations):
Data obtained by an investigator about human subjects/living
human beings through interaction/intervention with an individual
7. Example of a study that meets the definition of research with human
1/
,subjects (according to Federal regulations): 1 - A developmental
psychologist videotapes interactions between groups of toddlers and
their care givers to deter- mine 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 assess- ments of reading comprehension for each
child over a three-month period.
3 - An experiment is proposed on the relationship between gender-
related stereo- types 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.
8. Example of Public Information: Census data (final report as published
by the Census Bureau)
9. Example of Private Information: A medical record
10.Example of a study the IRB will not review because it is not research
(as defined by the Federal regulations): A professor at Big State
University is writing a biography about Bill Gates and conducting oral
histories with all of Bill Gates'
2/
,friends, family members, and business acquaintances. The researcher
submits the research proposal to the institution's IRB
11.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 (Answer)
Reporting the ad- verse 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
12.An investigator is required to keep consent documents, IRB correspon-
dence, and research records for (Answer) A minimum of 3 years after
completion of the study
13.Expedited review or a new, proposed study may be used by the IRB if
(Answer) - the study involves no more than minimal risks
- AND meets one of the allowable categories of expedited review
(specified in Federal regulations)
14.Amendments involving changes to IRB approved protocols do NOT
need prior IRB approval if (Answer) The changes must be immediately
implemented for the health and well-being of the subject
15.IRB Continuing Review of an approved protocol must occur (Answer)
at LEAST anually
16.Parental Permission using this example: A therapist at a free univer-
sity 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
3/
,case-based research project.: 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
17.Exculpatory Language: 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.
18.Exculpatory Language in Informed Consent: General requirement
for In- formed Consent is that no informed consent may include any
exculpatory lan- guage.
19.Example of Exculpatory Language in a consent form (Answer) "Taking
part in the research is voluntary, but if you choose to take the part,
you waive the right to legal redress for any research-related injuries."
4/
, 20.A criterion for waiving informed consent (Answer) When appropriate,
subjects are provided additional pertinent information after the study
21.A waiver of the requirement for documentation of informed consent
may be granted when (Answer) - The only record linking the subject and
the research is the consent document
- AND the principal risk is a breach of confidentiality
22.Example of a study in which it would NOT be appropriate to provide
subjects with information about missing elements of consent (Answer) A
study in which subjects were assigned to study activities based on an
undesirable or unflattering physical characteristic as assessed by
members of the research team.
23.As a part of the consent process, researchers are required (by the
Federal regulations) to provide subjects with information (Answer) At the
appropriate reading comprehension level
24.Breach of Confidentiality: The research data have been disclosed,
counter to the agreement between researcher and subjects
25.A Violation of Subjects' Privacy: The right of the individuals to be
protected against intrusion into their personal lives or affairs
26.Example of a study that constitutes both a Breach of Confidentiality
AND a Violation of Subjects' Privacy: A faculty member makes
identifiable data about sexual behavior available to graduate students,
although the subjects were assured that the data would be de-
identified
5/
1. Example of how the principle of beneficence is applied to a study
involving human subjects: Ensuring that the risks are reasonable in
relationship to antici- pated benefits
2. Harvard "Tastes, Ties, and Time (T3)" (2006-2009) Study involves this pri-
mary ethical violation: The researcher's failure to protect research
subjects from deductive disclosure (primary ethical violation)
3. "The Public Health Service Tuskegee Study of Untreated Syphilis in the
Negro Male" Study: 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"
4. The Belmont principle of Beneficence: Requires that: potential benefits
justify the risks of harm
5. The Belmont principle of Justice: Moral Requirement that: there be
fair out- comes in the selection of research subjects
6. Identifiable Private Information (according to Federal regulations):
Data obtained by an investigator about human subjects/living
human beings through interaction/intervention with an individual
7. Example of a study that meets the definition of research with human
1/
,subjects (according to Federal regulations): 1 - A developmental
psychologist videotapes interactions between groups of toddlers and
their care givers to deter- mine 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 assess- ments of reading comprehension for each
child over a three-month period.
3 - An experiment is proposed on the relationship between gender-
related stereo- types 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.
8. Example of Public Information: Census data (final report as published
by the Census Bureau)
9. Example of Private Information: A medical record
10.Example of a study the IRB will not review because it is not research
(as defined by the Federal regulations): A professor at Big State
University is writing a biography about Bill Gates and conducting oral
histories with all of Bill Gates'
2/
,friends, family members, and business acquaintances. The researcher
submits the research proposal to the institution's IRB
11.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 (Answer)
Reporting the ad- verse 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
12.An investigator is required to keep consent documents, IRB correspon-
dence, and research records for (Answer) A minimum of 3 years after
completion of the study
13.Expedited review or a new, proposed study may be used by the IRB if
(Answer) - the study involves no more than minimal risks
- AND meets one of the allowable categories of expedited review
(specified in Federal regulations)
14.Amendments involving changes to IRB approved protocols do NOT
need prior IRB approval if (Answer) The changes must be immediately
implemented for the health and well-being of the subject
15.IRB Continuing Review of an approved protocol must occur (Answer)
at LEAST anually
16.Parental Permission using this example: A therapist at a free univer-
sity 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
3/
,case-based research project.: 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
17.Exculpatory Language: 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.
18.Exculpatory Language in Informed Consent: General requirement
for In- formed Consent is that no informed consent may include any
exculpatory lan- guage.
19.Example of Exculpatory Language in a consent form (Answer) "Taking
part in the research is voluntary, but if you choose to take the part,
you waive the right to legal redress for any research-related injuries."
4/
, 20.A criterion for waiving informed consent (Answer) When appropriate,
subjects are provided additional pertinent information after the study
21.A waiver of the requirement for documentation of informed consent
may be granted when (Answer) - The only record linking the subject and
the research is the consent document
- AND the principal risk is a breach of confidentiality
22.Example of a study in which it would NOT be appropriate to provide
subjects with information about missing elements of consent (Answer) A
study in which subjects were assigned to study activities based on an
undesirable or unflattering physical characteristic as assessed by
members of the research team.
23.As a part of the consent process, researchers are required (by the
Federal regulations) to provide subjects with information (Answer) At the
appropriate reading comprehension level
24.Breach of Confidentiality: The research data have been disclosed,
counter to the agreement between researcher and subjects
25.A Violation of Subjects' Privacy: The right of the individuals to be
protected against intrusion into their personal lives or affairs
26.Example of a study that constitutes both a Breach of Confidentiality
AND a Violation of Subjects' Privacy: A faculty member makes
identifiable data about sexual behavior available to graduate students,
although the subjects were assured that the data would be de-
identified
5/
