Roadmap for developing Codes of Practice

What is a CoP

A Code of Practice (CoP) is a document drafted by experts that defines the best way to interpret and implement the 3R principles. The document is thus inherently time-phased. A CoP is an important source of information for Animal Welfare Bodies (AWBs) (Instanties voor dierenwelzijn (IvD’s)), Animal Ethics Committees (AECs) Dierexperimenten commissies (DEC’s)), researchers and biotechnicians, and all other parties involved in laboratory animal research. As the document provides an expert-informed model of best practice in implementing the 3R principles, it necessarily includes obligations regarding laboratory animal research, at least with respect to issues of morality and legality. It is crucial to have a CoP that’s been drafted by experts, is up to date and is adhered to by everyone in the field.

Procedure

The NCad establishes CoPs in collaboration with the platform of AWB’s (IvD-platform) and in consultation with people in the field. The NCad coordinates the process with governmental partners, facilitates people in the field in their involvement and upholds standards during the drafting process. In addition, the NCad disseminates draft CoPs nationally and internationally. The content of the CoP is the responsibility of the field, represented by an expert working group. Ownership of the CoP is shared by the NCad and the platform of AWB’s (IvD-platform).

Phasing

The establishment of a CoP proceeds in 5 stages:

Define, Develop, Align, Publish and Monitor, and Evaluate. The process is circular and usually starts at the definition stage (i.e., ‘Define’), but it can also start at any other stage, for instance, stage 5, with the Evaluation of a pre-existing but outdated document. Steps are defined for each stage along with associated explanations and questions that can be answered within the stage. Checkpoints are provided between the stages. These allow for reflection on the progress made and provide opportunities to seek NCad approval.

Explore (step 1 of 8)

This is the preparatory phase for drafting a CoP. The central focus during this phase is exploring the usefulness of a CoP, its scope, subject and goal. Include as many stakeholders as possible in this phase, so as to reduce the likelihood of encountering unexpected resistance later in the process. Choose several methods to gather the necessary information, such as brainstorming or dialogue sessions, workshops, expert meetings, consultation rounds or surveys. Ensure that the following questions are answered to gather the most important information.

What is the reason? (step 2 of 8)

What is the reason for drafting a CoP? This could be a report by another organisation, a question from the field or from the minister, or indications that certain elements of an existing CoP are outdated.

Task: Briefly describe why a CoP is being drafted.

Who is involved? (step 3 of 8)

Which scientific fields will be impacted by this CoP? Which organisations will have to implement this CoP? Are there any international organisations working on the same topic? Are there any other NCs or any 3R centres that also want to be involved in this drafting initiative?

Task: Provide an overview listing the parties involved in drafting a CoP. Also, state the time of their involvement in the process and who has what responsibility.

What is the issue? (step 4 of 8)

What question do you want the CoP to answer? For example: No standard guidelines or protocol exist for caring for this animal during this procedure; practices vary from one institution to the next. A recent publication explored this issue, and this is not yet standard practice in the Netherlands. This element of an existing CoP is outdated, leading to confusion in real-world practice.

Task: Describe the substantive question or issue you seek to answer in the CoP.

What is the objective? (step 5 of 8)

What changes or differences are envisaged after the CoP has been issued?

Task: List the intended impact of the document being drafted.

Is a CoP the best means of achieving this? (step 6 of 8)

Is a CoP sufficient for achieving your intended objective? Why not an advisory document, opinion or news release, or some other means? Is there a need for a CoP in the field?

Task: Check whether the envisaged final product meets the expectations of a CoP.

What is already available on this topic? (step 7 of 8)

Has this topic previously been addressed by other organisations?

Task: Make an inventory of other documents that are already available and can be used.

Start drafting (step 8 of 8)

Drafting a CoP begins with organising the further process. The focus of this section lies in assembling the expert working group, detailing the involvement of other parties and determining the most suitable working methods.

Task: Roughly go through the entire process (phases 1 to 5) at least once, briefly focusing on each phase. This will eventually result in a process initiation document or plan of action.

Assemble expert working group (step 1 of 3)

The expert working group writes the CoP and is responsible for its content. A diverse group of experts can help improve the quality of a CoP. The following is a list of experts that are essential for a well-assembled working group.

• Facilitator/ Lead Author (1) assists and guides the working group in the process and ensures an open, respectful and informative discussion, enabling the working group to function optimally. The facilitator inspires confidence and commitment among participants.
• Experts from the domain of laboratory animal science (6) They write the CoP and represent the field.
• Behavioural scientist, veterinary specialist from outside the domain of laboratory animal science (1 or 2) They provide a “fresh perspective” and can offer a different view on the subject
• Supervisory authority representative, guidelines specialist (1) Has a discerning eye and is adept at writing a well-informed and well-structured CoP so that it can be used optimally by the supervisory authority representative, among others. This person may also be involved at a later stage, if necessary.
• Ethicist (1)
• Animal welfare organisation with relevant expertise (1)
• Drafting partners such as NCad, IvD-platform, etc. (1 or 2)

Task: Assemble a working group in which the various experts and roles are laid down.

Draft CoP (step 2 of 3)

Now that the composition of the working group has been established and information needed for drafting the CoP has been obtained, work can begin on writing a CoP. It is important to consider several aspects:

Join forces!
The working group is an inter-disciplinary collaborative team. You may wish to initiate the process with a kick-off meeting at which the parties involved make a joint start, get to know each other and learn what each can contribute to the CoP. Conduct discussions within the working group on an equal footing and include the entire working group in the process. Also, communicate what is discussed to interested external parties from time to time.

Make it easy to assess
A CoP should be a clear document. Be sure to describe in unambiguous terms the “desired behaviour” and distinguish this from “undesired behaviour”. Make formulations easy to assess. Indicate clearly whether the CoP is referring to target values, requirements or recommendations. Also, link a timeline or timetable to the target values. Finally: opt for a modular structure of the CoP, where appropriate and possible. This can facilitate updating the CoP in the future.

90% peer review (step 3 of 3)

Once the text is 90% finished, it is time to produce a first prototype CoP and gather feedback from the field for this prototype. This review aims to assess the level of support for the work of the expert working group among experts who are not directly involved. Parts of the CoP can also be reviewed earlier in the process, if required.

If the subject has significant impact, an expert consultation might be considered in which other experts are given the opportunity to respond to what the working group has prepared. Enter this consultation with targeted questions and a clear idea of what the impact of the consultation might be on the document as produced. Experts might also include people who will have to work with the CoP (animal carers, biotechnicians, researchers, etc.)

Task: Obtain feedback on the CoP from colleagues in the field to get a picture of the level of support for the CoP among experts who are not directly involved. And update the CoP to incorporate the results of their feedback.

Check 95%: Is the level of support for the CoP sufficient and is its quality up to standard?

Align

In this phase, it is important that the CoP is shared with various parties to seek their feedback. Here, too, clear guidance should be provided on the permissible feedback for the expert working group.

Task: Collect feedback on the CoP from various stakeholders. Be sure to involve the NCad, NVWA¹ and CCD² in this phase. For each party, consider the importance of the CoP for that party and what question is being presented.

¹ Supervisory authority on animal testing in the Netherlands
² Dutch central body that is authorized to grant project licences to conduct animal procedures

Check 100%: Is the CoP finished and publishable?

Publish (step 1 of 2)

In this phase, the CoP is published, utilising in any event the standard strategies established by the involved parties.
If little has previously been published on the subject or an international group of experts has worked on the CoP, publication in a scientific journal can also be considered.

Task: What strategies and channels are best suited to reaching the target audience?

Impact and process (step 2 of 2)

After the process is concluded, it is important to analyse its performance to facilitate future learning. The CoP is also monitored during this phase. How is it handled? Does it have the desired impact?
Check success: Is the impact sufficient? Does the CoP stand up to critical assessment?

Task: Collect feedback on the CoP from the field.

Revise

A CoP needs aftercare. While it is up to date at the time of publication, it might become obsolete over time. It is important to bear this in mind and assess once in a while whether it needs revising.

Task: When concluding the process, consider at what point it is necessary to assess whether revision is required. Do this at least every 3 years.