IRB Administration & Management Flashcards
7 cards from real CIP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 IRB Administration & Management flashcards as text
An IRB determines that unanticipated problems involving risks to participants or others have occurred. Under 45 CFR 46, the institution must report this to:
Answer: OHRP and any other applicable federal department or agency
Unanticipated problems involving risks to participants or others must be reported promptly to OHRP and any applicable federal department or agency head.
When assessing the appropriateness of the research setting, an IRB administrator should consider all of the following EXCEPT:
Answer: The sponsor's projected profit margin for the intervention
Sponsor profit margins are a business consideration, not an ethical criterion for IRB review of research setting adequacy.
A study is approved under expedited review Category 6 (voice, video, digital, or image recordings). The IRB may approve it only if the only involvement of human subjects is:
Answer: Collection of data through noninvasive procedures routinely employed in practice
Expedited Category 6 applies when the sole involvement of subjects is collection of data through noninvasive procedures routinely used in clinical practice, including voice/video/image recordings.
An IRB administrator is preparing for an OHRP for-cause compliance oversight evaluation. Which document is MOST critical to have readily accessible?
Answer: Minutes of all IRB meetings for the past three years
IRB meeting minutes are the primary record of the board's deliberations and decisions and are the first documents OHRP examines during a compliance evaluation.
A non-affiliated IRB member (community member) serves a crucial role because they:
Answer: Represent the perspective of research participants and the broader community
Non-affiliated/community members bring the perspective of potential research participants and the public, ensuring IRB deliberations reflect community values.
A researcher asks the IRB to waive documentation of informed consent (i.e., no signed form) for an online survey involving sensitive mental health topics. Which criterion would SUPPORT granting this waiver?
Answer: The only record linking the subject to the research would be the consent document itself, creating a risk of harm
A waiver of documentation is appropriate when the signed consent form would be the only link between the participant and the research, and breach of confidentiality could cause harm.
Which of the following best illustrates the principle of 'justice' as defined in the Belmont Report in the context of subject selection?
Answer: Distributing the burdens and benefits of research fairly across society, avoiding exploitation of vulnerable groups
Justice in the Belmont Report refers to fair distribution of research burdens and benefits and preventing exploitation of vulnerable populations who are convenient to recruit but unlikely to benefit.