FAMILY DYNAMICS

From the VFrom the VAddress corof Nursing23298. E-m© 2010 Els1527-3369/doi:10.1053

Engaging Families in Neonatal Research

Brenda Baker, MN, RNc, CNS and Jacqueline M. McGrath, PhD, RN, FNAP, FAAN

As advances in technology and neonatal survival rates increaseand younger less mature preterm infants are surviving, theneed for excellent research to better guide our practice is alsoincreasing. Yet, it must be emphasized that the neonatalpopulation is a vulnerable population protected by federalrestrictions. Neonatal researchers and practitioners are in aunique position to identify relevant and ethical research, toprotect patients' safety, and to act as resources for familiesconsidering participation in research. Understanding theregulations associated with neonatal research, the role practi-tioners play in the process, and the experience of families whoconsent for their infant's participation in research will improvethe 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. Researchinvolving neonates is defined by 45CFR46 as a vulnerablepopulation and provides extra protection in the conduct ofresearch involving neonates.1 Any agency that is subject tofederal regulation, most commonly recipients of federal moneysuch as grants, contracts, and Medicate/Medicaid, mustcomply.1 Institutional review boards (IRBs), whether internalor external, are responsible for review and approval of humanresearch as guided by 45DFR46.1 Institutional review boardreview with regard to neonatal research critically examinesproposed research for risks and benefits to the neonate,minimization of risk, and avoidance of coercive recruitment,with true informed consent. Because of the perception ofvulnerability, infants and children are the most underrepre-sented population within health care research, leading to ahomogenous application of research involving newborns andchildren.2 Moreover, these regulations can make the processseem mysterious and scary for families, sometimes making theprocess of working with families of infants and young childrenin research more laborious for all involved.

Categories of risk associated with participation in researchare not clearly defined, nor are there specific guidelines forresearch involving children. The minimal risk is that the“probability and magnitude of harm or discomfort anticipated

CU School of Nursing, Richmond, VA.irginia CommonwealthUniversity, School of Nursing, Richmond, VA.respondence to Jacqueline McGrath, PhD, RN, NNP, FNAP, SchoolBox 980567, Virginia Commonwealth University, Richmond, VAail: jmmcgrath@vcu.edu.evier Inc. All rights reserved.09/1001-0338$36.00/0/j.nainr.2009.12.004

in research are not greater in and of themselves than thoseordinarily encountered in daily life or during the perfor-mance of routine physical or psychologic examinations ortests”(46.102(i)). Lack of specific details in these regulatoryguidelines allows for inconsistencies in interpretation by IRBsand often contributes to further challenges in conductingresearch in the neonatal population.

Parents of critically ill infants in the neonatal intensive careunit (NICU) are faced with a multitude of complex decisions,new and changing information, and stress associated with thebirth of a premature or critically ill infant. A request to consentfor the infants' participation in research creates an addedchallenge for families during the NICU experience. Parents facedwith the decision to participate in research must consider risksand benefits of research, explore their personal beliefs aboutresearch, and often times make decisions under time constraintsrelated to enrollment. Concurrently, families are often dealingwith the crisis of having a sick infant, not something they wereplanning for during the joys of pregnancy and developingtrusting relationships with a new group of caregivers.

Interpersonal communication is vital to the exchange ofinformation between caregivers and families in the NICU. Notonly do caregivers provide information about clinical aspects,but also the relationship between parents and caregivers oftensupports parents' decision-making abilities, parents' ability tomanage stress associated with the NICU experience, as well asthe beginning of the parent-child relationship.3 Nurses are oftenthe main source of information for NICU parents who need tobe well versed in the research topic to support decision makingand ongoing comfort with the research process. In a studyof 101 neonatology fellows designed to assess training relatedto family decision making for critically ill newborns, 41%indicated that they had no formal training of any kind specific tocommunication skills, 42% indicated their training did notinclude didactic conferences on communication skills, 75% hadnever participated in relevant role play or simulated scenarios,and only 6% had a clinical rotation that was focused ondeveloping communication skills.4 This study further supportsthe vital role nursing plays in communication between parentsand health care providers.

Consent to participate in research implies that comprehen-sive and understandable information has been disclosed toparticipants. Criteria in the consent process include the persongiving consent is competent, information provided is compre-hensible and relevant to the individual's decision to participate,participation is voluntary and free of coercion, and thatparticipants are able to withdraw without penalty.5 Methodsin which information related to research is shared significantly

Table 1. Nursing Interventions That SupportFamilies' Participation in Clinical ResearchDemystify the research process. Make sure familiesunderstand that conducting research and working withresearchers are integral parts of care in this setting.

Explain study protocols in terms the family understands.Anticipate questions; parents may hesitate to ask if theymight appear unknowledgeable in an area they feel otherparents might be more knowledgeable about.

Provide information about the research in a quiet privateplace away from the bedside and in a way that does notinterrupt time the family had planned to spend with theirchild.

Allow adequate time for families to ask questions during theconsent process and throughout the research experience.

Allow adequate time for families to make decisions regardingprotocols and during other aspects of the study.

Include both parents in discussions related to the researchand consent process.

Provide simple written information about the researchproject to families.

Provide parents with contact information to the researchteam.

Assure parents all infants are cared for by the same standardswhether they participate in research or not.

Make sure parents realize that at any time for any reason,they can choose to withdraw their infant from the studywith no consequences to their infant or to them.

Provide additional resources or information on the topic ofresearch for parents who desire more information.

influence a parents' understanding of the research. A studyinvolving 41 parents of immature but well infants in a tertiarycare NICU sought to understand various methods of providinginformation about a hypothetical research study. Parents wererandomly assigned to either a group that received only writteninformation or written information and explanation of theresearch details. Parents were then asked to complete aquestionnaire designed to obtain information about theirunderstanding about the purpose of the research, design ofthe study, procedures, and consent. Findings indicated thatverbal explanation significantly enhanced understanding of theprocess without regard to the written document. Notsurprising, shorter written documentation improved under-standing more than longer more complex documents.5

Other factors that influence a parent's experience of researchparticipation in the NICU include amount of time allowed tomake a decision, perception of risk and benefits, and sense ofvulnerability and control. Often times, research projects requireenrollment within a short period from the time of birth toinitiation of the study. In the chaos that can follow the birth of apremature or critically ill infant, parents are processing new andconfusing information and may be dealing with feelings of loss,grief, and vulnerability. These emotions can influence theirability to make decisions and evaluate risks and benefits. In aqualitative study by Hoehn et al.6 that included 37 parents ofNICU patients, parents, who reported having adequate time tomake a decision, were more likely to choose to participatecompared with parents who reported inadequate time to make adecision. For parents who chose not to participate, reasons citedincluded insufficient time to make an educated decision,consideration of study logistics, other parent not present attime of decision, and insufficient time to discuss the study.

Parents' perception of time was also identified in a largestudy, including parents of 5050 children designed todetermine parents' ability to assess risks and benefits of astudy. They found several other factors influenced decisionmaking, including use of a placebo, designated risk category ofthe study, clarity of information provided to parents, andamount of privacy afforded to parents while making a decision.7

Parental sense of vulnerability and control was examined in aqualitative descriptive study of 27 parents of neonates. Parentsdescribed feelings of confusion, desperation, and helpless-ness when asked to participate in neonatal research. Anothersignificant finding of this study was parents' concern that if theydid not participate in research, their infant would be cared forby health care providers. Time limitations were again identifiedin this study as stressors in decision making related to neonatalresearch.8 Acknowledgement of factors that influence parentalconsent to participate can have a significant influence onrecruitment of neonates in research.8

The role of nurses in neonatal research includes setting theresearch agenda and advocating for the infants and theirfamilies. Determining topics appropriate for neonatal research isoften based on funding, human resources, time constraints, andtechnology. High-priority neonatal research topics includepatient safety, workforce issues, long-term outcomes, andquality of life issues.9 Neonatal nurses can also become involved

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in IRBs as advocates for research in the neonatal population,educators on the population of neonates, and protectors ofneonates and their families. Advocating for neonates and parentsis a primary role of nurses and is dependent on clearcommunication between caregivers, research staff, and parents.Parents of premature or ill neonates are considered a “captive”audience for research and are at risk of intention or uninten-tional exploitation. This has been demonstrated most recentlyin 2004 in a study by Stenson et al10 of 154 parents of NICUinfants; 12% of parents who had given consent for a neonataltrial could not remember giving consent 18 months later.

Neonatal nurses play a key role in supporting families duringthe decision-making process, during the study phase, and infollow-up as results of research are experienced. When successwith a clinical trial or research protocol occurs, there is anopportunity to celebrate the decision made by parents. In situa-tions where outcomes may not have been successful whetherrelated to the study or circumstances beyond control, nursesare in a unique position to help families deal with feelings ofgrief or regret. Neonatal nurses can support parents in their roleof decision maker by enhancing availability of the researchstaff, providing information about the research in a mannerconsistent with the families' learning style, and being nonjudg-mental of families decision to participate or not (Table 1).

1, www.nainr.com

The neonatal nurse is vital to the future of research in theneonatal population. Neonatal nurses care for more thanpremature infants; they are in a unique position to advocate forfamilies as well as the NICU patient. Neonatal nurses have aunique knowledge base that can guide the development ofresearch agendas, study design, and translation of findings tothe bedside. Being well informed of guidelines governingneonatal research, resources available to support familiesinvolved in research and how research is experienced byfamilies will further support the growing efforts and outcomesof neonatal research.

References1. Thomas KA. When neonatal ICU infants participate in

research: special protections for special subjects. Crit CareNurs Clin North Am. 2009;21:277-281.

2. Carter B. Tick box for child? The ethical positioning ofchildren as vulnerable, researchers as barbarians andreviewers as overly cautious. Int J Nurs Stud. 2009;46:858-864.

NEWBORN & INFANT NURSIN

3. Jones L, Woodhouse D, Rowe J. Effective nurse parentcommunication: a study of parents' perceptions in theNICU environment. Patient Educ Couns. 2009;69:206-212.

4. Boss RD, Hutton N, Donohue PK, Arnold RM. Neonatol-ogist training to guide family decision making for criticallyill infants. Arch Pediatr Adolesc Med. 2009;163:783-788.

5. Freer Y, McIntosh N, Teunisse S, Anand KJS, Boyle EM.More information, less understanding: a randomized studyon consent issues in neonatal research. Pediatrics. 2009;123:1301-1305.

6. Hoehn KS, Nathan A, White LE, et al. Parental perception oftime and decision-making in neonatal research. J Perinatol.2009;29:508-511.

7. Tait AR, Voepel-Lewis T, Malviya S. Factors that influenceparents' assessments of the risks and benefits of researchinvolving their children. Pediatrics. 2004;113:727-732.

8. Ward FR. Chaos, vulnerability and control: parental beliefsabout neonatal clinical trials. J Perinatol. 2008;29:156-162.

9. Franck LS. Research with newborn participants. J PerinatNeonatal Nurs. 2005;19:77-186.

10. Stenson BJ, Becher JC, McIntosh N. Neonatal research: theparental perspective. Arch Dis Child Fetal Neonatal Ed.2004;89:F321-F324.

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