CIP EXAM 2025 QUESTIONS AND VERIFIED ANSWERS
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.
Recruitment - CORRECT ANSWER✅✅✅The first step in the consent process. How potential subjects
are identified and invited to participate in research.
DSMB - CORRECT 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 - CORRECT ANSWER✅✅✅General term for specific and predetermined parameters
that guide the data monitoring process.
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.
Recruitment - CORRECT ANSWER✅✅✅The first step in the consent process. How potential subjects
are identified and invited to participate in research.
DSMB - CORRECT 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 - CORRECT ANSWER✅✅✅General term for specific and predetermined parameters
that guide the data monitoring process.
