Foreseeable Risks Research Articles

Zone of Insolvency, Directors’ Duties and Creditors’ Protection in U.S.

When a company is navigating in the “zone of insolvency” – usually defined as the extent of the risk that creditors will not be paid – its directors face the dilemma related to their managerial decisions in the light of the foreseeable effects and risks for shareholders and for creditors. It is a generally accepted principle in U.S. that when a company is approaching such “zone of insolvency” or is in the “vicinity of insolvency” no fiduciary duties are owned to the creditors as expression of the shareholder primacy rule. The aim of this article is to demonstrate the existence of provisions of law together with important policy reasons that impose the duties shifting to creditors in the zone of insolvency and that allow to create a presumption of directors’ knowledge of when their duties shift, which means when the company is getting closer to insolvency. Accordingly, this article seeks to demonstrate that directors’ duties toward creditors should shift on the ground of two reasons: Firstly, the directors’ and shareholders’ opportunistic behavior – together with the opportunistic behavior of well-informed creditors–. Secondly, the need to preserve value for creditors. By comparing U.S. principles with UK insolvency system the conclusion is in the sense that in the zone of insolvency directors should have a clear duty to take every reasonable step in order to minimize the risk of potential losses for creditors. Moreover, this article shows that in U.S. from the interconnection of the MD&A provisions with the law of avoidable preferences, a general principle accordingly can be inferred. It brings that directors have the duty to know when the company is in trouble and therefore that insolvency is looming at the horizon, with a presumption that covers the period of time starting from the last financial statements release until the day of the bankruptcy filing. Specifically, the law of preferences as section 547 of the Bankruptcy Code – by striking down last-minute grabs – conceptually admits the principle that directors together with control shareholders and strong creditors know longer time in advance that the company will face a liquidation proceeding than other creditors and outsiders. As a consequence, the Delaware approach of allowing full discretion to the board of directors even at the “end game” stage with its actual risk of opportunistic behavior (asset dilution, asset substitution, debt dilution, conflicts among creditors) is incongruent with the retrospective approach of both state creditors’ remedies and federal bankruptcy law that after insolvency challenges distributions to shareholders and favors creditors and seeks recoupment. Therefore, this article argues for a pre-insolvency, “end stage” rule of constraint by demonstrating that the UK wrongful trading liability of directors is more coherent and congruent with majority legal systems’ post-bankruptcy recapture approaches than the U.S. one found in the Delaware jurisprudence.

An Ethical Analysis of the SUPPORT Trial: Addressing Challenges Posed by a Pragmatic Comparative Effectiveness Randomized Controlled Trial.

The SUPPORT trial highlights ethical challenges raised by comparative effectiveness randomized controlled trials (ceRCTs) involving one or more usual care interventions. Debate about the SUPPORT trial has focused on whether study interventions posed "reasonably foreseeable risks" to enrolled infants and, thereby, reflects a preoccupation with U.S. regulations. As ceRCTs are conducted globally, our analysis of the SUPPORT trial is grounded in internationally accepted ethical principles. We argue that the central ethical issue raised by the SUPPORT trial is the following: should the SUPPORT trial interventions be conceptualized as practice, or research? The answer to this question has important implications for "downstream" ethical requirements-including whether the usual care interventions in ceRCTs require research ethics committee review, undergo harm-benefit analysis, and are included in informed consent documents-and it is antecedent to the development of ethical guidance for ceRCTs.

Risk Assessment and Control for Main Hazards in Reverse Osmosis Desalination Plants

As the manpower is the most valuable and important element for production in any industrial plant or organisation, so their health and safety must be managed to protect them against the reasonably foreseeable risks. In this paper risk assessment is carried out for five Reverse Osmosis desalination plants to detect the main hazards in such type of plants. Health safety executive -five steps to risk assessment model is used including 5×5 risk matrix to rank the risk level and then represented by color code to clarify the priority. The materials, equipment, working place and peoples included in the operation are considered while assessing the risk and working activities are monitored and analyzed. The most common hazards are found in working at height, working inside confined spaces or under water, exposure to noise, contacting with uncovered rotating equipment, electricity, high pressurized fluid and fire. The control measures are introduced to mitigate the level of identified risks to an acceptable level like developing a permit to work system and procedures for confined space entry or working under water, lock out and tag out of the power supply while dealing with electrical equipment, guarding all rotating parts of the machines, provide the right equipment for working at height, reduce the exposure time to noise and providing sufficient training, information and safety instructions to the employees. This paper can be used as a safety booklet for RO desalination plants operators.

POST-BREXIT THREATS TO WORK SAFETY AND HEALTH STANDARDS AND GOOD WORKING CONDITIONS IN THE UK

This paper reviews how legal, political and economic threats to be borne out of Britain’s decision to leave the European Union (EU) will short-change pre-Brexit work protection standards in the United Kingdom (UK). These threat-factors are considered in view of their effects on two classes of workers: low-income temporary agency workers (TAW); and low-income self-employed workers in the growing UK gig economy. This paper describes impending post-Brexit threats, to pre-existing policy implementation threats curtailing legally envisaged occupational safety and health (OSH) standards, and the practice of proactively preventing all foreseeable work related risks to the mental or physical health of workers. Post-Brexit threats add to current limitations to employment protections for low income workers in the UK, and despite the recently proposed labour law reforms by the 2017 Taylor Review in regard to low-income workers, it is argued that these Brexit threat factors increase the risk of not extending the principle of equal protection to these two classes of workers in UK law, in ways envisaged under the current EU regulation. The paper concludes that in view of the notion of occupational well-being, the risks of physical and mental harms posed to low-income workers through exploitative work practices segment them from other workers who enjoy full employment law protections under UK labour law.

Tourism and aquaTic safeTy: no Lifeguard on duTy—swim aT your own risk

The law requires a tourism operator to undertake due diligence in relation to reasonably foreseeable risks. In the marine environment it is now well established that international tourists are a particular "at risk" group for drowning and near drowning events due to factors such as poor swimming ability, unfamiliarity with aquatic environments and marine recreational activities, language, possible alcohol and drug use, and general disorientation. The employment of lifeguards is increasingly recognized as an appropriate risk management and quality service response, as other popular injury prevention initiatives may not be as successful with tourists. This article examines the law and practice relating to the supply of lifeguards in tourist settings, suggesting that quality customer service has moved beyond reliance on static safety signage.

Protecting and preserving the marine environment in disputed areas: seismic noise and provisional measures of protection

This paper is the first to address the environmental legal issues that could arise from the conduct of unilateral seismic operations in disputed maritime areas. And that should be surprising: such operations are ongoing in many places across the globe as states seek to enhance their domestic natural resource potentials and establish their sovereign control in the areas under dispute. But, the lack of previous legal scholarship on the topic is even more surprising when one realises the serious and multifaceted risks posed by seismic surveys on the marine environment. As this paper discusses, there are known environmental risks that include permanent injuries to marine organisms or even immediate death. Other effects may include temporary injuries that may or may not directly result in death but that may make marine organisms less fit, resulting in lower chances of survival. These risks are in addition to less well understood but nonetheless plausible risks to marine ecosystems, such as the potential for noise-derived behavioural disturbance. This could have an impact on animals’ feeding, movement and reproduction, and might also have short- or long-term effects on catch success rates. The paper examines the possible application of provisional measures of protection under Article 290 of the United Nations Convention on the Law of the Sea (UNCLOS). This provision enables a court or tribunal exercising jurisdiction under UNCLOS to prescribe provisional measures not only to preserve the rights of the disputants, but also, or even solely, to prevent serious harm to the marine environment. The analysis explores the foreseeable risks posed by unilateral seismic surveys and examines if Article 290 of UNCLOS provides adequate protection to the complainant state against such operations, pending the final settlement of the dispute. The paper reviews the existing environmental jurisprudence of the International Tribunal for the Law of the Sea (ITLOS) on provisional measures and comments on the potential to respond meaningfully to unilateral seismic exploration activities in disputed maritime areas through recourse to provisional measures of protection.

Post Brexit Threats to Work Safety and Health Standards and Good Working Conditions in the UK

This paper reviews how legal, political and economic threats to be borne out of Britain’s decision to leave the European Union (EU) will short-change pre-Brexit work protection standards in the United Kingdom (UK). These threat-factors are considered in view of their effects on two classes of workers: low-income temporary agency workers (TAW); and low-income self-employed workers in the growing UK gig economy. This paper describes impending post-Brexit threats, to pre-existing policy implementation threats curtailing legally envisaged occupational safety and health (OSH) standards, and the practice of proactively preventing all foreseeable work related risks to the mental or physical health of workers. Post-Brexit threats add to current limitations to employment protections for low income workers in the UK, and despite the recently proposed labour law reforms by the 2017 Taylor Review in regard to low-income workers, it is argued that these Brexit threat factors increase the risk of not extending the principle of equal protection to these two classes of workers in UK law, in ways envisaged under the current EU regulation. The paper concludes that in view of the notion of occupational well-being, the risks of physical and mental harms posed to low-income workers through exploitative work practices segment them from other workers who enjoy full employment law protections under UK labour law.

Exploring the risk/benefit balance in biomedical research: some considerations

Abstract Risk and benefit assessment is one of the fundamental requirements in the ethical review of research involving human participants. As a result, researchers should evaluate and seek to minimize all foreseeable risks involved in their proposed research and members of research ethics committees should evaluate and balance the risks and potential benefits involved in each research proposal as a part of their ethical obligations regarding research protocols. However, current literature provides little detailed guidance on the specifics of how this balancing process should occur. Consequently, this article provides some details of the process to balance risks and benefits in biomedical research and reminds members of research ethics committees of their responsibility to protect those who are vulnerable from exploitation in research projects.

Risk Communication in EPA's Controlled Inhalation Exposure Studies and in Support.

On March 28, 2017, the National Academy of Sciences, Engineering, and Medicine (NASEM) released a much-anticipated report on the Environmental Protection Agency's controlled human inhalation exposure studies. This essay reviews the ethical controversies that led to the genesis of the report, summarizes its key findings, and comments on its approach to informing human subjects about the risks of inhalation exposure studies. NASEM's report makes a valuable contribution to our understanding of the scientific and ethical issues involved in conducting human inhalation exposure studies. Its definition of "reasonably foreseeable risks" provides useful guidance to investigators, research participants, and institutional review board members.

Informed Consent for Comparative Effectiveness Research Should Not Consider the Risks of the Standard Therapies That Are Being Studied as Risks of the Research

There is a debate at the highest levels of government about how to classify the risks of research studies that evaluate therapies that are in widespread use. Should the risks of those therapies be considered as risks of research that is designed to evaluate those therapies? Or not? The Common Rule states, “In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).” (CFR 46.111 (a)(2)). By contrast, the Office of Human Research Protections, in a proposed “guidance” states, “The reasonably foreseeable risks of research include already-identified risks of the standards of care being evaluated as a purpose of the research.” (emphasis added).In this paper, I argue that the Common Rule got it right and OHRP got it wrong. When treatments are in widespread use, the risks of those treatments are ever-present for all patients. By enrolling in formal studies that use rigorous methods to compare one treatment with another and that carefully monitor outcomes and adverse events, patients are protected from the risks of idiosyncratic practice variation. Their risks are decreased, rather than increased.If OHRP's approach becomes the law of the land, patients will be misinformed about the relative risks of treatment and research in ways that undermine autonomy rather than promoting it and that make truly informed consent impossible.

La responsabilidad contractual por los riesgos previsibles, entre la autonomía de la voluntad privada y la rigurosidad de las normas de contratación pública

Los riesgos contractuales previsibles carecen de reglas específicas en el régimen de “derecho común”. Con todo, la autonomía de la voluntad privada usualmente resuelve este vacío por medio de disposiciones contractuales accesorias. Con todo, en el derecho público de la contratación estatal, la rigidez del proceso precontractual impone deberes de tipificación, estimación y asignación de riesgos que no parecerían estar definidos por el régimen jurídico pertinente. En este artículo se argumenta que, debido a la dispersión normativa de la contratación administrativa, el régimen jurídico de los riesgos previsibles se encuentra indeterminado, muy a pesar de la inflexibilidad normativa de la etapa de diseño contractual.

Neonatologists' opinions about the 'foreseeable risks' in comparative effectiveness research: Results from an online survey.

To examine how neonatologists determine which risks require inclusion for informed consent per the 'Common Rule' and 'Draft Guidance' regulations in comparative effectiveness research (CER). Neonatologists active in research were invited to complete an online survey. Questions focused on clinical practices for treating hyperbilirubinemia in premature infants and about risk disclosure related to a hypothetical randomized trial. Response rate was 57%. 43% were primarily researchers; 31% primarily clinicians. 69% had conducted CER. 81% thought hypothetical study enrollment was not riskier than receiving routine care. 76% labeled the study 'minimal risk' by comparing study risks to clinical care risks. Respondents would not currently disclose many of the treatment risks but would disclose more if the Draft Guidance were enacted into law. Findings suggest the Draft Guidance requires disclosure of more risks than does the Common Rule; applying either rule results in disclosure of more risks than in standard clinical care.

The moral courage of nursing students who complete advance directives with homeless persons.

Homeless persons in the United States have disproportionately high rates of illness, injury, and mortality and tend to believe that the quality of their end-of-life care will be poor. No studies were found as to whether nurses or nursing students require moral courage to help homeless persons or members of any other demographic complete advance directives. We hypothesized that baccalaureate nursing students require moral courage to help homeless persons complete advance directives. Moral courage was defined as a trait of a person or an action that overcomes fears or other challenges to achieve something of great moral worth. The hypothesis was investigated through a qualitative descriptive study. Aside from the pre-selection of a single variable to study (i.e. moral courage), our investigation was a naturalistic inquiry with narrative hues insofar as it attended to specific words and phrases in the data that were associated with that variable. A total of 15 baccalaureate nursing students at a public university in the United States responded to questionnaires that sought to elicit fears and other challenges that they both expected to experience and actually experienced while helping homeless persons complete advance directives at a local, non-profit service agency. The study was approved by the Internal Review Board of the authors' university, and each participant signed an informed consent form, which stated that the study involved no reasonably foreseeable risks and that participation was voluntary. Before meeting with homeless persons, participants reported that they expected to experience two fears and a challenge: fear of behaving in ways that a homeless person would deem inappropriate, fear of discussing a homeless person's dying and death, and the challenge of adequately conveying the advance directive's meaning and accurately recording a homeless person's end-of-life wishes. In contrast, after their meetings with homeless persons, relatively few participants reported having encountered those obstacles. So, while participants required moral courage to assist homeless persons with advance directives, they required greater moral courage as they anticipated their meetings than during those meetings. Our study breaks new ground at the intersection of nursing, moral courage, and advance directives. It might also have important implications for how to improve the training that US nursing students receive before they provide this service. Our results cannot be generalized, but portions of our approach are likely to be transferable to similar social contexts. For example, because homeless persons are misunderstood and marginalized throughout the United States, our design for training nursing students to provide this service is also likely to be useful across the United States. Internationally, however, it is not yet known whether our participants' fears and the challenge they faced are also experienced by those who assist homeless persons or members of other vulnerable populations in documenting healthcare wishes.

Managing Health & Safety Risks (No. 52): Foreseeable risks

This article explains why risk assessments should always consider the potential for human error along with the consequences.

Abstract WP413: Recurrent Acute Ischemic Stroke in a Child on Novalung iLA® Treated Twice With Mechanical Clot Retrieval: a Case Report and Review of the Literature

Background: The American Heart Association recently amended their acute stroke guidelines to add recommendation for mechanical thrombectomy with stent retrieval in adults with proximal arterial occlusions. These guidelines further advise that stent retrieval may be reasonable for patients under age 18. Case: We present the case of an 8 year old girl who demonstrated acute stroke symptoms on two occasions, 4 days apart, while therapeutically anticoagulated on Novalung iLA® . Thrombectomy was offered in both instances since the patient had a severe persistent deficit (NIHSS > 6), a clot in a proximal large artery, the procedure could be facilitated within 6 hours of symptom onset, anticoagulation precluded her from tPA administration, and CT showed uninfarcted brain tissue distal to the thrombus. On both occasions, thrombi were non-occlusive and successfully recovered with a Trevo stent retrieval device. No hemorrhagic complications were observed despite continuing anticoagulation during and between the procedures. Post-procedural assessment found respective decreases in the patient’s NIHSS score from 10 to 4 and 12 to 7. Discussion: Treatment indications and immediate clinical benefits in our case are consistent with other thrombectomy cases reported. However, publication bias and the heterogeneity of paediatric cases make drawing conclusions about the safety and efficacy of thrombectomy in children difficult. Anticipating that recent changes to adult stroke guidelines would likely prompt paediatric stroke care providers to consider thrombectomy for their patients, our institution developed consensus-based guidelines for thrombectomy prior to the index case. This guideline served to facilitate multidisciplinary intervention and manage foreseeable risks. Conclusions: Thrombectomy in our case was safely performed and resulted in improvement in immediate neurological outcomes. This case demonstrates the importance of engaging in partnerships with paediatric stroke providers and neurointerventionalists to establish consensus-based guidelines before offering thrombectomy to a child.

Assessing the Impacts of Climate Change on the Built Environment: A Framework for Environmental Reviews

Federal agencies are beginning to incorporate descriptions of climate change impacts into environmental reviews for buildings and infrastructure, but there is no consistent methodology for evaluating these impacts and mitigating any foreseeable risks to the project or affected environment . This Article asserts that an assessment of climate-related risks and adaptation options falls within the scope of considerations that should be addressed under the National Environmental Policy Act and similar laws . It concludes with a set of recommended protocols for identifying the impacts of climate change on projects and their affected environment, evaluating physical and environmental risks, and selecting appropriate mitigation measures .

Promoting Informed Decision Making for Comparative Effectiveness Randomized Trials.

The US Code of Federal Regulations governing human participants research requires that investigators disclose reasonably foreseeable risks of a research study to prospective participants during the informed consent process. Although this mandate appears straightforward, controversy surrounds how investigators should define and describe risks of comparative effectiveness randomized clinical trials (CE-RCTs) that compare treatments within accepted standards of care. The Office for Human Research Protections (OHRP) has published draft guidance prompted by the controversy of the Surfactant, Positive Pressure, and Pulse Oximetry (SUPPORT) trial of oxygenation targets in premature infants to address this question. The draft guidance concludes that “if a research study examining standards of care includes as a purpose evaluating identified risks associated with those standards of care, the identified risks associated with the standards of care being evaluated that are different from the risks of standards of care at least some of the subjects would be exposed to outside of the research study are generally considered…to be reasonably foreseeable risks of research.” 1 Given the often subtle ways in which participation in a CE-RCT alters risk compared with treatment outside the trial, accurately framing disclosures is challenging. Unfortunately, if implemented, the OHRP’s draft guidance will impede rather than promote informed decisions. Investigators and institutional review boards that follow the guidance are likely to formulate consent documents that mischaracterize the disadvantages of the study treatments compared with one another as foreseeable risks of participation, unnecessarily dissuading patients from enrolling. The OHRP should reconsider its guidance and instead support disclosures aimed at the following simple goal: to provide patients with information, including about risks, that they need to decide whether to join the trial, request one of the study treatments outside the trial, or select another available treatment. Organizing disclosure around 4 core questions can effectively accomplish this goal (Table).

Implement Safety Measures to Avoid Resident Elopements

Implement Safety Measures to Avoid Resident Elopements

Muddled measures of risks and misremembered reasons.

AbstractA commentary on “Were There ‘Additional Foreseeable Risks’ in the SUPPORT Study?,” by Henry J. Silverman and Didier Dreyfuss; “SUPPORT: Risks, Harms, and Equipoise,” by Robert M. Nelson; “The Controversy over SUPPORT Continues and the Hyperbole Increases,” by Alan R. Fleischman; and “SUPPORT and Comparative Effectiveness Trials: What's at Stake?,” by Lois Shepherd, all in the January‐February 2015 issue.

Research on medical practices and the ethics of disclosure.

In March 2013, the Office of Human Research Protection (OHRP) issued a finding against the University of Alabama and other institutions for failing to meet regulatory informed consent requirements, in particular regarding reasonably foreseeable risks during the conduct of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial.1 This study compared 2 different target oxygen saturation levels that were part of usual practice in extremely premature infants. As a result of public disagreement regarding whether the differences in outcomes should be considered a “research risk,” OHRP suspended the determination and held a public hearing in August 2013.2 On October 24, 2014, the OHRP released draft guidance, for public comment, on disclosing reasonably foreseeable risks in research evaluating “standards of care,” which on the surface, seems to be a reasonable approach.3 But a more careful analysis reveals a view that may hinder research without increasing protection of participants. The OHRP draft guidance mischaracterizes the purpose of research, which we agree should be disclosed to participants, as risks of research. The OHRP draft guidance misidentifies minimal-risk research as greater than minimal risk. This will result in requiring misleading information in the informed consent process by making research sound riskier than it really is. This will be particularly problematic for pediatric research, as parents and institutional review boards (IRBs) need sound advice to protect children from risky research and to encourage ethically acceptable research that is important to improve child health. We suggest a number of changes should be made before any guidance becomes finalized. First, OHRP should not use the terminology of “standard of care” research. “Standard of care” is a legal construct to define a floor of treatment below which claims of negligence are appropriate. To better capture the range of … Address correspondence to Benjamin S. Wilfond, MD, Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Research Institute, 1900 9th Ave, Seattle, WA 98101. E-mail: benjamin.wilfond{at}seattlechildrens.org