Institutional review board approaches to the incidental findings problem

Institutional Review Boards (IRBs) are confronted with new challenges in the face of expanding technologies while fulfilling their existing regulatory mandate to ensure that plans are in place to protect subjects and to inform them of risks and benefits of research participation. Existing regulations and guidance do not address the issue of incidental findings (IFs), thus leaving awareness of the issue and the application of ethical principles to IRB judgment alone. In order to assure that researchers are aware of the potential for IFs, IRBs must identify which studies are likely to identify IFs and establish what plans should be put into place prior to study initiation to assure the subjects are appropriately informed of the likelihood of IFs, how IFs will be communicated to subjects, and whether the burden of follow-up falls on the researchers or is the subject's responsibility.     

Managing incidental findings in human subjects research: analysis and recommendations.

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.     

The Management of Incidental Findings in Neuro-Imaging Research: Framework and Recommendations

This paper addresses the question of how incidental findings (IFs) in clinical research should be managed by researchers, focusing in detail on IFs discovered in neuroimaging research. It begins by engaging the larger research ethics issue of whether researchers have any obligations of clinical care to participants, and assesses the content and merits of one particular framework for answering this question, Richardson and Belsky's ancillary care model. From here the paper develops an organizational structure for integrating the ancillary care model with existing research ethics standards, with the aim of better understanding their respective domains. It makes a distinction between incidental findings that are anticipated by informed consent documents, and those that are unanticipated, arguing that this distinction is critical for evaluating researcher obligations. Finally, it takes on the issue of incidental findings in neuroimaging research, translating the standards discussed into recommendations for both unanticipated and anticipated findings.     

Incidental findings in CT colonography: literature review and survey of current research practice

Incidental findings (IFs) of potential medical significance are seen in approximately 5-8 percent of asymptomatic subjects and 16 percent of symptomatic subjects participating in large computed tomography (CT) colonography (CTC) studies, with the incidence varying further by CT acquisition technique. While most CTC research programs have a well-defined plan to detect and disclose IFs, such plans are largely communicated only verbally. Written consent documents should also inform subjects of how IFs of potential medical significance will be detected and reported in CTC research studies.     

法律实证研究中的伦理问题 以刑事法为视角

在刑事法律实证研究中,由于被研究者多为极易受到研究伤害的弱势群体,研究过程及结果又往往涉及司法改革和司法公正等重大问题,因而研究伦理亟需规范。实证研究本质上是一种生产知识的方法,对刑事法律实证研究的伦理规范主要是对研究权力的规范,目的是防止知识、权力与资本的“共谋”。应当遵循自律、纪律和法律的总体思路,设立伦理审查委员会,依据尊重、保护、公正、全面的原则,规范我国的刑事法律实证研究。在规范的同时还要建立相应的保障机制,以解决实践中法律实证研究难以开展的不利局面。     

The Future of Incidental Findings: Should They be Viewed as Benefits?

This paper argues against considering incidental fndings (IFs) as potential benefts of research when assessing the social value of proposed research, determining the appropriateness of a study's risk/beneft ratio, and identifying and disclosing the risks and benefts of participation during informed consent. The possibility of generating IFs should be disclosed during informed consent as neither a risk nor beneft, but as a possible outcome collateral to participation. Whether specifc IFs will be disclosed when identifed is a separate question whose answer is material to determining whether IFs constitute a risk or a potential indirect beneft of participation. Finally, three types of IF should be distinguished and treated diferently during informed consent: those that will be routinely generated (e.g., results of testing to determine study eligibility), those that can reasonably be characterized in terms of their nature and frequency of generation (e.g., misattributed parentage), and those of unpredictable nature and frequency that can be characterized only in general terms. Research protocols should provide a rationale for sharing or not sharing IFs of these three types with participants. Regulatory review of such plans should not, however, be confused with regarding IFs as potential benefts when assessing the study's risk/beneft ratio or merit.     

Incidental findings in pediatric research

The approach to incidental research findings in children emerges by considering the child-parent relationship and balancing divergent interests and preferences. Incidental findings with clear and proximate clinical importance should be disclosed to both. We recommend that particularly sensitive or private information (e.g., pregnancy or drug use) should be disclosed to the adolescent first, while particularly serious information (e.g., cancer) should first be disclosed to the parent. These approaches allow the researcher to form an alliance with one party prior to engaging the other. However, unlike clinical settings, where there may be presumptive expectations of confidentiality about sharing information within the family, in most research settings it is reasonable to plan to disclose such information to both parties. It is important to communicate this plan during the informed consent process separately to adolescents to avoid enrolling adolescents when sensitive incidental findings such as pregnancy and drug use may be detected. The approach to incidental findings without clear and proximate benefit is challenging. Researchers should plan more limited disclosure of such incidental findings for pediatric participants than for adult participants.     

Researcher–practitioner partnerships and crime analysis: a case study in action research

This paper describes a recent researcher–practitioner partnership designed to address the challenges faced by law enforcement agencies when implementing crime control and prevention strategies. Using an action research methodology, the project embedded a group of trained students within the law enforcement community to assist with local crime problems and supplement existing crime analysis and research capabilities in six agency units. Results of this case study offer several implications for future researcher–practitioner partnerships focused on crime analysis and present an enhanced set of metrics for evaluating success.     

电子商务平台经营者涉税信息报送义务履行的规范化研究——基于我国《电子商务法》第28条规定的阐释

基于协助税收征管的需要,平台经营者应依法定条件和法定程序向有管辖权的税务部门履行报送平台内经营者涉税信息的义务。我国《电子商务法》设置涉税信息报送义务旨在防范数字经济时代下税收征管的失灵、实现税负的公平负担。该法规定的平台经营者涉税信息报送义务面临履行主体过于宽泛、履行对象含混模糊、履行内容有待明确、履行监督效果欠佳等突出问题。有必要通过我国《电子商务法》施行细则,允许平台委托报送、降低初创型平台报送负担、建立跨境报送国际协调机制,以界分平台经营者职责;经由分层化管理平台内经营者与细分服务领域,以厘清该义务的履行对象范围;通过制定信息报送正面清单、明确报送部门、统一报送时间、流程和方法,以明晰该义务的履行内容;通过丰富事后行政查处机制与强化事前合规指引,以激励该义务的有效履行。     

我国公共卫生领域公民权利的法律研究热点及对策

公民权利保护在公共卫生领域法律处于核心地位，目前我国学者对其研究热点主要包括人身自由权、财产权、知情权、隐私权，但研究存在对公共卫生领域公民权利界定不够统一、法律依据不尽准确、研究着眼点有些片面等不足，今后应高度重视公共卫生公民权利的研究，加强研究其体系及其法律渊源，优先现有公共卫生法律体系的完善和配套，积极开展国际比较研究，辨证理解各公民权利之间的相互关系。     

论行政主体义务的法律意义

行政主体义务对行政法关系乃至于行政法治的走向起着决定性作用,它与行政法中的"权利"和"权力"具有同等重要的地位。然而,在我国行政法学界历来重视对后两者的研究而忽视了前者,没有给行政主体义务以科学的定位,这不能不说是行政法学理论的一大缺憾。行政主体义务的成立,必须有法律或职权上的依据,有行政法上的义务形态,有行政法上的权利主体,有完成义务的行为能力;行政主体义务在法律表现上有其独特之处,它是一个复杂的义务链条,是管理义务与服务义务的统一,是积极义务与消极义务的统一,是职权义务与行为义务的统一,是法规义务与契约义务的统一;行政主体义务对行政职权定"责",对行政法关系定"性",对行政行为定"量",对行政救济定"度"有重要的法律意义。     

GOING TO COURT AS A LAST RESORT: ESTABLISHING A DUTY FOR ATTORNEYS IN DIVORCE PROCEEDINGS TO DISCUSS ALTERNATIVE DISPUTE RESOLUTION WITH THEIR CLIENTS

This Note advocates for the creation of a uniform ethical requirement that all attorneys in divorce proceedings involving children inform their clients about alternative dispute resolution (ADR), particularly mediation and collaborative law. By emphasizing cooperation and negotiation among the divorcing parents, both mediation and collaborative law offer these would-be litigants the opportunity to move forward with their parental duties long after the divorce is finalized. Using the ABA Model Rules of Professional Conduct as a template, this ethical requirement will ensure that clients are fully informed of the availability of ADR and of the chance to forgo potentially unnecessary litigation. Ultimately, the implementation of an ethical requirement holds the potential to minimize the impact of divorce on children by facilitating the process of moving forward for the family as a whole.     

The risks and benefits of searching for incidental findings in MRI research scans.

We weigh the presumed benefits of routinely searching all research scans for incidental findings (IFs) against its substantial risks, including false-positive and false-negative findings, and the possibility of triggering unnecessary, costly evaluations and perhaps harmful treatments. We argue that routinely searching for IFs may not maximize benefits and minimize risks to participants.     

Settlor control--what kind of a problem is it?

Trustee duties are defined when the trust is created, and thetrustee controls management and distribution with the powersgiven to the trustee by the trust instrument. If the settloror a third party has the power to consent to or direct trusteedecisions, is there a trust at all? Trust law is equivocal.It is a question of degree. Family law courts to the contrarywant to know what is really going on, and have refused to acknowledgesuch a trust. In New Zealand, Harrison v Harrison is the latestinstance of this.     

Children's street connections in a Canadian community

Preteen children's street activities in a small southern Ontario city were examined for understandings about how children on the street affiliate with one another and with adults after school. The everyday connections between children, shopkeepers, and municipal workers demonstrate that the municipal workers and merchants can offer caring, support, and sanctions to children when parents or teachers are not accompanying them. This provides children on the street with a form of guidance from extrafamilial mentors. The findings point to community-based potentials for naturally occurring crime prevention strategies, a significant aspect of Canada's new law: Youth Criminal Justice Act. 2003.     

从行政管理到综合管理:我国能源管理的模式变革

能源管理涉及产业发展、环境保护、国家安全等一系列重大问题,因此能源管理应当是一种综合性管理行为,行政管理只应当是能源管理中的一个环节。能源管理应当突破单纯行政管理的藩篱,淡化计划性、管制性色彩,增强服务性、适应性功能,设立综合性能源主管部门,实现主管、监管职责分离,完善能源法律体系,改进管理方式,以更好地服务于国民经济社会发展的大局。     

Policing Schools: Examining the Impact of Place Management Activities on School Violence

The present study examines whether the presence of school resource officers (SROs) and their level of involvement in place management activities are associated with higher or lower rates of school-based serious violence. This study uses data from the 2010 School Survey on Crime and Safety (SSOCS) conducted by National Center for Educational Statistics. Propensity score matching is used to create a quasi-experimental design and isolate the influence of SROs and their level of involvement in place management activities on school-based serious violence. The analysis reveals that schools with a school resource officer are associated with higher rates of reported serious violence and those schools with SROs that participate in more place manager duties are also associated with higher rates of reported serious violence. These findings do not support the notion that SROs are acting as effective place managers and through this place management, reducing reported serious violence. Rather, it appears that the presences of a SRO and their execution of place manager duties is associated with an increase in the reporting of serious violence. Policy implications and limitations of the current research are also discussed.     

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 effective design,implementation and enforcement of socio-economic equality duties: lessons from the pupil premium

Abstract

The UK has extremely high levels of socio-economic inequality, which are predicted to rise over the next five years. Traditionally, equality law was seen as inappropriate to address socio-economic inequality but in the last decade, a growing number of equality duties have been introduced to address this persistent form of inequality. There is, however, little research on the principles that underpin these duties. This article seeks to address this gap through the use of data from interviews conducted with primary school personnel implementing the pupil premium. The article explores understandings of socio-economic inequality by individuals in schools; policy conflicts; the wider context of action to address socio-economic inequality; different decision-making processes; and accountability mechanisms. On the basis of the findings of this study, broad principles are outlined to inform the design, implementation and enforcement of socio-economic equality duties in the future.     

法治视野中的行政指导行为——论我国行政指导的合法性问题与法治化路径

行政指导是行政民主化潮流下日益广泛运用并逐渐类型化的一种现代行政管理行为方式,同时也是一个理论基础薄弱、实务问题甚多、法治程度不高的重大行政现象,应当按照现代行政法治的要求将其纳入法治化轨道。本文透过依法行政理念的演进轨迹从多个角度探讨了行政指导行为的合法性问题和法学理论背景,并以实证研究方式结合我国行政法律制度现实进一步讨论了行政指导与依法行政的关系,在此基础上分析了行政指导实践中存在的突出问题及其原因,并从观念更新、制度创新、完善立法、配套措施等方面提出了推动行政指导法治化的完善路径和具体对策,期能为正在进行中的我国行政指导程序立法和制度建构提供参考。