Cardiothoracic Surgery at The Children’s Hospital of Philadelphia C Feudtner, Pediatric Generalist Research Group, Division of General Pediatrics, The Children’s Hospital of Philadelphia and the University of Pennsylvania Competing interests: none declared REFERENCES 1 Singhal N, et al. Parents’ perceptions of research with newborns. J Perinat 2002;22:57–63. 2 Mason S. Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet 2000;356:2045–51. 3 Mason S. Obtaining informed consent for neonatal randomised controlled trials: ‘‘an elaborate ritual’’? Arch Dis Child Fetal Neonatal Ed 1997;76:F143–5. 4 Stenson BJ, Becher JC, McIntosh N. Neonatal research: the parental perspective. Arch Dis Child Fetal Neonatal Ed 2004;89:F321–4. 5 Snowdon C, Elbourne DR, Garcia J. Perinatal pathology in the context of a clinical trial: attitudes of bereaved parents. 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Factors that influence parents’ assessments of the risks and benefits of research involving their children. Pediatrics 2004;113:727–32. 12 Zupancic JA, Gillie P, Streiner DL, et al. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics 1997;99:E6. 13 Schmidt B, Gillie P, Caco C, et al. Do sick newborn infants benefit from parti Introduction Historically and culturally, research has been performed on patients instead of with patients: Scientists used to determine and set-up their projects according to their ideas and areas of interest, with focus on scientific relevance rather than on the patient`s perspective or the real needs of patients. The different stakeholders worked separately rather than collaboratively. For various reasons, the focus of clinical research has started to shift towards a patient-centred approach, aiming for the provision of the best individualised healthcare for each patient. Working collaboratively, with the patient as the focus, is a necessary component to improve targeting in the development of new medicines and processes/pathways, with benefit for both the individual patient and the society. In neonatal research, the patient’s perspective is represented by the parents. Researchers may lack insight into the needs of the family, or the real-life/day-to-day challenges parents are facing, particularly following the emotionally traumatic experience of a preterm birth. Expert knowledge differs from the experience of someone living with a health condition, receiving a treatment, or using a service. The shift in research paradigms and research culture from scientific expert-driven projects that consider patients as “source of data” towards science-patient partnerships with patients as true collaborators is still an on-going process, which will move away from the label “research for society” to “research with society”. „In the past, research used to be on patients and not with patients which makes a big difference for people who are personally affected. Questions that might be scientifically interesting may not always meet the patients’ true and practical needs; it is therefore very important to involve them as equal partners as early as possible in research.“ Nicole Thiele, Vice Chair of the EFCNI Executive Board „ european foundthe care of newPowered by 5 Definitions Parents The term “parents” in the context of this paper refers to Individual parents: Parents (guardians) whose child was born preterm, with an illness or suffers from a birth complication and requires hospitalisation in the neonatal period. Parent representatives/Representatives of parent organisations: Persons who are mandated to represent and express views of parents in the field of preterm or ill born neonates. In the following, we are referring particularly to parents/persons as members of parent organisations, who are involved in research projects as (selected) representatives to reflect the point of view of a large group of affected families. Parent representatives in research projects Parents are parents; their first approach to research - also as representatives in research projects - will always be based on emotions rather than on data. Finding parent representatives capable and suitable to join research projects remains a big challenge for researchers. Parent representatives participating in (international) research delivery and governance are required to commit widely to the following: Investing time and resources Longitudinal motivation Sound knowledge of English Willingness to learn the academic and medical jargon and aspects of research Technical knowledge in research and development (R&D), study design or regulatory processes Knowledge on how to contribute to grant proposals, writing reports or lay summaries Openness to work collaboratively with the medical/professional world Having self-confidence to raise their voice in a big audience of scientific experts Since parents are personally affected, it is recommended that parents are invited into research projects who are not in an acute phase or who are not too emotionally challenged. For some research it is helpful if they have a link or experience with a certain topic and are at the same time able to cope with negative long-term effects of a specific condition. Depending on the research project,