Clinical trials of drugs used off-label in neonates: ethical issues and alternative study designs

The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called "off label use, "is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ethical and safety challenges. Since the passage of the Best Pharmaceuticals for Children Act (BPCA) in 2002, both the FDA and National Institutes of Health (NIH) have taken initiatives to facilitate and encourage research to achieve the necessary labeling for drugs routinely used in infants and children. Federal regulations provide broad rules and guidance for the protection of human subjects in research. However, there are ethical issues that a physician may face when designing clinical trials of drugs in neonates that are routinely used off-label and widely believed to be beneficial. We attempt to describe these ethical challenges and provide recommendations, including alternative study designs, to resolve them in an ethical framework that takes into account the Belmont Report, the statement of the World Medical Association (WMA), and federal regulations.     

Clinical Trials of Drugs Used Off-Label in Neonates: Ethical Issues and Alternative Study Designs

The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called “off-label use,” is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ethical and safety challenges. Since the passage of the Best Pharmaceuticals for Children Act (BPCA) in 2002, both the FDA and National Institutes of Health (NIH) have taken initiatives to facilitate and encourage research to achieve the necessary labeling for drugs routinely used in infants and children. Federal regulations provide broad rules and guidance for the protection of human subjects in research. However, there are ethical issues that a physician may face when designing clinical trials of drugs in neonates that are routinely used off-label and widely believed to be beneficial. We attempt to describe these ethical challenges and provide recommendations, including alternative study designs, to resolve them in an ethical framework that takes into account the Belmont Report, the statement of the World Medical Association (WMA), and federal regulations.     

Monitoring the Monitors: Medicaid Integration of Passive Remote Monitoring Technology

Implementation of passive remote monitoring is advancing faster than our knowledge base about appropriate and ethical use. For all the media and research attention these technologies are getting, there has been very little discussion about how they are positioned to be integrated into health plans, yet their integration is key to how they will be incorporated into social work practice. As coverage of passive remote monitoring technologies expands in Medicaid home and community-based services (HCBS), new policies that support informed decision-making, consenting processes, and regulations for ethical, appropriate use are urgently needed. Research translation often trails policy, but the rapid development and implementation of technologies that passively collect and transmit new information about older adults call for a more responsive approach. In this commentary, I describe passive remote monitoring technologies, their implementation in Medicaid HCBS, and ethical issues. I conclude with specific suggestions for policy and practice to start addressing these issues.     

Genetic screening technology: ethical issues in access to tests by employers and health insurance committees

Whereas the introduction of new technologies previously has raised the ethical question of who ought to have access to a new procedure or device, genetic testing technology raises the new ethical question of to whom access to a new technology ought to be limited. In this article we discuss the implications of employers and private health insurance companies having access to genetic testing technology. Although there may be legitimate business interests in allowing employers and insurers to conduct genetic screening, there are other valid societal interests in regulating or limiting the use of this technology by third parties. Public policy developed in the area of new genetic technology must reflect such interests.     

Reproducing women's nature: media constructions of IVF and related issues

This paper presents a quantitative and qualitative analysis of the way the Australian press constructed the issues related to conceptive technologies (IVF and IVF-surrogacy particularly) during the period when the technologies were most visibly controversial. It asks how medical technology, the profession, ethical debates and research were presented, focussing on the representation of women's bodies, ‘motherhood’, and consumerist conceptions of medical solutions to infertility. Moral, ethical and political issues, including feminist critiques of conceptive technologies and medical power were found to be presented in limited and partial ways - by the ‘medical-miracle’ (human interest) or the ‘experts-debate-legal-issues’ genres of press report. In text and in photographs, the press showed mothers and babies as the (positive) products of technology. Women were shown reacting, in emotional terms, to the productive power of technology. Men were active, protective, expert, and the source of rational, abstract talk. The press relied heavily on proponents of the technologies for their news stories. The results are discussed in terms of Foucault's general analysis of the history of discourses of sexuality and feminist critiques of conceptive technologies.     

Non-genetic mothers and their own children: infertility and IVF donor birth

Over the 1980s in Western societies which have used new reproductive technologies, there has been intense argumentation about connected philosophical, ethical and economic issues. This research on I.V.F. donor egg (i.e. 'non-genetic') motherhood is based on qualitative data from partial life histories of twelve women having children by this technology through a Melbourne infertility programme. Methodology, interpretation, and discussion place it within both critical social and feminist personal identity theoretical frameworks. None of the respondent women but all except one of their respective partners are the biological parents of a total of ten children already born at the data collection stage, and in three well-established pregnancies. Two-thirds of the respondents used 'unknown' donor ova. 'Known' donors were typically the recipients' sisters. Many of these Australian births represent world 'firsts' in medical technical applications. In biographical accounts, the focus was on experiences of social pressure towards parenthood, of infertility and medical treatment, and attitudes of openness or secrecy about using donated ova. While socially and technologically acquired parenthood added a highly-desired dimension to their social identities, a sense of loss appeared to persist in most of the women's personal identities. Where a policy of secrecy towards relatives and friends about use of reproductive technology and gamete donation was maintained, this loss was reinforced by a feeling of social isolation.     

Generation of Knowledge for Reproductive Health Technologies: Constraints on Social and Behavioral Research

Advances in new reproductive health technologies have surfaced an array of social and behavioral issues regarding decision-making and use of these technologies, underscoring the need for research on such topics as reproductive health decision-making, sexual practices, and norms and values for childbearing and family formation. Using topical microbicides as an example of a new method to prevent Sexually Transmitted infections (STIs), Human Immunodeficiency Virus (HIV) and/or pregnancy, we focus on gaps in information to inform reproductive health decision-making, noting in particular the discrepancies between data on clinical efficacy and typical use-effectiveness. Constraints on government and private sector support for research, particularly research on aspects of sexual behavior, contribute to problems with the availability of information for decision-making about use of reproductive health technologies .     

The Ethical and Clinical Implications of Utilizing Cybercommunication in Face-to-Face Therapy

Information and communication technology has created a new way for individuals to communicate and has entered a number of professional practices, including clinical social work. This article explores the potential ethical and clinical implications when cybercommunication is used in conjunction with traditional face-to-face clinical social work practice. Specific challenges addressed include confidentiality, professional boundaries, effective and competent practice, and unanticipated contact. The authors discuss how information and communication technology is emerging as an inevitable component of the therapeutic exchange, influencing in-person social work practice and the ways that practitioners interact with their clients.     

New reproductive technologies: Equity and access to reproductive health care

While attention has focused on the promise of new reproductive technologies to provide cures for infertility, efforts aimed at preventing infertility have languished, and the major cause of infant morbidity and morality--lack of prenatal care--has worsened. This article explores the social and ethical issues arising out of the uses of three new reproductive technologies: surrogacy, in vitro fertilization, and prenatal screening. In addition, coerced medical interventions during pregnancy are described. Examination of the social circumstances surrounding the use of these medical technologies supports the conclusion that new reproductive technologies have increased, rather than decreased, inequities in access to and allocation of health care resources.     

To tweet or not to tweet: Exploring the determinants of early adoption of Twitter by House members in the 111th Congress

The adoption of communication forms like Twitter presents students of congressional behavior an interesting case to examine the intersection of technology and politics. Twitter represents a social media venue that provides an immediate and direct link between the Member of Congress (MC) and constituents, which entails a benefit and a potential risk. In this paper, I examine Twitter use in the 111th Congress in order to better understand congressional early adoption of new technology. The primary question addressed is what systematic determinants shape the decision to adopt Twitter as a component of an MC's media strategy. Using data collected from MC Twitter accounts and the 2008 congressional election, I find partisan, cohort, and ideological determinants on early Twitter adoption. Republicans are more likely to use Twitter even in multivariate analysis; ideological extremism influences the use of Twitter. In contrast to past technologies, district demographics have no systematic effect on the early adoption of Twitter.     

Spinning a Stem Cell Ethics Web

The goal of this study was to provide an ethics education resource for trainees and researchers in the Canadian Stem Cell Network that would address the multiple ethical challenges in stem cell research including accountability in and for research across its multiple dimensions. The website was built using a bottom-up type approach based on an ethics needs assessment in combination with a top-down expert-driven component. There have been 3,615 visitors to the website since it was launched in July, 2011. The ongoing rate of returning visitors (20%) indicates that the website is becoming a valuable tool used multiple times.     

Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia

The review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible for the inspection and oversight of these registered RECs to ensure that they comply with the regulatory requirements. However, this study highlights that each REC in Malaysia has a different standard operating procedure and ethical review process. Other procedural challenges identified include inadequate membership, poor mechanism for research monitoring after ethical approval, and insufficient resources. Establishments of a national standard of REC and a central ethics committee are suggested to ensure procedural compliance in the oversight of clinical trials in Malaysia. While there is a growing concern that procedural compliance may not have a direct impact on the protection of human subjects, our key point is that an ethical review system compliant with the national standards could serve as a strong framework to support and enhance the ethical quality of decision-making and judgement. We believe that being aware of how influential procedural compliance can be would help committees improve the ethical quality of their research review.     

Opportunities and Challenges for Studying Disaster Survivors

Studying survivors of natural disasters and traumatic events provides a unique opportunity to address some of the important and difficult questions in psychology and other social sciences. However, such an opportunity does not come without challenges. Several methodological challenges to studying survivors of natural disasters are discussed, including recruiting participants, choosing appropriate procedures, and the safety of data collectors. Several ethical issues are also presented, such as the ability of participants to make decisions, the impact of participating, and the importance of informed consent. In addition, approaches are suggested that help to deal with these methodological and ethical challenges. We conclude that while attention must be focused on methodological and ethical considerations, research stemming from natural disasters should be employed to answer important basic and applied conceptual questions and address issues of practice and policy, while assuring that steps have been taken to protect participants and that the potential risks are minimal.     

Gender‐Sensitive Research in a Chinese Community

The aim of this article is to foster an awareness of the need for gender‐sensitive research in the context of the methodological and ethical challenges posed by such research. We trace the development of gender sensitivity and masculinity in social work practice and research and connect this to an overview of the issues posed by research on sensitive topics. Reflecting on a research project involving Chinese male sexual abuse survivors, we draw conclusions illustrating and proposing a range of methodological practices and ethical safeguards. We underscore the importance of gender‐sensitivity in performing research on sensitive topics with men in a Chinese community.     

Current ethical issues in synthetic biology: where should we go from here?

Synthetic biology (SynBio) is an emerging scientific field which has quickly established momentum and visibility. Although no single definition of SynBio prevails, the field broadly encompasses the application of engineering principles to biology, redesigning biological materials and using them as new substrates to create products and entities not otherwise found in nature. This article first reviews SynBio, highlighting the novel aspects of this technology. It then synthesizes ethical issues highlighted in the literature to date and makes some initial claims that research on the ethical aspects of SynBio should: avoid creating a new subtype of bioethics, concentrate on novel concepts and problems, and be situated within a context of cooperative interdisciplinary investigation.     

Caregivers' use of spirituality in ethical decision-making

This qualitative study examined ethical dilemmas faced by female caregivers of frail elders as well as the dominant role of caregivers' spirituality in addressing these dilemmas. Dilemmas are difficult decisions that involve conflicting values, e.g., freedom versus safety. In-depth interviews were conducted with thirteen ethnically diverse caregivers recruited from a home health agency and its parent hospital. Purposive sampling was used to obtain variation among research participants. Focus group interviews of home health staff, key informant caregivers, and interviewees provided guidance for the research design, reflection on findings and development of implications. In order to deal with ethical dilemmas, all caregivers used spirituality as (1) a philosophy of life, e.g., "This is what you do when you're family," (2) an aid to decision-making, e.g., through the use of prayer; and/or, (3) a way to transcend dilemmas, e.g., "no choice is hard." Implications include the importance of caregiver-driven assessment, professional self-reflection, and sustained formal services for caregivers.     

中国应对全球气候变化的伦理责任评估

应对气候变化是一项全球性的任务,中国承担着不可推卸的责任。从《伦理维度应对气候的变化》（EDCC）白皮书提出的八个伦理维度分析了中国应对全球气候变化需承担的伦理责任,指出了中国特例下履行责任所面临的赔偿责任、开发新技术与新能源、国际国内参与、程序公平与正义等重大挑战,构建了中国政府、国内其他参与者及境外参与机构组成的多层次气候治理框架,提供了决策参考和建议。     

Developing and delivering new medical technologies: issues beyond access

The articles in this issue illuminate psychosocial issues raised by the development and delivery of new medical technologies. Five kinds of questions surface repeatedly: questions about a technology's purpose(s), the value judgments it presumes, the locus of its control, the external forces that drive it, and its long-term social risks. These questions take the discussion of new technologies beyond the challenge of improving access to their benefits. They also raise issues that will become increasingly important as the capabilities of medical technology expand. For example, they suggest research questions for three other emerging medical technologies: use of biosynthetic growth hormone to treat short stature in hormonally normal children, genetic tests on fetal cells from the circulating maternal blood, and development of clinically reliable biomarkers of the aging process. Part Three of this issue provides a theoretical basis for encouraging psychosocial perspectives in this area, by illustrating the central role that "robust," multifaceted analysis has come to play within the methods of bioethics.     

The market for (Ir)reproducible econometrics

Context: As the volume and complexity of research have increased, the amount of time spent on Institutional Review Board (IRB) review has decreased. The complexity of research has expanded, requiring increasingly specialized knowledge to review it. Dilemma: Under the current system, increasing numbers of research studies requiring expertise in ethics, new technologies or diverse study designs place a substantial burden upon local IRBs and often result in substantial variability among their reviews. This lack of uniformity in the review process creates uneven human subjects’ protection thus undermining the intent of the Common Rule. Objectives: To outline a scenario for expert centralized IRB review via implementation of a national virtual IRB review system overseen by the Office for Human Research Protections (OHRP). Conclusions: The complicated ethical issues and science involved in much of current research warrant an expert review panel. Centralized review would enable expert review specific to the research at hand, ensure consistency in human subjects protection, reduce the burden on local IRBs, and may reduce time spent obtaining approval. A centralized virtual system would allow IRB members to remain at their institutions while providing unprecedented expert review through currently available technology, and make information regarding monitoring and adverse event reporting available online in real-time.