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Ethical review of every animal study
All animal experiments carried out at Novo Nordisk, or on our behalf by external contractors requires review and approval by our internal Ethics Review Council (ERC). The council has reviewed animal applications for internal studies since 2002 and all protocols for external studies since 2006.
75% of our animal studies are performed in-house
Novo Nordisk performs approximately 75% of our animal studies at our own research facilities presently only in Denmark. Before any of these studies are undertaken an application for the specific animal studies must be sent to the Ministry of Justice for legal and ethical approval. In addition, our internal Ethics Review Council (ERC) reviews and approves these applications before they are sent to the authorities.
25% of our animal studies are performed by external contractors
Novo Nordisk has established an assessment and monitoring procedure to ensure global animal welfare standards for all animals used in-house and ex-house. Animal studies planned to be performed by contractors are described in study protocols. They must all be reviewed and approved by our Ethics Review Council (ERC) before these animal studies can be initiated.
The impact on ethical standards has been very visible; information on ethical concerns is spread widely in the Novo Nordisk organisation, and the council and the scientists are having a closer dialogue than everLars Friis Mikkelsen, chair of Novo Nordisk Ethics Review Council (ERC)
There is no legal requirement in Denmark for an internal ethics review council. It was established as our way of making sure, that any animal study performed by or on behalf of Novo Nordisk is carefully reviewed from an ethical perspective and integration of the principles of the 3Rs (Reduce, Refine and Replace).
How our review works
The Ethics Review Council (ERC) has the means to challenge and change or even reject the study protocols or the application whenever ethical concerns about the animals' welfare and use arise.
The ethics review process is focusing on the following issues: 1) Adherence to Danish and European legislation presently setting the highest ethical standards globally, 2) Adherence to Novo Nordisk Bioethics Policy, 3) The principles of the 3Rs, and 4) Cost/benefit analyses of the experiment in question as well as assessments of humane end points and pain and distress to the animals. This includes justification of the choice of animal model, the number of animals required to test the given hypothesis and the study design.
The council meets monthly and the members of the council represent both academic and technical experts as well as lay people to ensure that the animals' welfare is taken into broad consideration.
There is no legal requirement for an internal ethics review council in Denmark. It was established as our way of making sure, that any animal study performed by or on behalf of Novo Nordisk is carefully reviewed from an ethical perspective and in accordance with the principles of the 3Rs (Reduce, Refine and Replace).
Sometimes ethical considerations increase cost
Conclusions from these global standardised animal welfare monitoring and decision points from the Ethics Review Council (ERC) do sometimes increase cost. We believe that this economical downside is more than outweighed by the value of the bilateral exchange of experience and better practices, more reliable scientific results, broader public acceptance and always, of paramount importance, improved animal welfare.
