Analyzing the Use of Race and Ethnicity in Biomedical Research from a Local Community Perspective

Lost in the debate over the use of racial and ethnic categories in biomedical research is community-level analysis of how these categories function and influence health. Such analysis offers a powerful critique of national and transnational categories usually used in biomedical research such as "African-American" and "Native American." Ethnographic research on local African-American and Native American communities in Oklahoma shows the importance of community-level analysis. Local ("intra-community") health practices tend to be shared by members of an everyday interactional community without regard to racial or ethnic identity. Externally created ("extra-community") practices tend to be based on the existence of externally-imposed racial or ethnic identities, but African-American and Native American community members show similar patterns in their use of extra-community practices. Thus, membership in an interactional community seems more important than externally-imposed racial or ethnic identity in determining local health practices, while class may be as or more important in accounting for extra-community practices.     

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.     

The Human Subjects Protection Committee: An Experiment in Decentralized Federal Regulation

The human subjects protection committee is the principal legal mechanism for protecting the rights and welfare of human subjects of biomedical and behavioral research. In this article the author explores the influence of variations in the structure of the review process and in the composition and operating procedures of the committees on committee performance. He also assesses revisions in the review process proposed by the National Commission on the Protection of Subjects of Biomedical and Behavioral Research.     

Biomedical telemetry transmitters--FCC. Final rule

By this Report and Order, the Commission amends its regulations regarding the unlicensed operation of biomedical telemetry transmitters in the 174-216 MHz (TV channels 7-13) and 470-668 MHz (TV channels 14-46) bands as proposed in the Notice of Proposed Rule Making ("Notice") in this proceeding, 61 FR 3367, January 31, 1996. These amendments will provide patients in health care facilities the ability to move about in a limited area while being continually monitored, speeding patient recovery times, shortening lengths of stay, and reducing health care costs. The standards being adopted for these devices should protect the licensed services operating in the TV bands. Further, a coordination procedure has been implemented to protect radio astronomy observatories from potential interference from biomedical telemetry systems operating on 608-614 MHz (TV channel 37).     

Off with their Heads: The Need to Criminalize some forms of Scientific Misconduct

Improvement in policy for the management of scientific misconduct has been slow. While assurance of due process at the ORI level is now in place, similar protections at the institutional level and institutional responsibility for further oversight and a workplace where the responsible conduct of research can be practiced have not yet been addressed. In contrast, policy regarding human subject protection has evolved rapidly to reflect firmer norms, with decisive priority given to subject protection over scientific or social needs. Perhaps because scientific misconduct policy has the potential to harm the careers of individual scientists and harms to individual subjects are thought to be indirect, the scientific community has been successful in blocking every move toward testing more rigorous regulation. The mantras that scientists can discipline their own, and the price of competitive science is some level of scientific misconduct are not persuasive. The standards by which science is judged should not be an exception to those governing others who deal with the public's money and have a duty to the public interest.     

Privacy and research involving humans

Human research ethics committees in Australia are required to consider compliance with privacy law as an element of the ethics of research. Recent legislation has introduced federal private sector privacy protection, as well as privacy protection at State and Territory levels. In Victoria, which is used as an example in this article, State privacy legislation covers public sector information and health records. This article considers the implications for research involving human participants and for ethics committees of the new privacy regimes. Although privacy law is a potential barrier to research about humans, the need for exceptions has been dealt with effectively in the context of medical or health research. However, privacy law and its chilling effect could potentially be a serious impediment to some forms of non-health-related research, such as social and socio-legal research.     

The development of technical and spectrum requirements for meeting federal, state and local public safety agency communication requirements through the year 2010, establishment of rules and requirements for priority access service--FCC. Proposed rule

The federal Communications Commission (Commission) adopted a Third Notice of Proposed Rule Making ("Third Notice") contemporaneously with a First Report and Order ("First Report") that is summarized elsewhere in this edition of the Federal Register. By its Third Notice, the Commission makes a range of proposals and seeks comment relating to public safety communications in the 746-806 MHz band ("700 MHz band") and in general. The Commission invites comment on how to license the 8.8 megahertz of 700 MHz band spectrum designated as reserved in the First Report and on whether to directly license each state or use a regional planning process to administer the nationwide interoperability frequencies (2.6 MHz of spectrum designated in the First Report) pursuant to the national interoperability plan to be established by the National Coordination Committee. The Third Notice also discusses protection requirements for the Global Navigation Satellite Systems and offers proposals to facilitate use of nationwide interoperability in public safety bands below 512 MHz. Finally, because many of the automated and intelligent machines and systems on which public safety entities depend for their operations were not designed to take into account the date change that will occur on January 1, 2000, the Commission also seeks comment on how best to ascertain the extent, reach, and effectiveness of Year 2000 compliance initiatives that have been or are being undertaken by public safety entities, to better understand the nature of the Year 2000 problem and the potential risks posed to public safety communications networks. This action addresses an urgent need for additional public safety radio spectrum and the need for nationwide interoperability among local, state, and federal entities. By this action, the Commission also takes additional steps toward achieving its goals of developing a flexible regulatory framework to meet vital current and future public safety communications needs and ensuring that sufficient spectrum to accommodate efficient, effective telecommunications facilities and services will be available to satisfy public safety communications needs into the 21st century.     

The emergence of biobanks in the legal landscape: towards a new model of governance

Biobanks are increasingly seen as new tools for medical research. Their main purpose is to collect, store, and distribute human body materials. These activities are regulated by legal instruments which are heterogeneous in source (national and international), and in form (binding and non-binding). We analyse these to underline the need for a new model of governance for modern biobanks. The protection initially ensured by respect for fundamental rights will need to focus on more interactions with society in order to ensure biobanks' sustainability. International regulation is more oriented on ethical principles and traces the limits of the uses of genetics, while European regulation is more concerned with the protection of fundamental rights and the elaboration of standards for biobanks' quality assurance. But is this protection adequate and sufficient? Do we need to move from the biomedical research analogy to new forms of legal protection, and governance systems which involve citizens?     

Exemption of certain research and demonstration projects from regulations for protection of human research subjects--DHHS. Notice of proposed rulemaking

The Department of Health and Human Services (the Department or HHS) is proposing to include 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. This proposed amendment to the revised final regulations for protection of human research subjects (published January 26, 1981) would, in effect, restore to the regulations an exemption included in the initial notice of proposed rulemaking (NPRM) (published August 14, 1979). 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 IRB would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of an unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation.     

Can the GDPR make data flow for research easier? Yes it can,by differentiating! A careful reading of the GDPR shows how EU data protection law leaves open some significant flexibilities for data protection-sound research activities

Against the common perception of data protection as a road-block, we demonstrate that the GDPR can work as a research enabler. This study demonstrates that European data protection law's regulatory pillars, the first related to the protection of the fundamental right to data protection and the second regarding the promotion of the free flow of personal data, result into an architecture of layered data protection regimes, which come to tighten or relax data subjects’ rights and data protection safeguards vis à vis processing activities differently grounded in public or merely economic interests. Each of the identified data protection regimes shape different “enabling regulatory spots” for the processing of sensitive personal data for research purposes.     

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.     

Intellectual Property and Global Health: From Corporate Social Responsibility to the Access to Knowledge Movement

Any system for the protection of intellectual property rights (IPRs) has three main kinds of distributive effects. It will determine or influence: (a) the types of objects that will be developed and for which IPRs will be sought; (b) the differential access various people will have to these objects; and (c) the distribution of the IPRs themselves among various actors. What this means to the area of pharmaceutical research is that many urgently needed medicines will not be developed at all, that the existing medicines will not be suitable for countries with a precarious health infrastructure or not target the disease variety that is prevalent in poorer regions. Such effects are commonly captured under the rubric of the “10/90 gap” in biomedical research. High prices will also restrict access to medicines as well endanger compliance to treatment schemes. IPRs are mainly held by multinational corporations situated in the developed world, which not only raises egalitarian concerns, but also severely limits the possibilities of companies in poorer countries to realize improvements on existing inventions, as they cannot financially afford to secure freedom to operate, which systematically shrinks the number of potential innovators. Those inequities lead to an enormous burden for the global poor and since no institution is willing to assume the responsibility to fulfil the right to health and the corresponding right of access to essential medicines, we have to analyse alternatives or additions to the actual intellectual property regimes in order to create new incentives to fill this gap.     

现代生命医学与美国相关法律的发展

近30年来现代医学技术的高速发展及惊人进步挑战着世界各国的法律及道德观念.本世纪更因生命科学的巨大发展而被命名为生命科学世纪.现代生命科学在变革世界的同时也带来了史无前例的道德伦理问题,引发了激烈的争论.为了适应这些新的发展,美国的法律做出了相应的变革.这些新的法律法规影响着美国人民的工作生活及几乎所有的法律领域,例如医疗法、家庭法、遗产法、商业法、专利法、刑法等都极大程度地受到现代医学及相关法律的制约与影响.当代各个领域中的美国律师及政治领导人必须熟悉生命医学的有关法律,以为社会提供高质量和全方位的服务.生命医学法律更是当代世界及美国政坛的激战舞台,美国总统布什于2006年7月19日第一次使用了总统否决权,驳回了美国国会新通过的干细胞研究的法律,此举引发了激烈的政治波澜.着重介绍当代美国生命医学法律中的最热点论题,包括医疗决定权、安乐死、人类克隆及人胚胎干细胞研究等有关法律的发展过程及存在的问题与面临的挑战.     

The COVID-19 pandemic: some thoughts on integrity in research and communication

Principles of integrity and ethical practice in research have been reinforced and honed over decades. In medical and biomedical fields, they have been shaped by challenges that include endemic, emerging, and re-emerging diseases [1], as well as the scientific responses to each disease as it occurs. These responses include clinical and community prevention trials, vaccine and drug trials for persons with life-threatening diseases, applied and basic research with dangerous microbial agents, and many others. Unexpected fatal pandemics caused by novel agents—for which neither drugs nor vaccines exist— present additional urgent challenges for scientists, defined here to mean biomedical, medical, and public health scientists and practitioners. In addition to conducting research, scientists are also often tasked with communicating research findings, not only to those who make policy decisions, but also to the media and the public.     

The most plausible pro-coercion view: requiring informed agreement while penalizing non-participation in research

In ‘(Why) should we require consent to research?’ Alan Wertheimer probes whether it is legitimate for the government to ‘coerce’ people into participating in biomedical research, including interventional biomedical research. In debating the rules that ought to govern participation in interventional biomedical research, we should distinguish two separate moral claims. First, interventional research should proceed only when the subject has given her informed agreement. Second, it is legitimate for the state to set a requirement that people participate in interventional biomedical research, and to penalize or punish those who refuse to participate. The most plausible ‘pro-coercion’ view accepts both of these claims. Though I stop short of endorsing this view, it captures important ‘pro-coercion’ and ‘anti-coercion’ intuitions.     

从义务主体到权利主体——当代大学生权利意识变化的法学审视

法制观念和维权意识的不断增强,是近年来当代大学生呈现出的一个显著特征,这一特征的凸现,使大学生在高校中的法律地位由过去的义务主体转向权利主体,致使高校的管理尤其是学生管理面临着新的挑战,应对挑战,改进管理,成为高校“依法办学,依法治校”的热门话题,本文运用法学原理,结合工作实际,对当代大学生权力意识的变化进行法学浅析,进而提出改进高校学生管理、加强高校法制化进程的几点建议。     

Management research in criminal justice: Exploring ethical issues

While there has been a steady increase of management research in criminal justice organizations in recent years, far too little attention has been devoted to the dilemmas surrounding these research efforts. The first dilemma is associated with the treatment of information or data while the second is associated with the treatment of human subjects. The purpose of this paper is to begin the debate in this sensitive area by exploring the primary ethical issues of each dilemma which must be constructively dealt with by management researchers if they are to avoid potential harm to their subjects, while at the same time, assure the validity of their results. Finally, several strategies which appear useful in addressing these ethical issues will be considered.     

Biomedical research with human embryos: changes in the legislation on assisted reproduction in Spain.

This study deals with issues of research with human embryos obtained through in vitro fertilization in the context of the Spanish Law. The paper focuses on Act 14/2006 on techniques of human assisted reproduction, which replaces the previous Act from 1988. The author claims that the main goals of Act 14/2006 are, on the one hand, to eliminate the restrictions affecting research with human embryos put in place by Act 45/2003 and, on the other, to pave the way for a future legislation on biomedical research. This paper argues for the need of an effective and adequate juridical protection of human embryos obtained in vitro according to responsibility and precautionary principles.     

Research ethics across the 49th parallel: the potential value of pilot testing "equivalent protections" in Canadian research institutions

Canada and the United States share the world's largest trade partnership and an increasing concern about divergent regulatory approaches to common industries. Canadian research institutes receive more research funding from the U.S. National Institutes of Health than any other country, much of it to fund multi-centre and collaborative research between the two countries. Because of these close economic and research ties, and the extensive similarities between the two countries in the review and oversight of ethics in human subjects research, we propose that Canada would be an ideal country for a pilot-test of the feasibility of "equivalent protections," a U.S. regulation that permits comparison of protections for human subjects between institutions in the two countries. The "equivalent protections" has been advocated by various bodies in the United States as a potentially beneficial mechanism for improving oversight of foreign trials. As well, we argue that "equivalent protections" could prove to be valuable for Canada in five specific ways: (1) by potentially reducing administrative burden on Canadian research institutions administering U.S. federal research funding; (2) by creating symbolic value of an explicit recognition by the United States that procedures normally followed for the protection of human subjects in Canadian research institutions are at least equivalent to those provided by the U.S. regulations; (3) by lowering the opportunity cost of investing in research in Canada; (4) by affording Canada an opportunity to enhance its leadership role in international research by offering an alternative to the U.S. regulatory model for the protection of human subjects; and (5) by providing a model for how the idea of equivalent protections might be addressed for research funded by Canadian agencies but conducted in other countries.