General Discussions

Looking for some ideas on how to collect personnel assurance signatures on the animal oversight protocol form.  This would be similar to the PI's assurance "signature".

Maybe another question is; Do you require assurance signatures from personnel listed on the protocol?

Thanks much!

------------------------------
Amy Cooper
IACUC Administrator
Buck Institute
------------------------------

Amy,

Several comments here.

I assume that what you want to do here is have every named individual attest that s/he has read and understands what is in the protocol.

As you know, only the PI can submit the protocol in AO for handling and review.  The notion of routing a protocol through a team doesn't exist (that I know of).  Thereby, the PI is taking the responsibility for assuring "knowledge and awareness" of all personnel on that team.

Incidentally, I believe most institutions assign this responsibility to the PI as the overseer of the protocol and its execution.  That does shift the burden away from the IACUC having to do what you want to be done with AO.  Signatures are not a regulatory requirement.

Still, when I implemented AO, there was an existing form for 'upper' approval to conduct the research that was collected on a paper form and a desire to continue the process.  Thus, I wrote/built what is shown in the image.  That indicates a form (electronic of paper) to complete by the PI who also uploads it into AO.  AO does have a nice feature to accumulate many files for various purposes like this.

I think what you could do is create a personnel assurance form (posted on your IACUC website) for the research staff to download and sign as needed.  Many would sign it with the original submission.  One or more would sign with each personnel addition through an amendment.  All forms would be uploaded as "attached files" and collected in AO.  And note the utility of the Description column to write in "Suzy's assurance form" or equivalent.

Do you think this would work for you?

Bruce


------------------------------
Bruce Kennedy
IACUC administrator
University of California, Santa Cruz
------------------------------

Original Message:
Sent: 07-18-2022 10:17
From: Amy Cooper
Subject: Animal Oversight Signatures

Looking for some ideas on how to collect personnel assurance signatures on the animal oversight protocol form.  This would be similar to the PI's assurance "signature".

Maybe another question is; Do you require assurance signatures from personnel listed on the protocol?

Thanks much!

------------------------------
Amy Cooper
IACUC Administrator
Buck Institute
------------------------------

Great solution, Bruce!
c:

------------------------------
Cheryl Cheney, CPIA
IACUC Coordinator/Compliance Specialist
Biogen
Cambridge, MA
------------------------------

Original Message:
Sent: 07-19-2022 07:23
From: Bruce Kennedy
Subject: Animal Oversight Signatures

Amy,

Several comments here.

I assume that what you want to do here is have every named individual attest that s/he has read and understands what is in the protocol.

As you know, only the PI can submit the protocol in AO for handling and review.  The notion of routing a protocol through a team doesn't exist (that I know of).  Thereby, the PI is taking the responsibility for assuring "knowledge and awareness" of all personnel on that team.

Incidentally, I believe most institutions assign this responsibility to the PI as the overseer of the protocol and its execution.  That does shift the burden away from the IACUC having to do what you want to be done with AO.  Signatures are not a regulatory requirement.

Still, when I implemented AO, there was an existing form for 'upper' approval to conduct the research that was collected on a paper form and a desire to continue the process.  Thus, I wrote/built what is shown in the image.  That indicates a form (electronic of paper) to complete by the PI who also uploads it into AO.  AO does have a nice feature to accumulate many files for various purposes like this.

I think what you could do is create a personnel assurance form (posted on your IACUC website) for the research staff to download and sign as needed.  Many would sign it with the original submission.  One or more would sign with each personnel addition through an amendment.  All forms would be uploaded as "attached files" and collected in AO.  And note the utility of the Description column to write in "Suzy's assurance form" or equivalent.

Do you think this would work for you?

Bruce

------------------------------
Bruce Kennedy
IACUC administrator
University of California, Santa Cruz

Original Message:
Sent: 07-18-2022 10:17
From: Amy Cooper
Subject: Animal Oversight Signatures

Looking for some ideas on how to collect personnel assurance signatures on the animal oversight protocol form.  This would be similar to the PI's assurance "signature".

Maybe another question is; Do you require assurance signatures from personnel listed on the protocol?

Thanks much!

------------------------------
Amy Cooper
IACUC Administrator
Buck Institute
------------------------------

Hi Amy,

We don't require protocol-specific assurance signatures--and I'm not sure how you could set this up in the Animal Oversight form.

We have a document we call the "Commitment to Humane Animal Use and Care", which includes a bullet-point list of basic expectations for animal users, inclusive of abiding by relevant approved protocols, which we require all animal users to e-sign via our in-house, online learning system.  Prior to uploading it as a "learning module", we used to obtain hand-written signatures on paper copies.

I'm sorry I don't have a simpler solution to offer you!

Cheers,
Cheryl

------------------------------
Cheryl Cheney, CPIA
IACUC Coordinator/Compliance Specialist
Biogen
Cambridge, MA
------------------------------

Original Message:
Sent: 07-18-2022 10:17
From: Amy Cooper
Subject: Animal Oversight Signatures

Looking for some ideas on how to collect personnel assurance signatures on the animal oversight protocol form.  This would be similar to the PI's assurance "signature".

Maybe another question is; Do you require assurance signatures from personnel listed on the protocol?

Thanks much!

------------------------------
Amy Cooper
IACUC Administrator
Buck Institute
------------------------------

Cheryl's approach (thank you!) is similar in concept to mine, but outside of AO.  So as not to encumber the protocol process and files, I feel training documentation - the details - should be part of an LMS.  Yes, a link that Suzy did training on salamander identification from the LMS documentation (and Cayuse has been working on that) that populates into AO is much desired!!

Bruce

------------------------------
Bruce Kennedy
IACUC administrator
University of California, Santa Cruz
------------------------------

Original Message:
Sent: 07-19-2022 07:22
From: Cheryl Cheney
Subject: Animal Oversight Signatures

Hi Amy,

We don't require protocol-specific assurance signatures--and I'm not sure how you could set this up in the Animal Oversight form.

We have a document we call the "Commitment to Humane Animal Use and Care", which includes a bullet-point list of basic expectations for animal users, inclusive of abiding by relevant approved protocols, which we require all animal users to e-sign via our in-house, online learning system.  Prior to uploading it as a "learning module", we used to obtain hand-written signatures on paper copies.

I'm sorry I don't have a simpler solution to offer you!

Cheers,
Cheryl

------------------------------
Cheryl Cheney, CPIA
IACUC Coordinator/Compliance Specialist
Biogen
Cambridge, MA

Original Message:
Sent: 07-18-2022 10:17
From: Amy Cooper
Subject: Animal Oversight Signatures

Looking for some ideas on how to collect personnel assurance signatures on the animal oversight protocol form.  This would be similar to the PI's assurance "signature".

Maybe another question is; Do you require assurance signatures from personnel listed on the protocol?

Thanks much!

------------------------------
Amy Cooper
IACUC Administrator
Buck Institute
------------------------------

These are great ideas, than you all!

------------------------------
Amy Cooper
IACUC Administrator
Buck Institute
------------------------------

Original Message:
Sent: 07-19-2022 07:33
From: Bruce Kennedy
Subject: Animal Oversight Signatures

Cheryl's approach (thank you!) is similar in concept to mine, but outside of AO.  So as not to encumber the protocol process and files, I feel training documentation - the details - should be part of an LMS.  Yes, a link that Suzy did training on salamander identification from the LMS documentation (and Cayuse has been working on that) that populates into AO is much desired!!

Bruce

------------------------------
Bruce Kennedy
IACUC administrator
University of California, Santa Cruz

Original Message:
Sent: 07-19-2022 07:22
From: Cheryl Cheney
Subject: Animal Oversight Signatures

Hi Amy,

We don't require protocol-specific assurance signatures--and I'm not sure how you could set this up in the Animal Oversight form.

We have a document we call the "Commitment to Humane Animal Use and Care", which includes a bullet-point list of basic expectations for animal users, inclusive of abiding by relevant approved protocols, which we require all animal users to e-sign via our in-house, online learning system.  Prior to uploading it as a "learning module", we used to obtain hand-written signatures on paper copies.

I'm sorry I don't have a simpler solution to offer you!

Cheers,
Cheryl

------------------------------
Cheryl Cheney, CPIA
IACUC Coordinator/Compliance Specialist
Biogen
Cambridge, MA

Original Message:
Sent: 07-18-2022 10:17
From: Amy Cooper
Subject: Animal Oversight Signatures

Looking for some ideas on how to collect personnel assurance signatures on the animal oversight protocol form.  This would be similar to the PI's assurance "signature".

Maybe another question is; Do you require assurance signatures from personnel listed on the protocol?

Thanks much!

------------------------------
Amy Cooper
IACUC Administrator
Buck Institute
------------------------------

Similar to Bruce's recommendation - We just have the PI attestation statement located on the Submit Protocol page.

Once the protocol is approved, we schedule a pre-Study meeting which involves all animal-users on the protocol, husbandry staff where the animals are to be housed, Research Services team who manage the colony, and the Veterinary care staff who cover the area where the animals are to be housed. They review the Study design, Biohazards (if any), Substances involved, Drugs involved, potential adverse conditions that could arise,  and endpoint criteria. IACUC Coordinator is also present as the facilitator and to confirm compliance via attendance/involvement. 

------------------------------
Evins Wardlaw
Systems Analyst of Bioresources
St. Jude Children's Research Hospital
------------------------------

Original Message:
Sent: 07-19-2022 13:52
From: Amy Cooper
Subject: Animal Oversight Signatures

These are great ideas, than you all!

------------------------------
Amy Cooper
IACUC Administrator
Buck Institute

Original Message:
Sent: 07-19-2022 07:33
From: Bruce Kennedy
Subject: Animal Oversight Signatures

Cheryl's approach (thank you!) is similar in concept to mine, but outside of AO.  So as not to encumber the protocol process and files, I feel training documentation - the details - should be part of an LMS.  Yes, a link that Suzy did training on salamander identification from the LMS documentation (and Cayuse has been working on that) that populates into AO is much desired!!

Bruce

------------------------------
Bruce Kennedy
IACUC administrator
University of California, Santa Cruz

Original Message:
Sent: 07-19-2022 07:22
From: Cheryl Cheney
Subject: Animal Oversight Signatures

Hi Amy,

We don't require protocol-specific assurance signatures--and I'm not sure how you could set this up in the Animal Oversight form.

We have a document we call the "Commitment to Humane Animal Use and Care", which includes a bullet-point list of basic expectations for animal users, inclusive of abiding by relevant approved protocols, which we require all animal users to e-sign via our in-house, online learning system.  Prior to uploading it as a "learning module", we used to obtain hand-written signatures on paper copies.

I'm sorry I don't have a simpler solution to offer you!

Cheers,
Cheryl

------------------------------
Cheryl Cheney, CPIA
IACUC Coordinator/Compliance Specialist
Biogen
Cambridge, MA

Original Message:
Sent: 07-18-2022 10:17
From: Amy Cooper
Subject: Animal Oversight Signatures

Looking for some ideas on how to collect personnel assurance signatures on the animal oversight protocol form.  This would be similar to the PI's assurance "signature".

Maybe another question is; Do you require assurance signatures from personnel listed on the protocol?

Thanks much!

------------------------------
Amy Cooper
IACUC Administrator
Buck Institute
------------------------------