IEC 62366 - Ethical approval

J

Julie_

#1
Hi all,

Do you always need an approval from an ethical commission before you can do usability testing?

Even if there is nothing ethical about the scenarios that are part of it?
 

Tobias_HF

Involved In Discussions
#3
Hi all,

Do you always need an approval from an ethical commission before you can do usability testing?

Even if there is nothing ethical about the scenarios that are part of it?
Yes, if you plan to submit it to FDA, later on.

IRB (ethical commission) is required when human subjects are involved. This is regardless if they are patients / lay persons or practitioners.
A usability study can cause harm, and the IRB will review your protocol / material if you did all necessary precautions to prevent this harm.

If you do a study in Europe, the IRB oversight is less strict.
 

Marcelo

Inactive Registered Visitor
#4
Yes, if you plan to submit it to FDA, later on.

IRB (ethical commission) is required when human subjects are involved..
Do you have any source that clearly says that an IRB approval is required for HF studies for all FDA submissions? I know that for some studies it will be required, but not all, and the only information I can find is exactly stating this.
 

Tobias_HF

Involved In Discussions
#5
No, I don`t have this. Unfortunately FDA is pretty vague about this in their official statements...

But, the Association of American Psychologists is clearer on this. They traditionally dealt with HF studies, and I assume this is why FDA is following their approach (Frequently Asked Questions about Institutional Review Boards). As I understand, if you are a registered psychologist and do a study that involves humans, you have to get IRB review. No matter what the subject of the study is.

I think somewhere in the CFR 820 it states that you should follow local and federal laws & regulations, and of course HIIPA. The IRB review also makes sure that you do that, so this would be your "certificate" that you are not breaking any federal laws, when doing a HF study (which might happen way easier than one might think...).

Also, one point to consider: if you have a good protocol, IRB review is usually fast, and not that expensive. So I`d do it anyway, as a "quality check" for a subject matter, that neither me nor my colleagues are experts in...
 

Marcelo

Inactive Registered Visitor
#6
You are right that you need to perform any test/study under local law/regulations, but Associations usually do not prescribe regulations or anything unless a regulatory body says so So I'm not sure anything from Association of American Psychologists is mandatory (on a regulatory level). Also, the link you mentioned is only a FAQ on how an IRB works (so I'm not sure what you meant by " why FDA is following their approach").

This transcript of a FDA meeting about the last hum an factors guidance mentions:
The IRB question again is it depends on the studies and the study design. So that will be -- again that's a case-by-case decision as to whether or not your human factors study should be going through an IRB or not. So I don't have a direct answer to that. Again, I would suggest working with your reviewing division to identify if there is a need for that for your study type.
This guidance Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development mentions that usability studies for IDEs would require IRB, because they would be under the same light as a clinical investigation.

Even the Usability Testing of Medical Devices book has a chapter on this, but also mentions that it[s not clear a requirement 9although it suggests that a best practice would be to go after it).
 
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