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 about parental permission is correct?
The parents of the children might feel pressure to give permission to the therapist to use their
children's data so that she will continue to provide services to their children.
A general requirement for informed consent is that no informed consent may include any
exculpatory language. Exculpatory language is that which waives or appears to waive any
of the subject's legal rights or releases or appears to release those conducting the research
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 about parental permission is correct?
The parents of the children might feel pressure to give permission to the therapist to use their
children's data so that she will continue to provide services to their children.
A general requirement for informed consent is that no informed consent may include any
exculpatory language. Exculpatory language is that which waives or appears to waive any
of the subject's legal rights or releases or appears to release those conducting the research
