Belgian Council Laboratory Animal Science
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BCLAS Workshop Day for Ethical Committees – 31 May 2017 – Report

This Workshop (WS) Day was organized at the premises of the Faculty of Veterinary Medicine of Ghent University, in Merelbeke. In parallel, a WS Day was organized for the Animal Welfare Bodies (AWB).

During the morning session, the 61 participants representing 29 institutions were challenged by David Anderson, Anne-Dominique Degryse, Marthe Schmit and Anne Vermeylen to estimate the discomfort scores in a number of case studies. The examples chosen by these organizers often resulted in animated discussions. The enigma why Belgian discomfort scores are in general higher compared to those attributed in other EU countries is still not elucidated…

Before lunch break, Guy De Vroey, president of BCLAS, explained what BCLAS stands for, illustrated by several achievements, and made a call for volunteers to help with the organization of the yearly BCLAS symposium, the organization of workshops, training and communication and to strengthen the BCLAS board.

The afternoon session was divided in two sessions. For both sessions, the participants were divided in groups of 7-8 participants. These small groups were mixed, so that members of different Ethical Committees (ECs) could share their ideas, their way of working… and discuss the items proposed by the organizing committee.

During the first session, the participants were asked to select 2 to 3 topics out of 5 suggested groups of topics relating to the EC functioning. These 5 groups of topics were: (1) collaboration & communication with the Animal Welfare Bodies (AWBs), (2) tasks and responsibilities of the EC towards the license holder, (3) modus operandi of the EC, (4) membership of the EC and (5) pros and cons of a local EC versus a national/regional Competent Authority (CA).

During the wrap-up at the end of this first afternoon session, it was clear that there were many topics that were withheld by the different groups. The main (common) topics are described below:

(1) collaboration & communication with the Animal Welfare Bodies (AWBs)

Here, the main question was how an EC can keep an oversight of all projects after project authorization. Furthermore, a strong and low-threshold (communication) link between the EC and the AWB(s) was advocated.

(2) tasks and responsibilities of the EC towards the license holder

Some participants had difficulties identifying their license holder(s): for some ECs it is the lab director, for others the head of a larger research facility.
Regarding the policy of the license holder on what kind of animal research is non-accepted or non-acceptable and the role of the EC in this ethical dilemma, there was no consensus at all. Is it up to the EC to decide about what kind of animal research is acceptable or not acceptable? Out of the reactions it seemed that not many ECs had addressed this moral question, whether or not together with the license holder.

With increasing number of projects and the demand for more in-depth project evaluation, the license holders should provide extra resources (staff, money,…) for the ECs.

(3) modus operandi of the EC

There was a large consensus that the harm/benefit-analysis is not sufficiently addressed in the current ethical matrix, so there might be a risk that this analysis is not explicitly carried out by the EC.
Most participants also agree that the EC is able to evaluate the experimental design, but has not always the knowledge to assess the scientific value. To solve this, a solution could be to seek advice of an external expert. A more fundamental question is whether ECs should evaluate the scientific benefits or value of the research.  At least some EC (members) argue that this is not the task of the EC, but rather of funding organizations.

Meetings of ECs should not only discuss applications (or not even in the first place), but also animal welfare, culture of care, eventual problems, legislation, 3Rs…

If possible, unanimity about the evaluation of a submitted project is preferable. If it is unlikely or impossible to reach consensus, a majority is also defendable. In this case, it is recommendable that a (face to face) discussion with the researcher is organized and that the minority view is documented and communicated to the researcher.

 (4) membership of the EC

There was a large consensus that both initial training for new EC members and continuing education for senior EC members is necessary. The big challenge is who is going to organize these courses? Could it be like the continuous education for all animal users? Integrated in the doctoral schools of universities? Is a collaboration possible with similar initiatives within the EU? A centralized list of existing courses and a system to communicate about interesting educational initiatives (e.g. seminars, symposia…) and of relevant guidelines (e.g. ARRIVE, EU and FELASA documents) would be very beneficial.

In order to have all necessary competencies present within the EC and to guarantee the quality by sharing good practices and general knowledge, proposals were made to exchange presidents or members of ECs and to hire and remunerate external experts.

(5) pros and cons of a local EC versus a national/regional Competent Authority (CA)

Pros of a local EC Cons of a local EC
Timing – quick decisions. Risk of “EC-shopping”.
Long-lasting expertise in Belgium: ECs exist since many years.

Risk of conflict of interest and a relational dynamic in the same institution: everyone knows each other.

Sometimes anonymity is not guaranteed; this can create tensions between colleagues.

National/Regional Competent Authorities might not have enough resources to do the ethical review properly. Not easy to harmonize. Standardization is less since the inspectors are no longer member by law.
Allow close discussions with researchers and a very close follow-up of/feedback on the projects. Still a lot of progress possible in the “culture of care”.
Not all ECs have all necessary resources (time, money, personnel) to fulfill all tasks.
Lacks “helicopter view”.

 

A national/regional Competent Authority should not replace the local ECs: the procedure for amendments and deviations will take too long.

Standardization of the ethical review procedure could be realized by membership of inspectors, by writing guidelines or SOPs and by creating a platform for ECs, where evaluation and authorization criteria and other relevant information can be shared.

Many participants believe the resources for local ECs should be increased.

After a refreshment break, Henriëtte Griffioen, animal welfare officer of the Academical Medical Centre of the University of Amsterdam and secretary of the Dutch Association of Animal Ethics Committees (Nederlandse Vereniging van DierExperimentenCommissies – NVDEC), presented this Dutch Association. Her presentation is sent as attachment.
Three books with essays about the ethical review procedure, alternatives to animal experimentation and the ethics of animal experiments are published by the NVDEC and can be downloaded from their website: http://www.nvdec.nl/styled-3/ (left margin).

During the refreshment break, the organizing committee listed the most frequently mentioned topics to be discussed in more depth during the second afternoon session. The goal of this second session was to try to formulate recommendations.

Topics selected to be addressed were:

  • Modus operandi of the EC
    • Harm benefit analysis
    • Necessity of unanimity
    • Necessity of discussion amongst members

What is your recommendation? What needs further/broader discussion?

  • Membership of the EC
    • Remuneration
    • Good external members
    • Exchange of experiences
    • Competencies/continuing education

What is your recommendation? What needs further/broader discussion?

  • Pros & Cons of a local EC vs. a regional/national Competent Authority
    • What is your recommendation? (e.g. platform, broader committees, general bylaws)

According to one group ECs need more training in harm/benefit analysis. A second group suggested that ECs should include experts in different models to better evaluate the possible scientific benefits. Another approach could be the re-organization of ECs by fields of expertise. A third group stated that it is often difficult to predict benefits and that a list of questions could facilitate this analysis. A fourth group had the opinion that the harm/benefit analysis should not explicitly be included in the form: they fear that the researcher might overemphasize the benefits to convince the EC. They made also the remark whether it should be the task of a scientist to convince the EC members?

Most participants found that unanimity in the decision is not necessary, but that this must be stipulated in the internal rules of the EC. One group was convinced that unanimous consent of all members of the Committee is required. Another group proposed to foresee a possibility to appeal to a higher authority when a project proposal is rejected.

A real discussion (face to face or by TeleConference) between the EC members is considered to be preferable; one group found it a real necessity when one of the members has a different opinion.
The frequency of face to face meetings differs a lot between the ECs; two meetings per year is considered to be a minimum. During these meetings, not only project proposals should be discussed, but also other topics related to animal use/welfare (e.g. legislation, 3Rs, etc…).

Several topics about the membership were addressed during this second session. Remuneration of members is considered an appropriate means to attract experts and to tackle the problem of finding competent external members while reducing the difference in quality between ECs. For the latter problem, a database of potential external certified members, managed by the EC Platform or by the respective regional authorities, could also be a valuable contribution. A possible risk of remuneration is the loss of independency and the creation of a financial dependency when the fees are too high; the compensation of (travel) expenses as a minimum and an upper limit of remuneration are proposed.
A limitation of the membership duration of the same EC was evaluated as an interesting idea, but this measure could exacerbate the problem of finding competent (external) members.

An intervision rotation system between ECs could stimulate the exchange of good practices and reduce the difference in evaluation of projects and the estimation of discomfort scores (something that became obvious during the morning session). Necessary arrangements must be made to guarantee confidentiality.

Initial training and Continuous Professional Development (CPD) are considered to be highly recommendable, but some groups were reluctant to make this obligatory. The training of ‘proefleider/maître d’ expérience’ (FELASA Cat. C) was not deemed enough as initial training. Topics could be: ways of working and internal rules, legislation, harm/benefit analysis. This initial training could be organized by the doctoral schools of the universities, as interuniversity course, in collaboration with the EC Platform.
For CPD, a database or communication system of the courses organized in Belgium should be developed.

The last topic that was addressed were the pros and cons of a local EC compared to a regional/national Competent Authority (CA). The table with these pros and cons can be found above. The EC members present deemed it necessary that a kind of control of harmonization is established. The fact that inspectors are no longer member of all ECs by law is perceived as a serious loss: the inspector could be a gatekeeper and facilitate the level playing field between all ECs.

Kris Meurrens ended this WS Day by summarizing the key messages and learnings. A poll by raise of hands indicated that there is need for a platform of ECs.  BCLAS is well positioned to take this initiative across all animal users (private, public and academia) in the 3 regions.

A written summary of the two sessions will be drafted and distributed, together with some reference documents and literature, to the participants.  Volunteers will be invited to kick-off this platform and to prioritize the objectives and tasks for the platform.

We received a limited number of completed feedback forms. The main conclusions are that a large majority appreciated the possibility of interaction during this WS Day, although the time was felt as restricted. Nearly all responding participants are in favour of establishing an EC Platform. The most cited tasks for this EC Platform are providing education & training and guidelines (e.g. Q&As) and enhancing the interaction between ECs to uniformize and harmonize the way of working by sharing best practices.

The organizing committee: Annie Delaunois, Katleen Hermans, Kris Meurrens & Filip Mulkens

Additional information

  1. Links to:
    1. the three publications/books of the NVDEC: http://www.nvdec.nl/styled-3/ (in the left margin: Reeks Dierproeven, Deel 1, 2 & 3)
    2. most relevant EU Guidance Documents Project Evaluation and Retrospective Assessment
  2. PREPARE guidelines (https://norecopa.no/PREPARE)
    1. guidelines for planning animal research & testing_August 2017
    2. Norecopa PREPARE Guidelines checklist
  3. ARRIVE guidelines
    1. Improving Bioscience Research Reporting_The ARRIVE Guidelines for Reporting Animal Research
    2. NC3Rs ARRIVE Guidelines Checklist_fillable
  4. Workshop presentations
    1. 170531 The Dutch Society of Animal Ethics Committees_BCLAS Short version
    2. BCLAS WS Day ECs & AWBs - Intro 1st Session ECs - 20170531
  5. FELASA papers on harm-benefit analysis
    1. HBA Part 1
    2. HBA Part 2