Emergency research in children: options for ethical recruitment

The paucity of research data to guide current paediatric practice has led to children being termed therapeutic orphans. This difficulty is especially pertinent to research in emergency situations, such as acute resuscitation or critical care, where accepted ethical standards for overall research, have historically created practical difficulties for researchers. The welcome establishment of organisations to support UK paediatric research is helping to ensure safer and more effective medications for children, however as the balance between protection and access at the heart of the paediatric research ethical debate shifts to ever increasing access for researchers to children, it remains crucial to ensure the protection for these vulnerable participants. The fundamental protection for research subjects, namely their full informed consent before any recruitment, is not tenable in true emergency situations and so other approaches are warranted if standards are to be improved by human subjects research in such areas. Proxy, deferred and retrospective consent have all been advocated as solutions to this difficulty and this paper explores the ethical justification for these approaches and their utility in safeguarding children and families in emergency situations when traditional informed consent, as currently defined, cannot be obtained in the necessary time frame to enable research.     

Ethics of clinical trials in Nigeria

The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.     

Informed consent in emergency research. Prehospital thrombolytic therapy for acute myocardial infarction

Can the conscious patient in the midst of a medical emergency provide adequate informed consent for a clinical research protocol? Adequate consent is crucial to the ethical conduct of clinical trials, including those performed in emergency settings. We examine the problem of emergency informed consent. As an illustrative case, we discuss a pilot trial of prehospital thrombolytic therapy for myocardial infarction. Federal regulations for clinical research do not provide clear guidelines on emergency research in the conscious patient. Clinical investigators currently approach emergency consent in four ways: (1) avoid such research, (2) omit the consent process, (3) obtain deferred consent, or (4) obtain customary consent. We suggest a fifth alternative, two-step consent, which permits the conduct of emergency research while protecting the rights of the emergency research subjects. Such a process may serve as an alternative solution for future studies faced with the problem of informed consent in emergencies.     

Is there a future for clinical ethics services in Australia?

Clinical ethics refers to the consideration of ethical issues arising directly in the context of patient care. Health professionals are generally adept at effectively and sensitively managing ethical issues in clinical care. However, in some settings, multidisciplinary clinical ethics services may enhance clinical practice by assisting clinicians, patients and others to identify, understand and manage ethical issues. Clinical ethics services may be particularly valuable for situations in which moral perspectives diverge or communication has deteriorated. Such services may facilitate discussion and help the parties find mutually satisfactory solutions. Clinical ethics services may take various forms, including clinical ethics committees, ethics consultants, patient advocates or other mechanisms for responding to complaints and grievances. There is considerable disagreement about key aspects of clinical ethics services, including who should conduct them, how they should be run and what role they should play in decision-making.     

上海市院前分类救护实施方案初探

急救资源的紧缺与不合理使用并存是上海乃至全国院前急救机构亟待解决的问题,在广泛调研和已有工作的基础上,提出上海市院前分类救护初步实施方案,尝试对院前急救资源进行分类,按照病人病情的轻重缓急来调派急救资源,使真正的危急重症患者得到及时救治,同时尽量满足群众的非急救服务需求。     

Medical merchants: conflict of interest, office product sales and notifiable conduct

Professional ethical codes identify the issue of conflict of interest, which can distort doctors' objective judgements concerning the best interests of patients. Legal fiduciary duties may be owed by doctors to patients in situations of potential conflict of interest. Prescribing and dispensing functions have been largely legally separated to prevent conflicts of interest arising. The advent of integrative medicine has been accompanied by an apparent growth of in-house selling of therapeutic products. Medical merchandising constitutes a prima-facie conflict of interest and may amount to notifiable conduct under the Health Practitioner Regulation National Law provisions. We believe that doctors who sell therapeutic products should adhere to strict conditions to avoid significantly departing from accepted professional standards. Doctors who have a reasonable belief that a colleague is failing to comply with these conditions could consider notifying the Medical Board of Australia.     

Ethical dilemmas in malaria vector research in Africa: Making the difficult choice between mosquito,science and humans

Malaria vector studies are a very important aspect of malaria research as they assist researchers to learn more about the malaria vector. Research programmes in various African countries include studies that assess various methods of preventing malaria transmission including controlling the malaria vector. Various institutions have also established mosquito colonies that are maintained by staff from the institutions. Malaria vector research presents several dilemmas relating to the various ways in which humans are used in the malaria vector research enterprise. A review of the past and present practices reveals much about the prevailing attitudes and assumptions with regard to the ethical conduct of research involving humans. The focus on the science of malaria vector research has led some researchers in African institutions to engage in questionable practices which reveal the ethical tensions inherent in the choice between science and the principles of justice, nonmaleficence and respect for individuals. The analysis of past and present choices in malaria vector research has relevance to broader questions of human dignity and are in line with the current emphasis on ethical research worldwide.     

Duty to disclose what? Querying the putative obligation to return research results to participants

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In support of this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of "research results," specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action.     

The return of individual research findings in paediatric genetic research

The combination of the issue of return of individual genetic results/incidental findings and paediatric biobanks is not much discussed in ethical literature. The traditional arguments pro and con return of such findings focus on principles such as respect for persons, autonomy and solidarity. Two dimensions have been distilled from the discussion on return of individual results in a genetic research context: the respect for a participant's autonomy and the duty of the researcher. Concepts such as autonomy and solidarity do not fit easily in the discussion when paediatric biobanks are concerned. Although parents may be allowed to enrol children in minimal risk genetic research on stored tissue samples, they should not be given the option to opt out of receiving important health information. Also, children have a right to an open future: parents do not have the right to access any genetic data that a biobank holds on their children. In this respect, the guidelines on genetic testing of minors are applicable. With regard to the duty of the researcher the question of whether researchers have a more stringent duty to return important health information when their research subjects are children is more difficult to answer. A researcher's primary duty is to perform useful research, a policy to return individual results must not hamper this task. The fact that vulnerable children are concerned, is an additional factor that should be considered when a policy of returning results is laid down for a specific collection or research project.     

重视急诊医疗中的伦理问题

目的探讨急诊医疗中伦理问题的重要性。方法参考相关文献,并融合本院急诊的特点,探讨目前急诊医疗中所存在的伦理问题,以及重视伦理问题的必要性,并根据本院急诊医生小范围调查结果所反映的问题探讨相应对策。结果因目前急诊医疗的特殊性,产生了与其他科室所不同的伦理问题。结论要重视急诊医疗中伦理问题产生的原因,要完善急诊医疗中相应的政策法规和急诊流程问题;要重视病人权益,加强医患沟通,保障病人返家后的安全;同时也要减轻急诊医生工作压力,加强急诊医生可持续性培训和团队合作精神。     

Medical research in clinical emergency settings in Europe

Clinical emergencies necessitate immediate action to avert the danger to the patient's life or health. Emergency patients might be in greatest need of novel therapies, and even presumed willing to assume some risk, but research into emergency conditions should be conducted under commonly accepted principles that fulfil the scientific, ethical, and legal criteria. Such criteria already exist in the US, but are still under development in Europe. This article introduces criteria upon which trials in emergency settings may be ethically and legally justified in Europe. Based on both legal texts and professional guidelines, the author has established seven conditions for emergency research, of which informed consent and its substitutes, as well as the conditions of direct benefit requirement and necessity, are considered most problematic and therefore analysed more closely. Other conditions include absence of alternative methods, scientific validity, and approval by an ethics committee.     

Participation of healthy volunteers in research projects

Research that involves healthy normal volunteers frequently is performed. This article examines ethical guide-lines for the recruitment of healthy volunteers in research projects. Ethical decisions on projects that are based on patient-volunteers or healthy normal volunteers should balance the risk to the volunteer and the collective benefit to the community. For healthy normal volunteers that risk should be minimal or trivial. Investigators should follow recruitment practices that avoid approaches to persons who are dependent upon them in some way, and should carry the day-to-day ethical responsibility even after institutional ethical approval has been granted. Pilot studies and self-experimentation readily can transgress ethical guide-lines. Compensation for mishaps or injuries that occur during research in which there is no question of negligence (for example, an unforeseeable reaction in a phase-1 drug trial) is an unresolved issue which should be addressed by the research community. It is recommended that action be taken to ensure that healthy volunteers who participate in approved research have redress in the rare event of an accident, whether this is a result of negligence, chance or misadventure. Hospitals/institutions or other bodies that sponsor research should extend their insurance to cover specifically such unforeseeable events in which there may be liability, and to have the facility for a payment of beneficence in the case of accidents in which liability cannot be established.     

Institutional ethics review of clinical study agreements

Clinical Study Agreements (CSAs) can have profound effects both on the protection of human subjects and on the independence of investigators to conduct research with scientific integrity. Sponsors, institutions, and even investigators may fail to give adequate attention to these issues in the negotiation of CSAs. Despite the key role of CSAs in structuring ethically important aspects of research, they remain largely unregulated and unreviewed for adherence to ethical norms. Academic institutions routinely enter into research contracts that fail to meet adequate ethical standards. This is a failing that can have serious consequences. Accordingly, it is necessary that some independent body have the authority both to review research contracts for compliance with norms of subject protection and ethical integrity, and to reject studies that fail to meet ethical standards. Such review should take place prior to the start of research, not later. Because of its expertise and authority, the institutional ethics review board (IRB or REB) is the appropriate body to undertake such review. Much recent commentary has focused on contractual restrictions on the investigator's freedom to publish research findings. The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review.     

从甲型H1N1流感看突发传染病事件防治中的伦理

防治甲型H1N1流感这类突发传染病事件是一种公共健康实践,其伦理问题实质上也是公共健康伦理问题。主要表现为个人利益与公共利益的冲突、个人人身自由与隔离的冲突、个人隐私权与部分医疗信息公开的冲突以及患者的自主择医权与强制治疗的冲突。问题的核心是要求个人利益服从于公共利益,同时也要求政府和社会尊重个人的人身自由、隐私权和健康权等。     

对人类胚胎干细胞来源的伦理审视

伦理审查的重点之一:胚胎干细胞的来源是否符合了伦理要求,2003年出台的《人胚胎干细胞研究的伦理指导原则》没有提供可操作的审查要求。结合我国国情,审视了人胚胎干细胞来源中若干伦理问题,并提出了四点审查要点:①在目前的情况下,"冷冻的多余的胚胎"可以作为胚胎干细胞研究的主要来源,但研究者不可过度依赖多余的胚胎;②在接受自愿捐献的卵子时,研究者要实现对捐卵者的伤害最低化,不得采取胁迫、引诱的方式获取卵子;③在使用"流产胎儿"时,要获得孕妇或家庭的知情同意,不可为获得一个研究用的流产胎儿,而让一个妇女先怀孕。④为达治疗性克隆研究之目的,研究者可以通过体细胞核移植技术制造胚胎干细胞,但研究中胚胎要在14天内销毁。     

Disaster management: lessons from immediate responses to the tsunami

There are many lessons learnt from the immediate reactions of people in the aftermath of the vast destruction from the giant waves that hit Sri Lanka. Reactions of victims fell between extremes of resilience and helplessness. Responses of those not directly harmed illustrated the two extremes--selflessness and depravity. These responses offer insight into how we live and how we react to situations, and also to an extent how we should be reacting. Among these is that helpers should respect and involve, from the inception, the resources within the group or community affected by the disaster. Control of the relief effort to the maximum feasible extent, should be in the hands of those at whom it is directed.     

Ethics in a scientific approach: the importance of the biostatistician in research ethics committees

In medical practice and research it is necessary to consider the rights of the researcher or physician and of the subject or patient, to conform to scientific standards and to examine the appropriateness with respect to laws and moral values. Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research on human subjects. Research of no scientific value is also against ethical principles. To obtain valid and reliable results from biomedical research, it is a scientific and ethical obligation to make use of the science of statistics. Therefore, for research to be evaluated using biostatistics intensively from ethical and scientific points of view, a biostatistics expert is necessary on research ethics committees. Developments in Turkey are used as examples.     

Methodological quality and reporting of ethical requirements in phase III cancer trials

BACKGROUND: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). RESULTS: The mean Jadad score was 9.86 +/- 1.117. The methodological quality was poor in 75 RCTs (Jadad score <9). The mean Berdeu score was 0.42 +/- 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 +/- 0.133; it was 0.43 +/- 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively. CONCLUSION: The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.     

What makes clinical research ethical?

Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.     

Emergency contraception for sexual assault victims in North Carolina emergency departments

INTRODUCTION: One in 5 women is a victim of sexual assault. This study examines the administration of emergency contraception to victims of sexual assault in North Carolina hospital emergency departments. METHODS: One hundred seventeen surveys were mailed to hospital emergency departments across the state to determine their emergency contraception practices for victims ofsexual assault. The survey contained 11 questions about emergency contraception practices for victims. RESULTS: Of the 117 surveys, 103 were returned revealing that just over 50% of the hospitals in North Carolina treated victims with emergency contraception without exception. Both dispensing emergency contraception and providing information about emergency contraception were significantly associated with having a sexual assault nurse examiner program. CONCLUSION: Results from this study demonstrate inconsistent provision of emergency contraception to victims of sexual assault; however, there is greater consistency of emergency contraception use by emergency departments using sexual assault nurse examiners.