What a Tangled Web We Weave: Ethical and Legal Implications of Deception in Recruitment

Deception in human subject research is neither uncommon nor prohibited. The use of deception in the recruitment phase of clinical research has received relatively little attention. Given that informed consent is foundational to human subject research, the practice of misrepresenting the study purpose in clinical research would seem to contradict one of the fundamental tenets of ethical human subjects research. Using the example of prodromal psychosis, this article the ethical and legal implications of deception in recruitment and the sufficiency of current guidance on the practice when the study involves a stigmatizing condition, the collection of genetic samples, or both. I conclude that when these two elements are present, deception should only be used when absolutely necessary and, if used, researchers should be required to debrief participants before the collection of genetic samples and give particular attention to minimizing risks of privacy breaches.     

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.     

Ethics of research design

Discussions of ethical issues in research involving human subjects most usually provoke concerns about valid informed consent procedures. However, considering the recognized limitations of informed consent, arguably the way a study is designed is a more consequential concern for subject well‐being. This paper summarizes ethical issues in the design of clinical research, with reference to historic and current guidelines. Special attention is given to randomized clinical trials (RCTs) and psychiatric research.     

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.     

Recruitment and retention of ethnically diverse long-term family caregivers for research

The inclusion of ethnically diverse long-term care family caregivers is significant in research, particularly in social work research because of the importance placed on diverse populations. However, the inclusion of diverse populations poses a set of unique recruitment and retention challenges for researchers. This process can be particularly complicated when multiple long-term care recruitment partners are utilized and when the project involves a multi-phase data collection plan with different minority recruitment needs for each phase. In our work we learned that: (a) research teams should plan for gender and ethnic differences in the ways that family caregivers think about and approach research involvement, (b) socioeconomic disadvantages and ethnic differences have both independent and interactive effects on research participation, (c) physical and emotional "costs," as well as financial costs, of caregiver participation should be given more attention in informed consent procedures, and (d) agency collaboration for minority recruitment and retention requires continuous nurturing and sustained effort by all members of the research team.     

Person-oriented research ethics: integrating relational and everyday ethics in research

Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this article presents a “person-oriented research ethics” approach. Five practical guideposts of person-oriented research ethics are identified, as follows: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making. These guideposts are defined and illustrated with respect to different aspects of the research process (e.g., research design, recruitment, data collection). The person-oriented research ethics approach provides a toolkit to individual researchers, research groups, and research institutions in both biomedical and social science research wishing to expand their commitment to ethics in research.     

Empirically supported ethical research practice: the costs and benefits of research from the participants' view

Researchers and institutional review boards are routinely called upon to evaluate the cost-benefit status of proposed research protocols that involve human participants. Often these assessments are based on subjective judgments in the absence of empirical data. This reliance on subjective judgments is of particular concern for studies involving clinical samples where unfounded assumptions may adversely affect research progress or clinical outcomes. The Reactions to Research Participation Questionnaire (RRPQ) was designed to address this shortcoming and to help promote ethical decision making about research practice. The present study describes development of the RRPQ and presents a series of exploratory and confirmatory analyses investigating its structure. Based on these findings, a revised version of the instrument and suggestions for future research are presented. This approach provides a foundation for scientifically informed protection of human subjects.     

Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices

Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.     

Research on environmental health interventions: ethical problems and solutions

This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects.     

Research on Environmental Health Interventions: Ethical Problems and Solutions

This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects.     

Empirically supported ethical research practice: The costs and benefits of research from the participants’ view

Researchers and institutional review boards are routinely called upon to evaluate the cost‐benefit status of proposed research protocols that involve human participants. Often these assessments are based on subjective judgments in the absence of empirical data. This reliance on subjective judgments is of particular concern for studies involving clinical samples where unfounded assumptions may adversely affect research progress or clinical outcomes. The Reactions to Research Participation Questionnaire (RRPQ) was designed to address this shortcoming and to help promote ethical decision making about research practice. The present study describes development of the RRPQ and presents a series of exploratory and confirmatory analyses investigating its structure. Based on these findings, a revised version of the instrument and suggestions for future research are presented. This approach provides a foundation for scientifically informed protection of human subjects.     

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.     

Assessing commercial feasibility: a practical and ethical prerequisite for human clinical testing

This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons--particularly for orphan diseases without sufficient revenue incentive for industry investment--regardless of the effectiveness which might be demonstrated in human clinical testing. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. A model compromising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.     

Letters to the editor

This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons—particularly for orphan diseases without sufficient revenue incentive for industry investment—regardless of the effectiveness which might be demonstrated in human clinical testing. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. A model comprising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.     

Ethics and research assessing the relative roles of genes and the environment

Research on the interaction of genes and the environment is revealing that many human diseases have both genetic and environmental components. Even traditional "environmental" diseases, such as infections, appear to interact with genetic components in the human host. Environmental genetics research will inevitably increase understanding of individual susceptibilities to toxic exposures in the environment and harmful side effects of medications; therefore, it has great promise for improving the prevention and treatment of human diseases. However, realizing the benefits of this research requires careful attention to ethical issues that are particularly relevant in this context. This article reviews some of the most pressing issues related to research design and methods, as well as from the application of research results (e.g., workplace genetic screening and legal toxic torts, personal medical responsibility, and the relationship between genetics and public health measures).     

Ethics and Research Assessing the Relative Roles of Genes and the Environment*

Research on the interaction of genes and the environment is revealing that many human diseases have both genetic and environmental components. Even traditional “environmental” diseases, such as infections, appear to interact with genetic components in the human host. Environmental genetics research will inevitably increase understanding of individual susceptibilities to toxic exposures in the environment and harmful side effects of medications; therefore, it has great promise for improving the prevention and treatment of human diseases. However, realizing the benefits of this research requires careful attention to ethical issues that are particularly relevant in this context. This article reviews some of the most pressing issues related to research design and methods, as well as from the application of research results (e.g., workplace genetic screening and legal toxic torts, personal medical responsibility, and the relationship between genetics and public health measures).     

Clinical trials integrity: a CRO perspective

When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.     

Researching Risk in the Probation Service

This paper will draw upon research and consultancy experience across a number of projects on risk assessment and management in the Probation Service between 1993 and 1999. The projects reflect a range of sponsors and funders, from central government bodies such as the Home Office and the Scottish Office, to professional, managerial and employment bodies such as the Association of Chief Officers of Probation and the Central Council of Probation Committees, to individual Probation Service areas. The projects have required engagement with different levels of staff and different vested interests, including the professional/union bodies representing the management and officer grades respectively, in addition to central government policy makers. All the projects have had an applied policy and practice focus. The paper begins with a review of current ethical and political dilemmas in research on offender risk assessment, and then contemporary responses to ethical dilemmas are critically reviewed, followed by an outline of 'practice guidance' for researchers. The paper concludes by arguing that researchers in the social arena should be subject to the same standards of defensible decision making as their counterparts in social care practice, and that essential to such defensibility is the transparent demonstration of the 'grounds' upon which ethical decisions are made.     

对人力资源会计研究的质疑与设想

虽然实施人力资源会计迫在眉睫 ,但多年来我国人力资源会计始终处于理论研究阶段 ,实际运用困难重重 ,主要原因在于存在研究误区 ,使现有的计量方法和模型难以应用。当前人力资源会计的学科归属、计量方法、人力资产及人力资本核算内容等存在许多问题。从具有可操作性出发 ,根据人力资产是能为企业带来超额收益的那部分人力资源的观点对人力资产及人力资本的计量、核算和报告形式等进行更为科学的设计。