CIP All Exam Questions Answer 2025/2026 Graded
A+
OHRP - 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 - 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 - Proactive, non-punitive, and focused on educating
investigators about their ethical and regulatory responsibilities in the conduct of
research.
IRB Director/Administrator - Primary person responsible for managing the IRB office
and many of the administrative aspects of IRB meetings.
IRB Membership - 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 - Refers to the number of voting member positions on the IRB.
Alternate Member - When there is more than one member for an IRB roster position.
IRB Subcommittee - 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 - 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 - A type of review that can be conducted by the Chair, designated
IRB members, or a subcommittee of the IRB.
Research - 45 CFR 46.102(d) A systematic investigation including development, testing,
and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subject - 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 - 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 - Probability and magnitude of the potential harm(s) or discomfort(s) anticipated by
participating in the research.
Privacy - 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 - 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 - 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 - 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 - The first step in the consent process. How potential subjects are identified
and invited to participate in research.
DSMB - 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 - General term for specific and predetermined parameters that guide the
data monitoring process.
, Exculpatory Language - 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 - 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.
Beneficence - The doing of good, obligates the researcher to secure the individual's
well-being by maximizing benefits and minimizing harms to the individual research
subject. Requires that the researcher perform a risk/benefit analysis. Requires that
competent investigators design ethical research, protect human subjects from risk, and
make continuing assessments of the risk/benefit ratio.
Factors that may determine when a DSMB is necessary - A large study population,
multiple study sites, highly toxic therapies or dangerous procedures, high expected
rates of morbidity or mortality in the study population, high chance of early termination.
Reasons a DSMB may stop a study - efficacy, futility, or safety
Serious or Continuing Non-compliance - A problem that indicates noncompliance that is
serious or continuing, OHRP will be notified within 48 hours, regardless of the funding
source. If applicable the FDA will be notified.
Renewal Interval - No more than 365 days and is determined by the risk to subjects.
Main Goals of HIPAA - To make health insurance portable and increase accountability
in Medicare billing.
Protected Health Information (PHI) - Individually identifiable health information held by a
covered entity.
Authorization - Written permission from an individual allowing a CE to use or disclose
specified PHI for a particular purpose.
Designated Record Set - The part of medical records that must be disclosed to the
individual--research information that is specifically for research is not typically part of
this.
Data Use Agreement - An agreement in which the data recipient promises not to
attempt to re-identify or contact the individuals.
Limited Data Set (LDS) - Allows more identifiers than a de-identified data set--in
particular allows all dates and ZIP codes , but street addresses are not allowed--this set
A+
OHRP - 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 - 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 - Proactive, non-punitive, and focused on educating
investigators about their ethical and regulatory responsibilities in the conduct of
research.
IRB Director/Administrator - Primary person responsible for managing the IRB office
and many of the administrative aspects of IRB meetings.
IRB Membership - 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 - Refers to the number of voting member positions on the IRB.
Alternate Member - When there is more than one member for an IRB roster position.
IRB Subcommittee - 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 - 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 - A type of review that can be conducted by the Chair, designated
IRB members, or a subcommittee of the IRB.
Research - 45 CFR 46.102(d) A systematic investigation including development, testing,
and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subject - 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 - 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 - Probability and magnitude of the potential harm(s) or discomfort(s) anticipated by
participating in the research.
Privacy - 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 - 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 - 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 - 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 - The first step in the consent process. How potential subjects are identified
and invited to participate in research.
DSMB - 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 - General term for specific and predetermined parameters that guide the
data monitoring process.
, Exculpatory Language - 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 - 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.
Beneficence - The doing of good, obligates the researcher to secure the individual's
well-being by maximizing benefits and minimizing harms to the individual research
subject. Requires that the researcher perform a risk/benefit analysis. Requires that
competent investigators design ethical research, protect human subjects from risk, and
make continuing assessments of the risk/benefit ratio.
Factors that may determine when a DSMB is necessary - A large study population,
multiple study sites, highly toxic therapies or dangerous procedures, high expected
rates of morbidity or mortality in the study population, high chance of early termination.
Reasons a DSMB may stop a study - efficacy, futility, or safety
Serious or Continuing Non-compliance - A problem that indicates noncompliance that is
serious or continuing, OHRP will be notified within 48 hours, regardless of the funding
source. If applicable the FDA will be notified.
Renewal Interval - No more than 365 days and is determined by the risk to subjects.
Main Goals of HIPAA - To make health insurance portable and increase accountability
in Medicare billing.
Protected Health Information (PHI) - Individually identifiable health information held by a
covered entity.
Authorization - Written permission from an individual allowing a CE to use or disclose
specified PHI for a particular purpose.
Designated Record Set - The part of medical records that must be disclosed to the
individual--research information that is specifically for research is not typically part of
this.
Data Use Agreement - An agreement in which the data recipient promises not to
attempt to re-identify or contact the individuals.
Limited Data Set (LDS) - Allows more identifiers than a de-identified data set--in
particular allows all dates and ZIP codes , but street addresses are not allowed--this set
