Guide & Definitions
COST-FA1301 CephsInAction Survey
Prospective Severity Assessment of procedures in Cephalopods
Directive 2010/63/EU on the protection of animals used for scientific purposes, requires that a prospective assessment is made on the severity of each procedure in a Project (Article 15) and that a severity classification is assigned (i.e. “non-recovery”, “mild”, “moderate” or “severe”). Annex VIII of the Directive provides guidance on the factors to be taken into account in the assessment of prospective severity and gives some examples in each severity category, but these are based mainly on procedures in vertebrates.
As stated in the “National Competent Authorities for the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes – Working document on a severity assessment framework”, these measures provide opportunities to improve the quality of science and welfare through prospective review of project proposals and, by inclusion of the actual suffering experienced by the animal, should provide greater transparency and understanding of the impact of scientific procedures on animal welfare.
Specific guidance on severity assessment for cephalopods is lacking although is available for fish, based on a Norwegian Consensus-Platform for the 3Rs (norecopa) initiative (see Hawkins et al., 2011).
The primary aim of this COST Action FA1301 initiative is to derive an objectively-based prospective severity classification of procedures (within the meaning of Directive 2010/63/EU) for cephalopods which can be used to inform project applications to the National Competent Authorities.
All members of COST Action FA1301 are invited to participate in the survey to facilitate the development of cephalopod-specific severity assessment criteria.
The findings from the survey will contribute to enhancing the welfare of cephalopods in the laboratory and the application of the 3Rs. Information originated from this initiative will also help to to identify areas where we may need to provide resources to clarify issues (e.g. assessing “suffering” of a newly hatched cephalopod paralarva).
The PAS-C Survey
The Prospective Severity Assessment of procedures in Cephalopods survey comprises 50 mini-scenarios each giving a brief description of a procedure (see Guidance below) which you are asked to make an assessment about regarding:
a) whether it exceeds the threshold for regulation and;
b) if it does what the severity level is likely to be (prospective assessment) assuming it can be justified in any project application to the National Competent Authority.
The scenarios, although hypothetical are based upon procedures included in previously published works, including papers from more than 25 years ago; this does not necessarily means that they could be justified or would be authorized under Directive 2010/63/EU.
All the scenarios contain sufficient information to make an assessment, and the Guidance notes and Definitions of key technical terms provided here (derived from Directive Annex VIII) will help to identifying the main issues to consider in making the assessment.
Please read the Guidance notes before starting the Survey
You may also access to the Guidance notes while filling your responses
To identify the upper limits of the severity categories we have deliberately included examples of procedures which it may never be possible to justify, and inclusion should not be taken to indicate that COST-FA1301 or anyone associated with it considers such procedures acceptable.
All responses will be treated confidentially and at no stage will you be identified by name.
Information about individual Personal Profile is requested (see last pad of the Survey) since it is expected that the final study will compare various groups of respondents (e.g. senior vs junior researchers).
The results of the PAS-C survey will be presented at the November 2015 Annual Scientific meeting of the FA1301 COST Action in Lisbon (Portugal) and a summary of results will be posted on this website. A publication in a peer-reviewed journal is expected as final outcome.
CephsInAction Prospective Assessment of Severity Survey is a milestone of WG4 and is coordinated by the FA1301 PAS subgroup
Treat this survey as confidential and do not confer with others about your responses as we wish to know the independent views of as many participants as possible
How the PAS-C Survey works
To have access to the PAS-C survey you should be registered on the CephsInAction website and logged-in. As indicated, the responses you will give are confidential and there will be no connection between your login and the final result of the survey from each one of the responders.
At the PAS-C Survey page there are 10 pads (numbered 1 to 10) each containing five scenarios.
In each pad – corresponding to a block of five scenarios – it is always possible to look at Guidance and Definitions as an additional aid to facilitate the responses.
Each pad is independent and self-standing.
It is suggested to respond to all five scenarios included in each pad before proceeding to the next one (button next at the end of each pad-page).
When logging-out, the information you provided will be automatically saved and retrieved the next time you will log-in.
Resuming your own activities on the survey will always ask you to start-over (i.e. start from the scratch, deleting all previously provided responses) or to continue keeping data you already provided.
You can always revise and edit the responses you provided while logged-in
After completing the survey, please be sure that you have also provided information in the Personal Profile pad.
This Survey will end in three weeks time. No late submissions will be allowed.
No further editing and revision of the responses provided will be allowed after submission
The list of the 50 scenarios and their content is available as collated PDF.
Guidance notes on how to assess the prospective severity of a procedure
Notes and Definitions contained herein are derived from Directive 2010/63/EU (Annex VIII) and Severity Assessment Framework document.
The Directive emphasises that the severity assigned prospectively (i.e. the severity anticipated) to a particular procedure should be the “highest severity anticipated for any animal”; this emphasises the significance placed upon the experience of an individual animal rather than the “average” of a group.
A number of specific factors should be considered:
Nature of pain, suffering, distress or lasting harm (PSDLH) likely to be caused by (all elements of) the procedure, and its intensity, the duration, frequency and multiplicity of techniques involved.
Cumulative suffering within a procedure. This takes account of anything done to the animal within a procedure that may cause PSDLH; for example daily injection and stressful behavioural testing over a week in a procedure has a greater degree of potential cumulative suffering than if the animal was only exposed to these challenges once in a week.
Prevention from expressing natural behaviour including restrictions on the housing, husbandry and care standards (this includes food restriction and physical confinement).
Type of species and genotype (whenever applicable).
Maturity, gender and age (may not always be known for cephalopods) of the animal.
All species of cephalopod are covered by the Directive from the time of hatching (i.e. paralarvae and newly hatched cuttlefish are included).
For the purpose of this survey only, please assume the following general points about each scenario unless stated otherwise:
a. Catching. For all procedures you should assume that the animals were either caught from the wild by a competent person using the most humane method or were obtained from eggs either from the wild or from other captive animals.
b. Handling. Assume that all handling of animals is done by trained personnel using appropriate techniques
c. Acclimatisation to the laboratory. Unless indicated otherwise assume that in all cases that if an animal has been taken from the wild that the animal has become acclimatized to being housed in a laboratory aquarium before study.
d. General anaesthesia. Where general anaesthesia is mentioned assume that the most humane technique and appropriate anaesthetic agent has been used.
e. Post-operative recovery. Unless otherwise stated, where a surgical procedure has been performed you should assume that all possible measures have been taken to alleviate any post–operative pain.
f. Conduct of procedures. You should assume that all procedures (including ones involving surgery) are performed by appropriately qualified and trained personnel. Personnel will also be familiar with the any adverse effects of the procedure and predetermined humane end points.
g. Overall effects of the procedure. If the scenario mentions an effect of the procedure on the animal (e.g. reduced food intake) you should take this into account in your assessment. If no effect is mentioned you should assume that the procedure has no effect that requires consideration in making your assessment.
Definitions of severity levels
For each scenario you are asked to assign one of the following severity levels
The initial decision regarding any procedure is whether it reaches the threshold for regulation under the Directive. The threshold is” any procedure which may cause pain, suffering, distress or lasting harm equivalent to, or higher than that caused by the insertion of a hypodermic needle in accordance with good veterinary practice.” It should be noted that this covers both invasive and non-invasive procedures so studies involving behavioural interventions may reach this threshold. Furthermore, the EC Expert Working Group noted that “applying several such (below threshold) techniques in one animal may require the procedure to be classified as mild or higher” (EC 2009).
These are procedures “performed entirely under general anaesthesia from which the animal shall not recover”. Such studies fall within the Directive as the animal is subject to procedures while still alive and hence this differs from “humane killing” here as although general anaesthesia may be used, and the animal does not recover, nothing is done to the animal until death is confirmed.
These are procedures which are likely to cause the animals to experience “short- term mild pain, suffering or distress as well as procedures with no significant impairment of the well-being or general condition of the animals”.
These are procedures which are likely to cause the animals to experience “short- term moderate pain, suffering or distress as well as procedures that are likely to cause moderate impairment of the well-being or general condition of the animals”.
These are procedures which are likely to cause the animals to “severe pain, suffering or distress or long-lasting moderate pain, suffering or distress as well as procedures that are likely to cause severe impairment of the well-being or general condition of the animals”.
Although not specifically a severity level it is described as a level of severity greater than that described by the definition of “severe”. It is defined as a “procedure involving severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated.” Article 55 indicates that a Member State may allow such procedures under “exceptional and scientifically justifiable reasons”.
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