Performance of Ethical Military Research is Possible: On and Off the Battlefield

Many of the same fundamental principles and regulations that govern civilian biomedical research also apply to research conducted by the US Military. Despite these similarities, the conduct of research by the US Military has additional requirements designed to preserve service members' informed consent rights, ethical standards and information that may be deemed classified. Furthermore, there are also additional rules and regulations associated with potential research to be done in a combat setting. Before conducting battlefield research, many unique circumstances must be considered to include: (1) the current legal and regulatory requirements for advanced informed consent (2) the tactical situations, and the ability to adequately document in the "austere" environment (3) the need to provide improved drugs and devices for combat casualty care and (4) the special nature of the superior-subordinate relationship. This paper discusses historical background, regulatory oversight, ethical implications and release of information as it pertains to research conducted by the US Military.     

Exploring Understanding of “Understanding”: The Paradigm Case of Biobank Consent Comprehension

Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether consent comprehension is an ethical requirement or an ethical aspiration.     

Collective Informed Consent and Decision Power

It has been suggested that, in addition to individual level decision-making, informed consent procedures could be used in collective decision-making too. One of the main criticisms directed at this suggestion concerns decision-making power. It is maintained that consent is a veto power concept and that, as such, it is not appropriate for collective decision-making. This paper examines this objection to collective informed consent. It argues that veto power informed consent can have some uses in the collective level and that when it is not appropriate the decision power a concerned party ought to have in connection with an arrangement should be made relative to the interest she has at stake in it. It concludes that the objection examined does not undermine collective informed consent.

Protecting people in research: a comparison between biomedical and traffic research

Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. Finally, we argue that there is a need for systematic studies of the ethics of traffic research and point to some of the issues that need to be addressed.     

The Role of the Humanities and Social Sciences in Nanotechnology Research and Development

The experience with genetically modified foods has been prominent in motivating science, industry and regulatory bodies to address the social and ethical dimensions of nanotechnology. The overall objective is to gain the general public’s acceptance of nanotechnology in order not to provoke a consumer boycott as it happened with genetically modified foods. It is stated implicitly in reports on nanotechnology research and development that this acceptance depends on the public’s confidence in the technology and that the confidence is created on the basis of information, education, openness and debate about scientific and technological developments. Hence, it is assumed that informing and educating the public will create trust, which will consequently lead to an acceptance of nanotechnology. Thus, the humanities and social sciences are seen as tools to achieve public acceptance. In this paper, the author argues that this is a narrow apprehension of the role of the humanities and social sciences. The humanities and social sciences have a critical function asking fundamental questions and informing the public about these reflections. This may lead to scepticism, however, the motivation for addressing the social and ethical dimensions of nanotechnology should not be public acceptance but informed judgement. The author illustrates this critical function by discussing the role, motivation and contribution of ethics as an example. Lastly, the author shows that a possible strategy for incorporating the humanities and the social sciences into nanotechnology research and development is Real-Time Technology Assessment, where the purpose is to integrate natural science and engineering investigations with ethical, legal and social science from the outset.

Neuropsychological Functioning and Recall of Research Consent Information Among Drug Court Clients

Evidence suggests that research participants often fail to recall much of the information provided during the informed consent process. This study was conducted to determine the proportion of consent information recalled by drug court participants following a structured informed consent procedure and the neuropsychological factors that were related to recall. Eighty-five participants completed a standard informed consent procedure to participate in an ongoing research study, followed by a 17-item consent quiz and a brief neuropsychological battery 2 weeks later. Participants performed within the normal range on most of the neuropsychological measures, although roughly one third showed deficits on measures of executive functioning. Participants failed to recall over 65% of the consent information within 2 weeks of entering the study, and their recall was significantly correlated with verbal IQ, drug problem severity, reading ability, memory, and attention. These factors may be useful in determining whether research participants require enhanced consent procedures.     

基因研究中的知情同意之惑

知情同意作为生命伦理的重要原则,在基因研究中同样占据重要的地位,由于基因研究中知情同意的异质性,在基因研究中面临着诸如如何理解其知情同意的异质性、群体知情同意、基因知情与基因隐私、利益冲突等问题.通过分析基因研究中知情同意的特殊性,综合国内外此领域的已有研究,运用理论联系实际的方法,得出结论认为,只有正确区分基因知情与基因隐私的权利主体,用伦理规范来解决利益冲突,在发展中不断完善知情同意,才能够取得科技与伦理的共赢.     

Assent and Dissent: Ethical Considerations in Research With Toddlers

In accordance with ethical principles and standards, researchers conducting studies with children are expected to seek assent and respect their dissent from participation. Little attention has been given to assent and dissent in research with toddlers, who have limited cognitive and emotional capabilities. We discuss research with toddlers in the context of assent and dissent and propose guidelines to ensure that research with toddlers still adheres to ethical principles. These guidelines include designing engaging studies, monitoring refusal and distress, and partnering with parents. Research with toddlers requires flexibility and creativity to respect toddlers in the context of their developmental capabilities.     

Balancing Ethical Principles in Emergency Medicine Research

This paper attempts to provide a broader view into the ethical issues surrounding the field of emergency medicine (EM) research. It starts from defining bioethically relevant features of EM and presents this field in the context of different models of health care provider–patient relationship. The paper also provides a short overview of the “post-Nuremberg” evolution of the main international research ethics guidelines relevant to EM research which demonstrates a tendency of liberalization of research on incapable persons. This tendency culminates with the exceptions to informed consent for EM research which is supposed to be balanced by other research ethics principles, especially a careful rationing of risks and benefits. This finally brings us towards a critical analysis of the minimal risk standard which is one of the main fundamental safeguards in EM research. An earlier version of this paper was presented at The 7th International Conference on Bioethics on “The Ethics of Research in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland.     

Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials Among Criminally Involved Substance Abusers?

We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants' perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies.