Attitudes of Health-Care Providers towards Research with Newborn Babies

Abstract

CONTEXT:By providing information and possibly shaping parents' preferences, health-care providers are thought to play a critical role in parental decisions to enroll their infants in research. Yet, little is known about health-care providers' beliefs about research with newborns. Previous studies suggest that parents and health-care providers are often at odds regarding attitudes towards research. OBJECTIVE:To examine the attitudes of health-care providers concerning the acceptability of research with newborn babies and the degree of researchrelated risk to which they would be willing to expose their own infant. These findings were compared with a previous study of parental attitudes. DESIGN, SETTING AND PARTICIPANTS:A survey (pretested questionnaire with 20 scaled items and five case scenarios) of 50 doctors and 64 nurses conducted in a large tertiary care center in western Canada. RESULTS:Study limitations were a response rate of 64.5% among nurses but only 22% among physicians. Both doctors and nurses were strongly supportive of research with newborns, but nurses were more averse to exposing infants to risk. Only 76.0% of nurses, compared to 92.2% of physicians, agreed that informed consent should be sought for all forms of research. When results were compared with parental perceptions, health-care providers were more likely to believe that research should be conducted for the good of all babies. Parents were generally less aware of the existence of an approval process for research in general. In responding to hypothetical scenarios with risk and direct benefit, parents were less willing to enroll their infants than were health-care providers. Approximately 30% of both groups would be willing to enroll their infants in a study involving moderate risk and no direct benefit. CONCLUSIONS:Views of nurses, physicians, and parents regarding research with newborns are different. Overall, there is support for research; however, nurses are more likely to never enroll their own baby and enroll babies into minor studies without consent.

Nurses’ Attitudes Toward Clinical Research

“…Limited research has shown that nurses generally have positive attitudes towards pediatric research but are reticent to recommend participation to their patients, due to a lack of understanding about clinical research, lack of familiarity with a specific trial or disapproval of the research question. (9, 11, 18) Our findings may help other study teams understand the potential impact of bedside nurses' attitudes on the planning and execution of complex multi-institutional studies.…”

“…However, pediatricians are often reluctant to refer their patients for research studies (5, 6) due to potential risks from treatment side effects, patient inconvenience, lack of physician time/resources and risk to the doctor-patient relationship. (7-9)…”

“…(10) Nurses, like pediatricians, view pediatric research as integral to enhancing health outcomes with concomitant reluctance to encourage patient participation. (9, 11)…”

Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials

“…Administrative challenges (multiple Institutional Review Board [IRB] approvals, subcontracts, and training), scientific challenges (equipoise and standardizing protocols among various centers) and financial challenges are common in multi-site trials (1, 2). These are compounded when pediatric researchers must identify eligible research subjects from smaller pediatric patient pools compared with adult trials, address complex issues of parental consent and child assent (3, 4), tackle the perceptions and lack of understanding among parents and pediatric healthcare providers about research with children (5–7), manage the range of IRB assessments of trial risks and benefits (4, 8, 9), and procure the requisite expertise and additional funds needed to perform study interventions and long-term follow-up in children (10). Strategies have been identified for simplifying research processes, streamlining activities and decreasing the often-excessive time required to complete a trial (11–14), yet investigators continue to struggle to complete recruitment on time and within the budget allotted (15, 16).…”

Children and Clinical Studies: The National Heart, Lung, and Blood Institute's New Multimedia Resource for Pediatric Research

“…Surveys show that nurses, doctors, and ancillary personnel might be unaware of studies for which their patients may be eligible and while largely supportive of pediatric research, express concern about how informed families are. They also acknowledge that it creates a burden and takes time to talk with parents about research, a topic about which they themselves may know little (8-10). …”