Certification for IRB Professionals (CIP) Exam Complete Questions & Answers
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
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
