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.

Dealing with the long-term social implications of research.

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards (IRBs) responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency.

Carrier testing for spinal muscular atrophy.

Spinal muscular atrophy is the most common fatal hereditary disease among newborns and infants. There is as yet no effective treatment. Although a carrier test is available, currently there is disagreement among professional medical societies who proffer standards of care as to whether or not carrier screening for spinal muscular atrophy should be offered as part of routine reproductive care. This leaves health care providers without clear guidance. In fall 2009, a meeting was held by National Institutes of Health to examine the scientific basis for spinal muscular atrophy carrier screening and to consider the issues that accompany such screening. In this article, the meeting participants summarize the discussions and conclude that pan-ethnic carrier screening for spinal muscular atrophy is technically feasible and that the specific study of implementing a spinal muscular atrophy carrier screening program raises broader issues about determining the scope and specifics of carrier screening in general.

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.