CIP Exam
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.
Informed Consent - CORRECT ANSWER-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
possibility of coercion or undue influence, and must include the 8 basic
information elements described in the regulations. Information must be presented
in a language understandable to the subject or LAR. The consent process must
be documented with a written form approved by the IRB and signed by the
subject/LAR.
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.
Informed Consent - CORRECT ANSWER-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
possibility of coercion or undue influence, and must include the 8 basic
information elements described in the regulations. Information must be presented
in a language understandable to the subject or LAR. The consent process must
be documented with a written form approved by the IRB and signed by the
subject/LAR.
