THE FEDERAL REGULATIONS SBE EXAMS SCRIPT
2026/2027 QUESTIONS AND ANSWERS RATED A+
✔✔The primary purpose of a Certificate of Confidentiality is to - ✔✔allow law
enforcement to investigate abuse cases
✔✔Identify the example of when situation and time is key to assessing risk of harm in a
research study: - ✔✔asking women if they've had an abortion
✔✔What statement about risks in social and behavioral sciences research is most
accurate: - ✔✔risks are specific to time, place, and culture
✔✔Additional safeguards that may be included in a social and behavioral study may
include: - ✔✔Remove all direct identifiers from the data as soon as possible.
✔✔Risk of harm in social and behavioral sciences generally fall in three categories,
which are: - ✔✔Invasion of privacy, breach of confidentiality, and study procedures
✔✔Which of the following statements about the relationship between an institution and
the institution's IRB(s) is correct? - ✔✔Officials of the institution may overrule IRB
approval
✔✔According to the federal regulations, research is eligible for exemption, if - ✔✔The
research falls into one of eight categories of research activity described in the
regulations.
✔✔Continuing review of an approved and ongoing study posing more than minimal risk
that was initially approved by a convened IRB: - ✔✔must occur within 12 months. of the
approval date
✔✔According to federal regulations, the expedited review process may be used when
the study procedures pose: - ✔✔No more than minimal risk and the research activities
fall within regulatory categories identified as eligible.
✔✔In addition to pregnant women, fetuses, and neonates, another subpart of the DHHS
regulations provides additional protections for which of the following vulnerable
populations? - ✔✔prisoners
✔✔A therapist at a free university 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 case-based
research project. Which of the following statements about parental permission is
correct? - ✔✔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.
✔✔A general requirement for 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? - ✔✔Taking part in the
research is voluntary, but if you choose to take part, you waive the right to legal redress
for any research-related injuries.
✔✔A criterion for waiving informed consent is that, when appropriate, subjects are
provided additional pertinent information after the study. In which of the following
studies would it NOT be appropriate to provide subjects with information about missing
elements of consent: - ✔✔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
✔✔A waiver of the requirement for documentation of informed consent may be granted
when: - ✔✔The only record linking the subject and the research is the consent
document and the principal risk is a breach of confidentiality
✔✔As part of the consent process, the federal regulations require researchers to -
✔✔Provide potential subjects with information at the appropriate reading
comprehension level.
✔✔A financial conflict of interest could involve - ✔✔Receiving stock in a company
funding your research.
✔✔A situation in which financial or other personal considerations have the potential to
compromise or bias professional judgment and objectivity is an example of: - ✔✔conflict
of interest
✔✔Current NIH rules require investigators to disclose details regarding financial
conflicts of interest to: - ✔✔designated institutional officials
✔✔Significant financial interest, as defined by the 2011 final rule that amended Public
Health Service (PHS) regulations on Responsibility of Applicants for Promoting
Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F)
and Responsible Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that
apply): - ✔✔- Equity/stock interests (regardless of value) in a non-publicly traded
company.
- Intellectual property rights upon receipt of income related to such rights.
- Consulting payments in excess of $5,000.
2026/2027 QUESTIONS AND ANSWERS RATED A+
✔✔The primary purpose of a Certificate of Confidentiality is to - ✔✔allow law
enforcement to investigate abuse cases
✔✔Identify the example of when situation and time is key to assessing risk of harm in a
research study: - ✔✔asking women if they've had an abortion
✔✔What statement about risks in social and behavioral sciences research is most
accurate: - ✔✔risks are specific to time, place, and culture
✔✔Additional safeguards that may be included in a social and behavioral study may
include: - ✔✔Remove all direct identifiers from the data as soon as possible.
✔✔Risk of harm in social and behavioral sciences generally fall in three categories,
which are: - ✔✔Invasion of privacy, breach of confidentiality, and study procedures
✔✔Which of the following statements about the relationship between an institution and
the institution's IRB(s) is correct? - ✔✔Officials of the institution may overrule IRB
approval
✔✔According to the federal regulations, research is eligible for exemption, if - ✔✔The
research falls into one of eight categories of research activity described in the
regulations.
✔✔Continuing review of an approved and ongoing study posing more than minimal risk
that was initially approved by a convened IRB: - ✔✔must occur within 12 months. of the
approval date
✔✔According to federal regulations, the expedited review process may be used when
the study procedures pose: - ✔✔No more than minimal risk and the research activities
fall within regulatory categories identified as eligible.
✔✔In addition to pregnant women, fetuses, and neonates, another subpart of the DHHS
regulations provides additional protections for which of the following vulnerable
populations? - ✔✔prisoners
✔✔A therapist at a free university 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 case-based
research project. Which of the following statements about parental permission is
correct? - ✔✔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.
✔✔A general requirement for 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? - ✔✔Taking part in the
research is voluntary, but if you choose to take part, you waive the right to legal redress
for any research-related injuries.
✔✔A criterion for waiving informed consent is that, when appropriate, subjects are
provided additional pertinent information after the study. In which of the following
studies would it NOT be appropriate to provide subjects with information about missing
elements of consent: - ✔✔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
✔✔A waiver of the requirement for documentation of informed consent may be granted
when: - ✔✔The only record linking the subject and the research is the consent
document and the principal risk is a breach of confidentiality
✔✔As part of the consent process, the federal regulations require researchers to -
✔✔Provide potential subjects with information at the appropriate reading
comprehension level.
✔✔A financial conflict of interest could involve - ✔✔Receiving stock in a company
funding your research.
✔✔A situation in which financial or other personal considerations have the potential to
compromise or bias professional judgment and objectivity is an example of: - ✔✔conflict
of interest
✔✔Current NIH rules require investigators to disclose details regarding financial
conflicts of interest to: - ✔✔designated institutional officials
✔✔Significant financial interest, as defined by the 2011 final rule that amended Public
Health Service (PHS) regulations on Responsibility of Applicants for Promoting
Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F)
and Responsible Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that
apply): - ✔✔- Equity/stock interests (regardless of value) in a non-publicly traded
company.
- Intellectual property rights upon receipt of income related to such rights.
- Consulting payments in excess of $5,000.
