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Posted by Larissa Singletary ·

Question about engagement in HSR during COVID-19

Hello!

I work for a local health department that is performing COVID-19 testing in our community. We send our specimens to a clinical diagnostic lab affiliated with an academic institution. Researchers at the academic institution would like to use the leftover specimens for COVID-19 research (specimens will be fully de-identified before research commences). In addition to obtaining IRB approval from their home institution, are they also required to receive approval from our local health department's IRB? Are we, the local health department, considered to be engaged in their human subjects research per the HHS definition of engagement in human subjects research, because we send our specimens to them for commercial testing? Any light you can shed on this matter would be incredibly helpful. Thank you!

Comments & Events

Joni Koenig Joni Koenig
Hi Larissa - No one is jumping at this, so let's figure it out together.  I would say, from what you've described so far, that your local health department is not engaged and your IRB does not need to review/approve the protocol.  My IRB has a policy that goes on to further interpret "engagement" and describes some activities that would be considered engagement and some that would not.  I don't know if yours does, but that can be helpful in situations like this.  

The researcher submitted it to their IRB and it is possible that their IRB determined the work to be not human subjects research (because not "human subjects" with no identification on or about specimen) or Research Exempt.  The risk is minimal if even any risk at all.  Unless your local health department is involved in some other aspect - other than just submitting the specimen for commercial testing and receiving those testing results, I don't think your local public health agency nor your IRB need to be involved.

Happy to consider further if there are more details.  Happy to open this up for other's input.  And happy to discuss 1:1 if you'd like.

Joni
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Navina Forsythe Navina Forsythe
Here is OHRP guidance on engagement that may help clarify: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html

That being said, your local IRB may have procedures that are more restrictive that require your IRB, so refer to them.

Additionally you may have statutory requirements for a specific IRB.  For example in our state some of our samples collected by our offices have statutory requirements to go through our agency IRB and it would not matter if we are engaged or not.  

Navina
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