Yale journal of health policy, law, and ethics最新文献

{"title":"Righting Research Wrongs: An Empirical Study of How U.S. Institutions Resolve Grievances Involving Human Subjects","authors":"K. Underhill","doi":"10.2139/SSRN.3271860","DOIUrl":"https://doi.org/10.2139/SSRN.3271860","url":null,"abstract":"Tens of millions of people enroll in research studies in the United States every year, making research a multi-billion-dollar industry in the U.S. alone. Research carries risks: although many harms are inevitable, some also arise from errors or mistreatment by researchers, and the history of research ethics is in many ways a history of scandal. Despite regulatory efforts to remedy these abuses, injured subjects nonetheless have little recourse to U.S. courts. In the absence of tort remedies for research-related injuries, the only venue for resolving such disputes is through alternative dispute resolution (ADR)—or more commonly, internal dispute resolution (IDR) through a process offered by the research institution. The federal regulations on human subjects are silent on resolving subject grievances, and to date, little is known about how institutions handle these disputes. This Article is the first empirical study of how U.S. universities and hospitals resolve subjects’ claims of physical injury, dignitary harm, non-compensation, deviations from research protocols, and maltreatment by research staff. I have conducted in-depth interviews with personnel from 30 hospitals and universities to understand how institutions respond to grievances involving research subjects. These interviews reveal highly flexible dispute resolution processes managed by institutional review boards (IRBs), the institutional authorities mandated by federal law to protect human subjects. Although many interviewees spoke intuitively of procedural justice—including elements such as voice, neutrality, and courtesy—these interviews also indicated problems with neutrality, expertise, representation of participants, one-sided appeals, and access to the dispute resolution process itself. This Article takes a close look at current practices, and then suggests strategies for improvement, addressing both the federal regulations and options for institution-led reforms.","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"18 1","pages":"2"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68580765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Paying Research Participants: Regulatory Uncertainty, Conceptual Confusion, and a Path Forward.","authors":"Emily A Largent,&nbsp;Holly Fernandez Lynch","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The practice of offering payment to individuals in exchange for their participation in clinical research is widespread and longstanding. Nevertheless, such payment remains the source of substantial debate, in particular about whether or the extent to which offers of payment coerce and/or unduly induce individuals to participate. Yet, the various laws, regulations, and ethical guidelines that govern the conduct of human subjects research offer relatively little in the way of specific guidance regarding what makes a payment offer ethically acceptable-or not. Moreover, there is a lack of definitional agreement regarding what the terms coercion and undue inducement mean in the human subjects research context. It is, therefore, unsurprising that investigators and Institutional Review Boards (IRBs) experience confusion about how to evaluate offers of payment, and lean toward conservative approaches. These trends are exemplified by our pilot data regarding the ways in which some IRB members and investigators (mis)understand the concepts of coercion and undue inducement, as well as the ways in which certain research institutions oversee offers of payment at a local level. This article systematically examines the legal and ethical dimensions of offering payment to research participants. It argues that many concerns about offers of payment to research participants can be attributed to the misguided view that such offers ought to be treated differently than offers of payment in other contexts, a form of \"research exceptionalism.\" We show that rejection of research exceptionalism with respect to payment helps settle open debates about both how best to define coercion and undue influence, and how to understand the relation between these concepts and offers of payment. We argue for adoption of our preferred definitions, ideally by regulatory authorities, and against the conventional conservatism toward payment of research participants. Instead, we draw attention to the rarely asked, even radical, question: are research participants paid <i>enough</i>? We conclude by arguing that we ought to change the default to favor, rather than encourage suspicion of, offers of payment to research participants.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"17 1","pages":"61-141"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5728432/pdf/nihms848393.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35664253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulatory Disruption and Arbitrage in Health-Care Data Protection.","authors":"Nicolas P Terry","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article explains how the structure of U.S. health-care data protection\u0000(specifically its sectoral and downstream properties) has led to a chronically\u0000uneven policy environment for different types of health-care data. It examines\u0000claims for health-care data protection exceptionalism and competing demands\u0000such as data liquidity. In conclusion, the article takes the position that healthcare-\u0000data exceptionalism remains a valid imperative and that even current\u0000concerns about data liquidity can be accommodated in an exceptional protective\u0000model. However, re-calibrating our protection of health-care data residing\u0000outside of the traditional health-care domain is challenging, currently even\u0000politically impossible. Notwithstanding, a hybrid model is envisioned with\u0000downstream HIPAA model remaining the dominant force within the health-care\u0000domain, but being supplemented by targeted upstream and point-of-use\u0000protections applying to health-care data in disrupted spaces.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"17 1","pages":"143-208"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36095473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Suffrage for People with Intellectual Disabilities and Mental Illness: Observations on a Civic Controversy.","authors":"Charles Kopel","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Most electoral democracies, including forty-three states in the United States,\u0000deny people the right to vote on the basis of intellectual disability or mental\u0000illness. Scholars in several fields have addressed these disenfranchisements,\u0000including legal scholars who analyze their validity under U.S. constitutional law\u0000and international-human-rights law, philosophers and political scientists who\u0000analyze their validity under democratic theory, and mental-health researchers\u0000who analyze their relationship to scientific categories. This Note reviews the\u0000current state of the debate across these fields and makes three contentions: (a)\u0000pragmatic political considerations have blurred the distinction between\u0000disenfranchisement provisions based on cognitive capacity and those based on\u0000personal status; (b) proposals that advocate voting by proxy trivialize the broad\u0000civic purpose of the franchise; and (c) the persistence of disenfranchisement on\u0000the basis of mental illness inevitably contributes to silencing socially disfavored\u0000views and lifestyles. Accordingly, the Note cautions reformers against\u0000advocating for capacity assessment or proxy voting, and emphasizes the\u0000importance of disassociating the idea of mental illness from voting capacity.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"17 1","pages":"209-250"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36095410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revisiting Incentive-Based Contracts.","authors":"Wendy Netter Epstein","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Incentive-based pay is rational, intuitive, and popular. Agency theory tells us\u0000that a principal seeking to align its incentives with an agent's should be able to\u0000simply pay the agent to achieve the principal's desired results. Indeed, this\u0000strategy has long been used across diverse industries-from executive\u0000compensation to education, professional sports to public service-but with mixed\u0000results. Now a new convert to incentive compensation has appeared on the scene:\u0000the United States' behemoth health-care industry. In many ways, the incentive\u0000mismatch story is the same. Insurance companies and employers are concerned\u0000about constraining the cost of care, and patients are concerned about quality of\u0000care. Physicians lack an adequate financial incentive to pay attention to either.\u0000Health care's recent move away from the traditional fee-for-service\u0000compensation model to incentive pay is perhaps unsurprising.\u0000But there is a problem: mixed preliminary evidence and potential mal-effects\u0000on vulnerable third-party patients. This Article employs a new lens-the legal\u0000and behavioral literature on optimal contract specificity-to suggest why\u0000incentive pay is problematic and why the health-care experience will be no\u0000different than other industries. The use of incentive pay is a change in contractdrafting\u0000strategy, a decision to write a more detailed, control-based contract\u0000rather than one that relies on discretion. The contracts literature suggests that this\u0000strategy will only work well where simple compliance is the goal rather than\u0000creativity or innovation. The health industry will not succeed in implementing\u0000incentive pay better than other industries have. What it needs is to recognize the\u0000limits of incentive pay and implement it sparingly. The new Trump\u0000Administration may be particularly primed to heed this call.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"17 1","pages":"1-59"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36095474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Antidotes to the Double Standard: Protecting the Healthcare Rights of Mentally Ill Inmates by Blurring the Line Between Estelle and Youngberg.","authors":"Rose Carmen Goldberg","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This Note is an examination of mentally ill inmates' constitutional right to treatment. It has significant doctrinal and practical implications. In terms of doctrine, the Supreme Court has created distinct standards for the minimum levels of care for inmates (Estelle) and the civilly committed mentally ill (Youngberg). Under this framework mentally ill inmates are constitutionally equivalent to inmates generally, but are entitled to less care than the civilly committed even if they suffer the same illness. This Note explores this gap through the lens of equal protection and argues that mentally ill inmates are similarly situated to the civilly committed. It further contends that inmates constitute a \"discrete and insular minority\" and thus the standard establishing their right to care should be subject to strict scrutiny. This Note finds that Estelle fails this test. Practically, this Note brings visibility to a consequential area of the law neglected by scholarship. Over half of inmates are mentally ill and yet treatment in prisons is inadequate. The literature at the intersection of health, criminal justice, and constitutional rights has not constructively considered how doctrine should be changed to protect the wellbeing of this vulnerable population. Scholars have also provided little oversight of the judicial administration of justice in this field; there are few reviews of how judges actually apply treatment rights standards. This Note lessens this blind spot by exposing how courts fail to properly distinguish between different standards. This Note proposes that the most promising antidote to the Estelle-Youngberg double standard, counterintuitively, is not the creation of a uniform standard. A standard that puts mentally ill inmates on equal footing with the civilly committed would solve the doctrinal puzzle, but would be subject to Youngberg's inherent flaws and the judicial malpractice in this area. Recognizing the deficiencies of a purely judicial remedy, this Note recommends a solution relying both on courts and Congress. It concludes by highlighting the importance of targeting the primary causes of society's neglect of mentally ill inmates--the stigmatization of mental illness and incarceration--as a necessary step in spurring these institutions to action. Vindication of mentally ill inmates' right to treatment requires that society first overcome its prejudice against this vulnerable population.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"16 1","pages":"111-45"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34625441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Breakthrough with the TPP: The Tobacco Carveout.","authors":"Sergio Puig,&nbsp;Gregory Shaffer","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"16 2","pages":"327-33"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36095472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reimagining the Risk of Long-Term Care.","authors":"Allison K Hoffman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>U.S. law and policy on long-term care fail to address the insecurity\u0000American families face due to prolonged illness and disability-a problem that\u0000grows more serious as the population ages and rates of disability rise. This\u0000Article argues that, even worse, we have focused on only part of the problem. It\u0000illuminates two ways that prolonged disability or illness can create insecurity.\u0000The first arises from the risk of becoming disabled or sick and needing long-term\u0000care, which could be called \"care-recipient\" risk. The second arises out of the\u0000risk of becoming responsible for someone else's care, which I call \"next-friend\"\u0000risk. The law and social welfare policy has focused on the first, but this Article\u0000argues that the second equally threatens the wellbeing of American families.\u0000While attempting to mitigate care-recipient risk, in fact, the law has steadily\u0000expanded next-friend risk, by reinforcing a structure of long-term care that relies\u0000heavily on informal caregiving. Millions of informal caregivers face financial\u0000and nonmonetary harms that deeply threaten their own long-term security. These\u0000harms are disproportionately experienced by people who are already\u0000vulnerable-women, minorities, and the poor. Scholars and policymakers have\u0000catalogued and critiqued these costs but treat them as an unfortunate byproduct of\u0000an inevitable system of informal care.\u0000This Article argues that if we, instead, understand becoming responsible for\u0000the care of another as a social risk-just as we see the chance that a person will\u0000need long-term care as a risk-it could fundamentally shift the way we approach\u0000long-term care policy. In risk-theory terms, this Article proposes we reimagine\u0000the risk of long-term care.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"16 2","pages":"147-232"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36095470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health and Taxes: Hospitals, Community Health and the IRS.","authors":"Mary Crossley","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Affordable Care Act created new conditions of federal tax exemption for nonprofit hospitals, including a requirement that hospitals conduct a community health needs assessment (CHNA) every three years to identify significant health needs in their communities and then develop and implement a strategy responding to those needs. As a result, hospitals must now do more than provide charity care to their patients in exchange for the benefits of tax exemption. The CHNA requirement has the potential both to prompt a radical change in hospitals' relationship to their communities and to enlist hospitals as meaningful contributors to community health improvement initiatives. Final regulations issued in December 2014 clarify hospitals' obligations under the CHNA requirement, but could do more to facilitate hospitals' engagement in collaborative community health projects. The Internal Revenue Service (IRS) has a rich opportunity, while hospitals are still learning to conduct CHNAs, to develop guidance establishing clear but flexible expectations for how providers should assess and address community needs. This Article urges the IRS to seize that opportunity by refining its regulatory framework for the CHNA requirement. Specifically, the IRS should more robustly promote transparency, accountability, community engagement, and collaboration while simultaneously leaving hospitals a good degree of flexibility. By promoting alignment between hospitals' regulatory compliance activities and broader community health improvement initiatives, the IRS could play a meaningful role in efforts to reorient our system towards promoting health and not simply treating illness.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"16 1","pages":"51-110"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34625440","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rehabilitation, Education, and the Integration of Individuals with Severe Brain Injury into Civil Society: Towards an Expanded Rights Agenda in Response to New Insights from Translational Neuroethics and Neuroscience.","authors":"Megan S Wright,&nbsp;Joseph J Fins","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Many minimally conscious patients are segregated in nursing\u0000homes, and are without access to rehabilitative technologies that could\u0000help them reintegrate into their communities. In this Article, we argue that\u0000persons in a minimally conscious state or who have the potential to\u0000progress to such a state must be provided rehabilitative services instead of\u0000being isolated in custodial care. The right to rehabilitative technologies\u0000for the injured brain stems by analogy to the expectation of free public\u0000education for children and adolescents, and also by statute under the\u0000Americans with Disabilities Act and under Supreme Court jurisprudence,\u0000namely the leading deinstitutionalization case, Olmstead v. L.C. ex rel.\u0000Zimring.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"16 2","pages":"233-87"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36095545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}