In this study, we examine investor and firm response to the California Transparency in Supply Chains Act of 2010. The CTSCA requires large retail and manufacturing firms to disclose efforts to eradicate slavery and human trafficking from their supply chains and is a rare example of mandated corporate social responsibility disclosure. Based on a sample of 105 retail companies subject to the CTSCA, we find a significant negative market reaction to the passing of the CTSCA. Furthermore, we find (...) that the reaction is significantly more negative for larger firms and companies facing greater supply chain risks, suggesting that investors place a negative value on exposure to legitimacy threats in the social domain. With respect to company disclosure response, we document relatively high compliance with the legislation, although we also find that the disclosure response appeared to be more symbolic than substantive in nature. Finally, our analysis indicates that both disclosure choice and disclosure extensiveness were significantly higher for the high-supply chain risk companies, suggesting that the response was influenced by concerns with strategic legitimation. Overall, the limited quality of disclosure suggests that, without additional rules and guidance, mandates alone may not lead to meaningful social disclosure. (shrink)

Enactment of mandated pre-procedure disclosures in abortion and assisted reproductive technology services has swelled in recent years. Calls to equally regard these mandates as neutral tools in furtherance of patient protection fail to acknowledge key substantive and structural differences in these reproduction-affecting mandates. While ART mandates permit physicians to use their medical judgment to protect presumptively vulnerable egg donors and gestational carriers, abortion disclosures impart scientifically suspect messaging aimed at dissuading women from pursuing pregnancy termination. These and other distinctions (...) counsel in favor of regarding and analyzing abortion and ART mandated disclosures as separate and distinguishable informed consent tools. (shrink)

The General Data Protection Regulation (GDPR) of the EU confirms the protection of personal data as a fundamental human right and affords data subjects more control over the way their personal information is processed, shared, and analyzed. However, where data are processed by artificial intelligence (AI) algorithms, asserting control and providing adequate explanations is a challenge. Due to massive increases in computing power and big data processing, modern AI algorithms are too complex and opaque to be understood by most data (...) subjects. Articles 15 and 22 of the GDPR provide a modest regulatory framework for automated data processing by, among other things, mandating that data controllers inform data subjects about when it is being used, and its logic and ramifications. Nevertheless, due to the phrasing of the articles and the numerous exceptions they allow, doubts have arisen about their effectiveness. In this paper, we empirically evaluate the quality and effectiveness of AI disclosures as mandated by the GDPR. By means of an online survey (N = 835), we investigated how data subjects expect to be informed about the automated processing of their data. We then conducted a content analysis of the AI disclosures of N = 100 companies and organizations. The combined findings reveal that current GDPR-mandated disclosures do not meet the expectations and needs of data subjects. Explanations drawn up following the guidelines of the generic formulations of the GDPR differ widely and are often vague, incomplete and lack transparency. In our conclusions we identify a path towards standardizing and optimizing AI information notices. (shrink)

A retraction notice is a formal announcement for the removal of a paper from the literature, which is a weighty matter. Xu et al. (Science and Engineering Ethics, 29(4), 25 2023) reported that 73.7% of retraction notices indexed by the Web of Science (1927–2019) provided no information about institutional investigations that may have led to the retractions, and recommended that Committee on Publication Ethics (COPE) retraction guidelines should make it mandatory to disclose institutional investigations leading to retractions in such notices. (...) While this recommendation would add to the transparency of the retraction process, a blanket mandate as such could be potentially problematic. For research misconduct (RM)-positive cases, a mandatory investigative disclosure may be abused by some to deflect responsibility. More importantly, a mandatory disclosure could harm authors and institutions in RM-negative cases (i.e. those stemming from honest errors with no misconduct). I illustrate with case vignettes the potential epistemic injustice and confusion that a mandate for investigation disclosure in retraction notices could incur, and suggest a more nuanced approach to its implementation. (shrink)

The dominant legal and regulatory approach to protecting information privacy is a form of mandated disclosure commonly known as “notice-and-consent.” Many have criticized this approach, arguing that privacy decisions are too complicated, and privacy disclosures too convoluted, for individuals to make meaningful consent decisions about privacy choices—decisions that often require us to waive important rights. While I agree with these criticisms, I argue that they only meaningfully call into question the “consent” part of notice-and-consent, and that they say (...) little about the value of notice. We ought to decouple notice from consent, and imagine notice serving other normative ends besides readying people to make informed consent decisions. (shrink)

Background The consistency of codes governing disclosure of terminal illness to patients and families in Islamic countries has not been studied until now. Objectives To review available codes on disclosure of terminal illness in Islamic countries. Data source and extraction Data were extracted through searches on Google and PubMed. Codes related to disclosure of terminal illness to patients or families were abstracted, and then classified independently by the three authors. Data synthesis Codes for 14 Islamic countries were (...) located. Five codes were silent regarding informing the patient, seven allowed concealment, one mandated disclosure and one prohibited disclosure. Five codes were silent regarding informing the family, four allowed disclosure and five mandated/recommended disclosure. The Islamic Organization for Medical Sciences code was silent on both issues. Conclusion Codes regarding disclosure of terminal illness to patients and families differed markedly among Islamic countries. They were silent in one-third of the codes, and tended to favour a paternalistic/utilitarian, family-centred approach over an autonomous, patient-centred approach. (shrink)

There is a long-running debate among legal scholars regarding the propriety and enforceability of SEC attempts to mandate disclosures of antisocial or illegal corporate activities that do not materially impact a company’s financial statements. This debate was recently revived by the issuance of SEC Staff Accounting Bulletin 99, Materiality in Financial Statements (SEC 1999), which suggests that quantitatively immaterial information relating to unlawful transactions or regulatory non-compliance should be considered for disclosure. This issue has important implications for the accounting (...) profession, although it has generally been ignored in the accounting literature. This paper reviews legal and ethical considerations raised by the issue of qualitative disclosures, and also presents the results of a preliminary empirical test of the impact of such disclosures on financial statement users’ judgments. The results of this study indicate that investors consider the nondisclosure of immaterial illegal acts to be unethical, and reject suggestions that such information lacks moral intensity. The results also suggest that immaterial illegal acts have a significant effect on investors’perceptions of the quality of corporate management and the likelihood of investment in a company. This effect was more pronounced when the illegal act was combined with self-dealing on the part of corporate executives. (shrink)

This article is an initial attempt to compare the pre-abortion disclosure mandates that have proliferated in the two decades since the Court decided Planned Parenthood v. Casey with laws that, in the context of assisted reproduction and reproductive health, require specific disclosures beyond a state's baseline informed consent requirements. While some scholars have characterized pre-abortion disclosure laws as sui generis, they share some important common features with disclosure mandates in the context of oocyte donation and other reproductive (...) health procedures. This article suggests that in critiquing pre-abortion disclosure mandates, scholars and advocates should be careful to differentiate the use of disclosure laws in general from uses where the government interest conveys a moral preference against a particular procedure. (shrink)

Recent years have featured a spate of regulatory action pertaining to the development and/or disclosure of corporate governance structures in response to financial scandals resulting in part from governance failures. During the same period, corporate governance activists and institutional investors increasingly have called for increased voluntary governance disclosure. Despite this attention, there have been relatively few comprehensive studies of governance disclosure practices and response to the regulation. In this study, we examine a sample of 50 U.S. firms (...) and their public disclosure packages from 2004. We find a high degree of variability in the presentation and reporting format choices for many elements of the governance structure. This variability includes several items for which disclosure is mandated by regulators or legislative action. In particular, smaller firms offer fewer disclosures pertaining to independence, board selection procedures, and oversight of management (including whistleblowing procedures). There are also trends associated with board characteristics: boards that are less independent offer fewer disclosures of independence and management oversight matters. Moreover, large firms provide more disclosures of independence standards, board selection procedures, audit committee matters, management control systems, other committee matters, and whistleblowing procedures but do not appear to have a strictly superior information environment when compared to smaller firms. The findings raise questions about compliance with regulatory requirements and the degree to which conflicts of interest between managers and directors are being controlled. While there have been notable improvements in the information environment of governance disclosures, there remain structural issues that may possess negative ramifications for stakeholders. (shrink)

Given the increasing importance attached to both corporate social responsibility (CSR) and corporate governance, this study investigates the association between these two complimentary mechanisms used by companies to enhance relations with stakeholders. Consistent with both legitimacy and stakeholder theory and controlling for industry profile, firm size, stockholder power/dispersion, creditor power/leverage, and economic performance, our analysis of the annual reports for a sample of 222 listed companies suggests that firms providing more CSR information: have better corporate governance ratings; are larger; belong (...) to higher profile industries; and are more highly leveraged. Our findings support the limited prior research suggesting a link between corporate governance quality and CSR disclosure in company annual reports and suggest that, rather than mandating specific disclosures, regulators might be better served focussing on corporate governance quality as a way of increasing CSR disclosures. (shrink)

State laws dictating “informed consent” about surgical and chemical abortions sometimes ensnare emergency contraceptives, as the science surrounding EC shows. Courts evaluating mandated disclosures gravitate to professional norms rather than the information most women would value: basic factual information about EC so that they can decide for themselves whether to use these drugs.

Disclosure of medical and errors to patients has been increasingly mandated in the U. S. and Canada. Thus, some health systems are developing formal disclosure policies. The present study examines how disclosure training may impact staff and the organization. We argue that organizations that support "disclose and apologize" activities, as opposed to "deny and defend," are demonstrating values-based ethics. Specifically, we hypothesized that when health care clinicians are trained and supported in error disclosure, this may (...) signal a valuesbased ethical environment, and staff may be more committed to the organization. We surveyed 325 clinical care providers employed by a large hospital that had recently begun implementing disclosure policies and training. Disclosure training explained significant variance in perceptions of the ethical environment, and the ethical environment mediated the relationship between disclosure training and organizational commitment. Although this study explored disclosure of medical errors, organizational support for error disclosure is a concept that could be relevant for many types of organizations. (shrink)

Conflicts of interest held by researchers remain a focus of attention in clinical research. Biases related to these relationships have the potential to directly impact the quality of healthcare by influencing decision-making, yet conflicts of interest remain underreported, inconsistently described, and difficult to access. Initiatives aimed at improving the disclosure of researcher conflicts of interest are still in their infancy but represent a vital reform that must be addressed before potential biases associated with conflicts of interest can be mitigated (...) and trust in the impartiality of clinical evidence restored. In this review, we examine the prevalence of conflicts of interest, evidence of the effects that disclosed and undisclosed conflicts of interest have had on the reporting of clinical evidence, and the emerging approaches for improving the completeness and consistency of disclosures. Through this review of emerging technologies, we recognize a growing interest in publicly accessible registries for researcher conflicts of interest and propose five desiderata aimed at maximizing the value of such registries: mandates for ensuring that researchers keep their records up to date; transparent records that are made available to the public; interoperability to allow researchers, bibliographic databases, and institutions to interact with the registry; a consistent taxonomy for describing different classes of conflicts of interest; and the ability to automatically generate conflicts of interest statements for use in published articles. (shrink)

I argue that the duty of confidentiality is relative, not absolute; and that it is primarily a matter for the professional judgment of the reflective health practitioner to determine in the particular case whether competing public interests (or other compelling reasons) override that duty. I have supported that account with an analysis of medical practice as a recourse role and with an account of law that emphasises not only its duty‐imposing character but also, and crucially, an embedded liberty to depart (...) from the plain requirements of a primary legal rule where in the conscientious judgment of the addressee of that law, there is ‘damn good reason’ to do so. This account of the moral nullification of law at the outer limits appears to be descriptively accurate over a wide range of law and normatively appealing not only to democratic citizens but also to professionals such as doctors and lawyers whose role involves testing the law on moral grounds and who should be ready to do so, if but only if, they believe in the good faith exercise of professional judgment that the outcome mandated by the literal application of the legal rule is inconsistent with the moral mission of their role. The argument is illustrated with cases from American and English courts which, perhaps, render plausible the otherwise paradoxical notion that the law itself admits of departures from the legal rules. (shrink)

The advent of personal genomics companies offering direct translation of scientific data into personal health information, calls into question traditional policies to refuse disclosure of such scientific data to research participants. This seems especially true for population biobanks, as they collect not only genotype information but also associated phenotype information, and thus may be in a unique position to translate their scientific findings into personal health information for their participants. Disclosure of such information seems mandated by the (...) expectations raised by biobanks ('to help bring about the era of personalized medicine') and their participants' rights to know health information, to know clinical research results, to life and health and particularly their right to benefit. Refusals to disclose such information can be grounded in the lack of analytical validity and/or clinical utility of most findings, the need to avoid the therapeutic misconception, the complexity and costs involved in translation and disclosure and the disproportionate burden resulting from the obligation to respect participants' right not to know before any disclosure can be made. Currently, any demands by participants in population biobanks for full disclosure of all pertinent personal health information potentially resulting from the biobank's scientific findings are unlikely to be granted by a Dutch court under Dutch and international law. As the law stands now, a population biobank is neither a doctor nor a personal genomics company. However, in view of the rapid scientific, medical, technological, commercial and social developments, population biobanks must prepare to take more care of their participants' legitimate interest in receiving as much validated personal health information as reasonably possible, in a timely fashion, by developing appropriate translation and disclosure mechanisms. This paper examines whether population biobank participants have the right, under Dutch civil law and international law, to full disclosure, i.e. to all information generated by the biobank that is pertinent to their present and future health. It pioneers the format of a hypothetical court case to elucidate the legal and policy arguments" for and against full disclosure. (shrink)

Physicians and other health care providers owe ethical and legal duties to patients to maintain the secrecy of the information learned during the course of patient care. This obligation is fulfilled by limiting access to such information to only those involved in the patient's care-that is, to those within the “circle of confidentiality.” As a general rule, providers may only disclose to others with the written prior consent of the patient. Exceptions may be “ethically and legally justified because of overriding (...) social considerations,” when permitted or compelled by law. For example, eleven states permit providers to disclose identified records to approved researchers.’ Many states compel disclosure in cases where a patient threatens serious bodily harm to another; require reporting to health or law enforcement authorities of communicable diseases, gunshot or knife wounds, or child abuse; and mandate reporting of cancer or other health care cases to state registries. (shrink)

The advent of personal genomics companies offering direct translation of scientific data into personal health information, calls into question traditional policies to refuse disclosure of such scientific data to research participants. This seems especially true for population biobanks, as they collect not only genotype information but also associated phenotype information, and thus may be in a unique position to translate their scientific findings into personal health information for their participants. Disclosure of such information seems mandated by the (...) expectations raised by biobanks and their participants' rights to know health information, to know clinical research results, to life and health and particularly their right to benefit. Refusals to disclose such information can be grounded in the lack of analytical validity and/or clinical utility of most findings, the need to avoid the therapeutic misconception, the complexity and costs involved in translation and disclosure and the disproportionate burden resulting from the obligation to respect participants' right not to know before any disclosure can be made. Currently, any demands by participants in population biobanks for full disclosure of all pertinent personal health information potentially resulting from the biobank's scientific findings are unlikely to be granted by a Dutch court under Dutch and international law. As the law stands now, a population biobank is neither a doctor nor a personal genomics company. However, in view of the rapid scientific, medical, technological, commercial and social developments, population biobanks must prepare to take more care of their participants' legitimate interest in receiving as much validated personal health information as reasonably possible, in a timely fashion, by developing appropriate translation and disclosure mechanisms. This paper examines whether population biobank participants have the right, under Dutch civil law and international law, to full disclosure, i.e. to all information generated by the biobank that is pertinent to their present and future health. It pioneers the format of a hypothetical court case to elucidate the legal and policy arguments" for and against full disclosure. (shrink)

In response to Morningstar’s release of carbon risk (CR) scores in May 2018, (environmentally) sustainable mutual funds in the U.S. showed a greater reduction in their portfolio CR relative to conventional funds. The observed causal impact of this third-party disclosure is consistent with the funds’ primary investment objectives. Differences in fund names, potentially driven by marketing considerations, appear irrelevant to the behavior of sustainable funds. Conventional funds that are signatories to the UN’s Principles for Responsible Investment (PRI) or those (...) with secondary sustainability mandates behave more like other conventional funds rather than sustainable funds. These funds appear relatively insensitive to disclosures as their sustainability considerations are superseded by other primary investment criteria. Fiduciary and legal bonding influences fund managers’ response to sustainability disclosures. Sustainable funds lower their CR score by reducing exposure to fossil fuels, not by increasing exposure to renewables. (shrink)

We examine whether investors value the disclosure of first-time standalone corporate social responsibility reports, and whether market valuations differ between government-controlled and privately controlled firms. Using a matched sample of Chinese publicly listed firms, we find that CSR initiators have higher market valuations than matched CSR non-initiators, and CSR initiators controlled by the central and local governments have lower market valuations than CSR non-initiators and CSR initiators controlled by private shareholders. Additional analyses demonstrate that CSR initiators with high CSR (...) reporting quality and perceived credibility have higher market valuations than CSR initiators with low CSR reporting quality and medium or low perceived credibility of CSR reporting. We do not find convincing evidence that CSR mandate, litigation risk, and prior stock returns affect market reactions to CSR reporting. Overall, we find that the market values standalone CSR reports, and that CSR reporting quality and perceived credibility are important factors in market valuation. (shrink)

As consumer lifestyles have changed over recent decades, people have increasingly turned to meals prepared away from home. A major consequence of this shift in eating patterns has been a concomitant rise in obesity rates worldwide. Research has consistently documented that consumers tend to make less healthy choices when purchasing prepared meals away from home. In part, this can be attributed to inadequate information at the time of purchase; both nutrition experts and lay consumers tend, for example, to underestimate calories (...) in food purchased away from home and thus portion sizes tend to be larger. Thus, by requiring restaurants and other purveyors of prepared foods to provide the calorie content and other nutrition information at the point of purchase, consumers should be able to make more informed decisions and public health should be improved. The often maligned Affordable Care Act (i.e., “Obamacare”) addressed this issue in a mandate calling for compulsory nutrition labeling of prepared foods at the point of sale. In response to this effort, conservatives in Congress introduced the “Common Sense Nutrition Disclosure Act” (CSNDA) which, if enacted, would have effectively eviscerated the menu labeling provisions mandated by the Affordable Care Act. The stated rationale behind this legislation: to protect small business and prevent job loss resulting from overly‐burdensome federal regulations. This article provides a historical look at the evolution of federally mandated menu labeling in the United States with particular emphasis on opposition to its passage. The position is taken such that this legislation is beneficial, warranted, and long overdue, and its opposition, as reflected in the CSNDA, points to the need for new metrics when evaluating public policy. (shrink)

Dietrich Bonhoeffer and Knud Ejler Løgstrup were WWII contemporaries: Lutheran theologians and religious figures in their respective German and Danish communities; both active in the anti-Nazi resistance. Being involved in the resistance, Bonhoeffer and Løgstrup were required to rethink what it meant to be ethical, in particular in relation to disclosure and the telling of truth, in a situation of war. In this paper, we consider the grounds on which both Løgstrup and Bonhoeffer acted, their belief in a duty (...) or requirement to resist, in light of the more general problem presented by resistance as action undertaken in a state of exception. We investigate the distinction between the normativity of ordinary or stable time, and action required in a state of exception, using the specific example of truth-telling as a normative demand and its conflict with the exceptional imperative to lie. The example of truth-telling raises important questions about the role of agency and phronetic judgment in a state of exception. In order to determine a foundation for such judgment, we turn to the framework adapted by both Bonhoeffer and Løgstrup to ground their requirement to lie: Luther’s concept of three estates. We consider how their respective concepts of mandates and laws of life/sovereign expressions of life both illuminate and highlight the more general problem of the relation between norm and exceptional action. (shrink)

The purpose of the article is to give a deontological defense of the reasonableness standard of corporate disclosure presently mandated by the Securities and Exchange Commission of the U.S. government. The first part of the article distinguishes the reasonableness standard from the older standard of materiality. The second part presents three deontological arguments, inspired by the work of Ross and Kant, for the prima facie compellingness of the new standard.

Despite a strong investor and social demand for firms to disclose information on political connections, mandatory disclosure requirements face considerable opposition. Given the challenges in enforcing mandatory disclosures, we investigate whether private information acquisition can be a viable alternative to disclosure. Using a setting of corruption investigations, we find that investors, on average, are not aware that the firms they have invested in have connections with the officials under investigation, suggesting a lack of visibility of the connections. However, (...) a small number of institutional investors exploit their private access to information and sell their shares in response to the investigations. We also show that the high costs of information acquisition and a lack of incentives for analysts to disseminate sensitive information they have obtained contribute to this lack of visibility and result in a significant delay in retail investors’ reaction to material information. Our study contributes to the debate on mandating disclosure of political connections by showing that the lack of mandatory disclosure results in an uneven playing field that undermines transparency and fairness. (shrink)

This issue’s “Legal Briefing” column covers recent legal developments involving informed consent. We covered this topic in previous articles in The Journal of Clinical Ethics. But an updated discussion is warranted. First, informed consent remains a central and critically important issue in clinical ethics. Second, there have been numerous significant legal changes over the past year. We categorize recent legal developments into the following 13 categories: 1. Medical Malpractice Liability2. Medical Malpractice Liability in Wisconsin3. Medical Malpractice Liability in Novel Situations4. (...) Enforcement by Criminal Prosecutors5. Enforcement by State Medical Boards6. Enforcement through Anti-Discrimination Laws7. Statutorily Mandated Disclosures Related to End-of-Life Counseling8. Statutorily Mandated Disclosures Related to Aid in Dying9. Statutorily Mandated Disclosures Related to Abortion10. Statutorily Mandated Disclosures Related to Telemedicine11. Statutorily Mandated Disclosures Related to Other Interventions12. Statutorily Mandated Gag and Censorship Laws13. Informed Consent in the Research Context. (shrink)

It is commonly accepted that clinicians are ethically obligated to disclose their use of medical machine learning systems to patients, and that failure to do so would amount to a moral fault for which clinicians ought to be held accountable. Call this ‘the disclosure thesis.’ Four main arguments have been, or could be, given to support the disclosure thesis in the ethics literature: the risk-based argument, the rights-based argument, the materiality argument and the autonomy argument. In this article, (...) I argue that each of these four arguments are unconvincing, and therefore, that the disclosure thesis ought to be rejected. I suggest that mandating disclosure may also even risk harming patients by providing stakeholders with a way to avoid accountability for harm that results from improper applications or uses of these systems. (shrink)

Disclosure has become the preferred way of addressing the threat to researcher objectivity arising from financial conflicts of interest. This article argues that the effectiveness of disclosure at protecting science from the corrupting effects of FCOIs—particularly the kind of disclosure mandated by US federal granting agencies—is more limited than is generally acknowledged. Current NIH and NSF regulations require disclosed FCOIs to be reviewed, evaluated, and managed by officials at researchers’ home institutions. However, these reviewers are likely (...) to have institutional and personal interests of their own that may undermine the integrity of their evaluations. This paper presents experimental findings suggesting that such interests affect third-party assessments of FCOIs. Over 200 participants gauged the ethical significance of various hypothetical yet realistic FCOIs in academic research settings. Some of them were led to believe they had a small personal interest in allowing conflicted research... (shrink)

Thirty-four states criminalize HIV in some way, whether by mandating disclosure of one’s HIV status to all sexual partners or by deeming the saliva of HIV-positive persons a “deadly weapon.” In this paper, we argue that HIV-specific criminal laws are rooted in historical prejudice against HIV-positive persons as a class. While purporting to promote public health goals, these laws instead legally sanction discrimination against a class of persons.

Under the Supreme Court's compelled speech cases, the context of government-mandated disclosures determines the standard of review. Pursuant to Casey, Zauderer, and Whalen, compelled disclosures in the medical context, such as speech-and-display ultrasound laws, are subject to – and survive – a form of rational basis scrutiny.

Twenty-four U.S. states have enacted HIV exposure laws that prohibit HIV-positive persons from engaging in sexual activities with partners to whom they have not disclosed their HIV-status. From a public health perspective, HIV serostatus exposure laws can be viewed as structural interventions that seek to limit the spread of HIV by acting at the policy level. A central premise of these laws is that informed partners are more likely to protect themselves by declining sex, by substituting less risky activities for (...) higher-risk ones, or by using condoms, than are uninformed partners. However, the effectiveness of these laws at preventing HIV transmission is not known.There is little standardization among existing HIV exposure laws, which vary substantially with respect to the sexual activities that are prohibited without prior serostatus disclosure. Among the strictest laws are those in Arkansas, Michigan, New Jersey, and Ohio which mandate disclosure prior to almost any type of sexual contact. (shrink)

This book examines the most controversial issues concerning the use of pre-drafted clauses in fine print, which are usually included in consumer contracts and presented to consumers on a take-it-or-leave-it basis. By applying a multi-disciplinary approach that combines consumer's psychology and seller's drafting power in the logic of efficiency and good faith, the book provides a fresh and unconventional analysis of the existing literature, both theoretical and empirical. Moving from the unconscionability doctrine, it criticizes (and in some cases refutes) its (...) main conclusions based on criteria which are usually invoked to sustain the need for public intervention to protect consumers, and specifically related to Law (contract complexity), Psychology (consumer lack of sophistication criterion) and Economics (market structure criterion). It also analyzes the effects of different regulations, such as banning vexatious clauses or mandating disclosure clauses, showing that none of them protect consumers, but in fact prove to be harmful when consumers are more vulnerable, that is whenever sellers can exploit some degree of market power. In closing, the book combines these disparate aspects, arguing that the solution (if any) to the problem of consumer exploitation and market inefficiency associated with the use of contracts of adhesion in these contexts cannot be found in removing or prohibiting hidden clauses, but instead has to take into account the effects of these clauses on the contract as a whole. (shrink)

The OpenNotes (ON) mandate in the 21st Century Cures Act requires that patients or their legally authorized representatives be able to access their medical information in their electronic medical record (EMR) in real time. Ethics notes fall under the domain of this policy. We argue that ethics notes are unique from other clinical documentation in a number of ways: they lack best-practice guidelines, are written in the context of common misconceptions surrounding the purpose of ethics consultation, and often answer questions (...) of a different nature than other documentation. Thus, we believe the clinical ethics community would benefit from clarification on when the withholding of ethics notes is justified. We provide recommendations for excluding information from ethics documentation based on the likelihood and magnitude of harm that may occur with particular disclosures and suggest approaches to decrease the potential harms that may occur. We define and explain six types of reasons to exclude information from ethics notes based on significant harms that are not addressed in the ON policy: (1) harmful revelations from a protected chart note; (2) negative emotional effects on patients or families; (3) the purpose of the consultation is undermined by harmful consequences; (4) avoidable negative impact on interpersonal dynamics; (5) inappropriate labeling or disclosure of medical, social, or financial information; and (6) inclusion of biasing or otherwise unfair information. We also suggest approaches to mitigate harm when excluding, including, reframing, or delaying release of information that is perceived to be relevant to an ethics case. Overall, we hope our analysis and recommendations will initiate a much-needed discussion about the impact of the ON mandate on clinical ethics documentation. (shrink)

This study investigates the relations among Machiavellianism, the stakeholder orientation, and Italian managers' support for corporate social and environmental reporting (SER). These relationships have not previously been investigated among a sample of experienced managers but have important implications. As anticipated, Machiavellianism had a strong negative association with the support for SER. Machiavellianism was also negatively related to the stakeholder orientation, which in turn was positively correlated with the support for SER. Support for the stakeholder orientation partially mediated the association between (...) Machiavellianism and SER. The findings advance our understanding of the motivations for sustainability reporting by documenting that managers' fundamental personality traits and economic ideologies are closely associated and are important determinants of normative support for social and environmental disclosures. We further suggest that the results support the case for mandated compliance‐with‐standard sustainability reports coupled with a requirement that such reports be independently audited. (shrink)

The U.S. health care system is ostensibly market based and therefore at least partially reliant on competition and consumer demand to regulate costs. Yet information about an essential feature of market transactions—costs—is typically obscure to patients until long after treatment. When discussing what must be disclosed for informed consent, the same list of required information is often mentioned regardless of the health care system in question, and information about costs rarely merits a place within this list. However, our assumptions about (...) what a moral principle requires need to be responsive to the realities of the health care system in which the principle is applied.This paper explores the moral foundations of disclosure and informed consent to argue that, in a market‐based system of the sort found in the United States, these same considerations support a requirement to disclose out‐of‐pocket costs before patients receive care. Next, I consider two objections to this view: first, that health care practitioners should focus solely on medical considerations in their encounters with patients and, second, that disclosing out‐of‐pocket costs would be too difficult to be mandated. I argue that medical and financial interests are inseparable within the U.S. health care system. If the difficulties in disclosing costs are deemed insurmountable, then the current system may prove unsustainable, both morally and financially, since we face the same practical impediments to implementing any meaningful consumer‐driven, market‐based health care reform. Finally, I explore some of the consequences of failing to disclose costs. The requirements of disclosing costs can be supported by the principle of respect for autonomy, regardless of the consequences, but in light of the consequences of the decision of whether to disclose, a concern about justice provides further support. (shrink)

We discuss how the approach taken by regulators to address financial reporting issues has a significant influence on tone at the top. While tone must ultimately be established internally, regulators are more likely to have a positive impact on the quality of financial reporting by addressing organizational tone. A strong tone at the top should ensure that the financial reports are characterized by greater transparency and complete disclosures, and a regulator’s response will depend upon their perspective as to what motivates (...) management. A compliance-based approach, rooted in agency theory’s assumption that managers act in their own best interests, seeks to mandate desirable behavior through elevated monitoring and reduced managerial discretion. Alternatively, an empowerment-based approach rooted in stewardship theory views managers as trustworthy guardians and grants them greater discretion without burdensome external monitoring. In practice, regulations fall on a continuum between these two approaches. To illustrate the continuum between compliance and empowerment, we present three cases in financial and tax reporting and examine the outcomes of these recent regulatory responses. We then provide conclusions regarding the effectiveness of each regulation by considering how tone was influenced within organizations. (shrink)

Genetic testing reveals information about a patient's health status and predictions about the patient's future wellness, while also potentially disclosing health information relevant to other family members. With the increasing availability and affordability of genetic testing and the integration of genetics into mainstream medicine, the importance of clarifying the scope of confidentiality and the rules regarding disclosure of genetic findings to genetic relatives is prime. The United Nations International Declaration on Human Genetic Data urges an appreciation for principles of (...) equality, justice, solidarity and responsibility in the context of genetic testing, including a commitment to honoring the privacy and security of the person tested. Considering this global mandate and recent professional statements in the context of a legal amendment to patient privacy policies in Australia, a fresh scrutiny of the legal history of a physician's duty to warn is warranted. This article inquiries whether there may be anything ethically or socially amiss with a potential future recommendation for health professionals or patients to universally disclose particular cancer predisposition genetic diagnosis to genetic family members. While much of the discussion remains applicable to all genetic diagnosis, the article focuses on the practice of disclosure within the context of BRCA1/2 diagnosis. An ‘ethic of care’ interpretation of legal tradition and current practice will serve to reconcile law and medical policy on the issue of physician disclosure of genetic results to family members without patient consent. (shrink)

In health care, the provision of pertinent information to patients is not just a moral imperative but also a legal obligation, often articulated through the lens of obtaining informed consent. Codes of medical ethics and many national laws mandate the disclosure of basic information about diagnosis, prognosis, and treatment alternatives. However, within publicly funded health care systems, other kinds of information might also be important to patients, such as insights into the health care priorities that underlie treatment offers made. (...) While conventional perspectives do not take this as an obligatory part of the information to be shared with patients, perhaps through viewing it as clinically “non-actionable,” we advocate for a paradigm shift. Our proposition diverges from the traditional emphasis on actionability. We contend that honoring patients as equal moral agents necessitates, among other principles, a commitment to honesty. Withholding specific categories of information pertinent to patients’ comprehension of their situation is inherently incompatible with this principle. In this article, we advocate for a recalibration of the burden of proof. Rather than requiring special justifications for adding to the standard set of information items, we suggest that physicians should be able to justify excluding relevant facts about the patient’s situation and the underlying considerations shaping health care professionals’ choices. This perspective prioritizes transparency and empowers patients with a comprehensive understanding, aligning with the ethos of respect for the patient as person. (shrink)

Rather than being inherently evil, business lobbying is a socially responsible activity which needs to be restrained by ethical standards. To be effective in a business environment, traditional ethical standards need to be translated into language which business persons can speak comfortably. Economical explanations must also be available to explain why ethical standards are appropriate in business. Eight such standards and their validating arguments are proposed with examples showing their use. Internal dialogues regarding the ethics of lobbying objectives and tactics (...) will plausibly occur only in businesses which recognize social responsibility mandates. Public interest stakeholders could hasten this recognition by making use of information made available by the Lobbying Disclosure Act of 1995 to institute external dialogues regarding lobbying by specific businesses and industry groups. Given practical ethical standards and the information on business lobbying provided by the law, the press, corporate activists, consumers, pension fund managers and the public can apply pressure for ethical lobbying practices. (shrink)

Purpose The purpose of this paper is to review current practice in sharing and mining medical data revealing benefits, costs and ethical issues. Based on stakeholder perspectives and values, the authors create an ethical code to regulate the sharing and mining of medical information. Design/methodology/approach The framework is based on a review of academic, practitioner and legal research. Findings Owing to the inability of current safeguards to protect consumers from risks related to the disclosure of medical information, the authors (...) develop a framework for ethical sharing and mining of medical data, security, transparency, respect, accountability, community and quality, which espouses security, transparency, respect, accountability, community and quality as the basic tenets of ethical data sharing and mining practice. Research limitations/implications The STRACQ framework is an original, previously unpublished contribution that will require modification over time based on discussion and debate within and among the academy, medical community and public policymakers. Social implications The framework for sharing borrows from the Fair Credit Reporting Act, allowing the collection and dissemination of identified medical data but placing strict limitations on use. Following this framework, benefits of shared and mined medical data are freely available with appropriate safeguards for consumer privacy. Originality/value Mandates for adoption of electronic health-care records require an understanding of medical data mining. This paper presents a review of data mining techniques and reasons for engaging in the practice of identifying benefits, costs and ethical issues. The authors create an original framework, STRACQ, for ethical sharing and mining of medical information, allowing knowledge exploration while protecting consumer privacy. (shrink)

This issue’s “Legal Briefing” column covers legal developments pertaining to informed consent. Not only has this topic been the subject of recent articles in this journal, but it also been the subject of numerous public and professional discussions over the past several months.Legal developments concerning informed consent can be usefully grouped into nine categories: 1. General disclosure standards in the clinical context2. Shared decision making3. Staturorily mandated abortion disclosures4. Staturorily mandated end-of-life counseling5. Other staturorily mandated subject-specific (...) disclosures6. U.S. Food and Drug Administration (FDA) labeling and federal pre-emption of state informed consent law7. Relaxed informed consent for HIV testing8. General disclosure standards in the research context9. Issues on the horizon. (shrink)

This study examines the impact of mandatory Corporate Social Responsibility reporting on firms’ financial reporting quality using a quasi-natural experiment in China that mandates a subset of firms to report their CSR activities starting in 2008. We find that mandatory CSR disclosure firms constrain earnings management after the policy. The result is robust to a battery of sensitivity tests and more prominent for firms with lower analyst coverage. Further analyses reveal that upward earnings management by mandatory disclosure firms (...) is more likely to be caught after the policy. The findings suggest that mandatory CSR disclosure mitigates information asymmetry by improving financial reporting quality. (shrink)

Objectives: To develop and pilot a questionnaire based assessment of the importance patients place on medical confidentiality, whether they support disclosure of confidential information to protect third parties, and whether they consider that this would impair full disclosure in medical consultations.Design: Questionnaire administered to 30 consecutive patients attending a GP surgery.Results: Overall patients valued confidentiality, felt that other patients might be deterred from seeking treatment if it were not guaranteed, but did not think that they would withhold information (...) for this reason themselves.Conclusions: When presented with brief details of five clinical situations in which a breach of confidentiality might be considered, a clear majority of subjects believed that doctors should disclose information in two of the situations, but subjects were not confident that doctors would do so. In three situations, about half felt that disclosure was justified—these included the only scenario in which disclosure was clearly mandated by statute. There was little change in patients’ general attitude to confidentiality after considering the scenarios. However, the views expressed were often inconsistent with responses to the clinical scenarios, suggesting that complex opinions were not accurately reflected in the responses. The format of the questionnaire has been amended, and the study will be repeated with other groups of patients. (shrink)

On February 2,2004,U.S. District Judge Federico Moreno issued the final order and judgment authorizing a settlement between the HMO CIGNA Healthcare and the physicians who treated patients covered by CIGNA, ending the companys involvement in the larger class action In re Managed Care Litigation, which stil includes eight other HMOs. The settlement, estimated by plaintiffs experts to be worth 1.3 billion, mandates changes in the companys business and disclosure practices, establishes a non-profit foundation dedicated to the promotion of high (...) quality health care, and guarantees at least 70 million in payments to the physicians. Similar in scope to the settlement approved between the physician class and Aetna Healthcare in October 2003,the settlement could potentially set a new standard for transparency and physician involvement in billing practices; however, much depends on the outcome of the remainder of the class action, which is set to go to trial later this year. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.3 (2002) 299-303 [Access article in PDF] Bioethics Inside the Beltway What Should IRBs Consider When Applying the Privacy Rule to Research? Julie Waltz Gerlach In 1996, Congress mandated the establishment of standards for the privacy of individually identifiable health information through the Health Insurance and Portability and Accountability Act of 1996 (HIPAA). Until the establishment of HIPAA, personal health information could be (...) distributed without notice or consent for reasons that had nothing to do with a patient's medical treatment or health care reimbursement. Patient information held by a health plan could be passed on to a lender who then might deny the patient's application for a home mortgage or a credit card or to an employer who might use it for personnel decisions. Congress failed to meet its 21 August 1996 deadline established by HIPAA to pass privacy legislation; the Act passed the responsibility to Department of Health and Human Services (DHHS). On 28 December 2000, the Secretary of Health and Human Services released final privacy regulations relating to the protection of patients' individually identifiable health information. The "Standards for Privacy of Individually Identifiable Health Information" (Privacy Rule/current) took effect 14 April 2001. As required by HIPAA, the Privacy Rule established conditions for the collection, use, and disclosure of protected health information by covered entities for research purposes. Covered entities, defined as health plans, health care clearinghouses, and health care providers that engage electronically in a wide range of financial and administrative transactions related to payment and reimbursement, must comply by 14 April 2003 (DHHS 2000, p. 82462). To ensure that the provisions of the final rule provide strong privacy protection without hindering access to health care, the Department of Health and Human Services (DHHS 2002, p. 14776) has proposed modifications to the Privacy Rule.The final Privacy Rule (DHHS 2001) grants substantial rights to individuals/research participants to be informed of how their protected health information is maintained and how that information may be used or disclosed. It also defines individual's/research participants' rights with regard to gaining access to information about themselves, when such information is held by covered entities. [End Page 299]The Privacy Rule requires researchers either to receive authorization from individuals/research participants to collect, use, and disclose protected health information, or to obtain a waiver of authorization that is approved by an institutional review board (IRB) or Privacy Board, or to use de-identified data. Section 164.508 of the Privacy Rule, entitled "Use and Disclosures for Which an Authorization Is Required," describes how IRBs will be directly affected. The rule focuses not just on research but on the overall privacy of all identifiable health information. Institutions have the option of adding these required duties to IRBs or establishing "privacy boards." Privacy boards, as defined by the Privacy Rule, are to be composed of members with varying backgrounds and professional competency to review the effect of the research protocol on the individual/research participant's privacy rights. The board must include at least one member who is not affiliated with the covered entity, or any entity conducting or sponsoring the research, and not related to any person who is affiliated with such entities. Board members cannot participate in the review of any research project in which the member has a conflict of interest.The basic concepts and tenets of privacy and confidentiality are well known to IRBs in the United States, which operate under the Common Rule (45 CFR 46) and/or the Food and Drug Administration's (FDA) human subject protection regulations. Both sets of regulations require IRBs to ensure that risks (including privacy risks) are minimized. Under these regulations, IRBs must consider the confidentiality of research data and whether researchers should have access to confidential medical information. IRBs also must review the consent form as a process of communication that will inform research subjects about the research study.One noteworthy aspect of the Privacy Rule is its application to all research regardless of funding source. Currently, research funded by... (shrink)

Organ donation after cardiac or circulatory death (DCD) has been introduced to increase the supply of transplantable organs. In this paper, we argue that the recovery of viable organs useful for transplantation in DCD is not compatible with the dead donor rule and we explain the consequential ethical and legal ramifications. We also outline serious deficiencies in the current consent process for DCD with respect to disclosure of necessary elements for voluntary informed decision making and respect for the donor's (...) autonomy. We compare two alternative proposals for increasing organ donation consent in society: presumed consent and mandated choice. We conclude that proceeding with the recovery of transplantable organs from decedents requires a paradigm change in the ethics of organ donation. The paradigm change to ensure the legitimacy of DCD practice must include: (1) societal agreement on abandonment of the dead donor rule, (2) legislative revisions reflecting abandonment of the dead donor rule, and (3) requirement of mandated choice to facilitate individual participation in organ donation and to ensure that decisions to participate are made in compliance with the societal values of respect for autonomy and self-determination. (shrink)

Rather than being inherently evil, business lobbying is a socially responsible activity which needs to be restrained by ethical standards. To be effective in a business environment, traditional ethical standards need to be translated into language which business persons can speak comfortably. Economical explanations must also be available to explain why ethical standards are appropriate in business. Eight such standards and their validating arguments are proposed with examples showing their use. Internal dialogues regarding the ethics of lobbying objectives and tactics (...) will plausibly occur only in businesses which recognize social responsibility mandates. Public interest stakeholders could hasten this recognition by making use of information made available by the Lobbying Disclosure Act of 1995 to institute external dialogues regarding lobbying by specific businesses and industry groups. Given practical ethical standards and the information on business lobbying provided by the law, the press, corporate activists, consumers, pension fund managers and the public can apply pressure for ethical lobbying practices. (shrink)

Organ donation after cardiac or circulatory death (DCD) has been introduced to increase the supply of transplantable organs. In this paper, we argue that the recovery of viable organs useful for transplantation in DCD is not compatible with the dead donor rule and we explain the consequential ethical and legal ramifications. We also outline serious deficiencies in the current consent process for DCD with respect to disclosure of necessary elements for voluntary informed decision making and respect for the donor's (...) autonomy. We compare two alternative proposals for increasing organ donation consent in society: presumed consent and mandated choice. We conclude that proceeding with the recovery of transplantable organs from decedents requires a paradigm change in the ethics of organ donation. The paradigm change to ensure the legitimacy of DCD practice must include: (1) societal agreement on abandonment of the dead donor rule, (2) legislative revisions reflecting abandonment of the dead donor rule, and (3) requirement of mandated choice to facilitate individual participation in organ donation and to ensure that decisions to participate are made in compliance with the societal values of respect for autonomy and self-determination. (shrink)

Public officials rely on performance data that are self-reported by organizations to evaluate progress on a wide range of prosocial outcomes. Policies that require public disclosure of performance in health care are thought to enable patients to select high-quality providers, which in turn may spur quality improvements as providers seek to protect their reputation or increase economic returns. Drawing on institutional theory that examines how conflicting institutional pressures influence organizational decisions, we theorize how profit orientation may mediate the response (...) of health care providers to disclosure mandates in a public health crisis. We focus on measures of data quality—completeness and accuracy—in self-reported data on COVID-19 status and outcomes generated by thousands of long-term care facilities. Using pooled regressions and a difference-in-differences style design, we find that overall, for-profit and not-for-profit facilities report similarly complete data but that for-profit facilities report less accurate data than their not-for-profit counterparts. Our results suggest that it may be important to incentivize each dimension of data quality separately to address differential institutional pressures that affect reporting practices. (shrink)

: State legislatures consider numerous bills to regulate managed care organizations. After identifying the legal, political, and economic barriers to state reform efforts, the paper assesses recent types of state regulation, particularly mandated benefits and disclosure requirements. Two prerequisites to future reform, coalition building and the diffusion of information about managed care, are analyzed.

Community-level legal and policy innovations or “experiments” can be important levers to improve health. States and localities are empowered through the 10th Amendment of the United States Constitution to use their police powers to protect the health and welfare of the public. Many legal and policy tools are available, including: the power to tax and spend; regulation; mandated education or disclosure of information, modifying the environment — whether built or natural ; and indirect regulation. These legal and policy (...) interventions can be targeted to specific needs at the community level and are often relatively low-cost, but high impact interventions. As every community is different, effective laws and policies will vary. This freedom allows states and localities to, as Justice Louis Brandeis argued, truly serve as “laboratories of democracy.”. (shrink)