CIP Exam with all Correct & 100% Verified Answers |
Latest Version| Already Graded A+
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. ✔Correct Answer-
Minimal Risk
Respect for persons, beneficence, and justice ✔Correct Answer-The Belmont Principles
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. ✔Correct Answer-IRB
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. ✔Correct Answer-Institutional Official (IO)
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.
✔Correct Answer-OHRP
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. ✔Correct Answer-Minutes
Proactive, non-punitive, and focused on educating investigators about their ethical and regulatory
responsibilities in the conduct of research. ✔Correct Answer-Research Audit Program
Primary person responsible for managing the IRB office and many of the administrative aspects of
IRB meetings. ✔Correct Answer-IRB Director/Administrator
Must consist of at least five members and include at least one scientist, one nonscientist and one
person not affiliated with the institution. ✔Correct Answer-IRB Membership
Refers to the number of voting member positions on the IRB. ✔Correct Answer-IRB Membership
Roster
When there is more than one member for an IRB roster position. ✔Correct Answer-Alternate
Member
Committee consisting of one or more experienced reviewers organized for the purpose of
managining a specific task or making a specific type of decision. ✔Correct Answer-IRB
Subcommittee
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. ✔Correct Answer-Social Harm
,A type of review that can be conducted by the Chair, designated IRB members, or a subcommittee of
the IRB. ✔Correct Answer-Expedited Review
45 CFR 46.102(d) A systematic investigation including development, testing, and evaluation, designed
to develop or contribute to generalizable knowledge. ✔Correct Answer-Research
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. ✔Correct Answer-Human Subject
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. ✔Correct Answer-
Emergency Use
Probability and magnitude of the potential harm(s) or discomfort(s) anticipated by participating in
the research. ✔Correct Answer-Risk
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. ✔Correct Answer-Privacy
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 ✔Correct Answer-Confidentiality
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. ✔Correct Answer-Criteria for waiver or alteration of 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. ✔Correct Answer-Informed Consent
The first step in the consent process. How potential subjects are identified and invited to participate
in research. ✔Correct Answer-Recruitment
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. ✔Correct Answer-DSMB
, General term for specific and predetermined parameters that guide the data monitoring process.
✔Correct Answer-Stopping Rules
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. ✔Correct Answer-Exculpatory Language
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. ✔Correct
Answer-Respect for Persons
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.
✔Correct Answer-Beneficence
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.
✔Correct Answer-Factors that may determine when a DSMB is necessary
efficacy, futility, or safety ✔Correct Answer-Reasons a DSMB may stop a study
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. ✔Correct Answer-
Serious or Continuing Non-compliance
No more than 365 days and is determined by the risk to subjects. ✔Correct Answer-Renewal
Interval
To make health insurance portable and increase accountability in Medicare billing. ✔Correct
Answer-Main Goals of HIPAA
Individually identifiable health information held by a covered entity. ✔Correct Answer-Protected
Health Information (PHI)
Written permission from an individual allowing a CE to use or disclose specified PHI for a particular
purpose. ✔Correct Answer-Authorization
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. ✔Correct Answer-Designated Record Set
An agreement in which the data recipient promises not to attempt to re-identify or contact the
individuals. ✔Correct Answer-Data Use Agreement
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 is still considered PHI and is subject to the minimum
necessary requirements of the Privacy Rule. ✔Correct Answer-Limited Data Set (LDS)
Latest Version| Already Graded A+
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. ✔Correct Answer-
Minimal Risk
Respect for persons, beneficence, and justice ✔Correct Answer-The Belmont Principles
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. ✔Correct Answer-IRB
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. ✔Correct Answer-Institutional Official (IO)
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.
✔Correct Answer-OHRP
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. ✔Correct Answer-Minutes
Proactive, non-punitive, and focused on educating investigators about their ethical and regulatory
responsibilities in the conduct of research. ✔Correct Answer-Research Audit Program
Primary person responsible for managing the IRB office and many of the administrative aspects of
IRB meetings. ✔Correct Answer-IRB Director/Administrator
Must consist of at least five members and include at least one scientist, one nonscientist and one
person not affiliated with the institution. ✔Correct Answer-IRB Membership
Refers to the number of voting member positions on the IRB. ✔Correct Answer-IRB Membership
Roster
When there is more than one member for an IRB roster position. ✔Correct Answer-Alternate
Member
Committee consisting of one or more experienced reviewers organized for the purpose of
managining a specific task or making a specific type of decision. ✔Correct Answer-IRB
Subcommittee
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. ✔Correct Answer-Social Harm
,A type of review that can be conducted by the Chair, designated IRB members, or a subcommittee of
the IRB. ✔Correct Answer-Expedited Review
45 CFR 46.102(d) A systematic investigation including development, testing, and evaluation, designed
to develop or contribute to generalizable knowledge. ✔Correct Answer-Research
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. ✔Correct Answer-Human Subject
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. ✔Correct Answer-
Emergency Use
Probability and magnitude of the potential harm(s) or discomfort(s) anticipated by participating in
the research. ✔Correct Answer-Risk
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. ✔Correct Answer-Privacy
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 ✔Correct Answer-Confidentiality
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. ✔Correct Answer-Criteria for waiver or alteration of 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. ✔Correct Answer-Informed Consent
The first step in the consent process. How potential subjects are identified and invited to participate
in research. ✔Correct Answer-Recruitment
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. ✔Correct Answer-DSMB
, General term for specific and predetermined parameters that guide the data monitoring process.
✔Correct Answer-Stopping Rules
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. ✔Correct Answer-Exculpatory Language
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. ✔Correct
Answer-Respect for Persons
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.
✔Correct Answer-Beneficence
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.
✔Correct Answer-Factors that may determine when a DSMB is necessary
efficacy, futility, or safety ✔Correct Answer-Reasons a DSMB may stop a study
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. ✔Correct Answer-
Serious or Continuing Non-compliance
No more than 365 days and is determined by the risk to subjects. ✔Correct Answer-Renewal
Interval
To make health insurance portable and increase accountability in Medicare billing. ✔Correct
Answer-Main Goals of HIPAA
Individually identifiable health information held by a covered entity. ✔Correct Answer-Protected
Health Information (PHI)
Written permission from an individual allowing a CE to use or disclose specified PHI for a particular
purpose. ✔Correct Answer-Authorization
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. ✔Correct Answer-Designated Record Set
An agreement in which the data recipient promises not to attempt to re-identify or contact the
individuals. ✔Correct Answer-Data Use Agreement
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 is still considered PHI and is subject to the minimum
necessary requirements of the Privacy Rule. ✔Correct Answer-Limited Data Set (LDS)
