Discuss SOCRA CCRP Exam Topic 2 Question 5

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

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).

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31 comments · newest first

Lizette 7 months ago

Same here! It’s all about understanding the regulations.

Lou 7 months ago

I just hope we don’t get too many questions like this!

Hyun 7 months ago

True, but A could be involved in ethical implications.

Lizette 8 months ago

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

Lou 8 months ago

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

Dianne 8 months ago

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

Hyun 8 months ago

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

Azzie 8 months ago

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

Donette 8 months ago

Totally agree with B! That makes the most sense.

Curtis 9 months ago

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

Ricarda 9 months ago

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

Queen 9 months ago

It's definitely B) The appropriate institutional officials.

Lynna 9 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.

Leonora 9 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.

Jeniffer 9 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.

Annamae 10 months ago

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

Avery 10 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.

Dianne 10 months ago

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

Laura 11 months ago

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

Mitsue 11 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.

Eun 11 months ago

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

Annice 11 months ago

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

Latanya 12 months ago

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

Lorean 12 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.

Tonette 12 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.

Catrice 1 year ago

Hmm, this seems like a tricky one. I'll need to review the 45 CFR 46 guidelines carefully to determine the correct reporting requirements.

Lonna 1 year ago

I'm pretty sure the answer is B, but I should double-check the regulations to be sure.

Wilda 6 months ago

↳ replying to Lonna

Good point! But I still feel B is the main requirement here.

Yuki 6 months ago

↳ replying to Lonna

I wonder if the local hospital's bioethics committee plays a role too?

Ernie 10 months ago

↳ replying to Lonna

I think you're right about B! It's crucial to inform the institutional officials.

Gladys 10 months ago

↳ replying to Lonna

Definitely! They need to be in the loop for compliance.

SOCRA CCRP Exam - Topic 2 Question 5 Discussion