NAPNAP Revises Position Statement on Protection of Children Involved in Research Studies

NEW YORK, Sept. 28, 2020 – Research generates the critical evidence needed to advance pediatric care and overall health. While research is imperative to evidence-based care, children under the age of 18 are classified as a vulnerable population because they cannot independently provide informed consent to participate in research. To advance advocacy efforts for the adequate protection of pediatric research participants, the National Association of Pediatric Nurse Practitioners (NAPNAP) has developed guidelines for conducting research involving children in its updated position statement.

“The physical and mental well-being of pediatric patients is always our top priority. NAPNAP advocates for the inclusion of children and adolescents in research studies while emphasizing the importance of protecting the rights and health of children in clinical research,” said NAPNAP President Jessica Peck, DNP, APRN, CPNP-PC, CNE, CNL, FAANP. “NAPNAP calls on researchers to design their investigations to advance pediatric health while safeguarding pediatric subjects.”

The position statement, published in the September/October edition of the Journal of Pediatric Health Care, stresses the importance of informed consent and/or assent with both the child and parent. It outlines the responsibility of the pediatric-focused advanced practice registered nurse to provide comprehensive information to guide decision-making and to be fully aware of the ethical implications of conducting research on children. The statement also includes guidelines for technology and biological measures.

The statement concludes with 10 points for which NAPNAP advocates, including: avoiding greater than minimal risk to the child, designing rigorous research methodologies to enhance the empirical foundation of the care provided to children and their families; protecting confidentiality and privacy throughout all research activities; obtaining consent and/or assent with appropriate IRB-approved procedures; conducting research studies involving children in an environment that provides for ethical treatment and physical, emotional, and psychological safety of the child and the family; implementing ethical principles of respect for person, beneficence and justice; providing ongoing continuing education on implementation of evidence-based practice; using a child and family-centered approach to recognize, respect, and consider cultural differences; using connected and open research ethics when designing studies involving mHealth, digital health, telemedicine, and/or social media; and considering ethical issues related to research involving biospecimens.

To view the full position statement, visit https://www.jpedhc.org/article/S0891-5245(20)30127-9/pdf

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The National Association of Pediatric Nurse Practitioners (NAPNAP) is the nation’s only professional association for pediatric-focused advanced practice registered nurses (APRNs) dedicated to improving the quality of health care for infants, children, adolescents and young adults. Representing more than 8,000 healthcare practitioners with 18 special interest groups and 53 chapters, NAPNAP has been advocating for children’s health since 1973 and was the first APRN society in the U.S. Our mission is to empower pediatric-focused advanced practice registered nurses and key partners to optimize child and family health. www.NAPNAP.org

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