IRB Decision Making Flashcards
Actions that the IRB can take when reviewing a study are?
a) Approve
b) Approve with conditions
c) Defer pending major modifications
d) Disapprove
e) All of the above may apply
e) All of the above may apply
a) Approve
b) Approve with conditions
c) Defer pending major modifications
d) Disapprove
The decision to approve with conditions implies:
a) Make specified changes to the protocol
b) Make specified changes to the informed consent
c) Submit specific clarifications or specified additional documents
d) All of the above
d) All of the above
a) Make specified changes to the protocol
b) Make specified changes to the informed consent
c) Submit specific clarifications or specified additional documents
The IRB may not approve a study if it is unable:
a) To make determinations about research risks
b) To determine the adequacy of privacy and confidentiality agreements
c) To determine the adequacy of the informed consent or the informed consent process
d) All of the above
d) All of the above
a) To make determinations about research risks
b) To determine the adequacy of privacy and confidentiality agreements
c) To determine the adequacy of the informed consent or the informed consent process
When an IRB defers a research project:
a) The research can proceed in the interim
b) The research may not proceed until reviewed by the IRB chair
c) The research may not proceed until reviewed by a qualified consultant to the IRB
d) The research may not proceed until reviewed again and approved by a fully convened IRB.
d) The research may not proceed until reviewed again and approved by a fully convened IRB.
When a study is reviewed under an expedited procedure the IRB may do all of the following except?
a) Approve the study without conditions
b) Approve the study with conditions
c) Defer the study pending major modifications
d) Disapprove the study
d) Disapprove the study
A research study would most likely be deferred in all of the following scenarios except?
a) Justification of the use of placebo
b) Justification for the enrollment of children
c) Alteration of the protocol or study design and hypothesis
d) Submission of additional specified documents
d) Submission of additional specified documents
A research study would most likely be approved with conditions in all of the following scenarios except?
a) Submission of additional documents
b) Making precise language changes in the protocol or informed consent
c) Confirmation of the specific assumptions and understandings on the part of the IRB regarding the application
d) Changes in the exclusion criteria for the study
d) Changes in the exclusion criteria for the study
When an IRB approves a study with conditions the subsequent review is likely done by any of the following except?
a) IRB chair
b) IRB member reviewer designated by the chair
c) Review by an IRB consultant followed by the review of an IRB designated reviewer
d) A fully convened IRB
d) A fully convened IRB
An IRB reviewing a study of surgical procedures requires that a change be made in the protocol to ensure that the informed consent is done at a prior clinical visit and not be scheduled on the day of the surgery. The action taken by the IRB would be?
a) Approve the study with the optional recommendation
b) Approve the study with the condition
c) Defer the study
d) Disapprove the study
b) Approve the study with the condition
An IRB reviewing a study which requires radiographic imaging requires the investigator to confirm that the contrast agent used in the imaging be confined to the type and dose of the reagent specified by the IRB. The action taken by the IRB should be?
a) Approve the study with the optional recommendation
b) Approve the study with the condition
c) Defer the study
d) Disapprove the study
b) Approve the study with the condition
An IRB reviewing a study requires the investigator to obtain a certificate of confidentiality and a letter of approval from the radiation safety committee. The action taken by the IRB would be?
a) Approve the study with the optional recommendation
b) Approve the study with the condition
c) Defer the study
d) Disapprove the study
b) Approve the study with the condition
An IRB reviewing a study requires the investigator to specify which procedures are standard of care and which are research related. The action taken by the IRB would be:
a) Approve the study with the optional recommendation
b) Approve the study with the condition
c) Defer the study
d) Disapprove the study
b) Approve the study with the condition
An IRB recommends that a research study be approved with conditions. The investigator submits the revised study and it is approved by the IRB chair. The approval date for the study would be?
a) The date of the initial review
b) The date of submission of the revision by the investigator
c) The date of approval by the IRB chair
d) The date the letter of approval is mailed out.
c) The date of approval by the IRB chair
An IRB reviewing a study requires the investigator to replace the placebo group with a comparator drug. The likely action taken by the IRB would be?
a) Approve the study with the optional recommendation
b) Approve the study with the condition
c) Defer the study
d) Disapprove the study
c) Defer the study
An IRB reviews a study which has two treatment groups one involving adults over the age of 18 and the other involving children under the age of 18. The IRB has reservations about the adequacy of the protocol for the inclusion of children. The IRB may?
a) Approve the study for adults and defer the study for children
b) Approve the study with conditions for both groups
c) Disapprove the study for both groups since one group does not qualify
d) Defer the study for both groups.
a) Approve the study for adults and defer the study for children
An IRB conducting a continuing review of a research study requiring a fully convened IRB determines that changes in the protocol, not previously specified are needed to ensure the safety of the subjects. The IRB may require all of the following except?
a) Approve the study to prevent disruption of the research protocol
b) Require that the altered protocol be put into effect only for newly enrolled subject
c) Require changes to the informed consent and re-consent of the subjects
d) Require appropriate changes to the long term follow up of current and future enrollees.
a) Approve the study to prevent disruption of the research protocol
When an IRB approves a study with conditions the IRB must?
a) Document the date of the acceptance of the changes by the IRB reviewer, the date of approval if different from this date and the date of continuing review
b) Document conditions for partial approval with conditions
c) Document all appropriate events and reviews in the minutes and IRB records
d) All of the above.
d) All of the above.
a) Document the date of the acceptance of the changes by the IRB reviewer, the date of approval if different from this date and the date of continuing review
b) Document conditions for partial approval with conditions
c) Document all appropriate events and reviews in the minutes and IRB records
