CITI TRAINING, MODULES 1-24 (BIOMEDICAL RESEARCH) – WITH WELL DETAILED
SOLUTIONS
A federally funded research study involving children 8 to 12 years old involves collecting a
single voided urine sample to assess the frequency of asymptomatic proteinuria (higher
amounts of protein in the urine without any signs or symptoms of illness or infection).
According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study
involves:
A. No risk to the child and no further IRB review is required.
B. No more than minimal risk to the child.
C. More than minimal risk with no prospect of direct benefit to the child.
D. More than minimal risk with prospect of direct benefit to the child.
B. No more than minimal risk to the child.
An investigator proposes a study to determine the clinical relevance of a new assay
technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer
patients undergoing chemotherapy. The study requires that two additional bone marrow
aspirates be performed during the course of chemotherapy. The subject's chemotherapy
will not be altered based on the results of the assay technique measures. However, future
patients with cancer would benefit from improved interventions based on study findings.
The IRB determined that the activity was a minor increase over minimal risk. Which of the
following statements best describes the IRB approval requirements for involving
adolescent cancer patients in the research study?
A. Assent of the child only is required.
B. Assent is not required, however, both parents must give permission for the inclusion of
the adolescent child.
C. Assent is not required, however, one parent must give permission for the inclusion of the
adolescent in this study.
D. Assent of the child and permission of both parents are required.
D. Assent of the child and permission of both parents are required.
,Investigators wish to evaluate a new treatment for eclampsia (a life-threatening condition
in pregnant women) in women 30 - 50 years of age. The research is intended to directly
benefit the pregnant woman who is otherwise healthy and competent. The investigator
must obtain consent from whom per Subpart B?
A. The pregnant woman and the father of the fetus.
B. The pregnant woman and her legally authorized representative.
C. The father of the fetus only.
D. The pregnant woman only.
D. The pregnant woman only.
A researcher wants to examine the efficacy of mushroom extract supplementation on fetal
loss, low birth weight, and severe preterm birth in healthy pregnant women. She plans to
enroll women who are 12-26 weeks pregnant and randomize them to either receive the
intervention or placebo until delivery. The IRB determines this intervention presents greater
than minimal risk to the pregnant women subjects, and potential direct benefit to both
mother and fetus. Is this research permitted under Subpart B?
A. Yes - this research is permitted.
B. No - this research is not permitted with pregnant women.
C. Yes- This research is permitted if because it may benefit the fetuses.
D. No - this research is not permitted because it involves fetuses.
A. Yes - this research is permitted.
According to 1994 NIH Guidelines, which of the following is adequate justification for
exclusion of women from NIH-funded research?
,A. There is compelling evidence that inclusion would be inappropriate with respect to the
health of the subjects.
B. Inclusion of women would complicate analysis of the results and increase the costs of
conducting the clinical trial.
C. The woman is of child-bearing potential.
A. There is compelling evidence that inclusion would be inappropriate with respect to the
health of the subjects.
A research study wants to determine the effectiveness of two prenatal care group programs
as compared to individual prenatal care in reducing the risk for HIV in young women during
and after pregnancy. The IRB determines the research is no greater than minimal risk for
the pregnant women and the fetuses. Is this research permitted under Subpart B?
A. No - this research is not permitted because it involves fetuses.
B. Yes - this research is permitted.
C. This research is only permitted if it also presents a direct benefit to the mother and the
fetus.
D. No - this research is not permitted with pregnant women.
Yes - this research is permitted.
A researcher wants to collect data about fetuses that were exposed to high levels of lead
during their mother's pregnancy. The researcher plans to review the medical records for a
control group (not known to be exposed to high levels of lead) and an experimental group
(exposed to high levels of lead) of fetuses from 12 weeks of gestation through delivery. Is
this research permitted under Subpart B?
A. No - research with vulnerable populations is not permitted under the federal regulations
B. Yes - this research with fetuses is permitted because it holds the direct benefit to the
mother
C. No - the researcher cannot collect data once the fetus is born under Subpart B
, D. Yes - research with neonates of uncertain viability may be involved because there is no
additional risk
D. Yes - research with neonates of uncertain viability may be involved because there is no
additional risk
Pregnant women, fetuses, and neonates are often considered vulnerable categories of
subjects. Additional protections are provided through regulation, however, the protections
are meant to be inclusive and not exclusive of pregnant women in research.
TRUE
FALSE
TRUE
Can research subject to Subpart B and that includes pregnant women as subjects be
exempt from the regulations, per 45 CFR 46, if all of the conditions of the exemption are
met?
A. No, research with pregnant women can never be exempt per 45 CFR 46.104.
B. Yes, but only for certain exempt categories per 45 CFR 46.104.
C. Yes, if there are limits on the blood draw amounts included in the research.
D. Yes, each of the exemptions in 45 CFR 46.104 may be applied to research subject to
Subpart B.
D. Yes, each of the exemptions in 45 CFR 46.104 may be applied to research subject to
Subpart B.
A research study will compare a new combined behavioral and pharmacologic treatment
with the standard behavioral treatment alone for individuals with severe seasonal affected
disorder (SAD). The researcher wants to include pregnant women in the study. However,
SOLUTIONS
A federally funded research study involving children 8 to 12 years old involves collecting a
single voided urine sample to assess the frequency of asymptomatic proteinuria (higher
amounts of protein in the urine without any signs or symptoms of illness or infection).
According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study
involves:
A. No risk to the child and no further IRB review is required.
B. No more than minimal risk to the child.
C. More than minimal risk with no prospect of direct benefit to the child.
D. More than minimal risk with prospect of direct benefit to the child.
B. No more than minimal risk to the child.
An investigator proposes a study to determine the clinical relevance of a new assay
technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer
patients undergoing chemotherapy. The study requires that two additional bone marrow
aspirates be performed during the course of chemotherapy. The subject's chemotherapy
will not be altered based on the results of the assay technique measures. However, future
patients with cancer would benefit from improved interventions based on study findings.
The IRB determined that the activity was a minor increase over minimal risk. Which of the
following statements best describes the IRB approval requirements for involving
adolescent cancer patients in the research study?
A. Assent of the child only is required.
B. Assent is not required, however, both parents must give permission for the inclusion of
the adolescent child.
C. Assent is not required, however, one parent must give permission for the inclusion of the
adolescent in this study.
D. Assent of the child and permission of both parents are required.
D. Assent of the child and permission of both parents are required.
,Investigators wish to evaluate a new treatment for eclampsia (a life-threatening condition
in pregnant women) in women 30 - 50 years of age. The research is intended to directly
benefit the pregnant woman who is otherwise healthy and competent. The investigator
must obtain consent from whom per Subpart B?
A. The pregnant woman and the father of the fetus.
B. The pregnant woman and her legally authorized representative.
C. The father of the fetus only.
D. The pregnant woman only.
D. The pregnant woman only.
A researcher wants to examine the efficacy of mushroom extract supplementation on fetal
loss, low birth weight, and severe preterm birth in healthy pregnant women. She plans to
enroll women who are 12-26 weeks pregnant and randomize them to either receive the
intervention or placebo until delivery. The IRB determines this intervention presents greater
than minimal risk to the pregnant women subjects, and potential direct benefit to both
mother and fetus. Is this research permitted under Subpart B?
A. Yes - this research is permitted.
B. No - this research is not permitted with pregnant women.
C. Yes- This research is permitted if because it may benefit the fetuses.
D. No - this research is not permitted because it involves fetuses.
A. Yes - this research is permitted.
According to 1994 NIH Guidelines, which of the following is adequate justification for
exclusion of women from NIH-funded research?
,A. There is compelling evidence that inclusion would be inappropriate with respect to the
health of the subjects.
B. Inclusion of women would complicate analysis of the results and increase the costs of
conducting the clinical trial.
C. The woman is of child-bearing potential.
A. There is compelling evidence that inclusion would be inappropriate with respect to the
health of the subjects.
A research study wants to determine the effectiveness of two prenatal care group programs
as compared to individual prenatal care in reducing the risk for HIV in young women during
and after pregnancy. The IRB determines the research is no greater than minimal risk for
the pregnant women and the fetuses. Is this research permitted under Subpart B?
A. No - this research is not permitted because it involves fetuses.
B. Yes - this research is permitted.
C. This research is only permitted if it also presents a direct benefit to the mother and the
fetus.
D. No - this research is not permitted with pregnant women.
Yes - this research is permitted.
A researcher wants to collect data about fetuses that were exposed to high levels of lead
during their mother's pregnancy. The researcher plans to review the medical records for a
control group (not known to be exposed to high levels of lead) and an experimental group
(exposed to high levels of lead) of fetuses from 12 weeks of gestation through delivery. Is
this research permitted under Subpart B?
A. No - research with vulnerable populations is not permitted under the federal regulations
B. Yes - this research with fetuses is permitted because it holds the direct benefit to the
mother
C. No - the researcher cannot collect data once the fetus is born under Subpart B
, D. Yes - research with neonates of uncertain viability may be involved because there is no
additional risk
D. Yes - research with neonates of uncertain viability may be involved because there is no
additional risk
Pregnant women, fetuses, and neonates are often considered vulnerable categories of
subjects. Additional protections are provided through regulation, however, the protections
are meant to be inclusive and not exclusive of pregnant women in research.
TRUE
FALSE
TRUE
Can research subject to Subpart B and that includes pregnant women as subjects be
exempt from the regulations, per 45 CFR 46, if all of the conditions of the exemption are
met?
A. No, research with pregnant women can never be exempt per 45 CFR 46.104.
B. Yes, but only for certain exempt categories per 45 CFR 46.104.
C. Yes, if there are limits on the blood draw amounts included in the research.
D. Yes, each of the exemptions in 45 CFR 46.104 may be applied to research subject to
Subpart B.
D. Yes, each of the exemptions in 45 CFR 46.104 may be applied to research subject to
Subpart B.
A research study will compare a new combined behavioral and pharmacologic treatment
with the standard behavioral treatment alone for individuals with severe seasonal affected
disorder (SAD). The researcher wants to include pregnant women in the study. However,
