My point was that if it is not a research project then it comes under FDA and state regulation of medical labs.

Peter Zavon
Penfield, NY

PZAVON**At_Symbol_Here**Rochester.rr.com

From: ACS Division of Chemical Health and Safety <DCHAS-L**At_Symbol_Here**PRINCETON.EDU> On Behalf Of Margaret Rakas
Sent: Friday, May 8, 2020 7:29 AM
To: DCHAS-L**At_Symbol_Here**PRINCETON.EDU
Subject: Re: [DCHAS-L] Covid Testing and Universities

Peter- you're absolutely right that an IRB wouldn't be required to be involved if it weren't a research project. And many businesses would not have qualms about proceeding down this path, with an HR review by some and not by others.

I was thinking of a university setting, where again an IRB review wouldn't be a regulatory requirement but I believe most colleges and universities would feel a strong need for some type of ethics review. Sloppy phrasing on my part..

Margaret

Sent from my iPhone

On May 8, 2020, at 5:28 AM, "pzavon**At_Symbol_Here**rochester.rr.com" <pzavon**At_Symbol_Here**rochester.rr.com wrote:

=EF=BB=BF

It is not a research project if you are using the results to guide your administrative actions.

I would also point out that, although we think it likely, and hope, that having antibodies indicates at least temporary immunity, that has yet to be shown to be the case and there are a few cases that may suggest otherwise.

Peter Zavon, CIH
Penfield, NY

PZAVON**At_Symbol_Here**Rochester.rr.com

From: ACS Division of Chemical Health and Safety <DCHAS-L**At_Symbol_Here**PRINCETON.EDU> On Behalf Of Yaritza Brinker
Sent: Thursday, May 7, 2020 3:42 PM
To: DCHAS-L**At_Symbol_Here**PRINCETON.EDU
Subject: Re: [DCHAS-L] Covid Testing and Universities

The question is more around the lines of what if you just tested your staff only as a "research study". Can you do it without going thru the certification hoops necessary to test the general public?

This article talks about 1/3 of test subjects testing positive for antibodies in Massachusetts. The random screening of 200 was done on the street. That's a lot of people that are immune and no-longer contagious (it takes 3+wks post recovery to build enough antibodies to be detectable in the test).

https://www.bostonglobe.com/2020/04/17/business/nearly-third-200-blood-samples-taken-chelsea-show-exposure-coronavirus/

Thank you,

Yaritza Brinker

260.827.5402

From: ACS Division of Chemical Health and Safety <DCHAS-L**At_Symbol_Here**PRINCETON.EDU> On Behalf Of Jeffrey Lewin
Sent: Thursday, May 7, 2020 2:28 PM
To: DCHAS-L**At_Symbol_Here**PRINCETON.EDU
Subject: Re: [DCHAS-L] Covid Testing and Universities

** External Email **

Yaritza,

We've done just that

https://www.mtu.edu/news/stories/2020/april/michigan-tech-opens-covid19-testing-lab.html

Just be prepared for the time and effort - it took 20 some staff, many grad students trained to perform the procedures, a board-certified pathologist to lead the group, a CLIA application, working through an FDA Emergency Use Authorization, tying up two laboratories, and a host of other management issues. Well worth it, but it takes work to start a testing lab from scratch. If you are seriously interested in starting one, message me privately and I'll put you in touch with the people that got it up and running.

Jeff

On Thu, May 7, 2020 at 1:05 PM Yaritza Brinker <YBrinker**At_Symbol_Here**fele.com> wrote:

Here's a thought provoking question-

Although research laboratories are not approved health laboratories, many do have the facilities to provide accurate testing. So, the question is- would it be okay for universities to test their employees and paid student staff in order to guide decision about resuming activities on campus. And could you extend testing to students enrolled in courses that require face-to-face interaction such as labs.

Of course, you'd have to have a health care professional collect the samples. "Test subjects" would have to voluntarily agree. Etc-

Thank you,

Yaritza Brinker

260.827.5402

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