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.     

The Ancillary-Care Responsibilities of Researchers: Reasonable But Not Great Expectations

This paper argues that, in a community of rights, the prima facie responsibilities of researchers to attend to the ancillary-care needs of their participants would be determined by a four-stage test (relating to placement, capacity, reasonable imposition, and fair demand). This test, it is suggested, sets a standard (and an example) for common law courts that are invited to recognize the ancillary-care responsibilities of researchers, whether as a matter of contract or tort law.     

Empirical analysis of current approaches to incidental findings

This paper presents results found through searching publicly available U.S. data sources for information about how to handle incidental findings (IF) in human subjects research, especially in genetics and genomics research, neuroimaging research, and CT colonography research. We searched the Web sites of 14 federal agencies, 22 professional societies, and 100 universities, as well as used the search engine Google for actual consent forms that had been posted on the Internet. Our analysis of these documents showed that there is very little public guidance available for researchers as to how to deal with incidental findings. Moreover, the guidance available is not consistent.     

Incidental findings in genetics research using archived DNA

Despite calls by some commentators for disclosing incidental findings in genetics research, several factors weigh in favor of caution. The technology of genetics has the power to uncover a vast array of information. The most potent argument for restraint in disclosure is that much research is pursued without consent so that the individual participant may not know that research is being conducted at all. Often the work is done by investigators and at institutions with which the person has no prior contact. Past practice is also relevant; genetics researchers historically have chosen not to disclose incidental findings, of which misattributed paternity and pleiotropic alleles such as ApoE have been the most common. Many people choose not to have genetic tests when given a choice. It may be desirable to discuss the topic of incidental findings when consent for research is obtained, but given the risk of unwanted surprise when there has been no prior discussion, the potential utility of incidental findings should be very high before they are even offered to individuals.     

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 spatial and temporal distribution of pollen in a room: Forensic implications

This paper presents two experimental studies that deal with the spatial and temporal distribution of pollen grains within a room of a domestic dwelling. The findings concur with the preliminary work of Morgan et al. [1] and provide greater detail as to the behaviour of pollen grains within indoor locations that are pertinent for forensic investigations. The spatial distribution of pollen in a room exhibits strong distance decay trends, with the majority of pollen recovered within 0.8 m of its source. The pollen was found to persist in increasing quantities during the time the flowers were in the room. This study also shows that 20 days after the flowers were removed, 25–32% of the original pollen was still present within the room. The influence of disturbance was investigated and whilst areas of high disturbance were found to retain less pollen than undisturbed locations, the influence of the proximity to source was a more dominant factor.These findings have significant implications for forensic investigation protocols, particularly the collection and interpretation phases of trace evidence analysis. The distribution of pollen around a room ensures that viable sources of trace pollen are available for transfer if contact is made between a location in the room and a suspect. The persistence of pollen many days after the flowers have been removed from a room indicates that many rooms in domestic dwellings will have distinctive assemblages that reflect the history of the flowers that have been displayed within that room in the past, and that these assemblages will persist and therefore be available for transfer. These preliminary findings indicate that investigation by forensic palynology in indoor domestic settings may well be an underutilised technique that has the potential to provide accurate and valuable intelligence and evidence for forensic enquiry.     

Genomic research and incidental findings.

The Human Genome Project showed that there is significant genetic variation within the population. Current research is accumulating large databases that may reveal genetic variations associated with disease or health risks, even if not intended as part of the study design. These incidental findings create legal, ethical, and financial challenges for researchers. Current federal and international guidelines are not adequate. Plans for dealing with incidental findings need to be established in the study design and reviewed and approved by the Institutional Review Board.     

Hospitals’ Liabilities in Times of Pandemic: Recalibrating the Legal Obligation to Provide Personal Protective Equipment to Healthcare Workers

The Covid-19 pandemic has precipitated the global race for essential personal protective equipment in delivering critical patient care. This has created a dearth of personal protective equipment availability in some countries, which posed particular harm to frontline healthcare workers’ health and safety, with undesirable consequences to public health. Substantial discussions have been devoted to the imperative of providing adequate personal protective equipment to frontline healthcare workers. The specific legal obligations of hospitals towards healthcare workers in the pandemic context have so far escaped important scrutiny. This paper endeavours to examine this overlooked aspect in the light of legal actions brought by frontline healthcare workers against their employers arising from a shortage of personal protective equipment. By analysing the potential legal liabilities of hospitals, the paper sheds light on the interlinked attributes and factors in understanding hospitals’ obligations towards healthcare workers and how such duty can be justifiably recalibrated in times of pandemic.

     

关联与互动：心理学研究方法的文化品性探新

心理学研究方法是心理学研究中的重要问题.长期以来,心理学家一直关注和强调心理学研究方法的工具属性,仅仅将其视为达成心理学研究的工具或者手段,这严重地窄化和局限了对心理学研究方法的理解和认识,也会影响和局限到对心理学的认识.事实上,在心理学研究方法与文化传统和社会现实之间,还存在着更深层次的关联和互动.心理学研究方法除了具有作为技术支撑的工具属性以外,其文化品质还应该从与文化传统和社会现实的关联和互动中,获得对研究方法全面而又深刻的认识和理解.     

The biomedical researcher and subpoenas: judicial protection of confidential medical data

An increasing number of medical researchers are being subpoenaed to testify or to supply records in cases in which they have not agreed to become involved as expert witnesses. The researchers' published works are alleged to have formed the basis of the opinions of physicians testifying as expert witnesses in these cases. Although the courts usually protect confidential medical data, the considerable burden of quashing these subpoenas is still imposed upon researchers and their universities. This Article argues that courts should protect these research records from subpoenas.     

Implementing economic and social rights in ‘domestic’ jurisdictions: understanding the minimum core obligations approach

This paper investigates the possibility and efficacy of identifying core obligations that should apply to all States in the implementation of Economic and Social Rights (ESRs). The paper acknowledges that ESRs are largely resource dependent, require progressive realisation and that States differ in their level of economic development. However, the paper finds that while the above factors are worth considering, they do not wholly offer reasonable justification to dismiss the core obligations approach. First, the paper examines the core obligations approach. This is followed by the discussion on why this approach should apply to all States. Thereafter, the discussion turns to objections that have been levelled against the core obligations approach. The paper attempts to offer responses to such criticisms. The paper then concludes with the view that although the approach has its challenges, it offers a good conceptual starting point towards the fulfilment of ESRs in domestic jurisdictions.     

从封闭到开放:教育研究方法范式的转换

我国教育学术界主要存在两种研究方法的范式,二者存在着矛盾与竞争,尤其表现为主张实证研究的学者往往反对思辨研究.其实,将任何一种方法范式的合法性强调到极端,而拒斥其他的研究方法,都是片面的.封闭的教育研究方法范式不仅会限制研究者的学术兴趣、学术视野和学术创新能力,而且往往会导致研究目的、研究过程甚至研究结论被局限在其方法所允许的比较狭隘的范围之内.因此,教育学术界应当超越封闭的方法范式,以实现以下三个转向:从封闭到开放,从控制到解放,从霸权到民主.只有如此,教育学才可能充满活力、具有学科竞争力和影响力.     

Relational legal consciousness in the punitive welfare state: How Dutch welfare officials shape clients' perceptions of law

With a growing number of strict obligations and harsh sanctions for welfare recipients, the Netherlands has increasingly become a punitive welfare state. This article looks at what this means for welfare clients and their commonsense understandings of the law. To analyze how welfare officials shape clients' legal consciousness, I draw on an online survey among Dutch welfare clients (N = 1305) and a correlation analysis. The findings show that there is a clear relationship between welfare clients' own legal consciousness and their assessment of welfare officials' beliefs about the law. However, not all elements of their legal consciousness are relationally influenced by the same factors. Also, clients' self-reported compliance behavior is less relationally influenced than other elements of their legal consciousness. This study adds to our understanding of the mechanisms that constitute the production of relational and second-order legal consciousness and it contributes to the development of new research methods to study people's perceptions of law.     

Understanding incidental findings in the context of genetics and genomics.

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, "incidental" or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent may no longer be appropriate. There is not yet consensus on the responsibilities of researchers to disclose individual research results to research participants. Empirical research suggests that participants want to know individual research results. On the other hand, the increased resolution and power afforded by new genomic analyses may lead to findings of statistical, but not necessarily clinical, significance. This paper addresses the issues to be considered in deciding whether and how to disclose "incidental" findings or other findings of clinical significance that arise in the course of human genomic and genetic research. What research results should be offered, and what should not be offered? For which research should individual results be offered to research participants, when should they be offered, how, and to whom?     

授益行政的义务主体及义务属性

授益行政由一定的权利义务构成。授益行政对于受益人而言,主要意味着权利,但它同时也负有一定的义务;对于行政主体而言,主要意味着义务,但对个人和组织负有义务的又不仅限于行政主体,国家、社会、受益人以及第三人均负有相应的义务。合理界分各方义务主体的义务属性和义务内容,正确处理各方之间的关系,科学配置权利义务资源,是完善授益行政制度体系的前提条件。     

PRO SE DIVORCE LITIGANTS

With the increased number of divorce litigants appearing pro se in the past century, trial court judges and court personnel are forced to deal with their conflicting obligations with more frequency. It is virtually impossible for a trial court judge to ensure all litigants have a fair and meaningful trial without compromising their neutrality. Likewise, court personnel are allowed to give out legal information but not legal advice, with the definition of legal information and advice not neatly packaged into two separate and distinct categories. Consequently, changes must be made. This note suggests various solutions that can be imposed to either reevaluate the role of trial court judges and court personnel so that they no longer have conflicting obligations and are able to accommodate the needs of the pro se litigants or implement services that can provide pro se litigants with other avenues of obtaining information and assistance.     

Incidental findings in human subjects research: what do investigators owe research participants?

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental findings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental findings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of this professional obligation to respond to incidental findings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship.     

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.     

From a Pluralism of Grounds to Proto‐Legal Relations: Accounting for the Grounds of Obligations of Justice

In this paper I discuss critically Mathias Risse's paper “Responsibility and Global Justice.” First, I argue that for Risse's pluralist account of the grounds of justice to hold together, there is need to presuppose a monist standpoint which ultimately contributes to grounding principles of justice. Second, I point out that Risse's understanding of obligations of accountability and justification is rather narrow in that it functions as an addendum to obligations of justice. Conversely, I will suggest that the obligation of accountability plays a deeper role: The conditions that ground it feature at the same time among the grounds of obligations of justice. Accordingly, the kind of relation that gives rise to a duty among agents to account for their actions must be in place when obligations of justice obtain. Following on from these remarks I will adumbrate an alternative account of the relation which grounds (enforceable) obligations of justice.     

The dual function of explanations: Why it is useful to compute explanations

Whilst the legal debate concerning automated decision-making has been focused mainly on whether a ‘right to explanation’ exists in the GDPR, the emergence of ‘explainable Artificial Intelligence’ (XAI) has produced taxonomies for the explanation of Artificial Intelligence (AI) systems. However, various researchers have warned that transparency of the algorithmic processes in itself is not enough. Better and easier tools for the assessment and review of the socio-technical systems that incorporate automated decision-making are needed. The PLEAD project suggests that, aside from fulfilling the obligations set forth by Article 22 of the GDPR, explanations can also assist towards a holistic compliance strategy if used as detective controls. PLEAD aims to show that computable explanations can facilitate monitoring and auditing, and make compliance more systematic. Automated computable explanations can be key controls in fulfilling accountability and data-protection-by-design obligations, able to empower both controllers and data subjects. This opinion piece presents the work undertaken by the PLEAD project towards facilitating the generation of computable explanations. PLEAD leverages provenance-based technology to compute explanations as external detective controls to the benefit of data subjects and as internal detective controls to the benefit of the data controller.