Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and Investigators

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants.     

Internationality of Women Specialty Journals: Content Analysis and Survey of Editors

In the USA, in criminology and criminal justice, the women specialty journals, Feminist Criminology, Violence Against Women, and Women and Criminal Justice, have played a key role as outlets for research on women and crime. The current study examined the internationality—presently a significant criterion used to measure the quality of scholarly journals—of these women specialty journals. In order to measure their level of internationality, two indicators are studied: (1) geographic diversity of editorial boards and (2) the patterns (frequency, countries, international collaborations, and thematic directions) of the foreign-authored articles between 2010 and 2016. The authors also conducted a survey of the editors of the three women specialty journals to identify trends in international submissions as well as editors’ perceptions of the internationalization of their journals. The results of this study confirm that the three women specialty journals are becoming more international. Finally, recommendations to encourage international diversity of editorial boards and authorships, especially from East Asia, are discussed.     

我国政府过程性信息公开的困局与纾解

在我国。政府过程性信息是否公开随着个案的陆续出现引发了较大的争议,相关立法、行政机关、司法机关对此存在着不同的判断。在城外一些国家信息公开的立法与实践中,均对过程性信息的公开有着充分的考虑和细致的制度规定,值得我国借鉴。为平衡公众知情权与行政机关的行政权。我国信息公开立法应将政府过程性信息列入免于公开的范围,但须制定公共利益的特别裁量标准,如公共政策的制定等影响面较大的政府行为,应最大程度地将政府过程性信息公开。     

Nonfinancial Risk Disclosure and the Costs of Private Ordering

In 2016 the Securities and Exchange Commission (SEC) considered for the first time whether financial disclosure reform should address information on sustainability matters and other sources of nonfinancial risk. The resulting debate over these issues raised fundamental questions about how well the federal disclosure regime addresses emerging risks and about how well private ordering, through shareholder engagement, the work of private standard‐setters, and corporate voluntary disclosure, can fill the gaps. This article argues that the current model of nonfinancial risk disclosure, based largely on private ordering, is ineffective and undermines the SEC's mission to protect investors, facilitate capital formation, and promote fair, orderly, and efficient markets. This conclusion rests on evidence that the current state of sustainability disclosure is inadequate for investment analysis and that these deficiencies are largely problems of comparability and quality that cannot readily be addressed by private ordering. This article also highlights the costs of agency inaction to investors and to public companies, which have been largely ignored in the debate over the future of financial reporting. It concludes by proposing avenues for disclosure reform.     

Mandatory accounting disclosure by small private companies

This article analyzes how mandatory accounting disclosure is grounded on different rationales for private and public companies. It also explores technological changes, such as computerised databases and the Internet, which have recently made disclosure of company accounts by small companies potentially less costly and more valuable, thanks to electronic filing and universal online access to credit information systems. These recent developments favour policies that would expand the scope of mandatory publication for small companies in countries where it is voluntary. They also encourage policies to reduce the costs and enhance the value of disclosure through administrative reforms of filing, archive and retrieval systems. Survey and registry evidence on how the information in the accounts is valued and used by companies is consistent with these claims about the evolution of the tradeoff of costs and benefits that should guide policy in this area.     

The Rigor of Research Design and “Forensic” Publications in Neuropsychological Research

Seven neuropsychology journals that publish on topics relevant to clinical neuropsychology were examined for their experimental rigor according to the standards of the American Academy of Neurology (AAN) in their Clinical Practice Guidelines. By using a keyword approach on topics relevant to forensic neuropsychology, all articles that reported empirical findings from 2003 through 2008 were identified. Each study was rated by AAN classification criteria that ranged from a level I classification (prospective, most rigorous, and independent) to level IV (least rigorous). The typical forensic neuropsychological study averaged a class III ranking. Few studies were based on large sample sizes or utilized a reported masking or blind technique with regards to subject selection and how diagnostic criteria were met and/or data analyzed. While the authors for the average study reported a university affiliation, few reported explicit Institutional Review Board statements. Considerable variability across these seven journals with regards to conflict of interest (COI) disclosure policies was observed and only a few studies reported explicit statements about funding or COI issues. These observations suggest that neuropsychological research on forensic topics currently has many limitations and that future research needs to address these issues.     

特色:公安学术期刊永恒的主题

公安学术期刊的特色就是以特色栏目的创建为基础,突出优势学科、选定研究方向,策划重点选题,展开学术争鸣。通过集中优质资源,办好特色栏目,更好地引导公安学术研究向纵深发展。为此必须以特色化为办刊理念,以优秀的编辑团队为主体,以高水平的学术成果为支撑。     

行为金融信息中介的网贷平台信息披露规则

从金融属性上看,网贷平台提供的是借贷信息中介服务。信息披露是其主营业务内容,平台不能参与借贷交易,否则将使流动性等风险大量集中到平台并引发严重后果。从法律性质来看,网贷平台则是借贷居间商,应当向交易双方履行相应的信息披露义务。网贷业务兼具金融和网络化特点,我国《合同法》第425条的一般性规定无法有效规制网贷平台的信息披露行为。P2P网络借贷信息披露监管规范虽初具体系,但还需围绕投资者等金融消费者保护这一根本宗旨进行改进,使信息披露内容以普通消费者等客户认知水平和需求为导向,信息披露义务的履行贯穿借贷合同存续的全过程,平台违反信息披露义务应当承担相应的民事责任等。     

Identity, genealogy, and the social family: the case of donor insemination

In this paper I discuss whether or not biographical information concerning the sperm donor should be disclosed to children conceived through donor insemination. Policies of disclosure for example in the context of adoption, have been justified on the basis of a notion of identity which emphasizes genetic ties. This notion of identity and the policies of disclosure of information concerning biological parents based on it, have been criticized by many writers, including feminists, as reinforcing explanations of human organization and development based on biological determinism rather than on ideas such as social construction. Further, this notion of identity is seen to emphasize the importance of genetic parenthood over the commitment involved in bringing up a child as a social parent. While agreeing with these criticisms of that particular notion of identity, I argue that the notion of identity as a whole should not be summarily rejected. Rather, it should be re-interpreted using a sociological approach incorporating the notion of narrative. This second narrative notion of identity is developed with reference to the situation of some groups of children, who like those born from donor insemination, generally do not have any knowledge of their biological parent[s], for example adoptees, the children of the disappeared in Argentina and child migrants. In this paper, policies of disclosure which allow these children to gain some knowledge of their biological parents are discussed in light of the two notions of identity. It is argued that disclosure may be justified on the basis of a narrative notion of identity. This allows for the rigid dichotomy created between biological determinism and social construction: the importance of social parents to the child is emphasized, however the desire a child may have to know something about her or his biological parent is not denied or dismissed.     

论违规披露、不披露重要信息罪的可能性失灵——以收益权凭证交易为例证

信息披露制度是金融监管法律制度的核心内容,需要刑法保护。为确保刑法调整信息披露制度的有效性,"违规披露、不披露重要信息罪"在原《刑法》条文的基础上,对主体、客观行为和行为结果都进行了修订完善。新的金融产品的出现使"违规披露、不披露重要信息罪"出现了漏洞,面临可能性失灵的现实问题,收益权凭证交易这一新型合成型资产证券化产品就是例证。创新资产证券化产品,监管部门要依据其交易特征,出台相应监管规则,注重完善信息披露制度,防止"违规披露、不披露重要信息罪"的可能性失灵。     

HMOs for Medicaid: the road to financial independence is often poorly paved.

During the 1980s both the federal government and the private sector articulated policies to encourage the development and participation of health maintenance organizations (HMOs) in the Medicaid program. However, the policies, intended to save costs, limited the ability of new HMOs to achieve financial independence. New plans that emphasize Medicaid participation have few, if any, options on benefit design or in setting capitation rates. Relative to fee-for-service Medicaid programs, their costs to provide services may be quite high, as they have neither the buying power not the ability to impose discounts. As a consequence, plans must focus their financial planning efforts on targeting and attaining a stable enrollment base and on controlling the amount of services provided, tasks that are difficult for all HMOs. Achieving a stable enrollment base is particularly hard because Medicaid eligibles have few incentives to enroll and once enrolled often lose their Medicaid eligibility. Traditional HMOs control the amount of services provided through physician selection, financial incentives on physicians, and monitoring and utilization review. Lack of information and the difficulty inherent in attracting sufficient provider participation limit the first two strategies, so new plans often adopt organization structures that rely heavily on monitoring activities. Unfortunately, management information systems for HMOs are often the weakest link. We discuss the tasks and present data on financial planning, on putting financial plans into operation, and on monitoring progress toward financial independence for a set of ten demonstration projects sponsored by the Robert Wood Johnson Foundation.     

财政活动公开是推进廉政建设的基础

腐败与我国的财政活动关系密切，只有公开财政活动，才能监督财政活动。廉政建设是大工程。财政活动公开是大工程的基础。本文对财政活动进行广义的定义，阐明了财政活动公开在推进廉政建设中的基础地位、财政活动公开的有效方式及财政活动公开的基本要求和内容，旨在从财政活动公开方面寻找反腐倡廉的新途径。     

金融公正理念的法学阐释

资本扩张所导致的金融危机与两极分化,将弘扬自由与平等为主旨的金融法拖入了目标和现实相背离的现代性悖论之中。从公正理念的维度,重新审视现代金融法的价值取向与功能定位,对于缓解法的服从性与正当性之间的紧张关系,以及维护法的权威性具有重要意义。推进中国金融法制的现代化进程,须对西方的现代性范式扬善抑恶,以求实现金融自由与社会秩序的良性互动。     

Beware the razorwire: Psychology behind bars

Nearly 2 million people are incarcerated in federal, state and local correctional facilities in this country. Individuals with serious mental disorders increasingly fill these ranks. The roles psychologists and other mental health professionals adopt while working with this population can become an issue of silent consternation. As a point of departure, some (e.g., Levinson, 1985) have suggested that psychologists rightly function as institutional mediators of conflict, a virtual Marcus Welby of the collective correctional “psyche”. In practice, it is not uncommon for some clinicians to retreat from this approach and do little, or conversely, march in one hundred directions at once. The authors suggest that as psychology service delivery has matured in the past few decades this latter, well-intentioned but unrealistic position should be reconsidered. We suggest that greater depth and definition in the area of forensic psychology, coupled with recently developed ethical and professional standards of care, may serve to guide the clinician when providing services “behind bars”. Authors' Note: The views expressed in this article are solely those of the authors and may not reflect the opinions of the United States Department of Justice, Federal Bureau of Prisons, Texas Department of Criminal Justice, other state or local criminal justice agencies, or the University of Texas at Austin.     

论信用行政评价的属性及其司法控制——一种后果取向的分析视角

信用行政评价是信用行政惩戒制度中的关键环节,其合法性对后续惩戒措施的合法性具有决定作用。关于其行为性质与可诉性,理论上存在行政处罚、行政确认、主动信息公开和行政事实行为四种认识。司法实践中,法院虽然通过严格的规范演绎推理否定了信用行政评价的行政处罚属性,但是未能就其行为性质与可诉性达成肯定而统一的认识。后果解释在信用评价案件中具有可适用性,通过澄清隐藏在司法判决中的后果考量,并以后果权衡的均衡性为标准,应当将信用评价定性为行政确认和政府主动的信息公开。在审查进路上,法院应进行独立审查和分类审查,根据不同的行为定性采取不同的审查强度,建构不同的审查标准。     

Fiduciary disclosure of medical mistakes: the duty to promptly notify patients of adverse health care events

Fiduciary obligations are imposed by the common law to ensure that a person occupying a societal role with a high potential for the manipulation of vulnerable persons exercises utmost good faith. Australian law has recognised that the doctor-patient relationship, while not wholly fiduciary, has fiduciary aspects. Amongst such duties are those prohibiting sexual or financial abuse of patients or disclosure without express authority of confidential information. One important consequence of attaching such fiduciary duties to the doctor-patient relationship is that the onus of proof falls not upon the vulnerable party (the patient), but upon the doctor (to disprove the allegation). Another is that consent cannot be pleaded as an absolute defence. In this article the authors advocate that the law should now accept that the fiduciary obligations of the doctor-patient relationship extend to creating a legal duty that any adverse health care event be promptly reported to the patient involved. The reasons for creating such a presumption, as well as its elements and exceptions, are explained.     

The Transparency Trap: Non‐Financial Disclosure and the Responsibility of Business to Respect Human Rights

This article examines the potential for transparency programs to improve corporations’ human rights performance. The primary focus is on “general” transparency programs such as the inclusion of human rights issues in sustainability reports. Regulators increasingly rely on such programs, one of which is the EU Directive on the Disclosure of Non‐financial Information, which many commentators view as a model for legislation in other countries and for a business and human rights treaty. This article identifies several problems with this approach. The human rights metrics used in current sustainability reporting standards often lack validity or are based upon data that is most easily collected, rather than most important. Moreover, the empirical evidence on sustainability reporting shows continued problems of selective disclosure, impression management, incomparable disclosures, and the use of disclosure as an end in itself (as opposed to a process that leads to organizational change). To move forward, regulators should shift focus to a model grounded in regulatory pluralism. Under this approach, regulators would combine a selection of targeted transparency mechanisms to create a more complete regulatory system that corrects for one disclosure mechanism's weaknesses by including others that have complementary strengths.