Privacy Act of 1974; proposed new routine uses--PHS. Notification of new routine uses permitting disclosure of information from four Privacy Act systems of records

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish new routine uses permitting disclosure of information from four Privacy Act systems of records maintained by the National Institutes of Health (NIH): 09-25-0008, "Administration: Radiation Workers Monitoring, HHS/NIH/ORS"; 09-25-0010, "Research Resources: Registry of Individuals Potentially Exposed to Microbial Agents, HHS/NIH/NCI"; 09-25-0077, "Clinical Research: Biological Carcinogenesis Branch Human Specimen Program, HHS/NIH/NCI"; and 09-25-0099, "Clinical Research: Patient Medical Records, HHS/NIH/CC." The NIH Office of Research Services (ORS) is responsible for the first of these systems. The National Cancer Institute (NCI), a component of NIH, maintains the second and third systems of records. The NIH Clinical Center (CC) maintains the fourth system. The new routine uses will allow disclosure to contractors for routine records keeping and processing activities. These disclosures will be wholly compatible with the purposes of these systems, as discussed below.     

Traineeships. National Institutes of Health, HHS. Final rule

The National Institutes of Health (NIH) is amending the regulations governing traineeships to add conditions under which NIH may terminate traineeship awards and revise the authorities for the awards.     

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.     

Recombinant DNA research: actions under the guidelines--NIH. Notice of actions under NIH guidelines for research involving recombinant DNA molecules

This notice sets forth actions taken by the Director, National Institute of Allergy and infectious Diseases (NIAID), by authority of the Director. NIH, under the June 1983 NIH Guidelines for Research Involving Recombinant DNA Molecules (48 FR 24556).     

Privacy Act of 1974; annual publication of records--NIH

The National Institutes of Health (NIH) is publishing this document to establish changes to notices of systems of records which have been revised following a comprehensive review of all systems of records maintained by NIH. None of these changes requires a report of altered system to be sent to the Congress and the Office of Management and Budget. The notices are complete and accurate as of August 26, 1983. Furthermore, we are summarizing additions of new systems which have been published since the last annual publication, establishment of new routine uses, and deletions of old systems terminated since the 1982 publication. We are also publishing a complete list of all systems of records which NIH currently maintains.     

Trends in Childhood Obesity Research: A Brief Analysis of NIH-Supported Efforts

Childhood obesity is an increasing health threat. The National Institutes of Health (NIH) is the primary funding agency for research into the causes, mechanisms, consequences, and prevention and treatment of childhood obesity. Using the NIH Strategic Plan for Obesity Research as the framework, this article summarizes the research that has been funded in the past five years as well as new research areas with great potential.     

Knowledge transfer in academia: an exploratory study on the Not-Invented-Here Syndrome

Today??s society is often claimed to be the ??knowledge society??. Knowledge transfer plays a pivotal role in the whole economic system, influencing innovation management in its very core. This study deals with one of the barriers that might hamper knowledge transfer: The Not-Invented-Here Syndrome (NIH). Until now, this phenomenon was mainly analyzed in an industrial context. However, as the universities play an increasingly important role in the knowledge society, the time seems ripe to analyze this barrier of knowledge transfer in an academic context. This paper examines the influence of the research discipline, the scientific output, the attitude towards basic science and the project experience on NIH by analyzing a sample of 166 Austrian professors from the fields of physics and engineering. While we cannot find a significant impact of the first two aspects, we can demonstrate that the latter two do have a significant influence on NIH. Summing up, this study supports results from the existing literature on NIH and sheds light on new aspects providing deeper insights into the comprehension of this complex phenomenon.     

Office of Recombinant DNA Activities; recombinant DNA research: action under the guidelines. National Institutes of Health (NIH), PHS, DHHS. Notice of action under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)

This notice sets forth an action to be taken by the Director, National Institutes of Health (NIH), under the NIH Guidelines for Research Involving Recombinant DNA Molecules (59 FR 34496, amended 59 FR 40170, 60 FR 20762, 61 FR 1482, 61 FR 10004, 62 FR 4782, 62 FR 53335, 62 FR 56196, 62 FR 59032, 63 FR 8052, 63 FR 26018).     

Innovation in the public sphere: reimagining law and economics to solve the National Institutes of Health publishing controversy

The National Institutes of Health (NIH) are responsible for the largest proportion of biological science funding in the United States. To protect the public interest in access to publicly funded scientific research, the NIH amended terms and conditions in funding agreements after 2009, requiring funded Principal Investigators to deposit published copies of research in PubMed, an Open Access repository. Principal Investigators have partially complied with this depository requirement, and the NIH have signaled an intent to enforce grant agreement terms and conditions by stopping funding deposits and engaging in legal action.The global economic value of accessible knowledge offers a unique opportunity for courts to evaluate the impact of enforcing ‘openness’ contract terms and conditions within domestic and international economies for public and economic benefit. Through judicial enforcement of Open Access terms and conditions, the United States can increase economic efficiency for university libraries, academic participants, and public consumers, while accelerating global innovation, improving financial returns on science funding investments, and advancing more efficient scientific publishing models.     

Privacy Act of 1974; altered system of records--PHS. Notification of altered Privacy Act system of records 09-25-0074

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to alter system of records 09-25-0074, "Clinical Research: Veterans Administration Bladder and Prostate Cancer Clinical Trials, HHS/NIH/NCI." The purpose of the alteration is to modify an existing system of records into an umbrella system by broadening both the categories of individuals under this system and the purposes for which the system is used. The names of the system of records is also being changed to reflect the alteration. The new name is "Clinical Research: Division of Cancer Biology and Diagnosis Patient Trials, HHS/NIH/NCI."     

Privacy Act of 1974; new system of records--Public Health Service. Notification of establishment of a new Privacy Act system of records, 09-25-0151

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new Privacy Act system of records, 09-25-0151, "Administration: Alert Records Concerning Investigations or Determinations of Misconduct by Current or Potential Recipients of Funds for Biomedical Research," HHS/NIH/OD. We are also proposing routine uses for this system. The National Institutes of Health (NIH) will use this system to make informed decisions on appropriate actions regarding awards of research funds to individuals who are or have been subjects of investigations or determinations of misconduct. PHS invites interested persons to submit comments on the proposed routine uses on or before June 11, 1982.     

Recombinant DNA research; actions under guidelines--NIH. Notice of actions under NIH guidelines for research

This notice sets forth actions taken by the Director, National Institute of Allergy and Infectious Diseases, by authority of the Director, NIH, under the April 1982 Guidelines for Research Involving Recombinant DNA Molecules (47 FR 17180).     

Do consensus conferences work? A process evaluation of the NIH Consensus Development Program

The purpose of this evaluation study is to identify problems and suggest modifications in the NIH Consensus Development Program. The current program consists of three-day conferences in which experts assess medical technologies for issues of efficacy, safety, conditions of use, and other related topics (e.g., costs and social impact). Eight consensus conferences held between 1980 and 1982 were studied in depth using a variety of methods; five of the conferences were investigated concurrently. In addition, archival material was examined for all but one of the 33 conferences held up to that time, and four planning meetings for future conferences were observed. The delay in publishing our findings provided an opportunity to examine the changes introduced by NIH; it also allowed us to avoid the criticism of numerous prior evaluations for finding fault with programs that are still developing. NIH adopted many of the recommendations in our evaluation report and has investigated others. Based on our evaluation and more recent evidence, however, we conclude that the major problem that was uncovered--selection bias, particularly with respect to the choice of questions and panelists--remains a significant threat to the credibility of the consensus process. More specifically, the results indicate that controversial issues cannot be properly addressed within the present conference format, although that was one of its major purposes. Recommendations for improving the consensus process are presented, as are their implications for a larger set of consensus activities that are currently being conducted.     

National Institutes of Health Center Grants. Final rule

The National Institutes of Health (NIH) is amending its regulations governing center grants to reflect their applicability to several new grant programs, including research on autism, Alzheimer's disease, fragile X disease, and minority health disparities and other types of health disparities.     

古代法制的生成及其演进逻辑——以事制为中心

中国古代法制在其发展过程中,实际上形成了事制与刑制并驾齐驱的两面:一方面是通过"议事以制"——"制事典"——"令以存事制",编成令典;一方面是历经"不为刑辟"——"正法罪"——"律以正罪名",编成律典。它们是中国古代法的两个重要组成部分。人定规则的生成、成文法的出现、法典编制成功及"诸法合体"格局的突破,是中国古代法生成发展的三个关键节点。而从先秦的"制事典",到中古的"益事律"、"存事制","议事以制"的传统一脉相承,演绎了中国古代法源远流长的另一面。     

布坎南宪政规则理论研究

立宪民主是宪法性规则约束下的一种有限民主,立宪规则理论是布坎南宪政民主理论的核心内容.布坎南相信一套政治和经济活动的宪法性规则可以有效约束政府行为.但是由于布坎南的规则理论太过理想化而招致很多批评,使得布坎南不得不对其规则理论进行不断修正,其规则理论经过了一致同意规则、超多数裁定规则、普遍性原则等几种形式流变.通过对布坎南的规则内容及规则形式流变的研究,有利于我们进一步看清布坎南规则理论的困境和乌托邦色彩,有助于我们深入地把握其立宪民主理论的内容实质.     

传闻证据规则变革评述——兼谈对我国确立传闻证据规则的启示与借鉴

传闻证据规则作为英美证据法上最古老的证据规则之一,经过几个世纪的演变,已面临着规则体系过于庞杂,规则适用趋于僵化的困境。为此,进入21世纪以来,各主要英美法系国家均对传闻规则进行了法典化和简化,不仅如此,传闻证据规则的基本理念和原则在各个国家发生了明显分化。英国的传闻规则日益宽松,其基本原则由排除变成采纳。而美国则限制了法官对传闻证据可采性的自由裁量权,从自由化向着严格排除规则回归。澳大利亚的传闻规则体现出一定的折衷性。传闻证据规则在英美法系国家的变革以及变革反映出的不同价值理念启示我们,应当以现代规则为蓝本,确立简明、易行、符合中国国情的传闻证据规则,并以渐进式为思路,逐步确立传闻证据规则及其配套制度。     

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.     

内化法律之路——以内化禁止性规则为切入点

法律作为一套外在的规则体系,存在规则制定者与遵守者的二元对立,为化解这种对立,本文先将法律限缩为禁止性规则,并将其分为自然禁止性规制和实证禁止性规则.然后借鉴康德的形式道德理论说明服从自律要求是遵守自然禁止性规则的原因,再通过演化博弈理论将遵守实证禁止性规则的动机还原为对利益的追求,分别提出内化两种规则的理论进路.从此法律就不再是对人的外在强加,而变成了自愿选择.