Ethical and legal aspects

NEOMUNE involves studies in healthy and sick infants. Such research has methodological and ethical limitations. Piglets and mice studies are used to gain information not possible from studies in infants. Data and biological samples are stored, distributed and analysed in many different countries that differ in cultural, clinical and scientific traditions. We work closely with industrial partners with commercial interests that support, but may also conflict with the interests of university and hospital partners.

The highly interdisciplinary and translational research in NEOMUNE creates ethical dilemmas that require careful decisions sensitive to the different cultural contexts of the scientists, parents, medical staff and industry partners. Many scientific aspects are already tightly regulated, exemplified by the required ethical approval to initiate studies in infants and animals, and the role of commercial partners in public research programs.

We encourage NEOMUNE researchers to have open discussions internally and with the public about ethical implications of research in the field. Discussions are facilitated by the inclusion of a separate work package that focusses on the ethical, social and cultural elements of translational research (WP 1.7).

NEOMUNE has no specific ethical views beyond current legislations but acknowledges some ethical dilemmas for the research field, e.g.:

  • Breast-feeding is considered optimal for mother and child, and improved formula composition must not discourage mothers that are able to breast-feed their child.
     
  • Infant studies must be designed to minimize the risk and discomfort and must balance this against potential benefits to these infants as well as to the infant population.
     
  • Animal studies must be designed to minimize pain and discomfort but a degree of discomfort for some individuals is difficult to avoid when animals act as a model for sick infants.
     
  • The care for compromised newborn infants and for experimental animals may be viewed differently in different countries and cultural contexts, precluding a universal ethical standard. 
     
  • While collaboration with industry is important for scientific, societal and financial reasons, it requires careful consideration related to possible bias and conflicts of interest.
  • Cultural and epistemological barriers may reduce translation of results between species (infants, animals), continents (Europe, US, Asia), and organisations (university, hospital, industries).