CERTIFICATION FOR IRB PROFESSIONALS CIP
COMPREHENSIVE EXAM 2026 QUESTIONS
WITH SOLUTIONS GRADED A+
◉ 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.
◉ Confidentiality. Answer: Treatment of information that an individual
has disclosed in a relationship of trust and with the expectation that it
will not be divulged to others in ways that are inconsistent with the
understanding of the original disclosure without permission. How
information that is obtained from individuals is protected
◉ Criteria for waiver or alteration of consent. Answer: 45 CFR
46.116(d) An IRB may approve a waiver or alteration of consent
requirements if:
*the research involves no more than minimal risk;
*the waiver or alteration will not adversely affect the rights and welfare
of the subjects;
*the research could not practicably be carried out without the waiver or
alteration; and
*whenever appropriate, the subjects will be provided with additional
pertinent information after participation.
COMPREHENSIVE EXAM 2026 QUESTIONS
WITH SOLUTIONS GRADED A+
◉ 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.
◉ Confidentiality. Answer: Treatment of information that an individual
has disclosed in a relationship of trust and with the expectation that it
will not be divulged to others in ways that are inconsistent with the
understanding of the original disclosure without permission. How
information that is obtained from individuals is protected
◉ Criteria for waiver or alteration of consent. Answer: 45 CFR
46.116(d) An IRB may approve a waiver or alteration of consent
requirements if:
*the research involves no more than minimal risk;
*the waiver or alteration will not adversely affect the rights and welfare
of the subjects;
*the research could not practicably be carried out without the waiver or
alteration; and
*whenever appropriate, the subjects will be provided with additional
pertinent information after participation.
