CITI Training
A graduate student wants to examine the effect of print media versus televised media
on individuals' position on several social issues. The superintendent of a local work
release facility, a family friend, will allow the graduate student access to the prison
population to help her quickly accrue subjects. The student's IRB should: - ANS - Not
approve this project because the prisoners are merely a population of convenience for
the student.
A HIPAA authorization has which of the following characteristics: - ANS - Uses "plain
language" that the data subject can understand, similar to the requirement for an
informed consent document.
A researcher asks an IRB to waive the requirement for parental permission for a study
conducted in schools because the nature of the research requires participation of all the
children present in classrooms on the day the research will take place. Assuming that
the basic research design could be approved by the IRB and the school, which of the
following requirements must be met before an IRB could waive parental permission? -
ANS - The research must pose no more than minimal risk.
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? - ANS - There was neither
a violation of privacy nor a breach of confidentiality
A researcher who is also a care provider needs to be very clear that a decision to
participate or not in a study will: - ANS - Not affect future care
A situation in which financial or other personal considerations have the potential to
compromise or bias professional judgment and objectivity is an example of: - ANS -
Conflict of interest
A study that involves interviews of adults is eligible for expedited review. The researcher
wants to add an adolescent population (aged 12 to 17) to the study and has designed a
, parental permission and assent process. No additional changes are planned. Which of
the following statements about review of the revised protocol is accurate? - ANS -
Unless the nature of the questions would raise the level of risk to more than minimal for
adolescents, the research would still qualify for expedited review.
A waiver of the requirement for documentation of informed consent may be granted
when: - ANS - The only record linking the subject and the research is the consent
document and the principal risk is a breach of confidentiality
According to fed. regulations, human subjects are living human beings about whom an
investigator obtains data through interactions or intervention with the individual or: -
ANS - identifiable PRIVATE information
(Public info does not meet criteria)
According to Subpart D, research with children may be eligible for exemption when: -
ANS - The research involves the use of educational tests
According to Subpart D, which of the following research activities with children would
qualify for an exemption? - ANS - Research about educational testing
According to the Belmont Report, the moral requirement that there be fair outcomes in
the selection of research subjects, expresses the principle of: - ANS - Justice
According to the DHHS 2011 updated of the PHS federal regulations, the threshold
amount for reporting a significant financial interest (investigator and his/her spouse and
dependents) is - ANS - Greater than $5,000 of ownership in any single public
entity/public company.
accounting of disclosures - ANS - •A list of all protocols for which their PHI may have
been disclosed, along with the timeframe for those disclosures.
•The purpose of those protocols, and the types of PHI sought.
•The researcher's name and contact information for each study
Activities preparatory to research, decedents' information exceptions - ANS - •Where
the PHI will be used solely for reviews preparatory to research (e.g., for protocol
development) and will not leave the covered entity.
•Where the PHI refers solely to deceased persons (the covered entity may ask for
documentation of death of all data subjects
A graduate student wants to examine the effect of print media versus televised media
on individuals' position on several social issues. The superintendent of a local work
release facility, a family friend, will allow the graduate student access to the prison
population to help her quickly accrue subjects. The student's IRB should: - ANS - Not
approve this project because the prisoners are merely a population of convenience for
the student.
A HIPAA authorization has which of the following characteristics: - ANS - Uses "plain
language" that the data subject can understand, similar to the requirement for an
informed consent document.
A researcher asks an IRB to waive the requirement for parental permission for a study
conducted in schools because the nature of the research requires participation of all the
children present in classrooms on the day the research will take place. Assuming that
the basic research design could be approved by the IRB and the school, which of the
following requirements must be met before an IRB could waive parental permission? -
ANS - The research must pose no more than minimal risk.
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? - ANS - There was neither
a violation of privacy nor a breach of confidentiality
A researcher who is also a care provider needs to be very clear that a decision to
participate or not in a study will: - ANS - Not affect future care
A situation in which financial or other personal considerations have the potential to
compromise or bias professional judgment and objectivity is an example of: - ANS -
Conflict of interest
A study that involves interviews of adults is eligible for expedited review. The researcher
wants to add an adolescent population (aged 12 to 17) to the study and has designed a
, parental permission and assent process. No additional changes are planned. Which of
the following statements about review of the revised protocol is accurate? - ANS -
Unless the nature of the questions would raise the level of risk to more than minimal for
adolescents, the research would still qualify for expedited review.
A waiver of the requirement for documentation of informed consent may be granted
when: - ANS - The only record linking the subject and the research is the consent
document and the principal risk is a breach of confidentiality
According to fed. regulations, human subjects are living human beings about whom an
investigator obtains data through interactions or intervention with the individual or: -
ANS - identifiable PRIVATE information
(Public info does not meet criteria)
According to Subpart D, research with children may be eligible for exemption when: -
ANS - The research involves the use of educational tests
According to Subpart D, which of the following research activities with children would
qualify for an exemption? - ANS - Research about educational testing
According to the Belmont Report, the moral requirement that there be fair outcomes in
the selection of research subjects, expresses the principle of: - ANS - Justice
According to the DHHS 2011 updated of the PHS federal regulations, the threshold
amount for reporting a significant financial interest (investigator and his/her spouse and
dependents) is - ANS - Greater than $5,000 of ownership in any single public
entity/public company.
accounting of disclosures - ANS - •A list of all protocols for which their PHI may have
been disclosed, along with the timeframe for those disclosures.
•The purpose of those protocols, and the types of PHI sought.
•The researcher's name and contact information for each study
Activities preparatory to research, decedents' information exceptions - ANS - •Where
the PHI will be used solely for reviews preparatory to research (e.g., for protocol
development) and will not leave the covered entity.
•Where the PHI refers solely to deceased persons (the covered entity may ask for
documentation of death of all data subjects
