appropriate for the type of engagement and include logistical or organisational tasks. Adequate sums (same as other project partners) calculated in person-months for the work of parent organisations, as well as reimbursements and honoraria for individual parents have to be factored in the budget planning from the very beginning. Yes No Did you receive financial support for your contribution to the research project? 1 28 2 european foundation for the care of newborn infants Powered by 16 If you were asked to participate in a research project in the future, when would you like to be involved? (multiple answers possible) 0 Other Dissemination of results Signalling that you as parent representatives approve the study Supporting patient recruitment for the research project/study Helping to obtain funding Defining a research question/ topic priorities 10 20 30 40 50 60 3. Summary and recommendations Research involving newborn infants should be meaningful for the individual child and families. Sharing of information and exchange of experience between researchers and families is essential and research should not happen in isolation from the families affected. Parent organisations as representatives of affected families are important bodies for fostering knowledge sharing and improved common understanding. They should be given a proactive role in research and be involved e.g. in identifying research questions, setting neonatal research agendas and research priorities or participating in the different phases of research projects. 2.8. Written Agreement In order to provide clarity on the roles, the degree of involvement as well as on expectations or the financial compensation for resources to be invested, a reliable and binding document is needed. If not in form of a consortium agreement, at least a letter of agreement as used in case of business projects should define and describe the elements of the collaboration (e.g. project objectives, parties involved, tasks, duties, project milestones and duration, confidentiality, transparency, data privacy, compensation, intellectual property, etc.). A comprehensive code of practice for a better guidance in the cooperation with various stakeholders in research or clinical trials (e.g. academics, industry) should be developed and endorsed by umbrella and national parent organisations. Number of answers european foundthe care of newPowered by 17 Being the proxy voice for the newborn, parents do not only have the moral right to be actively involved in research projects, they also bring invaluable expertise and first-hand insights that other stakeholders in a project might not see. Parent organisations as representatives of a larger group of families should be involved as partners throughout the entire research cycle, from planning, design or management to implementation. For optimal support by parent representatives, capacity building (e.g. training, mentoring) and financial support are as essential as the adherence to a set of principles such as equality, independency, or transparency. Special projects related to research communication, dialogues and reports in a non-specialised language would ease a better understanding not only by the parent representatives involved, but also by a broader range of stakeholders (e.g. policy, media, society) and should be promoted. There are already some best practice examples of patient involvement in other health topics, e.g. in HIV/ AIDS (the European Community Advisory Board) or oncology; there are platforms such as the PatientPartner project (supported by the EU, expired in 2011), the public-private partnership European Patients’ Academy on Therapeutic Innovation (www.eupati.eu), all stakeholders in the neonatal fields should learn from. These networks and platforms provide many valuable insights and tools for patient involvement in drug development and clinical trials. Some scientific stakeholders demonstrate the shift towards valuing and incorporating the patient perspective in their work: Regulatory bodies such as the Food and Drug Administration or European Medicines Agency are inviting patients to provide their perspective during decision-making. The exchange and active communication with patients is becoming one central part of their work. Some medical journals (e.g. the British Medical Journal) already include patients in peer review processes, they invite experts to coproduce articles together with patients or are open to patients publishing articles. „Research should not be a one way 'harvesting' of data from parents and children. Parents give their experience, their opinions, even their own child for research. The question 'What can we give them back?' should be asked. Research should also be meaningful for parents, so that parents feel cared for and engaged. The challenge is to find ways so that research is nourishing both researchers and parents.“ Yannic Verhaest, Chairwoman of Vlaamse Vereniging voor Ouders van Couveusekinderen (VVOC) „ european foundation for the care of newborn infants Powered by 18 „I am working in close collaboration with parent organisations in the area of follow-up after preterm birth. We see that especially these topics are of great value for parents and particularly those newly confronted with the situation of having a preterm infant want to know what they can do to help their baby.“ Prof Dr Dr Dieter Wolke, University of Warwick „ International and national research grants more and more demand an active involvement of patients in research projects, e.g. as joint grant holders or co-applicants. Medical conferences take steps to include patients in the planning and organisation. Patients participate as presenters and congress participants. The jENS congress (Congress of joint European Neonatal Societies) is one outstanding example for such congresses in Europe: Since its founding, the congress is collaborating with EFCNI and welcoming parent representatives in its audience. In newborn health, the paradigm shift has just started: Until recently, parent organisations have often been asked to be involved in research to represent the patient/family voice only once or