CIP Exam Test Questions and Answers Rated A
The probability of harm or discomfort...not greater...than
those ordinarily encountered in daily life or during the
Minimal Risk
performance of routine physical or psychological exami-
nations.
The Belmont Principles Respect for persons, beneficence, and justice
An administrative body composed of scientists and non-
scientists established to protect the rights and welfare
IRB of human research subjects recruited to participate in
research activities conducted under the auspices of the
institution with which it is aflliated.
The person who signs the OHRP Federalwide Assurance
and has the legal authority to act and speak for the in-
Institutional Oflcial (IO) stitution, and should be somone who can ensure that
the institution will ettectively fulfill its research oversight
function.
Charged with monitoring and promoting compliance with
DHHS regulations that relate to the ethical standards of
OHRP 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.
45 CFR 46.115 (2) Require suflciently detailed documen-
tation to include attendance at the meeting; actions taken
by the IRB; the vote on these actions, including the number
Minutes 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.
Proactive, non-punitive, and focused on educating inves-
Research Audit Program tigators about their ethical and regulatory responsibilities
in the conduct of research.
, Primary person responsible for managing the IRB oflce
IRB Director/Administrator
and many of the administrative aspects of IRB meetings.
Must consist of at least five members and include at least
IRB Membership one scientist, one nonscientist and one person not aflli-
ated with the institution.
Refers to the number of voting member positions on the
IRB Membership Roster
IRB.
When there is more than one member for an IRB roster
Alternate Member
position.
Committee consisting of one or more experienced review-
IRB Subcommittee ers organized for the purpose of managining a specific
task or making a specific type of decision.
Decreases in quality of life that result from information
being created or used in a way that is damaging to the
Social Harm individual in question-- A result of the creation or transfer
of information in a way that may negatively attect the
research subject.
A type of review that can be conducted by the Chair, des-
Expedited Review
ignated IRB members, or a subcommittee of the IRB.
45 CFR 46.102(d) A systematic investigation including de-
Research velopment, testing, and evaluation, designed to develop
or contribute to generalizable knowledge.
45 CFR 46.102(f)(1), (2) A living individual about whom an
investigator conducting research obtains (1) data through
Human Subject
intervention or interaction with the individual OR (2) iden-
tifiable private information.
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
Emergency Use treatment is available and there is insuflcient time to con-
vene a quorum for full board IRB approval.
Probability and magnitude of the potential harm(s) or
Risk
discomfort(s) anticipated by participating in the research.
Can be defined in terms of having control over the extent,
timing, and circumstances of sharing one's self (physical-
Privacy ly, behaviorally, or intellectually) with others. Individuals'
right to have control over access to themselves and their
information.
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
Confidentiality
with the understanding of the original disclosure without
permission. How information that is obtained from indi-
viduals is protected
45 CFR 46.116(d) An IRB may approve a waiver or alter-
ation of consent requirements if:
*the research involves no more than minimal risk;
*the waiver or alteration will not adversely attect the rights
Criteria for waiver or alteration of consent 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.
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 under-
Informed Consent
standable 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.
The first step in the consent process. How potential sub-
Recruitment
jects are identified and invited to participate in research.
A committee that is established specifically to monitor data
throughout the life of a study to determine whether it is
DSMB
appropriate, from both scientific and ethical standpoints,
to continue the study as planned.
General term for specific and predetermined parameters
Stopping Rules
that guide the data monitoring process.
Language through which the subject or the representative
is made to waive or appear to waive any of the subject's
Exculpatory Language legal rights or releases or appears to release the investi-
gator, the sponsor, the institution or its agents from liability
for negligence.
Principle underlying the doctrine of informed consent.
Requires recognition of the individual as an autonomous
Respect for Persons agent and protection of the individual with diminished
autonomy. Requires that researchers carry out the process
of informed consent and protect subject privacy.
The doing of good, obligates the researcher to secure
the individual's well-being by maximizing benefits and
Beneficence minimizing harms to the individual research subject. Re-
quires that the researcher perform a risk/benefit analy-
sis. Requires that competent investigators design ethical
The probability of harm or discomfort...not greater...than
those ordinarily encountered in daily life or during the
Minimal Risk
performance of routine physical or psychological exami-
nations.
The Belmont Principles Respect for persons, beneficence, and justice
An administrative body composed of scientists and non-
scientists established to protect the rights and welfare
IRB of human research subjects recruited to participate in
research activities conducted under the auspices of the
institution with which it is aflliated.
The person who signs the OHRP Federalwide Assurance
and has the legal authority to act and speak for the in-
Institutional Oflcial (IO) stitution, and should be somone who can ensure that
the institution will ettectively fulfill its research oversight
function.
Charged with monitoring and promoting compliance with
DHHS regulations that relate to the ethical standards of
OHRP 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.
45 CFR 46.115 (2) Require suflciently detailed documen-
tation to include attendance at the meeting; actions taken
by the IRB; the vote on these actions, including the number
Minutes 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.
Proactive, non-punitive, and focused on educating inves-
Research Audit Program tigators about their ethical and regulatory responsibilities
in the conduct of research.
, Primary person responsible for managing the IRB oflce
IRB Director/Administrator
and many of the administrative aspects of IRB meetings.
Must consist of at least five members and include at least
IRB Membership one scientist, one nonscientist and one person not aflli-
ated with the institution.
Refers to the number of voting member positions on the
IRB Membership Roster
IRB.
When there is more than one member for an IRB roster
Alternate Member
position.
Committee consisting of one or more experienced review-
IRB Subcommittee ers organized for the purpose of managining a specific
task or making a specific type of decision.
Decreases in quality of life that result from information
being created or used in a way that is damaging to the
Social Harm individual in question-- A result of the creation or transfer
of information in a way that may negatively attect the
research subject.
A type of review that can be conducted by the Chair, des-
Expedited Review
ignated IRB members, or a subcommittee of the IRB.
45 CFR 46.102(d) A systematic investigation including de-
Research velopment, testing, and evaluation, designed to develop
or contribute to generalizable knowledge.
45 CFR 46.102(f)(1), (2) A living individual about whom an
investigator conducting research obtains (1) data through
Human Subject
intervention or interaction with the individual OR (2) iden-
tifiable private information.
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
Emergency Use treatment is available and there is insuflcient time to con-
vene a quorum for full board IRB approval.
Probability and magnitude of the potential harm(s) or
Risk
discomfort(s) anticipated by participating in the research.
Can be defined in terms of having control over the extent,
timing, and circumstances of sharing one's self (physical-
Privacy ly, behaviorally, or intellectually) with others. Individuals'
right to have control over access to themselves and their
information.
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
Confidentiality
with the understanding of the original disclosure without
permission. How information that is obtained from indi-
viduals is protected
45 CFR 46.116(d) An IRB may approve a waiver or alter-
ation of consent requirements if:
*the research involves no more than minimal risk;
*the waiver or alteration will not adversely attect the rights
Criteria for waiver or alteration of consent 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.
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 under-
Informed Consent
standable 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.
The first step in the consent process. How potential sub-
Recruitment
jects are identified and invited to participate in research.
A committee that is established specifically to monitor data
throughout the life of a study to determine whether it is
DSMB
appropriate, from both scientific and ethical standpoints,
to continue the study as planned.
General term for specific and predetermined parameters
Stopping Rules
that guide the data monitoring process.
Language through which the subject or the representative
is made to waive or appear to waive any of the subject's
Exculpatory Language legal rights or releases or appears to release the investi-
gator, the sponsor, the institution or its agents from liability
for negligence.
Principle underlying the doctrine of informed consent.
Requires recognition of the individual as an autonomous
Respect for Persons agent and protection of the individual with diminished
autonomy. Requires that researchers carry out the process
of informed consent and protect subject privacy.
The doing of good, obligates the researcher to secure
the individual's well-being by maximizing benefits and
Beneficence minimizing harms to the individual research subject. Re-
quires that the researcher perform a risk/benefit analy-
sis. Requires that competent investigators design ethical
