CIP Exam Questions With Complete Solutions
510(k) Device Correct Answer A medical device that is
considered substantially equivalent to a device that was/is
legally marketed (a predicate device). FDA is given 90 days
notice when such a device is planned to be marketed.
8 Criteria for IRB Approval Correct Answer 1. Minimize risk
to subjects
2. Assess the risk/benefit ratio (potential benefits must
outweight the risks)
3. Ensure equitable selection of subjects
4. Evaluate the informed consent process
5. Review/edit the informed consent documents
6. Review privacy and confidentiality provisions
7. Data and safety monitoring plan
8. Vulnerable populations
Activities with schoolchildren that DO NOT qualify for
exemption under Subpart D Correct Answer 1. Research
involving surveys
2. Research involving interviews
3. Observation of public behavior when the researcher
participates in the activities being observed
Alternate Member Correct Answer When there is more than
one member for an IRB roster position.
Anonymized Samples Correct Answer Samples that were
originally collected with direct identifiers and from which the
,identifiers have been irretrievably stripped from the sample and
replaced with a random code.
Anonymous Samples Correct Answer Samples collected
without direct identifiers and involve the lowest level of risk.
Assent Correct Answer A child's affirmative agreement to
participate in research. The regulations do not indicate an age at
which this ought to be possible.
Authorization Correct Answer Written permission from an
individual allowing a CE to use or disclose specified PHI for a
particular purpose.
Beecher Article Correct Answer 1966 Dr. Henry K Beecher
(anesthesiologist) wrote an article in NEJM describing 22
studies with controversial ethics that had been conducted by
reputable researchers and published in major journals.
Beneficence Correct Answer 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.
Benefit Correct Answer The positive value or advantage of
being part of the research study.
,Business Associate Contracts (BACs) Correct Answer For
activities related to treatment, payment, or operations--the only
research activities for which this might be pertinent are
obtaining authorizations and creating a limited or de-identified
data set.
Certificates of Confidentiality (COC) Correct Answer Public
Health Act Section 301(d) Gives the HHS Secretary authority to
issue COCs which protect the privacy of subjects in health
research projects against compulsory legal process. NIH issues
the COCs. Effectiveness is retroactive once granted. Some
regulations can supersede COCs (e.g., domestic abuse, child
abuse). COCs only afford protections for information that is
recorded solely in research records (cannot protect clinical
records against forced disclosure).
Coded or Linked Samples Correct Answer Samples where the
direct identifier is replaced with a code and a key to the code
exists. These samples are the most used in research.
Component Analysis Correct Answer An ethical analysis of
risks and benefits built on the recognition that clinical research
often contains a mixture of therapeutic and non-therapeutic
procedures and that separate moral standards are required for
each.
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.
Data Use Agreement Correct Answer An agreement in which
the data recipient promises not to attempt to re-identify or
contact the individuals.
Deception in SBER Correct Answer Deception or incomplete
disclosure is permitted only when the researcher documents that
an alteration of the usual informed consent requirements is
justified under the criteria presented in the federal regulations at
45 CFR 46.116(d). Specifically, the IRB must review and
document:
1. There is some scientific value and validity to the use of
deception;
2. The relative efficacy of alternative procedures was considered
in relation to the proposed use of deception;
3. The deception does not extend to influence potential subjects'
willingness to participate;
510(k) Device Correct Answer A medical device that is
considered substantially equivalent to a device that was/is
legally marketed (a predicate device). FDA is given 90 days
notice when such a device is planned to be marketed.
8 Criteria for IRB Approval Correct Answer 1. Minimize risk
to subjects
2. Assess the risk/benefit ratio (potential benefits must
outweight the risks)
3. Ensure equitable selection of subjects
4. Evaluate the informed consent process
5. Review/edit the informed consent documents
6. Review privacy and confidentiality provisions
7. Data and safety monitoring plan
8. Vulnerable populations
Activities with schoolchildren that DO NOT qualify for
exemption under Subpart D Correct Answer 1. Research
involving surveys
2. Research involving interviews
3. Observation of public behavior when the researcher
participates in the activities being observed
Alternate Member Correct Answer When there is more than
one member for an IRB roster position.
Anonymized Samples Correct Answer Samples that were
originally collected with direct identifiers and from which the
,identifiers have been irretrievably stripped from the sample and
replaced with a random code.
Anonymous Samples Correct Answer Samples collected
without direct identifiers and involve the lowest level of risk.
Assent Correct Answer A child's affirmative agreement to
participate in research. The regulations do not indicate an age at
which this ought to be possible.
Authorization Correct Answer Written permission from an
individual allowing a CE to use or disclose specified PHI for a
particular purpose.
Beecher Article Correct Answer 1966 Dr. Henry K Beecher
(anesthesiologist) wrote an article in NEJM describing 22
studies with controversial ethics that had been conducted by
reputable researchers and published in major journals.
Beneficence Correct Answer 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.
Benefit Correct Answer The positive value or advantage of
being part of the research study.
,Business Associate Contracts (BACs) Correct Answer For
activities related to treatment, payment, or operations--the only
research activities for which this might be pertinent are
obtaining authorizations and creating a limited or de-identified
data set.
Certificates of Confidentiality (COC) Correct Answer Public
Health Act Section 301(d) Gives the HHS Secretary authority to
issue COCs which protect the privacy of subjects in health
research projects against compulsory legal process. NIH issues
the COCs. Effectiveness is retroactive once granted. Some
regulations can supersede COCs (e.g., domestic abuse, child
abuse). COCs only afford protections for information that is
recorded solely in research records (cannot protect clinical
records against forced disclosure).
Coded or Linked Samples Correct Answer Samples where the
direct identifier is replaced with a code and a key to the code
exists. These samples are the most used in research.
Component Analysis Correct Answer An ethical analysis of
risks and benefits built on the recognition that clinical research
often contains a mixture of therapeutic and non-therapeutic
procedures and that separate moral standards are required for
each.
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.
Data Use Agreement Correct Answer An agreement in which
the data recipient promises not to attempt to re-identify or
contact the individuals.
Deception in SBER Correct Answer Deception or incomplete
disclosure is permitted only when the researcher documents that
an alteration of the usual informed consent requirements is
justified under the criteria presented in the federal regulations at
45 CFR 46.116(d). Specifically, the IRB must review and
document:
1. There is some scientific value and validity to the use of
deception;
2. The relative efficacy of alternative procedures was considered
in relation to the proposed use of deception;
3. The deception does not extend to influence potential subjects'
willingness to participate;
