Key roles in which stakeholders can recognise their engagement with the OECD Test Guidelines Programme.
National Coordinator can identify regulatory needs and clarify the scientific background
Can offer financial support
Can introduce project(s) and seek support from other OECD member countries
Can nominate experts to be part of TG development and national delegation to OECD Working Parties
National Coordinator can prepare the project proposal (SPSF) in cooperation with their leading institutions
Submits SPSF to the Working Group of National Coordinators of the TGs programme (WNT) and leads discussions at WNT
Nominates experts for (Ad Hoc) Expert groups with the support of OECD secretariat
National Coordinator can support the development and writing of the OECD documents
National Coordinator submits the (draft) TG to the WNT for commenting and approval
Can support the experts during the commenting rounds
Leads the discussions at WNT
National Coordinator discusses the need for updating at WNT
The development or revision of an OECD Test Guideline (TG) or Guidance Document (GD) is typically led by an OECD Member country (including the European Commission) or countries adhering to the Mutual Acceptance of Data (MAD), represented by their National Coordinators (NCs) of the OECD Test Guidelines Programme (TGP).
The development of TGs is overseen by the Working Party of National Coordinators of the TGs programme (WNT) who decides on new projects to develop new or update existing TGs, and their inclusion in the work plan of the TGP. The standard project submission form (SPSF) for initiating a TG/GD project is submitted by the NC(s) to the WNT (with a strict deadline of November 15th) for decision during the annual WNT meeting in April. National Coordinators represent countries members of the OECD or adhere to the MAD. They nominate experts from research and regulatory areas to work together on developing tools and guidance. In addition, expertise and input are gathered from the Business and Industry Advisory Committee (BIAC), Environmental non-governmental organisations (i.e. the European Environmental Bureau (EEB)), and the International Council on Animal Protection (ICAPO).
Typically, the NCs will appoint experts to lead the TG development, both on a regulation as well as on a scientific level. See also Roles section on Project Lead Institution. For some developments, the NC might fulfil the role of policy lead on her/his own and if the project involves a minor change to an existing TG/GD then they will lead the majority of the activities. Vice versa, if you are interested in developing an OECD document for the TGP, the first step is to get in contact with your NC. The NC, together with the OECD secretariat, will support you with their expertise in the OECD process (Find more details in Pre-OECD phase). Therefore, good cooperation with your NC is vital for a successful OECD TG/GD development.
Typically a Test Guideline (TG) or Guidance Document (GD) project at OECD is led by an OECD Member country (including the European Commission) or countries adhering to MAD, represented by their National Coordinators (NCs) of the OECD Test Guidelines Programme (TGP) and supported by the OECD secretariat.
It is possible for projects to be co-led by a number of Member countries (MCs), in which case the project team may have members from various institutions from different MCs. Having projects led by more than one MC can be very useful in expanding the knowledge base and potential funding sources and generally improving resilience and is also a welcome indication of wide support.
OECD Member countries rely on OECD TGs in order to ensure reliable and relevant data for the safety assessment of chemicals and materials. Leading the revision or development of a TG/GD might be driven by the need to;
Lead institution can screen regulatory needs with the support of their national coordinator
Screens the scientific appropriateness of the proposed approach
Seeks for partners to contribute to the project/Find co-leader
Seeks for long-term financial support
Lead institution can clarify the aim of the project
Can draft the Standard Project Submission Form with the support of their National Coordinator
Can form the Ad Hoc Expert Group with the support of the OECD secretariat and its National Coordinator
Lead institution consults the expert group regularly
Organises intra and inter laboratories comparisons
Drafts the OECD documents with the support of their National Coordinator
Lead institution drafts the OECD documents and looks for support from experts
Can address the received comments with the support of its National Coordinator
Test Guideline (TG) or Guidance Document (GD) projects that form part of the OECD Test Guidelines Programme (TGP) are typically led at OECD by an OECDMember country (MC), the OECD secretariat or the European Commission. This is through the implication of the National Coordinator (NC), an EU representative or a secretariat member as described in the Roles section on Lead as Member country. If the project involves a minor change to an existing TG/GD then they will lead the majority of the activities, however, most OECD TG/GD projects will involve significant scientific input from key experts and as such most projects will also require the implication of a lead institution (or lead institutions). This institution could be a public research body, a university and/or other research institutions and will generally be responsible for leading and developing the standard operating procedure and working on the scientific background of the project, including leading intra- and inter-laboratory comparisons (ILCs).
It is also important to note that whilst the above reflects typical practice, this may vary with MC, and thus guidance should be sought from the NC to ensure the project lead institution(s) and lead team members have been identified and agreed in a way that is consistent with MC national requirements and practices.
The project lead or leads are identified in the Standard Project Submission Form (SPSF) and as such subject to agreement by the Working Party of National Coordinators of the TGs programme (WNT).
For successful development, Test Guideline (TG) or Guidance Document (GD) projects need input from both a scientific and policy/regulatory perspective and these need to be reflected in the project ‘team’ and the associated Ad Hoc Expert Group. Therefore, typically OECD projects are led by;
It is possible that projects could be co-led by other institutions and bodies, including representatives of the Business and Industry Advisory Committee (BIAC), or the International Council on Animal Protection (ICAPO). However, typically their involvement is through membership of the project team or the project Ad Hoc Expert Group or other less formal engagement (e.g. draft commenting and refinement).
It is possible for projects to be co-led by a number of Member countries (MCs), in which case the project team may have members from various institutions from different MCs. Having projects led by more than one MC can be very useful in expanding the knowledge base and potential funding sources and generally improving resilience and is also a welcome indication of wide support.
The lead(s) of a project will clearly require an understanding of the OECD TG/GD development process, the regulatory background and detailed expertise in the scientific area. It is likely that the individual(s) leading a TG/GD development will be at least a mid-career investigator with significant experience in scientific project management (i.e. Ability to work collaboratively with involved stakeholders and other experts). This is not a role for a recent post-doc.
Leading the development of an OECD Test Guideline (TG) or Guidance Document (GD) project requires a lot of time, expertise and project management skills, including diplomatic skills. A review of the experiences of project leaders highlighted that a successful TG/GD development is strongly linked to teamwork and support from the leading MC, in particular the NC, and the OECD secretariat.
The main reason for leading the development of an OECD TG/GD at the MC level is to take forward a regulatory priority of the MCs involved. Leading the corresponding WNT projects enables the leading MCs to close methodical gaps for regulatory risk assessment while tailoring the project to their needs and timescales. For the institutions and individuals involved in the project, there may be other benefits including:
Contribute to or provide SOP for a method
Review of available data
Contribute as an expert in the Ad Hoc Expert Group
Participate in inter-laboratory comparisons
Provide comments as an expert
Once projects enter the OECD by submission of a Standard Project Submission Form (SPSF), non-leading OECD Member countries (MCs) support or reject projects and can indicate if and how they are willing to contribute to the accepted project. An MC may only wish to provide comments on the document, either by involving the National Coordinator (NC) alone or the NC and experts. More extensive contributions may be provided by participating in expert meetings and may include practical co-drafting and/or validation work.
To validate their test method and standard operating procedure, lead institution(s) will organise the recruitment of laboratories for the inter-laboratory comparison (ILC), with the support of the OECD secretariat send out a request to participate to NCs and members of the relevant Expert Groups, and/or to Heads of Delegation in other OECD committees(e.g. (Working Party on Manufactured Nanomaterials), who will distribute the call to their networks. Interested parties can then directly contact the OECD Secretariat to manifest their intentions to contribute (ideally before the submission of the SPSF).
Stakeholders from various institutions can participate in the development of an OECD project, with specific roles depending on the stakeholder/institution groups. Nomination of such stakeholders is generally coordinated by the National Coordinators (NCs) of the OECD Member countries. NCs discuss in their country if and how they will participate. This generally depends on available expertise (e.g. at universities, research institutions, etc.) and resources. Similar nomination processes take place in representative bodies at OECD (e.g. Business and Industry Advisory Committee (BIAC) for industrial stakeholders, or the International Council on Animal Protection (ICAPO) for animal welfare non-governmental organisations).
Further details on roles and incentives for different stakeholders to participate in the OECD Test Guidelines Programme and the TG/GD revision/development are developed per institutions within the NanoHarmony OECD TG/GD Process Mentor tool.Institutions may get access to specific funding for developing standards and harmonised test methods (e.g. from European research projects, national funding, etc.).
Institutions can confirm/develop their analytical expertise during participation in validation (e.g. can open up to contract opportunities).
Participation can create new networks and opportunities (e.g. interaction with experts from various institutions and backgrounds).
For early career researchers participation can provide valuable experience to find a job in industry or risk assessment.
Participation may extend the exposure of scientific work: scientific papers are cited more if they are useful for regulators (e.g. for an OECD dossier)
Participation supports the production of regulatory usable science, i.e. your science will be used in a regulatory context.
Participation can ensure that the OECD TG/GD provides fit-for-purpose solutions for your country’s regulatory needs.
Participation will contribute to a safer and more sustainable world and a broader use of a test method.
Test method developers might have the opportunity to establish a company or spin-off and directly receive financial benefits.