Institutional Review Board (IRB) Processes Flashcards

An investigator wants to add a new questionnaire to an approved study. When can the change be put into use?

Answer: Only after IRB approval, unless the change is needed to eliminate an apparent immediate hazard to subjects

Changes need prior IRB approval, except when needed to remove an apparent immediate hazard to subjects.

A protocol amendment that corrects typos and adds one study staff member is MOST likely to be reviewed by which process?

Answer: Expedited review as a minor change to previously approved research

Minor changes to previously approved research during the approval period may be reviewed by expedited procedure.

Which combination of features defines an 'unanticipated problem involving risks to subjects or others' under OHRP guidance?

Answer: Unexpected, related or possibly related to the research, and suggests greater risk of harm than previously recognized

OHRP defines unanticipated problems as unexpected, related or possibly related, and placing subjects or others at greater risk.

When an IRB suspends or terminates approval of research, the suspension must be reported promptly to:

Answer: The investigator, appropriate institutional officials, and the federal department or agency head

46.113 requires that suspensions or terminations, with the reasons, be reported promptly to the investigator, institutional officials, and the agency head.

How long must IRB records relating to a research study be kept under the Common Rule?

Answer: At least 3 years after the research is completed

46.115(b) requires IRB records to be kept for at least 3 years after the research is completed.

A study's IRB approval expired before continuing review was completed. What should the investigator do?

Answer: Stop all research activities, including enrollment, unless the IRB finds that continuing is in currently enrolled subjects' best interests

Once approval lapses, research must stop unless the IRB determines that continuing is in the best interests of enrolled subjects.

To protect a participant from an immediate safety threat, an investigator departs from the protocol without first getting IRB approval. What should happen next?

Answer: Report the change to the IRB promptly

Changes made to eliminate immediate hazards are allowed without prior approval but must be reported promptly to the IRB.