Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network

PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.     

Ethics in behavioral genetics research

As research in behavioral genetics uncovers the genetic contribution to human behavior, it will undoubtedly further our understanding of normal human variation in many behavioral traits, such as personality, intelligence, and sexuality. This research also shows great potential for the diagnosis, treatment, and prevention of mental illnesses. Recent findings underscore this potential and document the increasing validity of research methods--methods that in the past have led to mistaken inferences about genes "for" violent behavior and homosexuality. Although all research with human subjects requires adequate attention to its ethical aspects, certain ethical issues involved with behavioral genetics are particularly acute and deserve careful attention. This article reviews these selected major ethical issues arising in (1) the conduct of behavioral genetics research; and (2) the application of its research findings. While some of the ethical concerns in the latter category are likely to be of substantial importance and animate considerable popular concern, they currently fall outside the realm of traditional research review. Determining how to deal with these concerns should be a focus of future scholarly work.     

Neonatal euthanasia: attributions of students and nurses

An attributional analysis of neonatal euthanasia was undertaken in two studies to compare the responsibility attributions of nursing and non-nursing students (Study 1) and nurses (Study 2) toward a physician for a critically ill neonate's death. In both studies, vignettes about a newborn's death differed with respect to the physician's treatment of the critically ill newborn. In the student study, the physician was attributed the least responsibility for the newborn's death when cardiopulmonary resuscitation was attempted but failed, followed by the physician's issuance of either a "Do Not Resuscitate" order or an order to turn off the infant's respirator. Greatest responsibility was attributed to the physician when he ordered the infant's nutritional and hydration support to be terminated. In addition, the student's major (nursing vs. non-nursing) and the nursing student's educational cohort impacted the level of physician responsibility attributed. In contrast, the nurses' study found that the termination of nutritional and hydrational support was viewed as different from the physician's other three actions.     

THE FAMILY CRISIS INTERVENTION LITERATURE: WHAT IS MEANT BY “FAMILY”?*

Family crisis intervention is a rapidly growing area of clinical care in family therapy which lacks clear conceptualization, especially with respect to how “family” fits into crisis intervention theory. This paper integrates recent concepts from the family therapy literature into three views: family as background, family as context, and family as a unit. The family crisis intervention literature (56 publications) is reviewed and categorized according to these three views. Clarity in how “family” is viewed and consistency between theory and practice are examined. Recommendations for improving the conceptualization of “family” in family crisis intervention theory and practice are made.     

Which countries protect intellectual property? The case of software piracy

Using data on software piracy, we examine how protection of intellectual property varies across countries. Consistent with other studies, we find that intellectual property receives greater protection in developed economies; high-income countries have lower piracy rates. We also find that protection depends on cultural factors. Countries with an individualist culture have lower piracy rates than do countries with a collectivist culture. Piracy rates are also lower in countries that have strong institutions that enforce contracts and protect property from expropriation. These results suggest that national policies toward intellectual property reflect not only economic concerns but also national culture and institutions.     

Comparison of conflict of interest policies and reported practices in academic medical centers in the United States

The authors reviewed the conflict of interest policies of 9 academic medical centers in the United States and interviewed members of the Institutional Review Boards (IRBs) and Conflict of Interest Committees (COICs) at those institutions. They found that many institutions used processes for reporting and managing conflicts of interest that were more decentralized than the processes described in their policies. Also, most institutions had no clear and comprehensive policy to guide investigators regarding disclosure of conflicts of interest to potential research participants. Considerable differences in understanding of conflict of interest policies were observed between IRB and COIC officials.     

Ethics in population-based genetic research

Population-based genetic research, including genetic epidemiology, shows tremendous potential to elucidate the role of genes as causal factors in complex and common human diseases. Like all research with human subjects, full realization of these benefits requires careful attention to its ethical conduct, establishing an appropriate balance between individual protections and the advancement of scientific and medical knowledge. This article reviews the growing literature on genetics research and ethics to describe some of the fundamental ethical issues in population-based genetics research, including research design, recruitment and informed consent, and dealing with research results. Its focus is on areas where consensus is forming and where future work is needed.