CIP Exam questions and answers
graded A+ updated
Minimal Risk - correct answer ✔✔ The probability of harm or discomfort...not greater...than
those ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations.
The Belmont Principles - correct answer ✔✔ Respect for persons, beneficence, and justice
IRB - correct 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) - correct 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 - correct 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 - correct 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 - correct answer ✔✔ Proactive, non-punitive, and focused on
educating investigators about their ethical and regulatory responsibilities in the conduct of
research.
IRB Director/Administrator - correct answer ✔✔ Primary person responsible for managing the
IRB office and many of the administrative aspects of IRB meetings.
IRB Membership - correct 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 - correct answer ✔✔ Refers to the number of voting member positions
on the IRB.
Alternate Member - correct answer ✔✔ When there is more than one member for an IRB roster
position.
IRB Subcommittee - correct 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 - correct 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 - correct answer ✔✔ A type of review that can be conducted by the Chair,
designated IRB members, or a subcommittee of the IRB.
Research - correct answer ✔✔ 45 CFR 46.102(d) A systematic investigation including
development, testing, and evaluation, designed to develop or contribute to generalizable
knowledge.
, Human Subject - correct 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 - correct 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 - correct answer ✔✔ Probability and magnitude of the potential harm(s) or discomfort(s)
anticipated by participating in the research.
Privacy - correct 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 - correct 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 - correct 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.
graded A+ updated
Minimal Risk - correct answer ✔✔ The probability of harm or discomfort...not greater...than
those ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations.
The Belmont Principles - correct answer ✔✔ Respect for persons, beneficence, and justice
IRB - correct 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) - correct 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 - correct 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 - correct 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 - correct answer ✔✔ Proactive, non-punitive, and focused on
educating investigators about their ethical and regulatory responsibilities in the conduct of
research.
IRB Director/Administrator - correct answer ✔✔ Primary person responsible for managing the
IRB office and many of the administrative aspects of IRB meetings.
IRB Membership - correct 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 - correct answer ✔✔ Refers to the number of voting member positions
on the IRB.
Alternate Member - correct answer ✔✔ When there is more than one member for an IRB roster
position.
IRB Subcommittee - correct 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 - correct 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 - correct answer ✔✔ A type of review that can be conducted by the Chair,
designated IRB members, or a subcommittee of the IRB.
Research - correct answer ✔✔ 45 CFR 46.102(d) A systematic investigation including
development, testing, and evaluation, designed to develop or contribute to generalizable
knowledge.
, Human Subject - correct 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 - correct 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 - correct answer ✔✔ Probability and magnitude of the potential harm(s) or discomfort(s)
anticipated by participating in the research.
Privacy - correct 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 - correct 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 - correct 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.
