CERTIFICATION FOR IRB PROFESSIONALS
EXAMINATION TEST COMPLETE
QUESTIONS AND SOLUTIONS
●● The Belmont Principles
Answer: Respect for persons, beneficence, and justice
●● IRB
Answer: An administrative body composed of scientists and
nonscientists established to protect the rights and welfare of human
research subjects recruited to participate in research activities conducted
under the auspices of the institution with which it is affiliated.
●● Institutional Official (IO)
Answer: The person who signs the OHRP Federalwide Assurance and
has the legal authority to act and speak for the institution, and should be
somone who can ensure that the institution will effectively fulfill its
research oversight function.
●● OHRP
Answer: Charged with monitoring and promoting compliance with
DHHS regulations that relate to the ethical standards of human-subject
resarch. They have the final word on when an institution is not
,complying with DHHS regulations and what the institution must do to
correct the problem.
●● Minutes
Answer: 45 CFR 46.115 (2) Require sufficiently detailed documentation
to include attendance at the meeting; actions taken by the IRB; the vote
on these actions, including the number of members voting for, against,
or abstaining; the basis for requiring changes in or disapproving
research; and a written summary of the discussion of controverted issues
and their resolution.
●● Research Audit Program
Answer: Proactive, non-punitive, and focused on educating investigators
about their ethical and regulatory responsibilities in the conduct of
research.
●● IRB Director/Administrator
Answer: Primary person responsible for managing the IRB office and
many of the administrative aspects of IRB meetings.
●● IRB Membership
Answer: Must consist of at least five members and include at least one
scientist, one nonscientist and one person not affiliated with the
institution.
,●● IRB Membership Roster
Answer: Refers to the number of voting member positions on the IRB.
●● Alternate Member
Answer: When there is more than one member for an IRB roster
position.
●● IRB Subcommittee
Answer: Committee consisting of one or more experienced reviewers
organized for the purpose of managining a specific task or making a
specific type of decision.
●● Social Harm
Answer: Decreases in quality of life that result from information being
created or used in a way that is damaging to the individual in question--
A result of the creation or transfer of information in a way that may
negatively affect the research subject.
●● Expedited Review
Answer: A type of review that can be conducted by the Chair, designated
IRB members, or a subcommittee of the IRB.
●● Research
, Answer: 45 CFR 46.102(d) A systematic investigation including
development, testing, and evaluation, designed to develop or contribute
to generalizable knowledge.
●● Human Subject
Answer: 45 CFR 46.102(f)(1), (2) A living individual about whom an
investigator conducting research obtains (1) data through intervention or
interaction with the individual OR (2) identifiable private information.
●● Emergency Use
Answer: A treating physician's request to use an investigational
drug/device in a single patient during an immediately life-threatening
situation in which no standard acceptable treatment is available and
there is insufficient time to convene a quorum for full board IRB
approval.
●● Risk
Answer: Probability and magnitude of the potential harm(s) or
discomfort(s) anticipated by participating in the research.
●● Privacy
Answer: Can be defined in terms of having control over the extent,
timing, and circumstances of sharing one's self (physically, behaviorally,
or intellectually) with others. Individuals' right to have control over
access to themselves and their information.
EXAMINATION TEST COMPLETE
QUESTIONS AND SOLUTIONS
●● The Belmont Principles
Answer: Respect for persons, beneficence, and justice
●● IRB
Answer: An administrative body composed of scientists and
nonscientists established to protect the rights and welfare of human
research subjects recruited to participate in research activities conducted
under the auspices of the institution with which it is affiliated.
●● Institutional Official (IO)
Answer: The person who signs the OHRP Federalwide Assurance and
has the legal authority to act and speak for the institution, and should be
somone who can ensure that the institution will effectively fulfill its
research oversight function.
●● OHRP
Answer: Charged with monitoring and promoting compliance with
DHHS regulations that relate to the ethical standards of human-subject
resarch. They have the final word on when an institution is not
,complying with DHHS regulations and what the institution must do to
correct the problem.
●● Minutes
Answer: 45 CFR 46.115 (2) Require sufficiently detailed documentation
to include attendance at the meeting; actions taken by the IRB; the vote
on these actions, including the number of members voting for, against,
or abstaining; the basis for requiring changes in or disapproving
research; and a written summary of the discussion of controverted issues
and their resolution.
●● Research Audit Program
Answer: Proactive, non-punitive, and focused on educating investigators
about their ethical and regulatory responsibilities in the conduct of
research.
●● IRB Director/Administrator
Answer: Primary person responsible for managing the IRB office and
many of the administrative aspects of IRB meetings.
●● IRB Membership
Answer: Must consist of at least five members and include at least one
scientist, one nonscientist and one person not affiliated with the
institution.
,●● IRB Membership Roster
Answer: Refers to the number of voting member positions on the IRB.
●● Alternate Member
Answer: When there is more than one member for an IRB roster
position.
●● IRB Subcommittee
Answer: Committee consisting of one or more experienced reviewers
organized for the purpose of managining a specific task or making a
specific type of decision.
●● Social Harm
Answer: Decreases in quality of life that result from information being
created or used in a way that is damaging to the individual in question--
A result of the creation or transfer of information in a way that may
negatively affect the research subject.
●● Expedited Review
Answer: A type of review that can be conducted by the Chair, designated
IRB members, or a subcommittee of the IRB.
●● Research
, Answer: 45 CFR 46.102(d) A systematic investigation including
development, testing, and evaluation, designed to develop or contribute
to generalizable knowledge.
●● Human Subject
Answer: 45 CFR 46.102(f)(1), (2) A living individual about whom an
investigator conducting research obtains (1) data through intervention or
interaction with the individual OR (2) identifiable private information.
●● Emergency Use
Answer: A treating physician's request to use an investigational
drug/device in a single patient during an immediately life-threatening
situation in which no standard acceptable treatment is available and
there is insufficient time to convene a quorum for full board IRB
approval.
●● Risk
Answer: Probability and magnitude of the potential harm(s) or
discomfort(s) anticipated by participating in the research.
●● Privacy
Answer: Can be defined in terms of having control over the extent,
timing, and circumstances of sharing one's self (physically, behaviorally,
or intellectually) with others. Individuals' right to have control over
access to themselves and their information.
