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In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?
Suggested Answer: C
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Minimal risk determination is a regulatory function of the IRB/IEC.
45 CFR 46.102(j): Defines minimal risk as harm or discomfort not greater than those ordinarily encountered in daily life.
45 CFR 46.109(a): The IRB has authority to approve, require modifications, or disapprove research, including assessment of risk level.
Investigators may propose a study as minimal risk, but only the IRB/IEC can formally classify it.
This ensures independent, unbiased evaluation of risk, protecting participants from investigator or sponsor bias.
33 comments · newest first
DE
Derrick
2 days ago
Agreed! The IRB/IEC ensures ethical standards.
IN
Inocencia
7 days ago
I think it's C) The reviewing IRB/IEC. They assess risk levels.
EL
Elliot
12 days ago
No, I believe it’s B) A data safety monitoring board. They monitor ongoing safety.
LO
Louisa
18 days ago
I’m not sure. Could it be A) The clinical investigator? They know the study well.
SH
Shaquana
23 days ago
Agreed! The IRB/IEC ensures participant safety.
AV
Avery
28 days ago
I think it's C) The reviewing IRB/IEC. They assess risk levels.
RI
Rikki
1 month ago
Still, the IRB/IEC has the final say on minimal risk.
NA
Narcisa
1 month ago
But what about A) The clinical investigator? They know the study well.
JA
Jannette
1 month ago
Agreed! They ensure ethical standards are met.
ST
Stevie
2 months ago
I think it's C) The reviewing IRB/IEC. They have the authority.
AL
Alva
2 months ago
I’m not so sure about that, could be more layers involved.
KA
Kaycee
2 months ago
Totally agree, the IRB/IEC is key for this kind of stuff.
LO
Lonny
2 months ago
Wait, is it really just the IRB? Seems like a big responsibility!
DE
Denise
2 months ago
I thought the clinical investigator had more say in that!
MI
Mike
2 months ago
It's definitely the reviewing IRB/IEC that decides on minimal risk.
RO
Rosann
3 months ago
Hmm, I’m not convinced that’s the right answer.
FE
Felicidad
3 months ago
Totally agree, the IRB/IEC has to approve that!
BR
Britt
3 months ago
Wait, are we sure it's not the medical monitor?
XU
Xuan
3 months ago
I thought it was the clinical investigator?
KE
Kendra
3 months ago
It's definitely the reviewing IRB/IEC!
RU
Rueben
4 months ago
This seems too straightforward; I have my doubts about it.
DE
Deeanna
5 months ago
Wait, are you sure? I thought the medical monitor had a say too.
CA
Carri
5 months ago
I agree, the IRB/IEC has to approve it first.
SH
Shayne
5 months ago
I thought it was the clinical investigator?
PH
Phil
6 months ago
It's definitely the reviewing IRB/IEC!
JE
Jesusita
6 months ago
I feel like the clinical investigator might have some input, but it seems like the IRB would have the final say.
TH
Theodora
6 months ago
I practiced a similar question, and I think it was about the IRB making the final call on minimal risk criteria.
RI
Rickie
6 months ago
I’m not entirely sure, but I remember something about the data safety monitoring board being involved in risk assessments.
AN
Anastacia
6 months ago
I think the reviewing IRB/IEC is the right answer since they evaluate the ethical aspects of studies.
LY
Lynna
6 months ago
I remember that the data safety monitoring board usually oversees the safety of the study, but I don’t think they make the initial risk determination. So I’m also thinking it’s C.
TR
Truman
7 months ago
I’m a bit confused. I thought the clinical investigator had some responsibility in assessing risk, but I guess it’s more about the IRB?
LI
Ling
7 months ago
I feel like I’ve seen a question like this before, and it was about the IRB being responsible for determining risk levels. So I’m leaning towards C as well.
AL
Alpha
7 months ago
I think the answer might be C) The reviewing IRB/IEC, but I’m not entirely sure. I remember something about their role in assessing risk.