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.

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.

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.

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.

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.

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.

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.

Regulating research with human subjects--is the system broken?

There has been a great deal of criticism of the system to regulate research and protect the interests of research participants. Structural problems in the system result from the nature of current research and the regulatory process that was created over thirty years ago. Procedural problems exist because local IRBs show wide variation in practices, resources, quality and experience.

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.

Ethical issues pertaining to research in the aftermath of disaster.

In January 2003, The New York Academy of Medicine and the National Institute of Mental Health sponsored a meeting entitled "Ethical Issues Pertaining to Research in the Aftermath of Disaster." The purpose of the meeting was to bring together various experts to examine evidence concerning the impact of research on trauma-exposed participants, review the applicable ethical principles and policies concerning protection of human subjects, and offer guidance to investigators, IRBs, public health and local officials, and others interested in assuring that research in the aftermath of a disaster is conducted in a safe and ethical manner. This article summarizes the group's key findings and outlines potential considerations for those working in this field.

Urban bioethics: adapting bioethics to the urban context.

Urban bioethics is an area of inquiry within the discipline of bioethics that focuses on ethical issues, problems, and conflicts relating to medicine, science, health care, and the environment that typically arise in urban settings. Urban bioethics challenges traditional bioethics (1) to examine value concerns in a multicultural context, including issues related to equity and disparity, and public health concerns that may highlight conflict between individual rights and the public good, and (2) to broaden its primary focus on individual self-determination and respect for autonomy to include examination of the interests of family, community, and society. Three features associated with urban life-density, diversity, and disparity-affect the health of urban populations and provide the substrate for identifying ethical concerns and value conflicts and creating interventions to affect population health outcomes.