Research Centers in Minority Institutions (RCMI).

The Research Centers in Minority Institutions (RCMI) Program was initiated in the United States of America in 1985 as a congressionally mandated program. The mission of the RCMI Program is to expand the national capacity for the conduct of biomedical and behavioral research by developing the research infrastructure at institutions granting doctoral degrees in health or health-related sciences, that have 50% or greater enrollment of minorities (African Americans, Hispanics, Native Hawaiians and Pacific Islanders, Native Americans and Alaska Natives) that are underrepresented in the biomedical sciences. The program administration is based in the National Center for Research Resources (NCRR), at the National Institutes of Health (NIH), an agency of the Department of Health and Human Services (DHHS). Since its inception, the program has provided critical resources (core research laboratories, equipment, personnel, supplies, etc.) at each of the RCMI-funded institutions. This article is intended to provide an overview of the RCMI Program, outline the research areas and list contact persons for additional information on research and core resources at each of the current RCMI sites.     

US policies on human embryonic stem cells

The United States is a federal union with separate state jurisdictions. In part owing to the sometimes heated debate about public support for human embryonic stem-cell (ESC) research, there has been restricted federal support and little central regulation of this research to date. Instead, guidelines developed by scientific organizations have set principles for oversight and good practice for this research. These guidelines are functioning well, have influenced developing state regulations and, one hopes, will affect any future federal regulation.     

RESEARCH ON PRISONERS – A COMPARISON BETWEEN THE IOM COMMITTEE RECOMMENDATIONS (2006) AND EUROPEAN REGULATIONS

The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki.     

US IRBs confronting research in the developing world

Increasingly, US‐sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear. METHODS: I conducted in‐depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%). RESULTS: US IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long‐standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst‐case scenarios’. CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice.     

Biotechnology and the Third World: the missing link between research and applications

A United Nations University study investigated the activities of four major United Nations agencies that focussed on helping developing countries gain advanced capabilities in biotechnology. Relevant program and project documents were scrutinized at agency headquarters and managers were interviewed. Then, projects underway in three case countries (Egypt, Thailand, and Venezuela) were examined. The resulting information was used to assess whether United Nations projects were fulfilling these countries' needs and (or) advancing their capabilities in biotechnology. The minute, United Nations originated assistance available was directed solely at increasing capabilities in research and thus benefited bioscientists and their institutes. However, as virtually no linkage exists between the research establishment and the industrial--marketing sector, results from indigenous research does not reach industrialists or health workers. Consequently, biotechnology is neither advancing economic development in the case countries nor helping solve national problems. This situation is likely to persist because corrective systemic changes will be difficult to implement. Major implications of these findings are discussed, particularly as they bear on the United Nations system.     

Normal Pathways: Controlling Isotopes and Building Biomedical Research in Postwar France

During the late 1940s and 1950s, radioisotopes became important resources for biological and medical research. This article explores the strategies used by French researchers to get access to this material, either from the local Atomic Energy Commission (CEA) or from suppliers in the United States or United Kingdom. It focuses on two aspects of this process: the transatlantic circulation of both isotopes and associated instrumentation; the regulation of use and access by the administrative bodies governing research in France. Analyzing the investigations conducted within laboratories associated either with the atomic energy agency or with the local National Institute of Health (INH), the paper discusses the part played by the new tools in the postwar transformation of biomedical research. It contrasts the INH successful development of biological studies and metabolic tracing with the mixed results of CEA in advancing cancer radiotherapy, thus highlighting locally defined “normal paths” to radiobiology.     

Informed consent and collaborative research: perspectives from the developing world

Introduction: Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. Methods: A survey of developing country researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in-depth interviews and 78 responses to open-ended questions in the questionnaire provided qualitative data. Results: 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. Discussion: This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research.     

Nonhuman primate quarantine: its evolution and practice

Nonhuman primates (NHPs) are imported to the United States for use in research, domestic breeding, and propagation of endangered populations in zoological gardens. During the past 60 years, individuals responsible for NHP importation programs have observed morbidity and mortality typically associated with infectious disease outbreaks. These outbreaks have included infectious agents such as tuberculosis, Herpesvirus sp., simian hemorrhagic fever, and filovirus infections such as the Ebola and Marburg viruses. Some outbreaks have affected both animal and human populations. These epizootics are attributable to a variety of factors, including increased population density, exposure of na?ve populations to new infectious agents, and stress. The practice of quarantining animals arriving in the United States was first applied by individual research programs to improve animal health and ensure the quality of animals entering research programs. The development of government regulations for nonhuman primate quarantine accompanied the recognition that imported NHPs could pose a risk to public health. This article briefly reviews the history of US NHP importation and the factors behind the development of NHP quarantine regulations. The focus is on regulations concerned with infectious disease, public health, and the health of domestic primate colonies. These regulations have had the dual benefit of protecting public health as well as reducing animal morbidity and mortality during importation and quarantine. We review current practices and facilities for nonhuman primate quarantine and identify challenges for the future.     

Transnational policy migration,interdisciplinary policy transfer and decolonization: Tracing the patterns of research ethics regulation in Taiwan

Research ethics regulation in parts of the Global North has sometimes been initiated in the face of biomedical scandal. More recently, developing and recently developed countries have had additional reasons to regulate, doing so to attract international clinical trials and American research funding, publish in international journals, or to respond to broader social changes. In Taiwan, biomedical research ethics policy based on ‘principlism’ and committee‐based review were imported from the United States. Professionalisation of research ethics displaced other longer‐standing ways of conceiving ethics connected with Taiwanese cultural traditions. Subsequently, the model and its discursive practices were extended to other disciplines. Regulation was also shaped by decolonizing discourses associated with asserting Indigenous peoples’ rights. Locating research ethics regulation within the language and practices of public policy formation and transfer as well as decolonization, allows analysis to move beyond the self‐referential and attend to the social, economic and political context within which regulation operates.     

Tracing the politics of changing postwar research practices: the export of ‘American’ radioisotopes to European biologists

This paper examines the US Atomic Energy Commission’s radioisotope distribution program, established in 1946, which employed the uranium piles built for the wartime bomb project to produce specific radioisotopes for use in scientific investigation and medical therapy. As soon as the program was announced, requests from researchers began pouring into the Commission’s office. During the first year of the program alone over 1000 radioisotope shipments were sent out. The numerous requests that came from scientists outside the United States, however, sparked a political debate about whether the Commission should or even could export radioisotopes. This controversy manifested the tension between the aims of the Marshall Plan and growing US national security concerns after World War II. Proponents of international circulation of radioisotopes emphasized the political and scientific value of collaborating with European scientists, especially biomedical researchers. In the end, radioisotopes were shipped from the Commission’s Oak Ridge facility to many laboratories in England and continental Europe, where they were used in biochemical research on animals, plants, and microbes. However, the issue of radioisotope export continued to draw political fire in the United States, even after the establishment of national atomic energy facilities elsewhere.     

Biodefense research: can secrecy and safety coexist?

Over the next 10 years, the United States will spend 6 billion US dollars to develop countermeasures against biological and chemical weapons. Much of this research on highly virulent pathogens will be done in academic settings around the country. This article explores the challenges in ensuring secrecy to protect national security while accommodating the right of local communities to have access to safety information regarding select agents and laboratory-acquired infections. Secrecy has been defended as being vital for protecting national security. Problems with secrecy can include the misinterpretation of intentions, particularly in laboratories located in nuclear weapons design facilities, and the restricted access to information relevant to public health and safety. While federal select agent legislation requires laboratories to have emergency plans in place with first responders, these plans do not necessarily include public health professionals, who will be responsible for any future public health action, such as quarantine, surveillance, or mass vaccinations, in the unlikely event that a laboratory-acquired infection spreads into a community. Laboratory-acquired infections do occur, even with the best safety mechanisms in place; however, the epidemiology of the incidence and severity of these infections are not known since there is no national surveillance reporting system. Evidence suggests that many of these infections occur in the absence of an actual laboratory accident. The best emergency plans and surveillance systems are only as good as the participation and vigilance of the laboratory workers themselves. Thus, laboratory workers have a responsibility to themselves and others to report all laboratory accidents and spills, regardless how minor. In addition, they should have a lower threshold than normal in seeking medical attention when feeling ill, and their physicians should be aware of what pathogens they work with to reduce the risk of a delay in diagnosis.     

An intellectual property sharing initiative in agricultural biotechnology: development of broadly accessible technologies for plant transformation

The Public Intellectual Property Resource for Agriculture (PIPRA) was founded in 2004 by the Rockefeller Foundation in response to concerns that public investments in agricultural biotechnology benefiting developing countries were facing delays, high transaction costs and lack of access to important technologies due to intellectual property right (IPR) issues. From its inception, PIPRA has worked broadly to support a wide range of research in the public sector, in specialty and minor acreage crops as well as crops important to food security in developing countries. In this paper, we review PIPRA's work, discussing the failures, successes, and lessons learned during its years of operation. To address public sector's limited freedom-to-operate, or legal access to third-party rights, in the area of plant transformation, we describe PIPRA's patent 'pool' approach to develop open-access technologies for plant transformation which consolidate patent and tangible property rights in marker-free vector systems. The plant transformation system has been licensed and deployed for both commercial and humanitarian applications in the United States (US) and Africa, respectively.     

United States patents and fungal cultures

Summary Fungal biotechnology has generated a voluminous amount of technical literature and scientific data. Patents probably contain the most complete and detailed information about the use of fungal cultures in biotechnology. This article contains a brief review of the United States patent system where microorganisms form an integral part of the disclosure and explains the role of the American Type Culture Collection (ATCC) as a patent culture depository. A list based on the application of the ATCC fungal strains which have been cited or used in US patents and the names of the inventors, the titles of the inventions, and their patent numbers are included. This provides resource material particularly for developing countries as they begin to establish their own biotechnology.     

HIV/AIDS research conducted in the developing world and sponsored by the developed world: reporting of research ethics committee review in two countries

We explored how often journal articles reporting HIV research sponsored by a developed country, but conducted in a developing country, mention research ethics committee (REC) approval from both countries, and what factors are involved. Of all such 2007 articles on Medline conducted in one of four developing countries (N = 154), only 52% mentioned such dual approval. Mention of dual vs. single approval was more likely among articles with ≥ 50% sponsor country authors, and the United States as the sponsor country. Also, dual approval was more likely among articles that mentioned informed consent and funding, had ≥ 50% sponsor country authors, were biomedical (vs. psychosocial), and appeared in journals adopting International Committee Medical Journal Editors (ICMJE) guidelines. Dual approval was thus obtained in only half of the articles and was associated with ethical and logistic issues, indicating the need for clearer and more universally accepted guidelines.     

Ethical Principles for Conducting Fieldwork

Federal regulations to protect human subjects assume a particular relationship between experimenter and subject based upon biomedical research. Because this relationship is not found in every type of research, the regulations are not universally applicable. Relationships between those who study and those who are studied vary with the kind of research. Such variations depend on the relative power and control of the researcher, the direction of interaction, and the level of possible harms and benefits. Measured on these continua, fieldwork is at the opposite end of the spectrum from biomedical research. Consequently, the ethical system on which federal regulations are chiefly based—using utilitarian risk-benefit calculations—becomes ineffective and inappropriate when applied to proposed fieldwork. Here, investigators have relatively little power and less control of the setting and context of research, interaction flows in two directions, and calculable harms and benefits are comparatively low. Various models of fieldwork are described, each having differing relationships between investigators and subjects. It is suggested that the Kantian categorical imperative, with its principle of respect for human autonomy, might be useful in judging the ethical adequacy of these varieties of fieldwork. [fieldwork, ethical principles, research relationships, federal regulations, risk-benefit calculations]     

Measuring progress in US endangered species conservation

Since passage of the Endangered Species Act in 1973, over 1300 endangered and threatened species have been protected in the USA and its territories. Most species continue to face a significant risk of extinction, but the status of many species is improving. Here we present analyses of federal agency reports to the United States Congress (1988–2002) that describe differences in species status and show which variables are correlated with improving or declining status. We found that 52% of species showed repeated improvements or were not declining over this time. Species status improves over time, with only 35% still declining 13 years or more after protection. Taxonomy, funding by US Fish and Wildlife Service and National Oceanic and Atmospheric Administration, and agency assessment of risk of extinction and potential to recover were significantly correlated with status.     

Comparative Analysis of Extended Producer Responsibility Policy in the United States and Canada

This article analyzes the policy choices and programmatic elements of extended producer responsibility (EPR) as implemented in the United States and Canada. The article traces the historical development of EPR in each country and defines common features of EPR in each nation. The U.S. states and the Canadian provinces have assumed the primary role, rather than the federal governments, for enacting producer responsibility requirements in their respective countries. However, the paths taken demonstrate several fundamental differences, including the prevalence of individual versus collective responsibility and the financing mechanisms implemented for EPR. Given the deepening experience with EPR and the breadth of its application to a widening array of products in the United States, the Canadian model for EPR is starting to receive more examination from policy makers in the United States, indicating that the policy and programmatic differences between the two nations may eventually be narrowing. The comparative policy analysis is illustrated through the lens of EPR regulatory efforts for waste electronics, with particular profiles of the programs in the State of Minnesota and Province of Ontario. Both approaches broadly reflect many of the policy considerations and governance and programmatic themes that dominate EPR programs in each country. Finally, the article offers recommendations for collaborative work between the United States and Canada to explore consistency between programs and other complementary strategies to support producer responsibility activities.     

PROFITS AND PLAGIARISM: THE CASE OF MEDICAL GHOSTWRITING

This paper focuses on medical ghostwriting in the United States. I argue that medical ghostwriting often involves plagiarism and, in those cases, can be treated as an act of research misconduct by both the federal government and research institutions. I also propose several anti‐ghostwriting measures, including: 1) journals should implement guarantor policies so that researchers may be better held accountable for their work; 2) research institutions and the federal government should explicitly prohibit medical ghostwriting and outline appropriate penalties; and 3) a publicly available database should be created to record researchers' ethics violations.     

The Origin of the USDA Regional Biomass Research Centers

The U.S. Department of Agriculture (USDA) Regional Biomass Research Centers (RBRC) were created to contribute to the planning, research, and development of entire long-term sustainable biofuel production supply chains based on agricultural and forest-based feedstocks. The intent of the centers is to provide a catalyst that links feedstock genetic development, sustainable production and management, logistics, conversion, co-product production, distribution, and market demand suited to the available economic, social, and natural resources within different regions. The centers provide a coordinated, region-based research focus designed with relatively short-term deliverables to help accelerate the commercial production of biomass and other biofuel feedstocks. The centers provide a leadership structure for coordinating biomass research across the country, providing a national perspective that complements other USDA agency efforts designed to help US rural communities participate in the emerging biofuels and biobased products economy. Through coordination with the RBRC, USDA research and service agency programs and resources have been leveraged with the U.S. Department of Energy (DOE) and other federal department, university, and private industry efforts to help accelerate commercial advancement of advanced biofuel production to promote rural economic opportunities and achieve transportation biofuel policy goals.     

Biological weapons, genetics, and social analysis: emerging responses, emerging issues--II

Recent terrorist attacks in the United States have generated significant attention in many countries to the threats posed by biological weapons. In response to these events and the specter of future attacks, bioscientists and professional organizations have begun or intensified asking questions about the possible malign applications of their research. Part II of this two-part article examines the emerging responses initiated by biomedical organizations and spokespersons in the US and the UK. In doing so it considers how scientific and medical research communities are defining and policing notions of professionalism, responsibility and accountability in the responses made. Through an examination of these issues, suggested lines for future social analysis are offered.