Institutional Review Board Procedures Flashcards

A researcher conducting a study under an approved protocol realizes they accidentally deviated from the protocol. What is the correct course of action?

Answer: Report the deviation to the IRB and submit a corrective action plan

Protocol deviations must be reported to the IRB, even if no harm occurred, along with a corrective action plan to prevent recurrence.

Which of the following is a distinguishing feature of research as opposed to quality improvement (QI) that determines IRB applicability?

Answer: Research is designed to contribute to generalizable knowledge beyond the local setting

The defining characteristic of research requiring IRB review is the intent to develop or contribute to generalizable knowledge, as opposed to QI aimed solely at local practice improvement.

What is the primary purpose of the Certificate of Confidentiality (CoC) in research?

Answer: To protect researchers from legal compulsion to disclose identifiable research data

A Certificate of Confidentiality protects researchers from being compelled by legal proceedings (e.g., subpoenas) to disclose identifiable private information about participants.

Under the 2018 Common Rule, which studies are no longer required to undergo continuing review?

Answer: Studies approved under expedited review when there is no greater than minimal risk

The 2018 Common Rule eliminated mandatory continuing review for studies approved via expedited review and for exempt research.

A researcher wishes to use a translated consent form for non-English-speaking participants. What is the IRB's requirement?

Answer: A translated short form or full consent document in the participant's language must be IRB-approved

When consent is obtained from non-English speakers, an IRB-approved translated document or short form with an oral presentation must be used.

What is the significance of 'assent' in pediatric research under Subpart D?

Answer: It is the child's affirmative agreement to participate in research, separate from parental permission

Assent is the child's affirmative agreement to participate and is required in addition to parental permission, based on the child's capacity to understand.

Which action would constitute a serious noncompliance finding by an IRB or oversight authority?

Answer: Enrolling participants before obtaining IRB approval

Enrolling human subjects before IRB approval is obtained is a serious noncompliance that violates federal regulations and can result in suspension of research activities.