The Wilderness Act and Fish Stocking: An Overview of Legislation, Judicial Interpretation, and Agency Implementation

Many high-elevation lakes in designated wilderness are stocked with native and nonnative fish by state fish and game agencies to provide recreational fishing opportunities. In several areas, this practice has become controversial with state wildlife managers who support historical recreational use of wilderness, federal wilderness managers who assert that stocking compromises some of the ecological and social values of wilderness, and different public groups that support one or the other position. Herein we examine this controversy from the perspective of the 1964 Wilderness Act, its judicial interpretation, the policies of the federal agencies, and formal agreements between federal and state agencies. Although some state stocking programs restore native fish populations, other programs may compromise some of the ecological and social values of wilderness areas. Further, although current federal regulations recognize state authority for fish stocking, judicial interpretation gives federal agencies the authority for direct involvement in decisions regarding fish stocking in wilderness. Where there are differences of opinion between state and federal managers, this judicial interpretation strongly points to the need for improved cooperation, communication, and coordination between state wildlife managers and federal wilderness managers to balance recreational fishing opportunities and other wildlife management activities with wilderness values. Received 28 March 2000; Accepted 16 August 2000.     

Best Practices for Core Facilities: Handling External Customers

This article addresses the growing interest among U.S. scientific organizations and federal funding agencies in strengthening research partnerships between American universities and the private sector. It outlines how core facilities at universities can contribute to this partnership by offering services and access to high-end instrumentation to both nonprofit organizations and commercial organizations. We describe institutional policies (best practices) and procedures (terms and conditions) that are essential for facilitating and enabling such partnerships. In addition, we provide an overview of the relevant federal regulations that apply to external use of academic core facilities and offer a set of guidelines for handling them. We conclude by encouraging directors and managers of core facilities to work with the relevant organizational offices to promote and nurture such partnerships. If handled appropriately, we believe such partnerships can be a win-win situation for both organizations that will support research and bolster the American economy.     

Stem cell politics, ethics and medical progress

Tremendous controversy has surrounded efforts to undertake research on totipotent human stem cells. To date public policy in the United States has attempted to skirt the ethical and social questions raised by this research. Annas et al. argue that research using human embryos as a source of totipotent stem cells can secure broad public support if there is an open and public discussion about the ethical justification for undertaking such research and the assurance of adequate federal regulation and oversight.     

U.S. Federal Initiatives to Support Biomass Research and Development

This article provides a brief overview of federal initiatives in the United States to support biomass research, demonstration, and development. The interest in the biomass industry and U.S. federal efforts to spur development of, increased production of, and use of biopower, biofuels, and biobased products, collectively known as the "biomass industry", are discussed. A growing level of leadership from the executive branch of the federal government and support by the U.S. Congress are documented. Five important policy drivers that support this heightened emphasis on biomass for power, fuels, and products are identified and discussed. The current status of U.S. dependence on these renewable energy sources is briefly outlined. Federal biomass funding activity for the current fiscal year by the U.S. Department of Agriculture and the U.S. Department of Energy, two major federal participants in research, demonstration, and development for this industry, is briefly outlined. This funding commitment is placed into an overall context of total federal support for all research and development. Finally, the article suggests future market penetration targets for this industry, emphasizes the importance of infrastructure development necessary to support the industry's growth, and notes the payoff from such development for farmers, foresters, rural communities, and the environment.     

Harmonizing regulations for biomedical research: a critical analysis of the US and Venezuelan systems

This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze - as an example - the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries.     

Facility design considerations for select agent animal research

The events of September 11, 2001, have piqued US interest and investment in infectious disease research and the facilities that support the research. Since 1999, federal grants for biosafety level (BSL)-3, -3 agricultural (Ag), and -4 research have increased by more than 900%--to 13.1B dollars in the fiscal years 2002 to 2004 compared with 1.2B dollars from 1999 to 2001. This dramatic growth has forced experienced professionals from government agencies, universities, industry, design firms, commissioning firms, and contractors to work together to construct buildings that meet the demanding and unique needs of the research. This discussion pertains primarily to select agent research and provides (1) an overview of the guidelines and standards pertinent to the design and construction of biocontainment research facilities using animals, (2) design considerations appropriate for these facilities, (3) special requirements associated with BSL-3Ag agricultural research, and (4) information to prepare for the use of a state-of-the-art infectious disease research facility.     

OECD guidelines on open access: commercialization in disguise?

The Organisation for Economic Co-operation and Development (OECD) has published a new set of principles and guidelines to promote open access to datasets and results from publicly funded research. However, there is reason to think twice about the implications of making demands for transparency and open access for publicly funded research only. How will such demands affect incentives and research agendas? Might this new regulation of publicly funded research have undesirable effects on the quality and value of research? Placing the OECD guidelines in a broader context of research regulation, we argue that they might provide a further push toward collaboration with commercially sponsored research and reinforce incentive structures that favour the creation of commercial value.     

End-of-life care in the nursing home--is a good death compatible with regulatory compliance?

By using relevant clinical practice guidelines for end-of-life care and by incorporating meaningful quality indicators into an effective continuous quality improvement program, nursing facilities can provide quality end-of-life care for their residents while complying with state and federal regulations.     

Why Are There So Many Waterfowl and So Few Northern Bobwhites? Rethinking Federal Coordination

In this paper we ask whether we should we re-examine the future of upland gamebird management and greater federal oversight and partnerships in the twenty-first century. Management for waterfowl in North America has been successful because of the 1918 Migratory Bird Treaty Act (MBTA) and the subsequent 1986 North American Waterfowl Management Plan (NAWMP). Although the MBTA included most migratory and non-migratory species, upland gamebirds, including the northern bobwhite (Colinus virginianus; bobwhite), were excluded and retained under state control. Although many waterfowl populations have been increasing, bobwhite populations have declined precipitously during much of the period. Excluding non-migratory gamebirds from the MBTA meant that the multistate coordinating efforts that made the MBTA successful for increasing the management of waterfowl have not been applied. The National Bobwhite Conservation Initiative (NBCI) has made a strong effort to unite states within the bobwhite range but does not have the federal anchoring and financial support that were given to states by the MBTA and NAWMP and currently integrate adaptive harvest, habitat management, and financial partnerships to acquire and manage wetlands that support waterfowl production. The NBCI Coordinated Implementation Program (CIP) is designed to serve the function of developing and monitoring habitat for bobwhites but is entirely voluntary and dependent entirely on state and non-governmental organization (NGO) funds, lacking federal grants and Federal Duck Stamp funds. To catch up with the successes of waterfowl, we discuss the implications of increasing coordination, partnerships, and funding mechanisms between the federal government, state governments, and NGOs to provide common landscape-level population monitoring and modeling, adaptive harvest regulations, habitat management goals, and a national upland gamebird stamp. © 2021 The Wildlife Society.     

Regulatory agency consideration of pharmacogenomics

This article discusses the current ambiguous state of federal regulatory agency control over pharmacogenomic testing, a subset of genetic testing that combines information about genetic variability with pharmacology in order to improve drug recommendations. An analysis of the common three terms used to evaluate regulation of pharmacogenomic testing: research validity, clinical validity, and clinical utility, followed by a case study involving U. S. Food and Drug Administration (FDA) regulation of laboratory developed tests, illustrates the present gap in pharmacogenomic oversight. The existing agency overlap in regulating pharmacogenomic testing leads to unclear or even contradictory authoritative advice.     

Federal consistency and ocs oil and gas development: A review and assessment of the “directly affecting”; controversy

Abstract

Attempts by the federal government, notably the Department of the Interior, to accelerate development of hydrocarbon resources on the Outer Continental Shelf have resulted in litigation between coastal states and the federal government. A principal issue involved has been whether federal consistency provisions contained in the Coastal Zone Management Act apply to federal lease sale decisions. Language contained in this statute (Section 307(c)(l)) requires federal activities directly affecting the coastal zone to be conducted in a manner consistent, to the maximum extent practicable, with state coastal zone management programs.

This paper reviews the evolution of this controversy in intergovernmental relations since its inception, and describes various proposals which have been made to define the term “directly affecting.”; Events involved in OCS Lease Sales Nos. 48, 53, and 68, offshore California, are described to illustrate the varying state/federal perspectives on federal consistency requirements. This assessment concludes that voluntary consistency determinations by federal agencies would best promote harmonious state/federal relations in developing hydrocarbon resources on the Outer Continental Shelf.     

Ethics of fetal tissue transplantation.

Now that the Clinton Administration has overturned the ban on federal funding for fetal tissue transplantation, old ethical issues renew their relevance and new ethical issues arise. Is fetal tissue transplantation necessary and beneficial? Are fetal rights violated by the use of fetal tissue in research? Is there a moral danger that the potential of fetal tissue donation will encourage elective abortions? Should pregnant women be allowed to designate specific fetal transplant recipients? What criteria should be used to select fetal tissue transplants? Whose consent should be required for the use of fetal tissue for transplantation? We review the current state of clinical research with fetal tissue transplantation, the legal history of fetal tissue research, the major arguments against the use of fetal tissue for transplantation, and the new postmoratorium ethical dilemmas. We include recommendations for guidelines to govern the medical treatment of fetal tissue in transplantation.     

Opportunistic research and sampling combined with fisheries and wildlife management actions or crisis response

Currently most of the activities of state, federal, first nation, and private conservation agencies, including management of and field research on free-ranging wildlife, are not regulated under the Animal Welfare Act (AWA) and thus not subject to National Institutes of Health guidelines or routine institutional animal care and use committee (IACUC) review. However, every day thousands of fish and wildlife management activities occur across North America that provide an opportunity to take observations, measurements, biological specimens, or samples that may have research value. Most of these opportunities are secondary to ongoing and often mandated wildlife management or conservation actions. Strange as it may seem to the academic and research community, the full research potentials of these opportunities are rarely utilized. IACUCs and research institutions should strive to facilitate such research, which by its very nature is often more opportunistic than designed. They can do this by ensuring that their policies do not unnecessarily impede the rapid research responses needed, or over burden researchers with inappropriate reporting requirements designed for laboratory research. The most prominent reasons for failures to utilize wildlife research opportunities include lack of the following: personnel and expertise to collect and use the information; preparation for inevitable (or predictable) events (e.g., oil spills); resources to preserve and curate specimens; a mandate to conduct research; and recognition of the value in data or sample collection. IACUC support of open protocols and generic sampling plans can go a long way toward improving the development of useful knowledge from animals that will otherwise be lost. Opportunities to sample wildlife are categorized generally as dead sampling (road kill surveys, harvest sampling, lethal collection, and "die-offs"); live sampling (handling for marking, relocation or restocking; and captures for field or biological studies); and crisis response (e.g., population salvage operations or oil spills). Examples of the many unique situations in each category serve to illustrate how valuable research and sampling can be accomplished opportunistically. Several unique limitations of sample collection situation are described. It is recommended that IACUCs have mechanisms in place to facilitate good research in all of these circumstances.     

Government regulation of nonhuman primate facilities

Myriad international, federal, and state laws, regulations, rules, guidelines, and standards directly affect the activities of all nonhuman primate research facilities. Federal regulations alone encompass every aspect of facility operations. They govern the procurement, possession, handling, care, and utilization of nonhuman primates, the design, construction, maintenance, and operation of the facility, and the occupational and environmental protection afforded not only facility personnel, but also the general public. Proper management of a nonhuman primate facility depends on continual monitoring of constantly changing laws and regulations applicable to the type of facility operated and research conducted. An in-house compliance assurance program is necessary to assure conformance with pertinent regulations.     

Chemicals from alternative feedstocks in the United States

Abstract: Growing industrial interest in products from renewable alternative feedstocks has resulted in the creation of more industry-led federal research and development programs. The basis of this interest is introduced, followed by an overview of the various federal programs that support basic through applied research relevant to chemical products from renewable resources, and evidence of the increased coordination efforts between programs. The majority of the paper outlines a new program within the U.S. Department of Energy, the Alternative Feedstocks Program, which specifically targets chemicals from renewables which have the potential to become part of the next generation of high-volume chemical feedstocks for the manufacturing industries. The first product of the program, an iterative process technology decision analysis tool, is broadly presented using the first process development project: succinic acid from fermentable sugars.     

Medical research; the program of the U.S. Public Health Service

Federal Government expenditures for medical research have increased apace in the last ten years. The increase in federal research funds has stimulated support from private sources; contributions from other than federal sources have doubled. More than half of medical research funds are being used by universities, hospitals, and other nonprofit institutions, and less than one-fourth by laboratories of the Federal Government.Grants-in-aid of research, fellowships and extended training are made on the advice of Advisory Councils made up of leaders in the various research fields. The previous record of research by staffs and faculties of institutions is taken into account. Special attention is given to unknown investigators and small projects. Noninterference with a scientist in the conduct of research is a basic principle of all grants. He may change the direction of his research to pursue promising leads without asking permission. Continuity of grants so that promising projects need not be abandoned at the end of a grant period is given special consideration.     

MEDICAL RESEARCH—The Program of the U. S. Public Health Service

Federal Government expenditures for medical research have increased apace in the last ten years. The increase in federal research funds has stimulated support from private sources; contributions from other than federal sources have doubled.More than half of medical research funds are being used by universities, hospitals, and other nonprofit institutions, and less than one-fourth by laboratories of the Federal Government.Grants-in-aid of research, fellowships and extended training are made on the advice of Advisory Councils made up of leaders in the various research fields. The previous record of research by staffs and faculties of institutions is taken into account. Special attention is given to unknown investigators and small projects.Noninterference with a scientist in the conduct of research is a basic principle of all grants. He may change the direction of his research to pursue promising leads without asking permission.Continuity of grants so that promising projects need not be abandoned at the end of a grant period is given special consideration.     

Disclosure of genetic information obtained through research

The rapid expansion of information and knowledge of genetics has implications for the question of whether, and under what circumstances, information discovered in the course of genetic research should be conveyed to research participants and/or their relatives. The aim of this paper is to propose an ethically defensible solution to a specific case example illustrating this problem. To do this we reviewed the literature to find answers to the following three questions: (1) What do current regulations, guidelines, and commentary say about the disclosure of genetic risk information obtained through research to research participants? (2) What do current regulations, guidelines, and commentary say about the disclosure of genetic risk information obtained through research to the relatives of research subjects? and (3) What do current regulations, guidelines, and commentary say about the disclosure of genetic risk information obtained through research about former research participants who are now deceased? Our conclusion is that current U.S. federal guidelines governing the use of human subjects in research, as well as much of the current literature, do not adequately address the familial dimension inherent in genetic research, are virtually silent on the issue of sharing information of relevance to family members, and do not protect the deceased. It is our belief that this omission needs to be corrected and that explicit guidance on this issue needs to be provided to institutional review boards and researchers alike.     

The route to a national health policy lies through the states.

National health program legislation has been becalmed in the Congress for almost 80 years. Despite periodic cries of "crisis," legislation never emerges from committee. Periodically, campaigns have been mounted without success. Tactical efforts to circumvent direct action by legislating bits and pieces of related programs, Medicare and Medicaid, health maintenance organization support, and pre-budgeting, have complicated operation of the medical care system and stimulated intractable cost inflation. For the first 150 years of American history, responsibility for public health and welfare legislation rested with the states. Most public health policies originated in a state or a few states and then later became national legislation. The state efforts were, in effect, natural experiments. After the Depression and the flood of funding from the federal government in subsequent years, the states faded as innovators. It is proposed that funding a few state models to restimulate state initiative in this regard will provide a more effective route to a national health program.     

Implications of managed care for health systems,clinicians, and patients.

The rhetoric and realities of managed care are easily confused. The rapid growth of managed care in the United States has had many implications for patients, doctors, employers, state and federal programmes, the health insurance industry, major medical institutions, medical research, and vulnerable patient populations. It has restricted patients'' choice of doctors and limited access to specialists, reduced the professional autonomy and earnings of doctors, shifted power from the non-profit to the for-profit sectors and from hospitals and doctors to private corporations. It has also raised issues about the future structuring and financing of medical education and research and about practice ethics. However, managed care has also accorded greater prominence to the assessment of patient satisfaction, profiling and monitoring of doctors'' work, the use of clinical guidelines and quality assurance procedures and indicated the potential to improve the integration and outcome of care.