Certification for IRB Professionals (CIP) Exam Complete Q&A 2023.
According to the Belmont Report, respect for persons usually demands that
subjects... - enter into research voluntarily & with adequate information
According to the Belmont Report, the moral requirement that there be fair
outcomes in the selection of research subjects, expresses the principle of: -
Justice
A poorly designed protocol is considered unethical because... - research
subjects may be put at risk or inconvenienced for insufficient reason
When should an IRB suspend or terminate approval of research? - When it is
not being conducted in accordance with the IRB's requirements
A quorum for a convened IRB meeting requires the presence of... - a
nonscientific member
What is required in research involving no more than minimal risk with
children? - Adequate provisions are made for assent of the child and
permission of parent or guardian
Federal regulations require each IRB to have written procedures for... - initial
& continuing review of research and for reporting its findings and actions to
the investigator and the institution
What are the 3 ethical principles discussed in the Belmont Report? - Respect
for Persons, Justice, & Beneficence
An example of how the Principle of Beneficence can be applied to a study
employing human subjects? - Determining that the study has a maximization
of benefits & a minimization of risks.
The researcher's failure to protect research subjects from deductive
disclosure is the primary ethical violation of which study? - Harvard "Tastes,
Ties, and Time (T3)" study (2006-2009)"
, What is an example of how the principle of beneficence is applied to a study
involving human subjects? - Ensuring that risks are reasonable in relationship
to anticipated benefits
Humphreys collecting data for the Tearoom Trade study under the pretense
that he was a lookout is an example of a violation of the principle of: - Respect
for Persons
Which study is linked most directly to the establishment of the National
Research Act in 1974 and ultimately to the Belmont Report and Federal
regulations for human subject protection? - "The Public Health Service
Tuskegee Study of Untreated Syphilis in the Negro Male"
The Belmont Principle of beneficence requires that... - potential benefits
justify the risks of harm
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? - 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? - For a minimum of three years after
completion of the study
According to federal regulations, when can the IRB use expedited review on a
new, proposed study? - 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: - The changes must be immediately implemented for the
health and well-being of the subject.
A therapist at a free university clinic treats elementary school children with
behavior problems who are referred by a social service agency. She is also a
doctoral candidate who proposes using data she has and will collect about the
children for a case-based research project. Which of the following statements
According to the Belmont Report, respect for persons usually demands that
subjects... - enter into research voluntarily & with adequate information
According to the Belmont Report, the moral requirement that there be fair
outcomes in the selection of research subjects, expresses the principle of: -
Justice
A poorly designed protocol is considered unethical because... - research
subjects may be put at risk or inconvenienced for insufficient reason
When should an IRB suspend or terminate approval of research? - When it is
not being conducted in accordance with the IRB's requirements
A quorum for a convened IRB meeting requires the presence of... - a
nonscientific member
What is required in research involving no more than minimal risk with
children? - Adequate provisions are made for assent of the child and
permission of parent or guardian
Federal regulations require each IRB to have written procedures for... - initial
& continuing review of research and for reporting its findings and actions to
the investigator and the institution
What are the 3 ethical principles discussed in the Belmont Report? - Respect
for Persons, Justice, & Beneficence
An example of how the Principle of Beneficence can be applied to a study
employing human subjects? - Determining that the study has a maximization
of benefits & a minimization of risks.
The researcher's failure to protect research subjects from deductive
disclosure is the primary ethical violation of which study? - Harvard "Tastes,
Ties, and Time (T3)" study (2006-2009)"
, What is an example of how the principle of beneficence is applied to a study
involving human subjects? - Ensuring that risks are reasonable in relationship
to anticipated benefits
Humphreys collecting data for the Tearoom Trade study under the pretense
that he was a lookout is an example of a violation of the principle of: - Respect
for Persons
Which study is linked most directly to the establishment of the National
Research Act in 1974 and ultimately to the Belmont Report and Federal
regulations for human subject protection? - "The Public Health Service
Tuskegee Study of Untreated Syphilis in the Negro Male"
The Belmont Principle of beneficence requires that... - potential benefits
justify the risks of harm
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? - 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? - For a minimum of three years after
completion of the study
According to federal regulations, when can the IRB use expedited review on a
new, proposed study? - 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: - The changes must be immediately implemented for the
health and well-being of the subject.
A therapist at a free university clinic treats elementary school children with
behavior problems who are referred by a social service agency. She is also a
doctoral candidate who proposes using data she has and will collect about the
children for a case-based research project. Which of the following statements
