IACUC Exemption

Samuel, Lee (CDC/OID/NCEZID)
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Mayfield, Kristin (CDC/OD/OADS)
Tuesday, February 23, 2016 10:27 AM
Artus, Aileen A. (CDC/OID/NCEZID) (CTR)
Schafer, Ilana J. (CDC/OID/NCEZID)
RE: PR canine lepto study

Yes! Sorry, I was out of town. She is fine with it not needing an IACUC protocol
From: Artus, Aileen A. (CDC/OID/NCEZID) (CTR)
Sent: Tuesday, February 23, 2016 9:20 AM
To: Mayfield, Kristin (CDC/OD/OADS)
Cc: Schafer, Ilana J. (CDC/OID/NCEZID)
Subject: RE: PR canine lepto study
Hi Kristin,
Have you been able to talk to Linda about our canine lepto project in Puerto Rico? You mentioned during the meeting
that it is exempt but that you would talk it over with Linda.
Thanks!
Aileen
From: Mayfield, Kristin (CDC/OD/OADS)
Sent: Tuesday, February 09, 2016 7:50 AM
To: Artus, Aileen A. (CDC/OID/NCEZID) (CTR)
Cc: Schafer, Ilana J. (CDC/OID/NCEZID) ; Pimentel, Linda Capewell (CDC/OD/OADS) ;
Salzer, Johanna S. (CDC/OID/NCEZID)
Subject: RE: PR canine lepto study
Great, see you then
From: Artus, Aileen A. (CDC/OID/NCEZID) (CTR)
Sent: Monday, February 08, 2016 3:53 PM
To: Mayfield, Kristin (CDC/OD/OADS)
Cc: Schafer, Ilana J. (CDC/OID/NCEZID) ; Pimentel, Linda Capewell (CDC/OD/OADS) ;
Salzer, Johanna S. (CDC/OID/NCEZID)
Subject: RE: PR canine lepto study
Thanks! We’re also in cubeland but I’ve reserved 11101A (Bldg 24) for us at 12 PM.
Talk to you soon!
From: Mayfield, Kristin (CDC/OD/OADS)
Sent: Monday, February 08, 2016 3:08 PM
To: Artus, Aileen A. (CDC/OID/NCEZID) (CTR)
Cc: Schafer, Ilana J. (CDC/OID/NCEZID) ; Pimentel, Linda Capewell (CDC/OD/OADS) ;
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Salzer, Johanna S. (CDC/OID/NCEZID)
Subject: RE: PR canine lepto study
I should be able to meet at noon, I could also come to your area if anyone has an office? I am in cubeland so hard to talk
to several people ☺
From: Artus, Aileen A. (CDC/OID/NCEZID) (CTR)
Sent: Monday, February 08, 2016 2:03 PM
To: Mayfield, Kristin (CDC/OD/OADS)
Cc: Schafer, Ilana J. (CDC/OID/NCEZID) ; Pimentel, Linda Capewell (CDC/OD/OADS) ;
Salzer, Johanna S. (CDC/OID/NCEZID)
Subject: RE: PR canine lepto study
Hi Kristin,
Would it be possible to meet with you for a quick chat about our protocol on Wednesday (2/10)? If you have some time
between 10am -12pm, we can come to your office.
Thanks,
Aileen
From: Mayfield, Kristin (CDC/OD/OADS)
Sent: Thursday, February 04, 2016 12:54 PM
To: Artus, Aileen A. (CDC/OID/NCEZID) (CTR)
Cc: Schafer, Ilana J. (CDC/OID/NCEZID) ; Pimentel, Linda Capewell (CDC/OD/OADS)
Subject: RE: PR canine lepto study
Unfortunately for canines there is not much of an expedited review as it has to go to full committee. Our next meeting
is March 7th, if you can get it in for that meeting you should be able to get approval with a couple of weeks after (unless
the committee any strong objections). I have added you to topaz and Ilana already has access
(http://topazenterprise.cdc.gov/) . You will sign in using your CDC user name and password. Just go to create original
protocol and select the field study form and start filling out ☺
After you are satisfied with the form, send a PDF to an ARB veterinarian for consult, they are listed on our site under
steps to protocol submission http://intranet.cdc.gov/od/oads/osi/acupo/protocol/ there is also other helpful
information there. Once the vet approves, you will need to presubmit the protocol to the branch and division designees
listed in the protocol and the vet that did the consult, I am also attaching instructions for this. Once they sign off you can
submit to my office for IACUC review. Let me know if you have any questions or if you would like me to come to your
office for more help.
-Kristin

From: Artus, Aileen A. (CDC/OID/NCEZID) (CTR)
Sent: Thursday, February 04, 2016 12:38 PM
To: Mayfield, Kristin (CDC/OD/OADS)
Cc: Schafer, Ilana J. (CDC/OID/NCEZID) ; Pimentel, Linda Capewell (CDC/OD/OADS)
Subject: RE: PR canine lepto study
Hi Linda, thanks for the timely response and for your input.
Hi Kristin,

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Unfortunately, we are in a tight timeframe at the moment because the test kits for the project have already been sent to
Puerto Rico and will be expiring in August, 2016. These were sent by Marta a few months ago so we are hoping to have
the clinics and shelters start testing as soon as possible.
Given this, what would you suggest? Does IACUC have expedited protocol reviews? What paperwork needs to be
completed? Do you have resource materials we can access to help guide us with the IACUC process?
If we did not change the protocol from what Marta had originally intended, would we be fine with proceeding forward
under IACUC exemption?
If you would like to discuss further, feel free to give me a call at 404-639-3474.
Thanks,
Aileen
From: Pimentel, Linda Capewell (CDC/OD/OADS)
Sent: Thursday, February 04, 2016 12:07 PM
To: Artus, Aileen A. (CDC/OID/NCEZID) (CTR) ; Schafer, Ilana J. (CDC/OID/NCEZID)
Cc: Mayfield, Kristin (CDC/OD/OADS)
Subject: RE: PR canine lepto study
Hi Aileen and Ilana,
Thanks for keeping us posted on the updates. Unfortunately, since CDC is now guiding the testing and you will have to
take additional samples, you will need a protocol for this activity. Kristin Mayfield is our IACUC administrator and can
assist you with setting up a protocol. Please contact her as soon as you can to get started as protocols can take
approximately 3 months or longer from start to finish to get approved.
Please let Kristin or I know if you have any additional questions. We are always here to help you.
Best, Linda
Linda Capewell Pimentel, VMD, MPH, DACVPM
LCDR, U.S. Public Health Service
Acting Chief, Animal Care and Use Program Office
Office of Scientific Integrity | Office of the Associate Director for Science
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS D-73, Atlanta, GA 30333
Tel: 404-639-7992; BB: 404-884-9412
Telework Fridays

From: Artus, Aileen A. (CDC/OID/NCEZID) (CTR)
Sent: Thursday, February 04, 2016 10:43 AM
To: Pimentel, Linda Capewell (CDC/OD/OADS) ; Mayfield, Kristin (CDC/OD/OADS)
Cc: Schafer, Ilana J. (CDC/OID/NCEZID)
Subject: PR canine lepto study
Hi Linda and Kristin,
Marta Guerra was working on setting up a project on canine leptospirosis in Puerto Rico. The project is as follows:

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Dogs suspect for leptospirosis will be tested with an in-house rapid test. The lepto test for canines in this project will be
used to guide treatment. There are currently no laboratories in PR that perform canine testing for leptospirosis. We will
be collecting clinical information from the veterinarian, and medical and exposure history from the owners. Blood and
urine for diagnostic purposes will be collected from a live dog. If the dog is euthanized, we will be collecting samples
from the kidney.
Unfortunately, Marta has moved to a new position in Togo in West Africa. Ilana Schafer (copied) and myself will be
taking over the project.
Based on previous emails, the study protocol was considered exempt from IACUC review since the intent is to treat the
animal and use the test to guide treatment. We have been reviewing the protocol and have considered adding a
recommendation to retest the dog after ~3-5 days if the initial test was negative and the dog had only been
symptomatic for <4 days when sample was collected (antibodies detected by the test may have not yet developed), and
if no other underlying cause of disease has been found. A retest would entail collecting additional samples from the dog.
The intent is still to treat as we are testing again to ensure that it is not a false negative.
With these changes, I want to verify with you that our protocol would still fall under exempt.
Marta discussed this project with you a while ago, so if there is someone else I should reach out to regarding IACUC
guidance, please let me know.
Thank you!
Aileen Artus, MPH
ORISE Fellow
Bacterial Special Pathogens Branch
Division of High-Consequence Pathogens and Pathology
Centers for Disease Control and Prevention
Phone: 404.639.3474 | Fax: 404.471.8642
Email: [email protected]
Telework: Tuesday

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