Discuss SOCRA CCRP Exam Topic 1 Question 1

Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?

AThe Department of Health and Human Services

BThe FDA or another regulatory authority

CThe IRB/IEC

DNo approvals are necessary if no pharmaceutical drugs are involved

Suggested Answer: C

Even if a study does not involve drugs, devices, or biologics, it still involves human subjects and therefore requires ethical review by an IRB/IEC.

45 CFR 46.109(a): ''An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.''

ICH E6(R2) 3.1.2: ''The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects.''

Quality-of-life (QOL) studies may involve surveys, interviews, or questionnaires, but since they involve human participants, they are subject to human research protection regulations. FDA involvement is not required unless drugs or devices are tested. Similarly, HHS approval is not required unless the study is federally funded.

Thus, the correct answer is C (The IRB/IEC).

45 CFR 46.109(a) (IRB review of research).

ICH E6(R2), 3.1.2 (IRB/IEC role in subject protection).

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14 comments · newest first

Hollis 10 months ago

I thought the Department of Health and Human Services had a say too?

Adrianna 10 months ago

Wait, does the FDA really not need to be involved?

Leandro 10 months ago

C) The IRB/IEC is a must!

Jamal 10 months ago

I think D) is misleading. Approvals are often needed.

Mona 10 months ago

Totally agree with Leandro!

Nickolas 11 months ago

I'm leaning towards option D, but I have a nagging feeling that some level of approval is always required, especially for ethical reasons.

Carlene 11 months ago

I feel like I saw a practice question similar to this, and it emphasized the importance of getting IRB approval for any research involving human subjects.

Nettie 11 months ago

I remember something about the Department of Health and Human Services, but I can't recall if they need to approve this kind of study.

Curtis 11 months ago

I think the IRB/IEC is definitely involved in approving studies like this, but I'm not entirely sure if the FDA has a role if there are no drugs involved.

Skye 12 months ago

I'm a bit confused on the distinction between a quality-of-life study and a clinical trial. Does the involvement of an IRB/IEC depend on that? I'll need to think this through carefully.

Nan 12 months ago

I'm feeling pretty confident about this one. Since it's a quality-of-life study and not a clinical trial of a drug, I don't think any regulatory approvals would be needed. I'm going with option D.

Stefan 12 months ago

Okay, I've got a strategy here. I'm going to focus on whether any pharmaceutical drugs are involved. If not, then I think option D might be the right answer.

Vincent 1 year ago

Hmm, this seems tricky. I'm not sure if a quality-of-life questionnaire would be considered a clinical trial or not. I'll need to review the regulations on that.

Helaine 1 year ago

I think the key here is to identify whether this is a clinical trial or just a quality-of-life survey. If it's a clinical trial, I'd say the IRB/IEC approval is definitely required.

SOCRA CCRP Exam - Topic 1 Question 1 Discussion