Certification for IRB Professionals (CIP) Exam
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: Correct
Answer 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 financial conflict of interest could involve Correct Answer
Receiving stock in a company funding your research.
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? Correct Answer "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 poorly designed protocol is considered unethical because...
Correct Answer research subjects may be put at risk or
inconvenienced for insufficient reason
A quorum for a convened IRB meeting requires the presence
of... Correct Answer a nonscientific member
, A researcher leaves a research file in her car while she attends a
concert and her car is stolen. The file contains charts of
aggregated numerical data from a research study with human
subjects, but no other documents. The consent form said that no
identifying information would be retained, and the researcher
adhered to that component. Which of the following statements
best characterizes what occurred? Correct Answer There was
neither a violation of privacy nor a breach of confidentiality.
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.
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? Correct Answer 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 waiver of the requirement for documentation of informed
consent may be granted when: Correct Answer The only
record linking the subject and the research is the consent
document and the principal risk is a breach of confidentiality.
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: Correct
Answer 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 financial conflict of interest could involve Correct Answer
Receiving stock in a company funding your research.
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? Correct Answer "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 poorly designed protocol is considered unethical because...
Correct Answer research subjects may be put at risk or
inconvenienced for insufficient reason
A quorum for a convened IRB meeting requires the presence
of... Correct Answer a nonscientific member
, A researcher leaves a research file in her car while she attends a
concert and her car is stolen. The file contains charts of
aggregated numerical data from a research study with human
subjects, but no other documents. The consent form said that no
identifying information would be retained, and the researcher
adhered to that component. Which of the following statements
best characterizes what occurred? Correct Answer There was
neither a violation of privacy nor a breach of confidentiality.
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.
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? Correct Answer 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 waiver of the requirement for documentation of informed
consent may be granted when: Correct Answer The only
record linking the subject and the research is the consent
document and the principal risk is a breach of confidentiality.
