1. Purpose of the Member's Charter
The purpose of this Charter is to describe the purpose, aims, structure and organization of the CONFIRM Initiative; the rights, obligations and expectations of the network members; and interactions between registered members, or between members and governing bodies of the network.
2. Purpose and aims of The CONFIRM Initiative
The acronym CONFIRM stands for COllaborative Network For Immunological safety Research in Minipigs. This collaborative network was set up to welcome and gather individual researchers or representatives of academic institutions and private organizations willing to investigate and promote the value of the minipig as a non-rodent species for the immunological safety evaluation of human pharmaceuticals.
The general purpose of the CONFIRM Initiative is: (i) to serve as a trigger for immunological safety research in Göttingen Minipigs; (ii) to assist and synergize fundamental, translational and regulatory investigative efforts relevant to immunological safety evaluation in Göttingen Minipigs; (iii) to spread current knowledge and new findings to the scientific and regulatory toxicology community.
Four objectives have been included in the initial 4-year timeline:
1. Publication of a white paper, the aim of which is to describe the CONFIRM Initiative and context regarding: (i) current knowledge and gaps on the immune system and immuno-pathophysiological processes in the minipig; (ii) available immunotoxicity data in minipigs; (iii) anticipated contribution of minipigs to the practice of immunological safety evaluation; (iv) introduction of the CONFIRM initiative to the scientific and regulatory toxicology community.
2. Creation and administration of a web-hosted database. The CONFIRM Initiative will create and administer web-pages hosted by the Ellegaard Göttingen Minipigs website. The main item of these web-pages will be a database providing validated information on minipig immunological safety assessment, including the appropriateness or not of given laboratory reagents and assays, the results of in vitro or in vivo studies, and any other relevant information. Information provided by any registered member will be kept confidential at his/her request through password-protected access.
3. Contribution to a better understanding of immunopathological processes in minipigs. The CONFIRM Initiative is expected to trigger or facilitate any relevant action considered to be relevant to extrapolate immunotoxicity assessment to humans. This is deemed to include oral or poster presentations to scientific congresses, especially Minipig Research Forums, as well as original and review papers.
4. Coordination of interlaboratory immunotoxicity studies in minipigs. The CONFIRM Initiative is intended to help standardize study plans, and validate results of studies with relevant panels of positive and negative reference compounds. One major goal is to contribute to study designs and strategies to be recommended for (regulatory) immunological safety evaluation in minipigs.
3. Structure and organization of The CONFIRM Initiative
The role of the Steering Committee is to select, stimulate and coordinate activities in accordance with the CONFIRM Initiative purpose and aims. The active assistance of dedicated working groups consisting of registered members is unambiguously welcome. The daily follow-up and logistics of the network are assumed by a 3-member Executive Committee including the chairman and the secretary of the Steering Committee.
Members of the network can be registered only after submission of a filled application form downloaded from the CONFIRM Initiative webpage, and then evaluation of the application by a membership review subcommittee. Every 2 years after formal acceptance, any membership is reassessed by the subcommittee to ensure registered members did follow the rules of the Members' charter, particularly active contribution to at least one CONFIRM project/program.
At least once a year, registered members gather in a General Assembly that is usually convened immediately before or after the Minipig Research Forum. Teleconferencing is organized to ensure that every member that wishes to participate can do so, even if not physically present.
Registered members are expected to:
Registered members of the CONFIRM initiative can expect to:
• Steering and Executive Committees: governing bodies of the CONFIRM Initiative
Members of the Steering Committee are accountable to registered members, especially during general assemblies. Their general duties are: to act with loyalty and in good faith in the best interests of the CONFIRM Initiative, not to misuse their position or information, and to avoid conflicts of interest, and to exercise their duty of care, skill and diligence.
The Executive Committee consisting of 3 members of the Steering Committee oversees the daily follow-up and logistics of the network activities. Their accountability is clearly in full agreement with any other member of the Steering Committee.
• Registered members
Registered members are accountable for their own actions and as such, should take responsibility for ensuring they always operate within the rules of the Members’ Charter.
6. Application of this Charter
To join the CONFIRM Initiative as a fully and officially registered member, every applicant must agree in writing to be bound by this Charter.