Integrating Parents in Neonatal and Pediatric Research

Abstract

Background: Parents and their infants are the beneficiaries of neonatal and pediatric research, but in the past they have been excluded from most stages of research projects. As a result, many projects may fail to produce the most worthwhile information for parents and families. Lately, veteran resource parents and patients have been increasingly integrated in research initiatives. Methods: Benchmarking of neonatal and pediatric research initiatives where resource parents and/or ex neonatal patients have helped to optimize pediatric research. We review ways in which resource parents/patients can be involved in research, with examples and practical ideas of how to proceed. Results: Resource parents/patients can be collaborators in research and be integrated in many steps: prioritizing research projects, designing trials, determining the outcomes of interest, ethics review, developing and improving consent procedures, collection and interpretation of data, participation in data safety monitoring committees, publication of results, and presentation to peer groups. Some of the strategies for integration of stakeholders in clinical research are more complex, may involve risk and require more training than others. Conclusion: We suggest that groups wanting to involve parents in their research endeavors start with simpler tasks that entail less risk and develop teams of resource parents who have differing interests and abilities. Quality control of programs is essential, such as frequently giving and obtaining feedback from resource parents/patients and researchers. In the future, integration of resource parents/patients into every step of clinical research will be essential to ensure that parent and family important outcomes are examined.

Trust and consent: a prospective study on parents’ perspective during a neonatal trial

“…In practice, ethics committees require that precise information about the study and about legal aspects of research be mentioned, so shortening the written information is difficult. Yet, the written information can be improved with collaborative work between physicians and parents, by making it more understandable and relevant for non-professionals 26–29. In Europe, the parents’ advisory board of the European Foundation for the Care of Newborn Infants and their family give recommendations about the consent process in neonatal trials 30.…”

Deferred consent for delivery room studies: the providers’ perspective

“…Some interviewed providers suggested that inviting parents to RECs may provide a solution. Involving parents in the ethical review of study protocols was also recommended by Janvier et al ,35 but actual membership to an REC is considered complex. Janvier et al 35 therefore recommended to start with more easily achievable goals when planning to involve parents in research, such as the revision and improvement of consent forms, collaboration in the selection of research topics, or collaborating in patient recruitment.…”

Perinatal Asphyxia: Predicting and Improving Outcome

“…Nowadays MRI with a field strength up to 3.0 Tesla (T) is routinely used in infants. The increase of a field strength of 1.5T to 3.0T has improved MRI quality in infants and enabled us to see more details and pathology (65). In adults, 7.0T has shown to further increase diagnostic value and is now frequently used.…”

“…We have to discuss the primary outcome of trials with parents and patients. What parents and patients consider as clinically relevant might differ from the opinion of researchers and clinicians (65). The aim of research should be to improve the quality of life of patients and their opinion about how their quality of life can be improved is therefore essential.…”

“…Patient participation should become more important for future grant applications and trial design (65). The opinion of parents and patients about the importance of a trial and the burden to parents and patients should always be considered.…”