SOCRA CCRP Exam - Topic 2 Question 5 Discussion

Actual exam question for SOCRA's CCRP exam

Question #: 5
Topic #: 2

[All CCRP Questions]

In accordance with 45 CFR 46, in addition to the Office for Human Research Protections (OHRP), a suspension of IRB/IEC approval must be reported to which of the following?

AThe local hospital's bioethics committee

BThe appropriate institutional officials

CThe Scientific Review Committee

DThe local hospital's medical director

Show Suggested Answer

Suggested Answer: B

If IRB/IEC approval is suspended or terminated, reporting is required to protect oversight and accountability.

45 CFR 46.113: ''An IRB shall notify the institutional officials, the department or agency head, and OHRP (when applicable) of any suspension or termination of IRB approval.''

This ensures transparency and institutional responsibility for compliance. Internal hospital committees or directors (A, C, D) are not mandated reporting entities.

Thus, the correct answer is B (Appropriate institutional officials).

45 CFR 46.113 (Suspension or termination of IRB approval).

by Bernadine at Oct 04, 2025, 09:13 PM

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Lizette

10 hours ago

But isn't B more critical? They oversee compliance.

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Lou

6 days ago

I’m leaning towards A. The bioethics committee should be informed too.

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Dianne

11 days ago

I agree, B seems right. Institutional officials need to know.

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Hyun

16 days ago

This question is tricky! I think it's B.

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Azzie

21 days ago

I’m not so sure about this. What if it should be C) The Scientific Review Committee?

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Donette

26 days ago

Totally agree with B! That makes the most sense.

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Curtis

1 month ago

Wait, is it really just the institutional officials? Seems too simple.

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Ricarda

1 month ago

I thought it was A) The local hospital's bioethics committee?

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Queen

1 month ago

It's definitely B) The appropriate institutional officials.

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Lynna

2 months ago

I’m confused because I thought the Scientific Review Committee was involved in some way, but I can't remember if they need to be notified about suspensions.

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Leonora

2 months ago

I feel like we practiced a question about IRB reporting, and I think it was about notifying institutional officials. So, I’m leaning towards B as well.

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Jeniffer

2 months ago

I remember discussing the importance of reporting to the right authorities, but I can't recall if it was the bioethics committee or the institutional officials.

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Annamae

2 months ago

Haha, the Scientific Review Committee? What is this, a game of "guess the random bureaucratic office"?

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Avery

2 months ago

I think the answer might be B, the appropriate institutional officials, but I'm not entirely sure. We covered something similar in class.

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Dianne

3 months ago

Good point! Still, I feel B is the primary requirement.

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Laura

3 months ago

D, the local hospital's medical director. They're the ones who really need to know about this, right?

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Mitsue

3 months ago

Hmm, I'm not sure about this one. Maybe the local hospital's bioethics committee would be the best option? They seem like they'd be interested in this kind of thing.

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Eun

4 months ago

B is the correct answer. The CFR clearly states that the suspension must be reported to the appropriate institutional officials.

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Annice

4 months ago

The appropriate institutional officials, of course. That's the only logical choice here.

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Latanya

4 months ago

B seems like the most logical choice here. The regulations would require notifying the appropriate institutional officials about an IRB/IEC suspension.

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Lorean

4 months ago

I'm a little confused by this question. Let me re-read the prompt and think through the different reporting entities that might be involved.

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Tonette

4 months ago

Okay, I think I know this one. The key is understanding the specific regulations around IRB/IEC suspensions. I'll walk through the options methodically.

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