1
IRB
IRB Professionals (CIP) Exam Questions
with Correct Verified Solutions 100%
Guaranteed Pass (Latest Update)
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? - ANS ✓"The Public Health Service
Tuskegee Study of Untreated Syphilis in the Negro Male"
The Belmont Principle of beneficence requires that... - ANS ✓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? - ANS
✓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? - ANS ✓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? - ANS ✓The study involves no more than minimal risk
and meets one of the allowable categories of expedited review specified in federal
regulations
IRB Professionals
, 2
IRB
Amendments involving changes to IRB approved protocols do NOT need
prior IRB approval if: - ANS ✓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? - ANS ✓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 from liability for
negligence. Which of the following statements in a consent form is an
example of exculpatory language? - ANS ✓"Taking part in the research is
voluntary, but we choose you as a participant, you waive the right to legal redress
for any research-related injuries"
A criterion for waiving informed consent is that, when appropriate, subjects
are provided additional pertinent information after the study. In which of
the following studies would it NOT be appropriate to provide subjects with
information about missing elements of consent: - ANS ✓A study in which
subjects were assigned to study activities based on an undesirable or unflattering
physical characteristic as assessed by members of the research team.
A waiver of the requirement for documentation of informed consent may be
granted when: - ANS ✓The only record linking the subject and the research is
the consent document and the principal risk is a breach of confidentiality.
As part of the consent process, the federal regulations require researchers
to: - ANS ✓Provide potential subjects with information at the appropriate
reading comprehension level.
IRB Professionals
IRB
IRB Professionals (CIP) Exam Questions
with Correct Verified Solutions 100%
Guaranteed Pass (Latest Update)
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? - ANS ✓"The Public Health Service
Tuskegee Study of Untreated Syphilis in the Negro Male"
The Belmont Principle of beneficence requires that... - ANS ✓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? - ANS
✓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? - ANS ✓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? - ANS ✓The study involves no more than minimal risk
and meets one of the allowable categories of expedited review specified in federal
regulations
IRB Professionals
, 2
IRB
Amendments involving changes to IRB approved protocols do NOT need
prior IRB approval if: - ANS ✓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? - ANS ✓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 from liability for
negligence. Which of the following statements in a consent form is an
example of exculpatory language? - ANS ✓"Taking part in the research is
voluntary, but we choose you as a participant, you waive the right to legal redress
for any research-related injuries"
A criterion for waiving informed consent is that, when appropriate, subjects
are provided additional pertinent information after the study. In which of
the following studies would it NOT be appropriate to provide subjects with
information about missing elements of consent: - ANS ✓A study in which
subjects were assigned to study activities based on an undesirable or unflattering
physical characteristic as assessed by members of the research team.
A waiver of the requirement for documentation of informed consent may be
granted when: - ANS ✓The only record linking the subject and the research is
the consent document and the principal risk is a breach of confidentiality.
As part of the consent process, the federal regulations require researchers
to: - ANS ✓Provide potential subjects with information at the appropriate
reading comprehension level.
IRB Professionals
