THE FEDERAL REGULATIONS SBE FINAL EXAM
2026/2027 QUESTIONS AND ANSWERS RATED A+
✔✔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: - ✔✔Not
approve this project because the prisoners are merely a population of convenience for
the student.
✔✔A researcher is studying women recently admitted to a state prison. All potential
subjects must have children under the age of five. Research subjects will be given a
basket of toys to use at their children's first visit that the children can then take home. In
assessing this proposal, the IRB needs to determine that the toys are: - ✔✔not an
excessive incentive
✔✔Which of the following statements about prison research is true? - ✔✔Researchers
may study the effects of privilege upgrades awarded by the prison.
✔✔Which example of research with prisoners would be allowable under the
regulations? - ✔✔Examining age at first arrest as a predictor of adult criminal history.
✔✔Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the
correctional systems since Wardens of Juvenile prisoners - unlike those for adult
prisoners - act in loco parentis for juvenile offenders. This statement is false because: -
✔✔Both subparts apply since these individuals are under the legal age of consent and
are incarcerated
✔✔When required, the information provided to the data subject in a HIPAA disclosure
accounting... - ✔✔must be more detailed for disclosures that involve fewer than 50
subject records.
✔✔If you're unsure about the particulars of HIPAA research requirements at your
organization or have questions, you can usually consult with: - ✔✔An organizational
IRB or Privacy Board, privacy officer ("Privacy Officer"), or privacy official ("Privacy
Official"), depending on the issue.
✔✔Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI
generally ... - ✔✔is research, and so requires either an authorization or meeting one of
the criteria for a waiver of authorization.
✔✔HIPAA's protections for health information used for research purposes... -
✔✔supplement those of the Common Rule and FDA.
, ✔✔A HIPAA authorization has which of the following characteristics: - ✔✔Uses "plain
language" that the data subject can understand, similar to the requirement for an
informed consent document.
✔✔Vulnerable persons are those who are less able to protect themselves than other
persons in a given situation. The Common Rule (45 CFR 46) has specific requirements
for the following vulnerable populations, except: - ✔✔workers
✔✔When a research project includes the collection of biological samples, all planned
future uses of the samples, identifiers, and the data obtained from the samples, must be
fully explained to the research subject. - ✔✔true
✔✔According to Subpart D, research with children may be eligible for exemption when:
- ✔✔research uses educational tests
✔✔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? - ✔✔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.
✔✔The specific Department of Health and Human Services (DHHS) Regulations that
apply to research with children are known as: - ✔✔Subpart D: Additional Protections for
Children Involved as Subjects in Research
✔✔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?
- ✔✔research must pose no more than minimal risk
✔✔In addition to the general provisions of the Common Rule (the federal regulations for
protecting research subjects), the following regulations also govern research in the
public schools: - ✔✔FERPA, PPRA, and Subpart D of the federal regulations
✔✔Which of the following types of information may schools disclose without consent
from the parent or student to a researcher at a local university? - ✔✔directory
information
2026/2027 QUESTIONS AND ANSWERS RATED A+
✔✔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: - ✔✔Not
approve this project because the prisoners are merely a population of convenience for
the student.
✔✔A researcher is studying women recently admitted to a state prison. All potential
subjects must have children under the age of five. Research subjects will be given a
basket of toys to use at their children's first visit that the children can then take home. In
assessing this proposal, the IRB needs to determine that the toys are: - ✔✔not an
excessive incentive
✔✔Which of the following statements about prison research is true? - ✔✔Researchers
may study the effects of privilege upgrades awarded by the prison.
✔✔Which example of research with prisoners would be allowable under the
regulations? - ✔✔Examining age at first arrest as a predictor of adult criminal history.
✔✔Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the
correctional systems since Wardens of Juvenile prisoners - unlike those for adult
prisoners - act in loco parentis for juvenile offenders. This statement is false because: -
✔✔Both subparts apply since these individuals are under the legal age of consent and
are incarcerated
✔✔When required, the information provided to the data subject in a HIPAA disclosure
accounting... - ✔✔must be more detailed for disclosures that involve fewer than 50
subject records.
✔✔If you're unsure about the particulars of HIPAA research requirements at your
organization or have questions, you can usually consult with: - ✔✔An organizational
IRB or Privacy Board, privacy officer ("Privacy Officer"), or privacy official ("Privacy
Official"), depending on the issue.
✔✔Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI
generally ... - ✔✔is research, and so requires either an authorization or meeting one of
the criteria for a waiver of authorization.
✔✔HIPAA's protections for health information used for research purposes... -
✔✔supplement those of the Common Rule and FDA.
, ✔✔A HIPAA authorization has which of the following characteristics: - ✔✔Uses "plain
language" that the data subject can understand, similar to the requirement for an
informed consent document.
✔✔Vulnerable persons are those who are less able to protect themselves than other
persons in a given situation. The Common Rule (45 CFR 46) has specific requirements
for the following vulnerable populations, except: - ✔✔workers
✔✔When a research project includes the collection of biological samples, all planned
future uses of the samples, identifiers, and the data obtained from the samples, must be
fully explained to the research subject. - ✔✔true
✔✔According to Subpart D, research with children may be eligible for exemption when:
- ✔✔research uses educational tests
✔✔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? - ✔✔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.
✔✔The specific Department of Health and Human Services (DHHS) Regulations that
apply to research with children are known as: - ✔✔Subpart D: Additional Protections for
Children Involved as Subjects in Research
✔✔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?
- ✔✔research must pose no more than minimal risk
✔✔In addition to the general provisions of the Common Rule (the federal regulations for
protecting research subjects), the following regulations also govern research in the
public schools: - ✔✔FERPA, PPRA, and Subpart D of the federal regulations
✔✔Which of the following types of information may schools disclose without consent
from the parent or student to a researcher at a local university? - ✔✔directory
information
