BRAINSCAPE1
ACRP-CP Exam with complete
solutions latest version
Belmont Report (1979) - CORRECT ANSWER-ethical principles and guidelines for the
protection of human subjects of research.
respect for persons - CORRECT ANSWER-individuals should be treated as
autonomous agents and persons with diminished autonomy are entitled to protection
An autonomous person - CORRECT ANSWER-A person capable of deliberation about
personal goals and of acting under the direction of such deliberation
Beneficence - CORRECT ANSWER-Do not harm and maximize possible benefits and
minimize possible harms
Justice - CORRECT ANSWER-1) to each person an equal share 2) to each person
according to individual need 3) to each person according to individual effort 4) to each
person according to societal contributions 5) to each person according to merit
Justice - CORRECT ANSWER-· The selection of research subjects needs to be
scrutinized in order to determine whether some classes are being systematically
selected simply because of their easy availability, their compromised position, or their
manipulability, rather than for reasons directly related to the problem being studied.
Justice - CORRECT ANSWER-· Whenever research supported by public funds leads to
the development of therapeutic devices and procedures, justice demands both that
these not provide advantages only to those who can afford them and that such research
should not unduly involve persons from groups unlikely to be among the beneficiaries of
subsequent applications of the research.
Three elements of the consent process - CORRECT ANSWER-information,
comprehension, voluntariness
BRAINSCAPE1
, BRAINSCAPE1
What is an example of how the principle of beneficence can be applied to a study
employing human subjects - CORRECT ANSWER-Determining the study has a
maximization of benefits and a minimization of risks
What are the three principles discussed in the Belmont Report? - CORRECT ANSWER-
Respect for persons, beneficence, justice
The Belmont Report's principle of respect for persons incorporates at least 2 ethical
convictions: first, that individuals should be treated as autonomous agents, and second,
that: - CORRECT ANSWER-Persons with diminished autonomy are entitled to
protection
Nuremberg Code (1947) - CORRECT ANSWER-1) a requirements for voluntary
consent 2) the research must have scientific merit 3) The benefits of the research must
outweigh the risks 4) Subjects have the ability to terminate participation in the research
at any time
National Research Act (1974) - CORRECT ANSWER-1) Authorized the creation of the
National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research, which was charged with developing an ethical code and
guidelines for researchers 2) Required the establishment of IRBs at organizations
receiving PHS support for human subject's research
The National Commission (1975-1978 - CORRECT ANSWER-Issued a series of reports
on vulnerable populations (such as fetuses, children, prisoners, and the "mentally
infirm") psychosurgery, IRBs, and other topics that included recommendations for
regulating human subjects' research. These recommendations had significant influence
on the development of the federal regulations governing human subject research.
45 CFR 46 - CORRECT ANSWER-Also known as the Common Rule, this legislation
established the role of institutional review boards (IRBs) for research on human rights.
Additional protection for these individuals in research - CORRECT ANSWER-1)
pregnant women, human fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - CORRECT ANSWER-Informed Consent
21 CFR 56 - CORRECT ANSWER-IRB
21 CFR 812 - CORRECT ANSWER-Investigational Medical Devices
21 CFR 312 - CORRECT ANSWER-Investigational Drugs and Biologics
Declaration of Helsinki (1964) - CORRECT ANSWER-Recommendations guiding
medical doctors in biomedical research involving human subjects
BRAINSCAPE1
, BRAINSCAPE1
WHO Guidelines (1996) Standards and Operational Guidance for Ethics Review of
Health-related Research with Human Participants" - CORRECT ANSWER-Documents
designed to serve as international guidelines for the review and conduct of research
involving human subjects
ICH E6 - CORRECT ANSWER-Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice
because: - CORRECT ANSWER-Prisoners may not be used to conduct research that
only benefits the larger society
What was the result of the Beecher article? - CORRECT ANSWER-Realization that
ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - CORRECT ANSWER-US
Public Health Service Policy
What is included in the Nuremberg Code? - CORRECT ANSWER-Informed consent
Informed consent is considered an application of which Belmont principle? - CORRECT
ANSWER-Respect for persons
IRB (Institutional Review Board) - CORRECT ANSWER-A review committee
established to help protect the rights and welfare of human research subjects
Regulations require: - CORRECT ANSWER-IRB review and approval for research
involving human subjects if it is conducted, supported, or regulated by US federal
departments and agencies
Federal regulations stipulate that an IRB can: - CORRECT ANSWER-Approve
research, require modifications, disapprove research, conduct continuing reviews, verify
no material changes occurred since previous review, observe, suspend/terminate
approval
Conveyed committee review - CORRECT ANSWER-Full committee review. Standard
type of review described in the federal regulations. Must be used for the initial review of
all studies that are not eligible for expedited review or exemption
Expedited review - CORRECT ANSWER-Can be used for established categories and
minor changes in previously approved research, and for limited IRB review of select
exemption categories
Categories for expedited review: - CORRECT ANSWER-1) The research does not
involve more than minimal risk
2) The entire research project must be consistent with one or more of the federally
defined categories (IND/IDE note required)
BRAINSCAPE1
, BRAINSCAPE1
Types of IRB submissions - CORRECT ANSWER-1) Application for initial review
2) Application for continuing review: IRB must re-review greater than minimal risk not
less than once per year
3) Amendments or modifications
4) Reports of unanticipated problems
US Department of Health and Human Services - CORRECT ANSWER-Responsible for
45 CFR 46
National Institutes of Health (NIH) - CORRECT ANSWER-Includes funding agencies
that provide federal funding for biomedical research
U.S. Food and Drug Administration (FDA) - CORRECT ANSWER-Oversees the use of
all drugs, devices, biologics, etc. including their use in research with human subjects
International Council for Harmonisation (ICH) - CORRECT ANSWER-offers GP
guidelines
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the
discovery of the adverse event occurrence? - CORRECT ANSWER-Report the adverse
drug experience in a timely manner, in keeping with the IRB's policies and procedures,
using the forms or the mechanism provided by the IRB
How long is an investigator required to keep consent documents, IRB correspondence,
and research records? - CORRECT ANSWER-A minimum of three years after
completion of the study
According to federal regulations, which of the following best describes when expedited
review of a new, proposed study may be used by the IRB? - CORRECT ANSWER-The
study involves no more than minimal risk and meets one of the allowable categories of
expedited review specified in federal regulations
Amendments involving changes to IRB approved protocols do NOT need prior IRB
approval if: - CORRECT ANSWER-The changes must be immediately implemented for
the health and well-being of the subjects
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must: - CORRECT ANSWER-occur at least annually
Informed consent - CORRECT ANSWER-The process that begins with the recruitment
and screening of a subject and the signing of the consent document and continues
throughout the subject's involvement in the research and beyond study termination
Informed consent is mandated by the US Department of HHS at 45 CFR 46 and the US
FDA at 21 CFR 50. These regulations were developed to: - CORRECT ANSWER-1)
protect human subjects 2) Ensure that potential study subjects clearly understand the
BRAINSCAPE1
ACRP-CP Exam with complete
solutions latest version
Belmont Report (1979) - CORRECT ANSWER-ethical principles and guidelines for the
protection of human subjects of research.
respect for persons - CORRECT ANSWER-individuals should be treated as
autonomous agents and persons with diminished autonomy are entitled to protection
An autonomous person - CORRECT ANSWER-A person capable of deliberation about
personal goals and of acting under the direction of such deliberation
Beneficence - CORRECT ANSWER-Do not harm and maximize possible benefits and
minimize possible harms
Justice - CORRECT ANSWER-1) to each person an equal share 2) to each person
according to individual need 3) to each person according to individual effort 4) to each
person according to societal contributions 5) to each person according to merit
Justice - CORRECT ANSWER-· The selection of research subjects needs to be
scrutinized in order to determine whether some classes are being systematically
selected simply because of their easy availability, their compromised position, or their
manipulability, rather than for reasons directly related to the problem being studied.
Justice - CORRECT ANSWER-· Whenever research supported by public funds leads to
the development of therapeutic devices and procedures, justice demands both that
these not provide advantages only to those who can afford them and that such research
should not unduly involve persons from groups unlikely to be among the beneficiaries of
subsequent applications of the research.
Three elements of the consent process - CORRECT ANSWER-information,
comprehension, voluntariness
BRAINSCAPE1
, BRAINSCAPE1
What is an example of how the principle of beneficence can be applied to a study
employing human subjects - CORRECT ANSWER-Determining the study has a
maximization of benefits and a minimization of risks
What are the three principles discussed in the Belmont Report? - CORRECT ANSWER-
Respect for persons, beneficence, justice
The Belmont Report's principle of respect for persons incorporates at least 2 ethical
convictions: first, that individuals should be treated as autonomous agents, and second,
that: - CORRECT ANSWER-Persons with diminished autonomy are entitled to
protection
Nuremberg Code (1947) - CORRECT ANSWER-1) a requirements for voluntary
consent 2) the research must have scientific merit 3) The benefits of the research must
outweigh the risks 4) Subjects have the ability to terminate participation in the research
at any time
National Research Act (1974) - CORRECT ANSWER-1) Authorized the creation of the
National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research, which was charged with developing an ethical code and
guidelines for researchers 2) Required the establishment of IRBs at organizations
receiving PHS support for human subject's research
The National Commission (1975-1978 - CORRECT ANSWER-Issued a series of reports
on vulnerable populations (such as fetuses, children, prisoners, and the "mentally
infirm") psychosurgery, IRBs, and other topics that included recommendations for
regulating human subjects' research. These recommendations had significant influence
on the development of the federal regulations governing human subject research.
45 CFR 46 - CORRECT ANSWER-Also known as the Common Rule, this legislation
established the role of institutional review boards (IRBs) for research on human rights.
Additional protection for these individuals in research - CORRECT ANSWER-1)
pregnant women, human fetuses, and neonates 2) children 3) prisoners
21 CFR 50 - CORRECT ANSWER-Informed Consent
21 CFR 56 - CORRECT ANSWER-IRB
21 CFR 812 - CORRECT ANSWER-Investigational Medical Devices
21 CFR 312 - CORRECT ANSWER-Investigational Drugs and Biologics
Declaration of Helsinki (1964) - CORRECT ANSWER-Recommendations guiding
medical doctors in biomedical research involving human subjects
BRAINSCAPE1
, BRAINSCAPE1
WHO Guidelines (1996) Standards and Operational Guidance for Ethics Review of
Health-related Research with Human Participants" - CORRECT ANSWER-Documents
designed to serve as international guidelines for the review and conduct of research
involving human subjects
ICH E6 - CORRECT ANSWER-Guideline for Good Clinical Practice
The use of prisoners in research is a concern under the Belmont principle for Justice
because: - CORRECT ANSWER-Prisoners may not be used to conduct research that
only benefits the larger society
What was the result of the Beecher article? - CORRECT ANSWER-Realization that
ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: - CORRECT ANSWER-US
Public Health Service Policy
What is included in the Nuremberg Code? - CORRECT ANSWER-Informed consent
Informed consent is considered an application of which Belmont principle? - CORRECT
ANSWER-Respect for persons
IRB (Institutional Review Board) - CORRECT ANSWER-A review committee
established to help protect the rights and welfare of human research subjects
Regulations require: - CORRECT ANSWER-IRB review and approval for research
involving human subjects if it is conducted, supported, or regulated by US federal
departments and agencies
Federal regulations stipulate that an IRB can: - CORRECT ANSWER-Approve
research, require modifications, disapprove research, conduct continuing reviews, verify
no material changes occurred since previous review, observe, suspend/terminate
approval
Conveyed committee review - CORRECT ANSWER-Full committee review. Standard
type of review described in the federal regulations. Must be used for the initial review of
all studies that are not eligible for expedited review or exemption
Expedited review - CORRECT ANSWER-Can be used for established categories and
minor changes in previously approved research, and for limited IRB review of select
exemption categories
Categories for expedited review: - CORRECT ANSWER-1) The research does not
involve more than minimal risk
2) The entire research project must be consistent with one or more of the federally
defined categories (IND/IDE note required)
BRAINSCAPE1
, BRAINSCAPE1
Types of IRB submissions - CORRECT ANSWER-1) Application for initial review
2) Application for continuing review: IRB must re-review greater than minimal risk not
less than once per year
3) Amendments or modifications
4) Reports of unanticipated problems
US Department of Health and Human Services - CORRECT ANSWER-Responsible for
45 CFR 46
National Institutes of Health (NIH) - CORRECT ANSWER-Includes funding agencies
that provide federal funding for biomedical research
U.S. Food and Drug Administration (FDA) - CORRECT ANSWER-Oversees the use of
all drugs, devices, biologics, etc. including their use in research with human subjects
International Council for Harmonisation (ICH) - CORRECT ANSWER-offers GP
guidelines
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the
discovery of the adverse event occurrence? - CORRECT ANSWER-Report the adverse
drug experience in a timely manner, in keeping with the IRB's policies and procedures,
using the forms or the mechanism provided by the IRB
How long is an investigator required to keep consent documents, IRB correspondence,
and research records? - CORRECT ANSWER-A minimum of three years after
completion of the study
According to federal regulations, which of the following best describes when expedited
review of a new, proposed study may be used by the IRB? - CORRECT ANSWER-The
study involves no more than minimal risk and meets one of the allowable categories of
expedited review specified in federal regulations
Amendments involving changes to IRB approved protocols do NOT need prior IRB
approval if: - CORRECT ANSWER-The changes must be immediately implemented for
the health and well-being of the subjects
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must: - CORRECT ANSWER-occur at least annually
Informed consent - CORRECT ANSWER-The process that begins with the recruitment
and screening of a subject and the signing of the consent document and continues
throughout the subject's involvement in the research and beyond study termination
Informed consent is mandated by the US Department of HHS at 45 CFR 46 and the US
FDA at 21 CFR 50. These regulations were developed to: - CORRECT ANSWER-1)
protect human subjects 2) Ensure that potential study subjects clearly understand the
BRAINSCAPE1
