CIP IRB Administration & Management 4

Question 1

An IRB determines that unanticipated problems involving risks to participants or others have occurred. Under 45 CFR 46, the institution must report this to:

Accepted Answer

OHRP and any other applicable federal department or agency

Answer

Unanticipated problems involving risks to participants or others must be reported promptly to OHRP and any applicable federal department or agency head.

Question 2

When assessing the appropriateness of the research setting, an IRB administrator should consider all of the following EXCEPT:

Accepted Answer

The sponsor's projected profit margin for the intervention

Answer

Sponsor profit margins are a business consideration, not an ethical criterion for IRB review of research setting adequacy.

Question 3

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:

Accepted Answer

Collection of data through noninvasive procedures routinely employed in practice

Answer

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.

Question 4

An IRB administrator is preparing for an OHRP for-cause compliance oversight evaluation. Which document is MOST critical to have readily accessible?

Accepted Answer

Minutes of all IRB meetings for the past three years

Answer

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.

Question 5

A non-affiliated IRB member (community member) serves a crucial role because they:

Accepted Answer

Represent the perspective of research participants and the broader community

Answer

Non-affiliated/community members bring the perspective of potential research participants and the public, ensuring IRB deliberations reflect community values.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP IRB Administration & Management 4