Expedited IRB Exam Video
[video:http://www.youtube.com/watch?v=sy6aEOBGhUI&feature=youtu.be]
Expedited IRB Exam Questions
In order to be an Investigator, you must have a professional degree. (9:10, Video 1)
A. True. An investigator must have completed formal, post-graduate education in order to understand the guidelines and regulations and effectively perform their duties.
B. False. An investigator can be a professional, a scientist, nurse, administrative staff, student, non-scientist, among others, and must be qualified by completing a certification.
(Answer: B)
Ethical Research Regulations are based on the Belmont Report, which focuses on the three ethical principles of (10:30, Video 1)
A. Beneficence, Learning, Privacy
B. Risk, Justice, Privacy
C. Beneficence, Justice, Respect for Persons
D. Risk, Learning, Respect for Persons
(Answer: C)
Human Subjects are involved in research when (17:30, Video 1)
A. Identifiable Private information about a subject is obtained.
B. Data is obtained through an intervention with a subject.
C. Identifiable Private information about a Deceased subject is obtained.
D. A and B only.
(Answer: D)
When is IRB review and approval necessary? (22:12, Video 1)
A. Prior to involving subjects in research activities.
B. At least annually for prolonged research activities.
C. Prior to initiating any changes to approved research.
D. All of the above.
(Answer: D)
The IRB may only approve research without re-review if (35:30, Video 2)
A. There is concern that employees are encouraged to participate in research.
B. It is not know what part of the body biopsies are taken from.
C. Precise language changes in the protocol have been recommended.
D. None of the above.
(Answer: C)
Changes to protocol that do not require IRB review approval are (46:30, Video 2)
A. Enrolling ineligible participants.
B. Adding a test for emergent risk
C. Increasing enrollment limits.
D. Adding new recruitment ads.
(Answer: B)
Informed Consent is not necessary for (49:00, Video 2)
A. Deceptive Research
B. Study on couple therapy in alcohol treatment
C. Study on teaching vascular surgery interns surgery skills
D. Informed Consent is necessary for all research.
(Answer: A)
What is the main criteria for IRB approval? (48:35, Video 3)
A. Risk minimized with benefits reasonable.
B. Equitable subject selection.
C. Informed Consent.
D. All of the above.
(Answer: D)
Which of the following must be considered in determining the frequency of an IRB review? (51:00, Video 3)
A. The gender of the subjects
B. The benefits to the research society
C. The degree of risk to the subjects
D. Whether informed consent has been waived
(Answer: C)
IRB Regulations on Human Subjects Research apply to (3:20, Video 4)
A. Deceased Individuals only.
B. Living Individuals only.
C. Both Living and Deceased Individuals.
D. Neither Living nor Deceased Individuals.
(Answer: B)
Human Subjects are considered not involved in a research study if the Investigator can (6:35, Video 4)
A. Readily identify the individual to whom the specimen pertains.
B. Identify through code the individual to whom the specimen pertains.
C. Cannot identify the individual to whom the specimen pertains under any circumstances.
D. All specimen from individuals are considered as Human Subjects Research.
(Answer: C)
Unanticipated Problems involving risks to subjects or others are (3:30, Video 6)
A. Unexpected in terms of nature, severity, or frequency.
B. Related or possibly related to the research being conducted.
C. Those that place subjects or others at increased risk or harm than initially anticipated.
D. All of the Above.
(Answer: D)
Adverse Events are (5:30, Video 6)
A. Recognized as Unanticipated Problems and should be reported as such.
B. Temporarily related to the Research, but not considered Unanticipated Problems in general.
C. Never considered as Unanticipated Problems and do not need to be reported at any point.
D. Those events which are expected, and have been documented.
(Answer: B)
After the onset of an Adverse Event, an Investigator should (11:30, Video 6)
A. Propose changes to minimize risks to the protocol, submitting it for approval with the IRB before enacting such changes.
B. Make no changes to the protocol as it has already been approved by the IRB.
C. Make immediate changes to the protocol to eliminate apparent hazards even without approval from the IRB.
D. Stop the research immediately and create a new protocol to submit to the IRB.
(Answer: C)
Unanticipated Problems need to be reported to (18:40, Video 6)
A. The IRB only.
B. The IRB and OHRP.
C. The IRB, Institutional Officials, Funding Agency, and OHRP.
D. The IRB, Funding Agency and OHRP.
(Answer: C)
Human Subjects research is subject for Expedited Review so long as it (8:30, Video 9)
A. Complies with regulations stated under OHRP code 45 CFR 46.110.
B. Complies with regulations stated under OHRP code 45 CFR 46.110, and does not include Prisoners.
C. Complies with regulations stated under OHRP code 45 CFR 46.110, and does not include Children.
D. Complies with regulations stated under OHRP code 45 CFR 46.110, and does not include Pregnant Women.
(Answer: A)