Certification for IRB Professionals (CIP)
Exam UPDATED ACTUAL Exam
Questions and CORRECT Answers
According to the Belmont Report, respect for persons usually demands that subjects... -
CORRECT ANSWER - 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: - CORRECT ANSWER - Justice
A poorly designed protocol is considered unethical because... - CORRECT ANSWER -
research subjects may be put at risk or inconvenienced for insufficient reason
When should an IRB suspend or terminate approval of research? - CORRECT ANSWER -
When it is not being conducted in accordance with the IRB's requirements
A quorum for a convened IRB meeting requires the presence of... - CORRECT
ANSWER - a nonscientific member
What is required in research involving no more than minimal risk with children? - CORRECT
ANSWER - 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... - CORRECT
ANSWER - 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? - CORRECT
ANSWER - Respect for Persons, Justice, & Beneficence
, An example of how the Principle of Beneficence can be applied to a study employing human
subjects? - CORRECT ANSWER - 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? - CORRECT ANSWER - 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? - CORRECT ANSWER - 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: - CORRECT ANSWER - 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? -
CORRECT ANSWER - "The Public Health Service Tuskegee Study of Untreated Syphilis
in the Negro Male"
The Belmont Principle of beneficence requires that... - CORRECT ANSWER - 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? - 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 - For a minimum of three years after completion
of the study
Exam UPDATED ACTUAL Exam
Questions and CORRECT Answers
According to the Belmont Report, respect for persons usually demands that subjects... -
CORRECT ANSWER - 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: - CORRECT ANSWER - Justice
A poorly designed protocol is considered unethical because... - CORRECT ANSWER -
research subjects may be put at risk or inconvenienced for insufficient reason
When should an IRB suspend or terminate approval of research? - CORRECT ANSWER -
When it is not being conducted in accordance with the IRB's requirements
A quorum for a convened IRB meeting requires the presence of... - CORRECT
ANSWER - a nonscientific member
What is required in research involving no more than minimal risk with children? - CORRECT
ANSWER - 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... - CORRECT
ANSWER - 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? - CORRECT
ANSWER - Respect for Persons, Justice, & Beneficence
, An example of how the Principle of Beneficence can be applied to a study employing human
subjects? - CORRECT ANSWER - 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? - CORRECT ANSWER - 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? - CORRECT ANSWER - 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: - CORRECT ANSWER - 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? -
CORRECT ANSWER - "The Public Health Service Tuskegee Study of Untreated Syphilis
in the Negro Male"
The Belmont Principle of beneficence requires that... - CORRECT ANSWER - 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? - 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 - For a minimum of three years after completion
of the study
