Protection of human subjects; informed consent--FDA. Final rule

The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.     

Educational Research and the Protection of Human Subjects

Educational research is increasingly subject to legal restrictions designed for the protection of human subjects of research. In this article the author discusses legal restrictions–both in the courts and under HEW regulations–on educational research, comparing these restrictions with those on biomedical research. He finds that although educational research in particular instances may give rise to suits for damages for invasion of privacy or intentional infliction of psychological distress, the legal issues relating to educational research will most often be resolved in proceedings before institutional review boards charged by HEW with the responsibility for passing upon proposals to conduct research on human subjects. He argues that the interests protected in proceedings before institutional review boards are not limited to those that have received judicial recognition in suits for damages. The author finds that the requirement that the informed consent of subjects be obtained presents difficult issues for educational research. He notes in particular the problems presented by research proposals that as an element of the research design contemplate the observation of subjects without their knowledge and the use of children as research subjects.     

China: people living with HIV complain about conduct of medical research

In January 2004, four people living with HIV/AIDS from Shuangmiao village, Henan Province, China, went public with complaints about the conduct of a medical experiment, raising questions about whether research subjects gave their informed consent to participate in the experiment. The complaints and questions were contained in a letter to the Ethics Review Panel of the Center for STD/AIDS Prevention and Control at the China Center for Disease Prevention and Control.     

Legal prerequisites for clinical trials under the revised Declaration of Helsinki and the European Convention on Human Rights and Biomedicine.

Biomedical research is a perennially controversial subject. While the provisions of the Revised Declaration of Helsinki enjoy world-wide acceptance, they are increasingly placed in question--not least by the Council of Europe's Bioethics Convention, which allows non-therapeutic research in restricted cases on those incapable of giving informed consent. Taking as its starting-point the fundamental conflict between the general interest in research and the individual interests of the patients concerned, this article analyses the conditions under which medical experimentation on human beings is permissible. The article recognises the model of risk/benefit analysis and the doctrine of informed consent as equally valid core principles which do not conflict with restricted, non-therapeutic research, whether on patients who lack the capacity to consent or in placebo-controlled trials.     

Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions

Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.     

Incidental findings in CT colonography: literature review and survey of current research practice

Incidental findings (IFs) of potential medical significance are seen in approximately 5-8 percent of asymptomatic subjects and 16 percent of symptomatic subjects participating in large computed tomography (CT) colonography (CTC) studies, with the incidence varying further by CT acquisition technique. While most CTC research programs have a well-defined plan to detect and disclose IFs, such plans are largely communicated only verbally. Written consent documents should also inform subjects of how IFs of potential medical significance will be detected and reported in CTC research studies.     

Medical devices; procedures for investigational device exemptions--Food and Drug Administration. Final rule

This rule sets forth the procedures and conditions under which investigations of medical devices involving human subjects may be exempt from certain requirements of the Federal Food, Drug, and Cosmetic Act, in accordance with the Medical Device Amendments of 1976. The rule sets out the procedures to obtain an investigational device exemption (IDE); it delineates the responsibilities of sponsors, institutional review boards, and clinical investigators with respect to clinical investigations of medical devices; and the rule also prescribes informed consent requirements and specifies recordkeeping and reporting requirements.     

医疗行为中的患者承诺研究

医疗行为中的患者承诺不是一种对利益的处分与放弃,而是一种对医疗风险的分担,其体现了“被允许的危险”理论与“危险分配”的法理;患者承诺的有效要件包括认识能力与真实意思两个方面;未经患者承诺的医疗行为是专断的医疗行为,应根据医疗效果是否最终实现分别进行处理。     

Legal and ethical considerations of forensic anthropological research

In the UK, Forensic Anthropology is maturing rapidly, consequently demanding discussion of previously overlooked yet fundamental principles of this discipline. UK law and ethics are interpreted from a forensic anthropological standpoint. First, the influence of UK law and ethics on the stages of forensic anthropological research (the collection, analysis and storage of human remains) are discussed. Existing ethical codes of conduct are investigated for their relevance to researching forensic anthropologists. It is concluded that: when appropriately interpreted, UK law and ethics are extremely influential on forensic anthropological research; debate within this area is required; and that an understanding of the law and ethical thought is vital for the successful growth of forensic anthropology in the UK.     

Consent forms in genomics: the difference between law and practice

Consent forms are the principal method for obtaining informed consent from biomedical research participants. The significance of these forms is increasing as more secondary research is undertaken on existing research samples and information, and samples are deposited in biobanks accessible to many researchers. We reviewed a selection of consent forms used in European Genome-Wide Association Studies (GWAS) and identified four common elements that were found in every consent form. Our analysis showed that only two of the four most commonly found elements in our sample of informed consent forms were required in UK law. This raises questions about what should be put in informed consent forms for research participants. These findings could be beneficial for the formulation of participant information and consent documentation in the future studies.     

Tackling legal challenges posed by population biobanks: reconceptualising consent requirements

This paper examines, from an Australian and international perspective, the phenomenon of population 'biobanks' (research platforms comprising collections of human genetic samples or 'biospecimens' and relevant personal information) and the legal challenges that this development presents. In particular, the paper focuses on the legal concept of consent and the tensions on the traditional understanding of consent that large-scale, long-term population biobanks exert. The aim of the paper is to review the operation of consent principles as they apply to population biobanks and to propose a way forward for how the consent concept can be reconceptualised to meet their demands. In particular, the paper argues for a more liberal approach which allows for 'broad' (or 'enlarged' or 'open') consent in circumstances where permission is sought for future use of samples in, as yet unspecified, genetic research. In pursuing this aim, the objectives underlying this paper are to ensure that unnecessary impediments to research are removed and, at the same time, to facilitate research participation and respect for autonomous choices by research subjects.     

Regulating Political Donations by Companies: Challenges and Misconceptions

This paper analyses the regulation of company political donations in the UK. It argues that UK policy makers have failed to understand the nature of company donors and, consequently, that the UK Companies Act 2006 requirement for shareholder consent for company donations is not an effective solution to concerns about company donors. To this end, the paper presents a comprehensive empirical analysis of company donations to show that the vast majority of donor companies are closely held or owner‐managed entities where shareholder consent rules are ineffective. The paper highlights particular concerns that arise with donation by such companies and argues for a more accurate understanding of company donations in order to formulate effective policy responses to concerns about the role of company donors.     

Ethics of Population-Based Research

This paper considers the morally relevant ways in which population-based research is a distinct type of human subjects research that have unique moral considerations relevant for public health practitioners and researchers. By defining population-based research, the authors distinguish it from public health practice and then consider, in more detail, the ways in which population-based research differs from clinical human subjects research. Based upon the distinctions between these types of research and practice, they identify five important issues that arise in the design and conduct of certain kinds of population-based research. The authors hope that public health practitioners find these distinctions useful in determining when their work may actually be population-based research and that public health researchers use them to identify the areas where ethical issues in their research may arise.     

mHealth and data protection – the letter and the spirit of consent legal requirements

In this article, the role of consent is discussed in the framework of fundamental rights and in the context of mobile health technologies (mHealth), such as smart phones, mobile phones or tablet/palm-held computing devices to provide healthcare. The authors surmise how, in practice, although there will be more emphasis on informed consent formally, there will be less space for genuine individual consent. This betrays a focus more on the letter of consent rules in data protection than their spirit. This risks reducing consent to a tick box operation in a manner analogous to consumer transactions, something manifestly unsuitable for consent, even if only in informational terms, during medical procedures.     

医疗正当行为中被允许的危险理论初探

医疗行为作为一种正当业务行为,其合法化根据应立足于被允许的危险之法理加以解释;对被允许的危险的判断,应坚持结果无价值的立场,并考虑行为无价值的因素进行综合评价;医疗行为中被允许的危险理论的适用主要体现在医疗主体、社会必要性、患者的承诺、法益衡量几个方面。     

The legal geographies of transnational cyber-prosecutions: extradition,human rights and forum shifting

This article describes legal and human rights issues in three cases of transnational online offending involving extradition requests by the United States (US). These cases were selected as all suspects claimed the negative impacts of autism spectrum disorders (ASDs) were sufficient to deny extradition on human rights grounds. We demonstrate how recent developments in UK and Irish extradition law raise human rights and prosecutorial challenges specific to online offending that are not met by established protections under domestic and internationally sanctioned approaches to extradition or human rights law. In these cases, although the allegedly unlawful conduct occurred exclusively online and concurrent jurisdiction enables prosecution at both the source and location of harm, we demonstrate why national courts hearing extradition challenges are extremely reluctant to shift the trial forum. We conclude by discussing the implications of the new geographies of online offending for future criminological research and transnational criminal justice.     

Exemption of certain research and demonstration projects from regulations for protection of human research subjects--Office of the Secretary, HHS. Final rule

The Department of Health and Human Services (the Department or HHS) is including among the types of research specifically exempt from the application of the regulatory requirements of 45 CFR Part 46 (protection of human research subjects) research and demonstration projects conducted under the Social Security Act and other federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment. These demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices. Review by an Institutional Review Board (IRB), as required under Part 46, would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of this unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation. However, in order to ensure the continued protection of human subjects participating in such research activity, the Department is adding a specific requirement of written, informed consent in any instance, not reviewed by an IRB, in which the Secretary determines that the research activity presents a danger to the physical, mental or emotional well-being of a participant.     

Research on medical records without informed consent

Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.     

The Human Transplantation (Wales) Act 2013: an Act of Encouragement,not Enforcement

The Human Transplantation (Wales) Act became law in Wales in September 2013. The Act aims to increase deceased donor organ and tissue donation in Wales by introducing a ‘soft opt‐out’ system to replace the previous requirement of express ‘appropriate’ consent under the Human Tissue Act 2004. Adults dying in Wales (with certain exceptions) will be ‘deemed’ to consent to donation, unless evidence of their objection is produced, and a duty is imposed on Ministers to promote transplantation and inform the public through awareness campaigns about how to choose the deemed status or opt out. Although a welcome development, these campaigns may obscure the effects of deemed consent, especially in the context of generally rising UK donation rates. There may also be problems of legal interpretation and of integration with the ‘opt‐in’ laws in the rest of the UK. In the absence of any statutory duty to retrieve all lawfully donated organs, the apparently restricted influence of donor relatives is likely to remain effectively dominant.