CIP Exam Question And Answers 2024
Minimal Risk - correct answers✅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 answers✅Respect for
persons, beneficence, and justice
IRB - correct answers✅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 answers✅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 answers✅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.
,CIP Exam Question And Answers 2024
Minutes - correct answers✅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 answers✅Proactive,
non-punitive, and focused on educating investigators
about their ethical and regulatory responsibilities in the
conduct of research.
IRB Director/Administrator - correct answers✅Primary
person responsible for managing the IRB office and many
of the administrative aspects of IRB meetings.
IRB Membership - correct answers✅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 answers✅Refers to
the number of voting member positions on the IRB.
Alternate Member - correct answers✅When there is
more than one member for an IRB roster position.
,CIP Exam Question And Answers 2024
IRB Subcommittee - correct answers✅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 answers✅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 answers✅A type of review
that can be conducted by the Chair, designated IRB
members, or a subcommittee of the IRB.
Research - correct answers✅45 CFR 46.102(d) A
systematic investigation including development, testing,
and evaluation, designed to develop or contribute to
generalizable knowledge.
Human Subject - correct answers✅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.
, CIP Exam Question And Answers 2024
Emergency Use - correct answers✅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 answers✅Probability and magnitude of
the potential harm(s) or discomfort(s) anticipated by
participating in the research.
Privacy - correct answers✅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 answers✅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
answers✅45 CFR 46.116(d) An IRB may approve a
waiver or alteration of consent requirements if:
Minimal Risk - correct answers✅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 answers✅Respect for
persons, beneficence, and justice
IRB - correct answers✅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 answers✅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 answers✅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.
,CIP Exam Question And Answers 2024
Minutes - correct answers✅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 answers✅Proactive,
non-punitive, and focused on educating investigators
about their ethical and regulatory responsibilities in the
conduct of research.
IRB Director/Administrator - correct answers✅Primary
person responsible for managing the IRB office and many
of the administrative aspects of IRB meetings.
IRB Membership - correct answers✅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 answers✅Refers to
the number of voting member positions on the IRB.
Alternate Member - correct answers✅When there is
more than one member for an IRB roster position.
,CIP Exam Question And Answers 2024
IRB Subcommittee - correct answers✅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 answers✅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 answers✅A type of review
that can be conducted by the Chair, designated IRB
members, or a subcommittee of the IRB.
Research - correct answers✅45 CFR 46.102(d) A
systematic investigation including development, testing,
and evaluation, designed to develop or contribute to
generalizable knowledge.
Human Subject - correct answers✅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.
, CIP Exam Question And Answers 2024
Emergency Use - correct answers✅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 answers✅Probability and magnitude of
the potential harm(s) or discomfort(s) anticipated by
participating in the research.
Privacy - correct answers✅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 answers✅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
answers✅45 CFR 46.116(d) An IRB may approve a
waiver or alteration of consent requirements if:
