Ethical issues in neonatal research involving human subjects.

Research involving critically ill neonates creates many ethical challenges. Neonatal clinical research has always been hard to perform, is very expensive, and may generate some unique ethical concerns. This article describes some examples of historical and modern controversies in neonatal research, discusses the justification for research involving such vulnerable and fragile patients, clarifies current federal regulations that govern research involving neonates, and suggests ways that clinical investigators can develop and implement ethically grounded human subjects research.

Term pregnancy: time for a redefinition.

The designation term pregnancy and the distinction between term, preterm, and postterm pregnancy carry with them significant clinical implications with respect to the management of pregnancy complications. Although the potential hazards of both preterm birth and postterm pregnancy have been long recognized, little attention has, until recently, been given to the differential morbidity experienced by neonates born at different times within the 5-week interval classically considered term gestation. This article is a reevaluation of the concept of term pregnancy in light of current data.

Fortification of corn masa flour with folic acid in the United States.

Food fortification is an effective public health tool for addressing micronutrient deficiencies. The mandatory fortification of enriched cereal grains (e.g., wheat flour) with folic acid, which began in the United States in 1998, is an example of a successful intervention that significantly reduced the rate of neural tube defects (NTDs). However, despite the drop in NTD rates across all racial/ethnic groups after fortification, Hispanics continue to have the highest rates of this condition. One possible way to reduce this disparity is to fortify corn masa flour to increase the overall intake of folic acid in Hispanic women. We present the available evidence in favor of this approach, address possible safety issues, and outline next steps in the fortification of corn masa flour with folic acid in the United States.

Rethinking the definition of "term pregnancy".

Term birth (37-41 weeks of gestation) has previously been considered a homogeneous group to which risks associated with preterm (less than 37 weeks of gestation) and postterm births (42 weeks of gestation and beyond) are compared. An examination of the history behind the definition of term birth reveals that it was determined somewhat arbitrarily. There is a growing body of evidence suggesting that significant differences exist in the outcomes of infants delivered within this 5-week interval. We focus attention on a subcategory of term births called "early term," from 37 0/7 to 38 6/7 weeks of gestation, because there are increasing data that these births have increased mortality and neonatal morbidity as compared with neonates born later at term. The designation "term" carries with it significant clinical implications with respect to the management of pregnancy complications as well as the timing of both elective and indicated delivery. Management of pregnancies should clearly be guided by data derived from gestational age-specific studies. We suggest adoption of this new subcategory of term births (early term births), and call on epidemiologists, clinicians, and researchers to collect data specific to the varying intervals of term birth to provide new insights and strategies for improving birth outcomes.

Surgeon General's Conference on the Prevention of Preterm Birth.

To address the serious and seemingly intractable problem of preterm birth, the Surgeon General's Conference on the Prevention of Preterm Birth convened many of the country's experts from the public and private sectors of research, public health, and health care delivery to discuss preventive strategies. The purpose of the conference was to increase awareness of preterm birth in the United States, review key findings and reports issued by experts in the field, and establish an agenda for activities in both the public and private sectors to mitigate the problem. The six work groups created focused on biomedical research, epidemiological research, psychosocial and behavioral factors in preterm birth, professional education and training, outreach and communication, and quality of care and health services. Several cross-cutting issues between the work groups were identified, and the conference concluded with the request to the Surgeon General to make the prevention of preterm birth a national public health priority. Reaching this goal through the implementation of the conference recommendations will require new resources to create broad-based research capacity, a vigorous national vital records system, multidisciplinary intervention programs, careful study of factors contributing to racial and ethnic disparities, reinvigorated health professional and consumer education programs, and access to high-quality preconception and perinatal healthcare for all Americans. Clinicians must be adequately informed to initiate activities to prevent this serious problem. Recommendations from this conference will inform Congress and create a national agenda to address the identification of the causes, risk factors, prevention, and treatment of preterm birth.

Community engagement in epidemiological research.

OBJECTIVE: Engaging communities has become a critical aspect of planning and implementing health research. The role community engagement should play in epidemiological and observational research remains unclear since much of this research is not directly generated by community concerns and is not interventional in nature. The National Children's Study (NCS), an observational longitudinal study of 100,000 children and their families, provides a model to help guide the development of community engagement strategies in epidemiologic research. METHODOLOGY: This manuscript describes community engagement activities of the NCS during the planning phases of the study. RESULTS: There are many challenges of community engagement in epidemiologic research particularly before the actual research sites are determined. After communities of interest are designated many further issues must be resolved, including: defining the specific community, determining which residents or institutions represent the identified community, and developing trust and rapport through respectful engagement. CONCLUSIONS: Community engagement is critical to the long-term success of any longitudinal epidemiologic study. A partnership with the community should be formed to ensure mutual respect and the establishment of an enduring relationship. Genuine community engagement offers the hope of enhancing recruitment, retention, and participant satisfaction.

Roadmap for the protection of disaster research participants: findings from the World Trade Center Evacuation Study.

INTRODUCTION: This report addresses the development, implementation, and evaluation of a protocol designed to protect participants from inadvertent emotional harm or further emotional trauma due to their participation in the World Trade Center Evacuation (WTCE) Study research project. This project was designed to identify the individual, organizational, and structural (environmental) factors associated with evacuation from the World Trade Center Towers 1 and 2 on 11 September 2001. METHODS: Following published recommended practices for protecting potentially vulnerable disaster research participants, protective strategies and quality assurance processes were implemented and evaluated, including an assessment of the impact of participation on study subjects enrolled in the qualitative phase of the WTCE Study. RESULTS: The implementation of a protocol designed to protect disaster study participants from further emotional trauma was feasible and effective in minimizing risk and monitoring for psychological injury associated with study participation. CONCLUSIONS: Details about this successful strategy provide a roadmap that can be applied in other post-disaster research investigations.

New and lingering controversies in pediatric end-of-life care.

OBJECTIVES: Professional societies, ethics institutes, and the courts have recommended principles to guide the care of children with life-threatening conditions; however, little is known about the degree to which pediatric care providers are aware of or in agreement with these guidelines. The study's objectives were to determine the extent to which physicians and nurses in critical care, hematology/oncology, and other subspecialties are in agreement with one another and with widely published ethical recommendations regarding the withholding and withdrawing of life support, the provision of adequate analgesia, and the role of parents in end-of-life decision-making. METHODS: Three children's hospitals and 4 general hospitals with PICUs in eastern, southwestern, and southern parts of the United States were surveyed. This population-based sample was composed of attending physicians, house officers, and nurses who cared for children (age: 1 month to 18 years) with life-threatening conditions in PICUs or in medical, surgical, or hematology/oncology units, floors, or departments. Main outcome measures included concerns of conscience, knowledge and beliefs, awareness of published guidelines, and agreement or disagreement with guidelines. RESULTS: A total of 781 clinicians were sampled, including 209 attending physicians, 116 house officers, and 456 nurses. The overall response rate was 64%. Fifty-four percent of house officers and substantial proportions of attending physicians and nurses reported, "At times, I have acted against my conscience in providing treatment to children in my care." For example, 38% of critical care attending physicians and 25% of hematology/oncology attending physicians expressed these concerns, whereas 48% of critical care nurses and 38% of hematology/oncology nurses did so. Across specialties, approximately 20 times as many nurses, 15 times as many house officers, and 10 times as many attending physicians agreed with the statement, "Sometimes I feel we are saving children who should not be saved," as agreed with the statement, "Sometimes I feel we give up on children too soon." However, hematology/oncology attending physicians (31%) were less likely than critical care (56%) and other subspecialty (66%) attending physicians to report, "Sometimes I feel the treatments I offer children are overly burdensome." Many respondents held views that diverged widely from published recommendations. Despite a lack of awareness of key guidelines, across subspecialties the vast majority of attending physicians (range: 92-98%, depending on specialty) and nurses (range: 83-85%) rated themselves as somewhat to very knowledgeable regarding ethical issues. CONCLUSIONS: There is a need for more hospital-based ethics education and more interdisciplinary and cross-subspecialty discussion of inherently complex and stressful pediatric end-of-life cases. Education should focus on establishing appropriate goals of care, as well as on pain management, medically supplied nutrition and hydration, and the appropriate use of paralytic agents. More research is needed on clinicians' regard for the dead-donor rule.