CIP Credentialing Exam – Institutional Review Board
Standards
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. - correct
answer ✔✔Minimal Risk
Respect for persons, beneficence, and justice - correct answer ✔✔The Belmont Principles
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. - correct answer
✔✔IRB
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. - correct answer ✔✔Institutional Official (IO)
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. -
correct answer ✔✔OHRP
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. - correct
answer ✔✔Minutes
,Proactive, non-punitive, and focused on educating investigators about their ethical and
regulatory responsibilities in the conduct of research. - correct answer ✔✔Research Audit
Program
Primary person responsible for managing the IRB office and many of the administrative aspects
of IRB meetings. - correct answer ✔✔IRB Director/Administrator
Must consist of at least five members and include at least one scientist, one nonscientist and
one person not affiliated with the institution. - correct answer ✔✔IRB Membership
Refers to the number of voting member positions on the IRB. - correct answer ✔✔IRB
Membership Roster
When there is more than one member for an IRB roster position. - correct answer ✔✔Alternate
Member
Committee consisting of one or more experienced reviewers organized for the purpose of
managining a specific task or making a specific type of decision. - correct answer ✔✔IRB
Subcommittee
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. - correct answer ✔✔Social Harm
A type of review that can be conducted by the Chair, designated IRB members, or a
subcommittee of the IRB. - correct answer ✔✔Expedited Review
45 CFR 46.102(d) A systematic investigation including development, testing, and evaluation,
designed to develop or contribute to generalizable knowledge. - correct answer ✔✔Research
, 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. - correct answer ✔✔Human Subject
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. - correct answer
✔✔Emergency Use
Probability and magnitude of the potential harm(s) or discomfort(s) anticipated by participating
in the research. - correct answer ✔✔Risk
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. - correct answer ✔✔Privacy
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 - correct answer ✔✔Confidentiality
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. - correct answer ✔✔Criteria for waiver or alteration of consent
45 CFR 46.116(a),(b); 46.117 Process to obtain informed permission from potential subjects
before they participate in research, and an ongoing opportunity to retain subjects in trials
whenever new information is available. Must be sought under circumstances that minimize the
Standards
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. - correct
answer ✔✔Minimal Risk
Respect for persons, beneficence, and justice - correct answer ✔✔The Belmont Principles
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. - correct answer
✔✔IRB
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. - correct answer ✔✔Institutional Official (IO)
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. -
correct answer ✔✔OHRP
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. - correct
answer ✔✔Minutes
,Proactive, non-punitive, and focused on educating investigators about their ethical and
regulatory responsibilities in the conduct of research. - correct answer ✔✔Research Audit
Program
Primary person responsible for managing the IRB office and many of the administrative aspects
of IRB meetings. - correct answer ✔✔IRB Director/Administrator
Must consist of at least five members and include at least one scientist, one nonscientist and
one person not affiliated with the institution. - correct answer ✔✔IRB Membership
Refers to the number of voting member positions on the IRB. - correct answer ✔✔IRB
Membership Roster
When there is more than one member for an IRB roster position. - correct answer ✔✔Alternate
Member
Committee consisting of one or more experienced reviewers organized for the purpose of
managining a specific task or making a specific type of decision. - correct answer ✔✔IRB
Subcommittee
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. - correct answer ✔✔Social Harm
A type of review that can be conducted by the Chair, designated IRB members, or a
subcommittee of the IRB. - correct answer ✔✔Expedited Review
45 CFR 46.102(d) A systematic investigation including development, testing, and evaluation,
designed to develop or contribute to generalizable knowledge. - correct answer ✔✔Research
, 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. - correct answer ✔✔Human Subject
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. - correct answer
✔✔Emergency Use
Probability and magnitude of the potential harm(s) or discomfort(s) anticipated by participating
in the research. - correct answer ✔✔Risk
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. - correct answer ✔✔Privacy
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 - correct answer ✔✔Confidentiality
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. - correct answer ✔✔Criteria for waiver or alteration of consent
45 CFR 46.116(a),(b); 46.117 Process to obtain informed permission from potential subjects
before they participate in research, and an ongoing opportunity to retain subjects in trials
whenever new information is available. Must be sought under circumstances that minimize the
