| TO: |
Researchers Who Use Animals |
| FROM: |
Dr. R. Adamec, Chair, Institutional Animal Care Committee (IACC) |
| SUBJECT: |
CONTENTS OF PROTOCOLS CONSIDERED BY THE IACC |
I am writing to investigators who use animals in research for two reasons. The first reason is to suggest ways in which investigators may expedite the processing of their research protocols. The second reason is to clarify a possible misconception about protocol review.
The kind of detail the committee needs are in the following areas:
| I. |
Lay summary:
We require a one paragraph summary of your proposed work in the protocol which is accessible to a non-scientific audience. This should include background and significance of the work and a general overview of what you are doing. We will send back protocols with overly complicated lay summaries. If you have written press releases for granting agencies, this will give you an example of how to write the kind of lay summary we would like to see. |
| II. |
Details the committee looks for in protocols: |
| |
| a. |
aim of the experiment, in other words, why are you doing it? |
| b. |
identification of all agents administered to animals including doses, route of administration; |
| c. |
dosages should be justified; |
| d. |
if agents are given repeatedly, the rate and number of repetitions should be specified; |
| e. |
the rate and number of repetitions of any procedure on an individual animal should be specified; |
| f. |
the numbers of animals in different experiments should be clearly identified, this is especially useful when an overall large number of animals is requested. If available, power analysis or other sources of information justifying the numbers of animals used is helpful, especially if the numbers per group are large. |
| g. |
details of surgical procedures, including pre surgical preparation and post operative care, and a statement of credentials of those performing the surgery. |
|
| III. |
Endpoints:
Often experiments involve endpoints, such as oncological studies of tumour growth. Death as an endpoint should be avoided, and if necessary requires strong justification. The Canadian Council on Animal Care (CCAC) has new guidelines on endpoints, and these are available from Animal Care Services. These should be consulted if your protocol has an endpoint paradigm. The committee wishes to see detailed in the protocol the following: a standard operating procedure (SOP) for dealing with endpoints; details of procedures for measuring the status of animals and by whom and how often; a statement of criteria used to make the decision to terminate the experiment on a given animal; interventions provided to minimize stress and pain within the boundaries of the experimental requirements. |
This is an update of the list. I expect that this list may have to be updated again. When that becomes necessary, I will write again on this matter.
Remember that there are individuals from diverse disciplines as well as non-scientists on the IACC. It is of use, therefore, to include a brief (one page maximum) introduction describing the nature of the work, its significance, and any relevant progress in your laboratory. If you feel this is too burdensome, then ensure that the IACC representative from your constituency is able to speak to general questions regarding your work in both scientifically sophisticated and lay terms.
These suggestions are meant to help you in expediting the review of your research protocols. I hope you will seriously consider them, especially if you have encountered delays in obtaining approval of research protocols in the past.
| IV. |
Misconception:
The misconception I wish to clarify is that the IACC rereads expired protocols which come up again for renewal. We do not do this because of the very large number of protocols considered at meetings. To read old protocols would increase this number unmanageably. Therefore, while it is appropriate to refer to past protocols which have been approved by the IACC, each protocol submitted for renewal should be complete in all the required detail. It should stand on its own. |
Finally, I should point out that prior approval of a research procedure does not guarantee indefinite reapproval. The reason for this is that CCAC standards are not static, but are periodically updated. A procedure considered acceptable in the past may be considered less acceptable in the future. The IACC does not wish to undermine research which has relied on such procedures for some time. Each case will be considered individually, and where possible a compromise solution will be sought. Investigators will be encouraged to defend the use of their procedures, and the committee will seriously consider their input. Nevertheless, it may be necessary to terminate procedures if to continue them is a clear violation of the CCAC guidelines.
Should you wish to comment on this memo, I would be happy to hear from you.
| |
Sincerely and with best wishes,
Dr. Robert Adamec
University Research Professor
Chair, IACC |
|
