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Human Factor Assessment for IRB (Institutional Review Board) Approval?

K

knspann

#1
Hello,
I have a question about Human Factor Assessments. The company I work for is relatively new; we are currently working on the CE Mark approval.
A human assessment study is currently taking place in-house for calibrating the medical device.
Do these types of studies need an IRB approval? Would the company be the sponsor and the investigator? We do not currently have an MD on staff.
Thanks for all the responses--let me know if more information is needed. I will disclose what I can.
Sincerely.
 
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Stijloor

Staff member
Super Moderator
#2
Re: Human Factor Assessment for IRB approval?

Can someone with this type of expertise help?

Thank you very much!!

Stijloor.
 

yodon

Staff member
Super Moderator
#3
Re: Human Factor Assessment for IRB approval?

Well, I was a bit hesitant to reply but since no one has jumped in maybe I'll at least start the discussion. This is not my area of expertise so I'm only speaking on what I've seen.

I presume the HF study is not a case where they are using the device on patients. If that's the case, I haven't ever seen that as part of an IRB and so I think it would be outside the scope.

I typically see HF assessments as just part of product validation.

Hopefully this starts the ball rolling.
 
K

knspann

#4
Re: Human Factor Assessment for IRB approval?

I have a more detailed question about this to our IRB. I will post their reply when I get it.
Thanks to you for your explanation.
 
K

knspann

#5
Re: Human Factor Assessment for IRB approval?

Hello,
To answer my own question, all Human Assessment Factor trials should be reviewed by the IRB that include human subject testing. We are currently applying for a Request for Exemption Determination because no devices will be used in this trial. The IRB will ultimately make any and all decisions related to clinical trials that have human subjects.
Just thought I would let everyone know. Thanks for the attempts! And Happy Halloween. :thanks:
Sincerely.
 
D

domche

#6
Re: Human Factor Assessment for IRB approval?

Your Human Factor Assessment study is not a straight use of your device, as defined in its registration with authorities. It is "A human assessment study" "taking place in-house for calibrating the medical device".

Therefore, it should fulfill all development requirements of a clinical investigation (CIP, ICF, investigator, IRB, etc), as defined in the ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice.

It must follow the World Medical Association Declaration of Helsinki, to which all doctors must abide.

The IRB will assess the protocol (CIP), the potential risks to participants, the suitability of the site and investigator, and all other ethical aspects.
 
K

knspann

#7
Thank you very much for the information.
We were denied the exemption and the Human Factors Assessment must go through the WIRB.
Your assessment is correct.
Best,
K
 
D

domche

#8
Thanks for your reply.
As an advice for these challenging tasks for writing a protocol (CIP), an informed consent, for becoming a clinical sponsor, for identifying a qualified and experienced investigator, please refer to
> ISO 14155 (2011 version, though you are probably based in the US and you could use an earlier version)
> Declaration of Helsinki (google these words)
> Visit your IRB website

You might also refer to ICH Good Clinical Practice Guidelines e6 (google again) and look for the [B]www.ich.org[/B] website. In the ICH website, select Work Products tab, then ICH guidelines, followed by E Efficacy guidelines, and finally the item Good Clinical Practice E6. It applies to the drug envelopment - not medical devices, but it gives information about IRB/IEC.

Your work is more than the calibration process; it's all the little add-ons that make a clinical investigation. It can be done!

Dominique

PS: apologies for not giving you the links, but the forum does accept them (till I have sent 5 messages)
 
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