CITI Training
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic
neuropathy. While the study is on going, a new drug becomes commercially available
that may have equal or greater benefit to the subject. The investigator should do which
of the following?
A. Withhold this new information to avoid confusing the subject with other treatment
options or alternatives
B. Give the subject comprehensive information about the new drug, including its side
effects. Discuss the pros and cons of both the investigational drug and the commercially
available drug and then allow the subject to decide whether to withdraw from the
research to take the new drug.
C. Do not tell the subject about the new drug since physicians have the right to try out
new treatments with their patients
D. Tell the subject about the new drug but discourage him from switching treatments
until the study is completed - ANS - B. Give the subject comprehensive information
about the new drug, including its side effects. Discuss the pros and cons of both the
investigational drug and the commercially available drug and then allow the subject to
decide whether to withdraw from the research to take the new drug.
A general requirement for the informed consent is that no informed consent may include
any exculpatory language. Exculpatory language is that 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. Which of the following statements
in a consent form is an example of exculpatory language?
A. I waive any possibility of compensation for injuries that I may receive as a result of
participation in this research.
B. The investigator may stop you from participating in this research without your
consent if you experience side effects that make your condition worse. If you become ill
during the research, you may have to drop out.
C. Your participation in this research is voluntary. If you choose not to participate, or
change your mind later, your decision will not affect your relationship with your doctor or
your right t - ANS - A. I waive any possibility of compensation for injuries that I may
receive as a result of participation in this research.
,A medical record is an example of:
A. Public behavior.
B. Public information.
C. Private information.
D. Private behavior. - ANS - C. Private information.
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.
What action can he expect by the IRB?
A. The IRB will not review this study because it does not involve an investigational new
device.
B. The IRB will not review this study because it does not include human subjects as
defined by the federal regulations.
C. The IRB will not review this study because it is not research as defined by the federal
regulations.
D. The IRB will review this study because it includes human subjects and is considered
research. - ANS - C. The IRB will not review this study because it is not research as
defined by the federal regulations.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human
subjects research study. He wants to know at what point he and his study team must
submit COI disclosures to comply with the PHS regulation.
A. Researchers must only submit COI disclosures if they have a significant financial
interest related to the research
B. Not until a notice of award is received
C. Never -- the PHS regulation does not require researchers to submit COI disclosures
D. No later than the time of proposal submission - ANS - D. No later than the time of
proposal submission
A researcher leaves a research file in her car while she attends a concert and her car is
stolen. The file contains charts of aggregated numerical data from a research study with
human subjects, but no other documents. The consent form said that no identifying
information would be retained, and the researcher adhered to that component. Which of
the following statements best characterizes what occurred?
, A. The subjects' privacy has been violated.
B. There was neither a violation of privacy nor a breach of confidentiality.
C. Confidentiality of the data has been breached.
D. There was both a violation of privacy and a breach of confidentiality. - ANS - B.
There was neither a violation of privacy nor a breach of confidentiality.
A researcher wants to conduct a secondary analysis using a Centers for Disease
Control and Prevention (CDC) database that was collected by the agency solely for
surveillance purposes from 1996-2006. The researcher did not participate in the initial
collection of the data. The database is publicly available. The database does not include
any identifiers. The IRB makes a determination that the individuals whose records will
be reviewed do not meet the federal definition of human subjects.
Which of the following considerations was relevant to the IRB's determination that this
activity does not constitute research with human subjects?
A. The researcher will not be interacting/intervening with subjects and the data has no
identifiers.
B. The database reflects data collected originally for surveillance purposes.
C. The CDC is a federal agency.
D. The data was collected between 1996-2006. - ANS - A. The researcher will not be
interacting/intervening with subjects and the data has no identifiers.
A researcher's membership on an advisory board with an organization sponsoring
research can create a COI because:
A. The research result could be flawed from missing data
B. The organization can have policies that affect the research
C. It may be difficult for the researcher to appear neutral, as the researcher may have
an interest in the research's success
D. The members of the advisory board know each other - ANS - C. It may be difficult for
the researcher to appear neutral, as the researcher may have an interest in the
research's success
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the
discovery of the adverse event occurrence?
A. Do not report the adverse drug experience to the IRB since it is a common adverse
experience.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic
neuropathy. While the study is on going, a new drug becomes commercially available
that may have equal or greater benefit to the subject. The investigator should do which
of the following?
A. Withhold this new information to avoid confusing the subject with other treatment
options or alternatives
B. Give the subject comprehensive information about the new drug, including its side
effects. Discuss the pros and cons of both the investigational drug and the commercially
available drug and then allow the subject to decide whether to withdraw from the
research to take the new drug.
C. Do not tell the subject about the new drug since physicians have the right to try out
new treatments with their patients
D. Tell the subject about the new drug but discourage him from switching treatments
until the study is completed - ANS - B. Give the subject comprehensive information
about the new drug, including its side effects. Discuss the pros and cons of both the
investigational drug and the commercially available drug and then allow the subject to
decide whether to withdraw from the research to take the new drug.
A general requirement for the informed consent is that no informed consent may include
any exculpatory language. Exculpatory language is that 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. Which of the following statements
in a consent form is an example of exculpatory language?
A. I waive any possibility of compensation for injuries that I may receive as a result of
participation in this research.
B. The investigator may stop you from participating in this research without your
consent if you experience side effects that make your condition worse. If you become ill
during the research, you may have to drop out.
C. Your participation in this research is voluntary. If you choose not to participate, or
change your mind later, your decision will not affect your relationship with your doctor or
your right t - ANS - A. I waive any possibility of compensation for injuries that I may
receive as a result of participation in this research.
,A medical record is an example of:
A. Public behavior.
B. Public information.
C. Private information.
D. Private behavior. - ANS - C. Private information.
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.
What action can he expect by the IRB?
A. The IRB will not review this study because it does not involve an investigational new
device.
B. The IRB will not review this study because it does not include human subjects as
defined by the federal regulations.
C. The IRB will not review this study because it is not research as defined by the federal
regulations.
D. The IRB will review this study because it includes human subjects and is considered
research. - ANS - C. The IRB will not review this study because it is not research as
defined by the federal regulations.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human
subjects research study. He wants to know at what point he and his study team must
submit COI disclosures to comply with the PHS regulation.
A. Researchers must only submit COI disclosures if they have a significant financial
interest related to the research
B. Not until a notice of award is received
C. Never -- the PHS regulation does not require researchers to submit COI disclosures
D. No later than the time of proposal submission - ANS - D. No later than the time of
proposal submission
A researcher leaves a research file in her car while she attends a concert and her car is
stolen. The file contains charts of aggregated numerical data from a research study with
human subjects, but no other documents. The consent form said that no identifying
information would be retained, and the researcher adhered to that component. Which of
the following statements best characterizes what occurred?
, A. The subjects' privacy has been violated.
B. There was neither a violation of privacy nor a breach of confidentiality.
C. Confidentiality of the data has been breached.
D. There was both a violation of privacy and a breach of confidentiality. - ANS - B.
There was neither a violation of privacy nor a breach of confidentiality.
A researcher wants to conduct a secondary analysis using a Centers for Disease
Control and Prevention (CDC) database that was collected by the agency solely for
surveillance purposes from 1996-2006. The researcher did not participate in the initial
collection of the data. The database is publicly available. The database does not include
any identifiers. The IRB makes a determination that the individuals whose records will
be reviewed do not meet the federal definition of human subjects.
Which of the following considerations was relevant to the IRB's determination that this
activity does not constitute research with human subjects?
A. The researcher will not be interacting/intervening with subjects and the data has no
identifiers.
B. The database reflects data collected originally for surveillance purposes.
C. The CDC is a federal agency.
D. The data was collected between 1996-2006. - ANS - A. The researcher will not be
interacting/intervening with subjects and the data has no identifiers.
A researcher's membership on an advisory board with an organization sponsoring
research can create a COI because:
A. The research result could be flawed from missing data
B. The organization can have policies that affect the research
C. It may be difficult for the researcher to appear neutral, as the researcher may have
an interest in the research's success
D. The members of the advisory board know each other - ANS - C. It may be difficult for
the researcher to appear neutral, as the researcher may have an interest in the
research's success
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the
discovery of the adverse event occurrence?
A. Do not report the adverse drug experience to the IRB since it is a common adverse
experience.
