Engaging Families in Neonatal Research

As advances in technology and neonatal survival rates increase and younger less mature preterm infants are surviving, the need for excellent research to better guide our practice is also increasing. Yet, it must be emphasized that the neonatal population is a vulnerable population protected by federal restrictions. Neonatal researchers and practitioners are in a unique position to identify relevant and ethical research, to protect patients' safety, and to act as resources for families considering participation in research. Understanding the regulations associated with neonatal research, the role practitioners play in the process, and the experience of families who consent for their infant's participation in research will improve the experience for researchers, practitioners, and families. The Code of Federal Regulations Title 45, Public Welfare, Department of Health and Human Services, Part 46 (45CFR46), provides protection for human research subjects. Research involving neonates is defined by 45CFR46 as a vulnerable population and provides extra protection in the conduct of research involving neonates. Any agency that is subject to federal regulation, most commonly recipients of federal money such as grants, contracts, and Medicate/Medicaid, must comply. Institutional review boards (IRBs), whether internal or external, are responsible for review and approval of human research as guided by 45DFR46. Institutional review board review with regard to neonatal research critically examines proposed research for risks and benefits to the neonate, minimization of risk, and avoidance of coercive recruitment, with true informed consent. Because of the perception of vulnerability, infants and children are the most underrepresented population within health care research, leading to a homogenous application of research involving newborns and children. Moreover, these regulations can make the process seem mysterious and scary for families, sometimes making the process of working with families of infants and young children in research more laborious for all involved. Categories of risk associated with participation in research are not clearly defined, nor are there specific guidelines for research involving children. The minimal risk is that the “probability and magnitude of harm or discomfort anticipated