CIP exam Study Material with complete
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. 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.
Recruitment - ANSWER The first step in the consent process. How potential subjects are
identified and invited to participate in research.
DSMB - ANSWER A committee that is established specifically to monitor data
throughout the life of a study to determine whether it is appropriate, from both
scientific and ethical standpoints, to continue the study as planned.
Stopping Rules - ANSWER General term for specific and predetermined parameters that
guide the data monitoring process.
Exculpatory Language - ANSWER Language through which the subject or the
representative is made to waive or appear to waive any of the subject's legal rights or
releases or appears to release the investigator, the sponsor, the institution or its agents
from liability for negligence.
Respect for Persons - ANSWER Principle underlying the doctrine of informed consent.
Requires recognition of the individual as an autonomous agent and protection of the
individual with diminished autonomy. Requires that researchers carry out the process of
informed consent and protect subject privacy.
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. 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.
Recruitment - ANSWER The first step in the consent process. How potential subjects are
identified and invited to participate in research.
DSMB - ANSWER A committee that is established specifically to monitor data
throughout the life of a study to determine whether it is appropriate, from both
scientific and ethical standpoints, to continue the study as planned.
Stopping Rules - ANSWER General term for specific and predetermined parameters that
guide the data monitoring process.
Exculpatory Language - ANSWER Language through which the subject or the
representative is made to waive or appear to waive any of the subject's legal rights or
releases or appears to release the investigator, the sponsor, the institution or its agents
from liability for negligence.
Respect for Persons - ANSWER Principle underlying the doctrine of informed consent.
Requires recognition of the individual as an autonomous agent and protection of the
individual with diminished autonomy. Requires that researchers carry out the process of
informed consent and protect subject privacy.
