CIP Exam Questions With Solved Solutions
Minimal Risk - 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 - 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.
Informed Consent - 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.
Minimal Risk - 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 - 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.
Informed Consent - 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.
