Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); methodology for coverage of phase II and phase III clinical trials sponsored by the National Institutes of Health. Office of the Secretary; DoD. Final rule

This final rule allows the Department of Defense to waive normal requirements so that covered beneficiaries can participate in Phase II and Phase III clinical trials sponsored or approved by the National Institutes of Health National Cancer Institute (NIH NCI). This waiver authority is expected to promote beneficiary access to promising new treatments and contribute to the development of such treatments.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE; coverage of phase II and phase III clinical trials sponsored by the National Institutes of Health National Cancer Institute. Final rule

The final rule allows the Department of Defense to waive normal requirements so that covered beneficiaries can participate in Phase II and Phase III clinical trials sponsored or approved by the National Institutes of Health National Cancer Institute (NIH NCI). This waiver authority is expected to promote beneficiary access to promising new treatments and contribute to the development of such treatments.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). Office of the Secretary, DoD. Notice of expansion of cancer treatment clinical trials demonstration project

This notice is to advise interested parties of an expansion of a demonstration project in which the DoD provides CHAMPUS reimbursement for eligible beneficiaries who receive cancer treatment under approved National Cancer Institute (NCI) clinical trials to include NCI sponsored cancer prevention clinical trials. Participation in these clinical trials will improve TRICARE/CHAMPUS eligible beneficiary access to emerging new therapies that have significant promise for the prevention and successful treatment of cancers. DoD financing of these procedures will assist in meeting clinical trial goals and arrival at conclusions regarding the safety and efficacy of emerging therapies in the prevention and treatment of cancer. At this time, there is insufficient demonstration data for a full evaluation of costs associated with enrollment in clinical trials. Expanding the current demonstration to provide reimbursement for costs associated with NCI sponsored clinical trials for cancer prevention will augment current patient accruals to clinical trials and allow for data collection in order to perform a comprehensive economic analysis. This demonstration also affects TRICARE, the managed health care program that includes CHAMPUS. This demonstration project, which is under the authority of 10 U.S.C., section 1092, will expire December 31, 1999.     

Ethics at Phase 0: Clarifying the Issues

The Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) recently issued documents encouraging sponsors to consider microdose testing before launching Phase I trials, and many commentators predict that such methodologies will be applied more routinely in drug development. However, exploratory testing has provoked several ethical criticisms. Skeptics question the value and validity of microdose trials, and whether they present a reasonable balance of risks and benefits for subjects. Another major criticism is that such studies serve mainly commercial ends. The present article explores these and other ethical concerns for studies conducted in the oncology setting. It concludes that microdosing is not inconsistent with prevailing practices in Phase I research, and that in principle, such studies could strengthen the ethical basis for Phase I trials by providing them better evidentiary justification.     

Towards the development of ethical practices in paediatric clinical trials: the special position of the terminally ill child

This article examines the emotive and vexing issue of the involvement of terminally children in paediatric clinical trials. Particular emphasis is placed on the participation of such children in Phase I clinical studies, as such studies do not yield any benefit to the individual child. It provides an historical overview of medical research involving children and examines the moral arguments surrounding the participation of children in clinical trials. The article examines the conflict between doctor-as-researcher and doctor-as-treater as well as the problems presented by proxy consent providers. The role played by the human research ethics committee in this area is examined, as is the regulatory framework established by the National Health and Medical Research Council. The article argues that the participation of terminally ill children in Phase I clinical trials is not morally repugnant provided that there is a total commitment to the protection of the child participant's well-being during the dying process. It is argued that the moral justification for such position derives from the utilitarian notion that participation in such studies aims to benefit future generations of ill children.     

A four-phase process for translating research into police practice

ABSTRACT

This article presents a framework that extends the discussion of translational criminology and the dynamic process of translating research to practice. The goal is to provide an explicit dissection of the translation process into four phases to help outline a structured way of thinking about how to incorporate research into police practice. The four-phases include: Phase I: ‘Does it Work?’ Research and Evaluation; Phase II: ‘What Works?’ Synthesis and Dissemination; Phase III: ‘How to Make it Work?’ Implementation and Evaluation; and Phase IV: ‘Make it Work!’ Institutionalization and Sustainability. The process is founded in implementation science and the ‘Knowledge to Action’ model (KTA) used in the medical and public health fields, as well as current translation activities for policing, and the authors’ experience as practitioners, researchers, and ‘translators’ over the last 25 years. It is the hope that parsing out four distinct phases for the translation of research to practice will assist researchers and police leaders to identify and fill gaps in current and future translation activities.     

Medicare program; physicians' referrals to health care entities with which they have financial relationships (Phase II). Interim final rule with comment period

This interim final rule with comment period (Phase II of this rulemaking) incorporates into regulations the provisions concerning ownership and investment exceptions in paragraphs (c) and (d) and the compensation exceptions in paragraph (e) of section 1877 of the Social Security Act (the Act). Phase II also addresses comments concerning the reporting requirements in section 1877(f) of the Act. Phase I (as defined below) addressed the majority of issues in implementing section 1877 of the Act. Phase II both addresses the remaining issues not addressed in Phase I and responds to public comments. In general, in response to public comments, the Department has attempted to reduce regulatory burden by broadening exceptions using the Secretary's discretionary authority under the statute to create exceptions that pose no risk of fraud or abuse. For the convenience of affected parties, we have set out the entire rule as previously promulgated, including the changes made by this rulemaking.     

Cancer treatment clinical trials--DoD. Notice of demonstration project

This notice is to advise interested parties of a demonstration project in which the DoD will expand a current demonstration for breast cancer treatment clinical trials to include all cancer treatment clinical trials under approved National Institutes of Health, National Cancer Institute (NCI) clinical trials. Participation in these clinical trials will improve accessing to promising cancer therapies for CHAMPUS eligible beneficiaries when their conditions meet protocol eligibility criteria. DoD financing of these procedures will assist in meeting clinical trial goals and arrival at conclusions regarding the safety and efficacy of emerging therapies in the treatment of cancer. This demonstration project is under the authority of 10 U.S.C. 1092.     

Multilevel public funding for small business innovation: a review of US state SBIR match programs

US State governments invest in early-stage innovative activity as an economic development strategy. Nevertheless, attention directed at the public sector’s role in this capacity has been placed on federal policy actions overlooking the growing role of states. The primary aims of this paper are two-fold: (1) to articulate the motivations for multilevel public support for small business innovative activity, placing emphasis on state level incentives directed towards entrepreneurial activity; and (2) to empirically evaluate the State Match Phase I (SMP-I) program. The SMP-I program is a diffuse state level policy designed to complement the federal Small Business Innovation Research (SBIR) program by offering noncompetitive matching funds to the state’s successful SBIR Phase I recipients. This offers an opportunity to examine the marginal impact of public R&D given the state intervention. This paper employs a state and year fixed effects model and considers two outcome variables—SBIR Phase II success rates and SBIR Phase I application activity. To account for industrial heterogeneity, the data are stratified by the federal mission agencies. Results from the empirical analysis indicate that the state match increases the Phase II success rates for firms participating in the National Science Foundation SBIR program.     

How does initial public financing influence private incentives for follow-on investment in early-stage technologies?

One common rationale supporting public financing programs for small firms is that initial public investment creates incentives for follow-on private investment. However, there does not appear to be a unified statement in the literature describing how initial public investment creates incentives for follow-on private investment. Focusing on external private investors, we use a two-stage net present value model to identify four effects from initial public investment on the private decision for follow-on investment. Our empirical analysis uses a sample of non-venture backed firms entering the SBIR program to examine how reduced risk, the number of SBIR awards, and size of initial public investment influence the likelihood of follow-on venture capital investment. We find the probability of follow-on venture capital investment is more likely when firms reach Phase II of the program, is less likely as firms win multiple Phase I and Phase II awards, and is more likely as the size of initial public investment in Phase I increases.

Hazardous waste management programs; Florida: authorization for interim authorization phase I--Environmental Protection Agency. Notice of final determination

The State of Florida has applied for interim Authorization Phase I. EPA has reviewed Florida's application for Phase I and has determined that Florida's hazardous waste program is substantially equivalent to the Federal program covered by Phase I. The State of Florida is, hereby, granted Interim Authorization for Phase I to operate the State 's hazardous waste program, in lieu of the Federal program.     

Transforming Land‐Taking Disputes in Socialist Asia: Engaging an Authoritarian State

Few studies have responded to the calls by sociolegal scholars to explore how disputes evolve. This article takes up the challenge by examining how intermediaries in socialist Asia resolve land‐taking disputes that are intractable for administrative appeals and courts. Exploring alternatives to state‐based dispute resolution is a pressing issue for conflicts that pit citizens against authoritarian regimes. Using in‐depth interviews, this article investigates how intermediaries such as retired state officials navigate in and around authoritarian regimes, flattening power asymmetries between citizens and land officials. This analysis draws from, links, and advances three literatures that examine dispute resolution in different ways: the sociolegal “naming, blaming, and claiming” literature examines the trajectory of disputes, regulatory studies use legitimacy expectations to analyze how disputants evaluate and prioritize competing regulatory frameworks, and the collective identity literature analyzes how communities respond to disputes. This article contributes to the literature by developing a theoretical framework that explains how intermediaries circumvent conceptual differences and transform disputes. The findings compel researchers to consider the use of intermediaries as an alternative to state‐sponsored dispute resolution in authoritarian settings.     

The Practice of Law With LGBT‐Parent Families

In this article, I examine how a history of legal conflict has produced a constantly evolving professional identity for lawyers representing lesbian/gay/bisexual/transgender (LGBT) clients on family matters. Drawing on in‐depth interviews with 21 lawyers, I describe variation across areas of specialization, advertising, clientele, and access to professional networks. In addition, I focus on how sociopolitical and legal context shapes professional identity and practice for these lawyers, demonstrating the importance of practice location for this group of lawyers. Although interviews were conducted prior to national marriage recognition, these findings provide insight into the future development of the LGBT family law profession post‐Obergefell.     

Better Regulation of Industry-Sponsored Clinical Trials Is Long Overdue

Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization — perhaps tied to a broader clinical effectiveness research enterprise — which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products.     

A Leap of Faith? Sanctioning Xenotransplant Clinical Trials

Introducing a new medical technique, procedure or drug to the public via clinical trials is risky at the best of times. When the trial involves a biotechnology which holds out the promise of prolonging, if not saving, life the push to move from the laboratory to clinical trials may be hard to resist. In this article I explore whether the regulatory scheme for clinical trials in the UK is able to accommodate developing technologies by considering how the current legal and ethical frameworks determine when a procedure such as xenotransplantation should proceed to trials. In particular, I discuss whether basing our regulatory schemes on the principles espoused in the Declaration of Helsinki offer sufficient protection to those who may be affected by xenotransplant trials – the recipient, their health-care workers, close contacts and, unusually, the wider public. I question whether it is possible for a technology to be approved for clinical trials when allowing such trials may benefit the individual but ultimately negatively impact on society as a whole.     

SBIR first decade-results,benefits, problems from a Michigan perspective

This paper reports on the economic contributions and impact of the Small Business Innovation Research (SBIR) Program in Michigan during the first decade. The Michigan SBIR experience is examined to learn how researchers and small businesses use the SBIR Program, whether to start or strengthen businesses, how they view SBIR after a decade, and how the program has served Michigan businesses that have successfully carried out Phase I, Phase II, and Phase III SBIR projects. From the beginning of the SBIR Program, MERRA has coordinated annual SBIR conferences for Michigan companies. The MERRA staff has helped small businesses prepare suitable R&D projects and write effective SBIR proposals. Numerous SBIR awards have resulted from MERRA supportive efforts, and the MERRA small business outreach activity has kept MERRA in touch with successful firms to assist them in getting the best results from their SBIR projects and to assess progress. For this study, in-depth evaluations were made of various Michigan firms that won SBIR awards, including both mature small businesses and start-up companies to learn in what ways their SBIR experiences are parallel and in what ways they diverge. The study covers those that have used SBIR funds to diversify and add new areas of business to existing core areas. Other companies examined were created by researchers associated with universities, industry, or research organizations who utilized SBIR awards to assist in starting new businesses. Also considered were Michigan companies at different levels of development that have employed SBIR awards as seed money to perfect innovative new products for marketing.     

International Criminal Courts and Political Reconciliation

In A Moral Theory of Political Reconciliation, Colleen Murphy devotes a full chapter to arguing that international criminal trials make significant contributions to political reconciliation within post-conflict and transitional societies. While she is right to claim that these trials serve an important function, I take issue with her with respect to what that important function is. Whereas Murphy focuses on the contributions international criminal prosecutions might make to political reconciliation within the borders of transitional societies, I claim instead that their primary function is to restore order at the international level and to dispense justice. The aims of justice are not always consistent with the aims of reconciliation. Moreover, several features of international criminal trials should give us pause with respect even to how well, in fact, they manage to serve the ends of international justice.     

Main Achievements of the ICTR

Since trials began in 1997, the International Criminal Tribunalfor Rwanda (ICTR) has conducted cases involving 50 accused,involving a prime minister and several ministers, prefects,bourgmestres and other leaders, who would otherwise not havebeen brought to justice. Judgments have been rendered in respectof 25 accused, with three acquittals. During the first mandate(1995–1999), the Tribunal delivered ground-breaking judgmentsconcerning genocide, such as Akayesu and Kambanda. In the secondmandate (1999–2003), the judicial output doubled and includedthe Media judgment. Halfway into the third mandate (2003–2007),trials involving 25 accused are ongoing. The ICTR is an efficientjudicial institution which has conducted fair trials, createdimportant jurisprudence, and made a significant contributionto the development of international criminal justice.     

Interpretation of postmortem change in cadavers in Spain

Estimating time since death is especially difficult in the examination of poorly preserved cadavers and depends on the experience of the examiner and comparison with previously documented cases showing similar characteristics. The present study reports on information obtained over the past ten years through the work of the Laboratorio de Antropología y Odontología Forense (LAF) of the Instituto Anatómico Forense de Madrid, Spain, in particular evaluating how the type of fracture influences postmortem change. From the original 225 forensic cases examined between 1992 and 2002 in the LAF, a sample of 29 cases were selected from various regions of the Spanish mainland. A data collection protocol was established to reflect factors which the existing specialized literature, documenting the relation existing in the sample analyzed between time since death and the extent of postmortem change, which in the environments examined are distributed into the following phases: Phase 1 (putrefaction): one week to one month on the surface and two months in water. Phase 2 (initial skeletonization): two months on the surface and five to six months in water. Phase 3 (advanced skeltonization): six months to 1.5 years on the surface and 2.5 years buried. Phase 4 (complete skeletonization): about one year on the surface and three years buried. This paper also provide useful information on the impact of carrion insect activity, location, climate, seasonality, and predator.     

No effects in independent prevention trials: can we reject the cynical view?

Recent studies suggest that the reported effect sizes of prevention and intervention trials in criminology are considerably larger when program developers are involved in a study than when trials are conducted by independent researchers. This paper examines the possibility that these differences may be due to systematic bias related to conflict of interest. A review of the evidence shows that the possibility of a substantial problem cannot be currently rejected. Based on a theoretical model about how conflict of interest may influence research findings, the paper proposes several strategies to examine empirically the extent of systematic bias related to conflict of interest. It also suggests that, in addition to improved standards for conducting and publishing future experimental studies, more research is needed on the extent of systematic bias in the existing body of literature.