Certification for IRB Professionals Case Questions
100% Plus Correctly answered and Graded A++
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.
100% Plus Correctly answered and Graded A++
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.
