General Discussions

Hi All,

Would anyone using Animal Oversight be willing to share how you deal with procedures at a core facility in terms of how they're described on protocols?  We have a small shared equipment facility for imaging (not quite a core), which does non-invasive in vivo imaging.  We are trying to develop a new process for how PIs with existing AO/IACUC protocols can add the imaging procedures to their studies.  They would pick an appropriate time in their study timeline to transfer animals to the facility, have them imaged by an expert, then transfer them back to the animal facility to resume the original study.

Two potential models we've come up with for how to handle this are:

1. Have all participating PIs add standard language for the imaging non-surgical procedures, drugs, use location, personnel, etc. to their original study protocols.  This would be done as a comprehensive amendment for each protocol.  (The standard language could be submitted to the IACUC as a stand-alone protocol by the imaging facility in advance, to get approval, but all relevant language would have to be added to the individual protocols of anyone having imaging done.)
2. Have the imaging facility submit a stand-alone protocol for all the available imaging procedures.  Any participating PIs who are interested in having their animals imaged would transfer animals to the imaging protocol and then have the animals transferred back to their original protocol afterwards.  They would still need to submit an amendment to add the transfer to their study timeline.  The stand-alone protocol would have to use general enough language to cover multiple strains, personnel, etc.

Each model has pros and cons, and we can't find much in the way of references to support or rule out either.  Do you all use one or the other, or some other model entirely?  Any advice would be appreciated.  Thanks.

------------------------------
Caitlyn Conley
Administrative Support
Oakland University
------------------------------

Hi All,

Would anyone using Animal Oversight be willing to share how you deal with procedures at a core facility in terms of how they're described on protocols?  We have a small shared equipment facility for imaging (not quite a core), which does non-invasive in vivo imaging.  We are trying to develop a new process for how PIs with existing AO/IACUC protocols can add the imaging procedures to their studies.  They would pick an appropriate time in their study timeline to transfer animals to the facility, have them imaged by an expert, then transfer them back to the animal facility to resume the original study.

Two potential models we've come up with for how to handle this are:

1. Have all participating PIs add standard language for the imaging non-surgical procedures, drugs, use location, personnel, etc. to their original study protocols.  This would be done as a comprehensive amendment for each protocol.  (The standard language could be submitted to the IACUC as a stand-alone protocol by the imaging facility in advance, to get approval, but all relevant language would have to be added to the individual protocols of anyone having imaging done.)
2. Have the imaging facility submit a stand-alone protocol for all the available imaging procedures.  Any participating PIs who are interested in having their animals imaged would transfer animals to the imaging protocol and then have the animals transferred back to their original protocol afterwards.  They would still need to submit an amendment to add the transfer to their study timeline.  The stand-alone protocol would have to use general enough language to cover multiple strains, personnel, etc.

Each model has pros and cons, and we can't find much in the way of references to support or rule out either.  Do you all use one or the other, or some other model entirely?  Any advice would be appreciated.  Thanks.

------------------------------
Caitlyn Conley
Administrative Support
Oakland University
------------------------------

Hi Caitlyn,

I'd advise against the first option, since if the imaging core's processes need to change, that means a bunch of protocols will need to be updated to avoid noncompliance.  I'd also advise against the second option, since that's a lot of transfer transactions to complete.  I'd advise what we do, which is a variation on the second option that seems to work pretty well.

The core prepares a protocol that describes the procedures they perform on behalf of other research protocols. They will add some animals of their own for optimization efforts (or if they don't plan to do any, they at least need to include one animal...).  The research protocols that want to take advantage of the core services will include that intention, and indicate at what point in the experiments it will happen.  When it does happen, the animals are NOT transferred to the core protocol; they remain affiliated with the original protocol, but get a sticker/special card of some kind on their cages to make the relationship clear while it's in effect.  We prepared an IACUC policy to explain the process.

I hope that helps--and sorry for not noticing and responding to your query sooner!

Cheers,

Cheryl 

Hi All,

Would anyone using Animal Oversight be willing to share how you deal with procedures at a core facility in terms of how they're described on protocols?  We have a small shared equipment facility for imaging (not quite a core), which does non-invasive in vivo imaging.  We are trying to develop a new process for how PIs with existing AO/IACUC protocols can add the imaging procedures to their studies.  They would pick an appropriate time in their study timeline to transfer animals to the facility, have them imaged by an expert, then transfer them back to the animal facility to resume the original study.

Two potential models we've come up with for how to handle this are:

1. Have all participating PIs add standard language for the imaging non-surgical procedures, drugs, use location, personnel, etc. to their original study protocols.  This would be done as a comprehensive amendment for each protocol.  (The standard language could be submitted to the IACUC as a stand-alone protocol by the imaging facility in advance, to get approval, but all relevant language would have to be added to the individual protocols of anyone having imaging done.)
2. Have the imaging facility submit a stand-alone protocol for all the available imaging procedures.  Any participating PIs who are interested in having their animals imaged would transfer animals to the imaging protocol and then have the animals transferred back to their original protocol afterwards.  They would still need to submit an amendment to add the transfer to their study timeline.  The stand-alone protocol would have to use general enough language to cover multiple strains, personnel, etc.

Each model has pros and cons, and we can't find much in the way of references to support or rule out either.  Do you all use one or the other, or some other model entirely?  Any advice would be appreciated.  Thanks.

------------------------------
Caitlyn Conley
Administrative Support
Oakland University
------------------------------

Hi All,

Would anyone using Animal Oversight be willing to share how you deal with procedures at a core facility in terms of how they're described on protocols?  We have a small shared equipment facility for imaging (not quite a core), which does non-invasive in vivo imaging.  We are trying to develop a new process for how PIs with existing AO/IACUC protocols can add the imaging procedures to their studies.  They would pick an appropriate time in their study timeline to transfer animals to the facility, have them imaged by an expert, then transfer them back to the animal facility to resume the original study.

Two potential models we've come up with for how to handle this are:

1. Have all participating PIs add standard language for the imaging non-surgical procedures, drugs, use location, personnel, etc. to their original study protocols.  This would be done as a comprehensive amendment for each protocol.  (The standard language could be submitted to the IACUC as a stand-alone protocol by the imaging facility in advance, to get approval, but all relevant language would have to be added to the individual protocols of anyone having imaging done.)
2. Have the imaging facility submit a stand-alone protocol for all the available imaging procedures.  Any participating PIs who are interested in having their animals imaged would transfer animals to the imaging protocol and then have the animals transferred back to their original protocol afterwards.  They would still need to submit an amendment to add the transfer to their study timeline.  The stand-alone protocol would have to use general enough language to cover multiple strains, personnel, etc.

Each model has pros and cons, and we can't find much in the way of references to support or rule out either.  Do you all use one or the other, or some other model entirely?  Any advice would be appreciated.  Thanks.

------------------------------
Caitlyn Conley
Administrative Support
Oakland University
------------------------------

Hi Caity,

We follow more of what you have described in #2.  UK has core protocols for MRI, Behavior (2), X-ray Irradiation, Metabolism, Cryopreservation, and Multiphoton imaging (2).  We tried the route of the Cores making up SOPs and distributing them to PIs to incorporate into their own IACUCs and it just became too much.  Like Cheryl said, if the Core SOP changed then 20 protocols could need amending.  Instituting Core protocols really has reduced the burden on PIs who want to use these services.   As long as the research protocol follows the Core protocol approved procedures, the research protocol only has to do the following: 

1. List the IACUC Protocol Number of the Core
2. Specific test(s) requested
3. Number of animals that will undergo the core procedures (sex, strain, ages, etc.)
4. Timeline/frequency for each test
5. Scientific rationale/justification for the tests
6. Possible adverse consequences to the animals
7. Special housing, food, or health issues
8. An attached completed core service request form (behavioral)

If the researcher deviates from the Core procedures, that needs to be explained in detail in the methods; otherwise all other details are kept on the Core.    We don't actually "transfer" the animals in the Cayuse system between protocols for the Cores because it would be very difficult to do.  I couldn't imagine the back and forth traffic the DLAR office would have to deal with, as our Cores are pretty busy, especially the two behavioral ones.  Each Core keeps records of users and animals used on the Core, and reports numbers yearly to the IACUC office.  Each Core protocol outlines/details the responsibilities of the Core group and the PI using the Core.  

Hope this helps.

Rebecca

1<o:p></o:p>

Hi All,

Would anyone using Animal Oversight be willing to share how you deal with procedures at a core facility in terms of how they're described on protocols?  We have a small shared equipment facility for imaging (not quite a core), which does non-invasive in vivo imaging.  We are trying to develop a new process for how PIs with existing AO/IACUC protocols can add the imaging procedures to their studies.  They would pick an appropriate time in their study timeline to transfer animals to the facility, have them imaged by an expert, then transfer them back to the animal facility to resume the original study.

Two potential models we've come up with for how to handle this are:

1. Have all participating PIs add standard language for the imaging non-surgical procedures, drugs, use location, personnel, etc. to their original study protocols.  This would be done as a comprehensive amendment for each protocol.  (The standard language could be submitted to the IACUC as a stand-alone protocol by the imaging facility in advance, to get approval, but all relevant language would have to be added to the individual protocols of anyone having imaging done.)
2. Have the imaging facility submit a stand-alone protocol for all the available imaging procedures.  Any participating PIs who are interested in having their animals imaged would transfer animals to the imaging protocol and then have the animals transferred back to their original protocol afterwards.  They would still need to submit an amendment to add the transfer to their study timeline.  The stand-alone protocol would have to use general enough language to cover multiple strains, personnel, etc.

Each model has pros and cons, and we can't find much in the way of references to support or rule out either.  Do you all use one or the other, or some other model entirely?  Any advice would be appreciated.  Thanks.

------------------------------
Caitlyn Conley
Administrative Support
Oakland University
------------------------------

Hi Caity,

We follow more of what you have described in #2.  UK has core protocols for MRI, Behavior (2), X-ray Irradiation, Metabolism, Cryopreservation, and Multiphoton imaging (2).  We tried the route of the Cores making up SOPs and distributing them to PIs to incorporate into their own IACUCs and it just became too much.  Like Cheryl said, if the Core SOP changed then 20 protocols could need amending.  Instituting Core protocols really has reduced the burden on PIs who want to use these services.   As long as the research protocol follows the Core protocol approved procedures, the research protocol only has to do the following: 

1. List the IACUC Protocol Number of the Core
2. Specific test(s) requested
3. Number of animals that will undergo the core procedures (sex, strain, ages, etc.)
4. Timeline/frequency for each test
5. Scientific rationale/justification for the tests
6. Possible adverse consequences to the animals
7. Special housing, food, or health issues
8. An attached completed core service request form (behavioral)

If the researcher deviates from the Core procedures, that needs to be explained in detail in the methods; otherwise all other details are kept on the Core.    We don't actually "transfer" the animals in the Cayuse system between protocols for the Cores because it would be very difficult to do.  I couldn't imagine the back and forth traffic the DLAR office would have to deal with, as our Cores are pretty busy, especially the two behavioral ones.  Each Core keeps records of users and animals used on the Core, and reports numbers yearly to the IACUC office.  Each Core protocol outlines/details the responsibilities of the Core group and the PI using the Core.  

Hope this helps.

Rebecca

1<o:p></o:p>

Hi All,

Would anyone using Animal Oversight be willing to share how you deal with procedures at a core facility in terms of how they're described on protocols?  We have a small shared equipment facility for imaging (not quite a core), which does non-invasive in vivo imaging.  We are trying to develop a new process for how PIs with existing AO/IACUC protocols can add the imaging procedures to their studies.  They would pick an appropriate time in their study timeline to transfer animals to the facility, have them imaged by an expert, then transfer them back to the animal facility to resume the original study.

Two potential models we've come up with for how to handle this are:

1. Have all participating PIs add standard language for the imaging non-surgical procedures, drugs, use location, personnel, etc. to their original study protocols.  This would be done as a comprehensive amendment for each protocol.  (The standard language could be submitted to the IACUC as a stand-alone protocol by the imaging facility in advance, to get approval, but all relevant language would have to be added to the individual protocols of anyone having imaging done.)
2. Have the imaging facility submit a stand-alone protocol for all the available imaging procedures.  Any participating PIs who are interested in having their animals imaged would transfer animals to the imaging protocol and then have the animals transferred back to their original protocol afterwards.  They would still need to submit an amendment to add the transfer to their study timeline.  The stand-alone protocol would have to use general enough language to cover multiple strains, personnel, etc.

Each model has pros and cons, and we can't find much in the way of references to support or rule out either.  Do you all use one or the other, or some other model entirely?  Any advice would be appreciated.  Thanks.

------------------------------
Caitlyn Conley
Administrative Support
Oakland University
------------------------------