In their important and insightful article, Joseph Millum and Danielle Bromwich distinguish two informational requirements for valid consent—the disclosure requirement and the understanding requirem...

Personal life events of a chief executive officer can generate tensions between the CEO’s right to personal privacy and the desire of shareholders for information. Such circumstances can create information asymmetry between the executive management and the shareholders of a firm, a situation likely to produce unfavorable pressures on an organization’s stock price. Failure to fully disclose material personal life events can impact the decision-making actions of the CEO, causing the stock price of the firm to vacillate as a result (...) of rumors and other informational uncertainties. These vacillations in stock price may impact a firm’s liquidity, increase the cost of capital, and affect long term returns to shareholders. We draw upon the ethical leadership and signaling theory literatures to demonstrate how a firm can reduce stock price volatility through a CEO making non-required disclosures that reduce information asymmetry. (shrink)

Millum and Bromwich provide a thorough and thoughtful analysis of what is required for sufficient informed consent, offering distinct conceptualizations of the ethical requirements of disclo...

BackgroundIn Saudi clinical settings, benevolent family care that reflects strongly held sociocultural values is commonly used to justify overriding respect for patient autonomy. Because the welfare of individuals is commonly regarded as inseparable from the welfare of their family as a whole, these values are widely believed to obligate the family to protect the welfare of its members by, for example, giving the family authority over what healthcare practitioners disclose to patients about their diagnoses and prognoses and preventing them from (...) making informed decisions about their healthcare.DiscussionFamily dominance over the healthcare decisions of competent patients is ethically problematic when the family prevent healthcare practitioners from disclosing diagnoses and prognoses to patients who have the capacity to consent and make decisions in their own best interests. Thus, the author holds that sociocultural values ought to be respected only when they do not prevent competent patients from knowing their diagnoses and prognoses or prevent them from making their own decisions.ConclusionHealthcare practitioners should not allow patients’ families to control what can or cannot be disclosed to competent patients. This is particularly important when patients are approaching death so that they may address their material and spiritual wishes—among other needs—as they prepare for death. Justification for this position is drawn from the Maqasid Al-Shariah-based Islamic bioethics approach, from which it is possible to argue that the harm of withholding diagnoses and prognoses from patients who are imminently dying outweighs the potential benefits. (shrink)

Volume 19, Issue 5, May 2019, Page 27-28.

Ensuring confidentiality is the cornerstone of trust within the doctor–patient relationship. However, health care providers have an obligation to serve not only their patient’s interests but also those of potential victims and society, resulting in circumstances where confidentiality must be breached. This article describes the attitudes of mental health professionals when patients disclose past crimes unknown to the justice system. Twenty-four MHPs working in Swiss prisons were interviewed. They shared their experiences concerning confidentiality practices and attitudes towards breaching confidentiality in (...) prison. Qualitative analysis revealed that MHPs study different factors before deciding whether a past crime should be disclosed, including: the type of therapy the prisoner-patient was seeking, the type of crime that is revealed, and the danger posed by the prisoner-patient. Based on this study’s findings, risk assessment of dangerousness was one of the most important factors determining disclosures of past crimes, taking into consideration both the type of therapy and the crime involved. Attitudes of MHPs varied with regard to confidentiality rules and when to breach confidentiality, and there was thus a lack of consensus as to when and whether past crimes should be reported. Hence, legal and ethical requirements concerning confidentiality breaches must be made clear and known to physicians in order to guide them with difficult cases. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

The Securities and Exchange Commission requires publicly held US corporations to disclose all information, whether it is positive or negative, that might be relevant to an investor's decision to buy, sell, or hold a company's securities. The decisions made by corporate managers to disclose such information can significantly affect the judgments and decisions of investors. This paper examines academic accounting research on corporate managers' voluntary disclosures of earnings forecasts and non-GAAP earnings measures. Much of the evidence from this research indicates (...) that some managers engage in opportunistic disclosure behavior that often benefits one group (managers and shareholders) at the expense of other groups (often other investors). The paper concludes by discussing the ethical implications of this behavior. (shrink)

PEOPLE WITH MENTAL HEALTH conditions are often required to address the question of whether they should disclose information about their mental health. Should they inform their employers, colleagues, friends, family, neighbors, and so on, that they have a mental health condition? Should they be encouraged by others to do so? There has been a recent move to promote disclosure as a way to increase the empowerment and decrease the self-stigma of people with mental health conditions. For instance, a three-week (...) intervention, Coming Out Proud, has been devised to inform people about the costs and benefits of disclosure, forms of disclosure, and helpful ways to tell... (shrink)

The disclosure of information that identifies deceased organ donors and/or organ transplant recipients by organ donation agencies and transplant centres is regulated in Australia by state and territory legislation, yet a significant number of donor family members and transplant recipients independently establish contact with each other. To describe and synthesize Australian laws and guidelines on the disclosure of identifying information. Legislation and guidelines relevant to organ donation and transplantation were obtained following a search of government and DonateLife network (...) websites. Information about the regulation of identity disclosure was extracted and synthesised using a process guided by Walt and Gilson’s (1994) policy analysis framework. Nineteen documents were examined. Six guidelines refer to and were consistent with current legislation. Four documents did not address identity disclosure. All jurisdictions prohibit healthcare professionals from disclosing identifying information. In three states, the prohibition extends to all members of the public including donor family members and transplant recipients. Restrictions on identity disclosure have implications for public promotion of donation and transplantation where sharing of stories and images of organ donors and transplant recipients is common. Further research is required to understand the perspective of donor family members, transplant recipients, and healthcare professionals impacted by the current laws. (shrink)

Many governments and corporations have embraced information disclosure as an alternative to conventional environmental and public health regulation. Public policy research on transparency has examined the effects of particular disclosure policies, but there is limited research on how the construction of disclosure policies relates to social movements, or how transparency and ignorance are related. As a first step toward filling this theoretical gap, this study seeks to conceptualize disclosure conflicts, the social processes through which secrecy is (...) challenged, defended, and mobilized in public technoscientific controversies. In the case of shale oil and gas development in the United States, activists and policy makers have demanded information about the contents of fluids used in the extraction process and the routes of oil shipments by rail. Drilling and railroad companies have resisted both demands. Studies of such disputes reveal the dynamic and conflictual nature of information disclosure. In both cases, disclosure conflicts unfold dynamically over time, reflecting power disparities between industry groups and their challengers and requiring coalitions of activists to pursue multiple tactics. When a disclosure policy is established, it does not resolve social conflict but shifts the focus of struggle to the design of information systems, the quality of disclosed data, and the knowledge gaps that are now illuminated. (shrink)

Using a sample of 15,174 firms from 24 countries included in the 2009 World Bank Enterprise Survey, we investigate the impact of disclosure standards and auditing infrastructure on the bribery of public officials to secure government contracts. We find that firms are less likely to grant gift to secure a government contract in countries having more extensive financial reporting requirements and countries where audit firms face a higher litigation and sanction risk. Findings also show that firms are less (...) likely to bribe bureaucrats in case financial statements are reviewed by an external audit firm. Our results are economically significant and are robust to several sensitivity analyses. These findings support certain policies that are currently being implemented or discussed to mitigate bribery within the public sector across the globe. (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)

Objectives Disclosures of funding sources and conflicts of interests (COI) in published peer-reviewed journal articles have recently begun to receive some attention, but many critical questions remain, for example, how often such reporting occurs concerning research conducted in the developing world and what factors may be involved. Design Of all articles indexed in Medline reporting on human subject HIV research in 2007 conducted in four countries (India, Thailand, Nigeria and Uganda), this study explored how many disclosed a funding source and (...) COI, and what factors are involved. Results Of 221 articles that met the criteria, 67.9% (150) disclosed the presence or absence of a funding source, but only 20% (44) disclosed COI. Studies from Uganda were more likely, and those from Nigeria were less likely to mention a funding source (p<0.001). Of articles in journals that had adopted International Committee of Medical Journal Editors (ICMJE) guidelines, 56% did not disclose COI. Disclosure of funding was more likely when: ≥50% of the authors and the corresponding author were from the sponsoring country, the sponsor country was the USA, and the articles were published in journals in which more of the editors were from the sponsoring countries. Conclusions Of the published studies examined, over a third did not disclose funding source (ie, whether or not there was a funding source) and 80% did not disclose whether COI existed. Most articles in ICMJE-affiliated journals did not disclose COI. These data suggest the need to consider alteration of policies to require that published articles include funding and COI information, to allow readers to assess articles as fully as possible. (shrink)

This study analyzes 435 oocyte donor recruitment advertisements to assess whether entities recruiting donors of oocytes to be used for in vitro fertilization (IVF) procedures include a disclosure of risks associated with the donation process in their advertisements. Such disclosure is required by the self-regulatory guidelines of the American Society for Reproductive Medicine (ASRM) and by law in California for advertisements placed in the state. We find very low rates of risk disclosure across entity types and regulatory (...) regimes, although risk disclosure is more common in advertisements placed by entities subject to ASRM's self-regulatory guidelines. Advertisements placed in California are more likely to include risk disclosure, but disclosure rates are still quite low. California-based entities advertising outside the state are more likely to include risk disclosure than non-California entities, suggesting that California's law may have a modest “halo effect.” Our results suggest that there is a significant ethical and policy problem with the status quo in light of the known and unknown risks of oocyte donation and the importance of risk disclosure to informed consent in the context of oocyte donation. (shrink)

Despite the developing influence of the Internet as a tool for reaching potential subjects, little empirical information exits on how individuals are recruited to participate in clinical research via the Internet or on what type of information clinical trial Web sites provide. This study revealed that roughly half of the sites failed to mention study risks or specific details about what the study required on the part of participants, while nearly three-quarters described incentives to participate. Moreover, for-profit entities were more (...) likely to be the sponsors of Web sites that did not appear to provide balanced information. These data suggest that policy-makers and IRBs should increase oversight of current online recruitment practices. (shrink)

Background: When a genetic mutation is identified in a family member, internationally, it is usually the proband’s or another responsible family member’s role to disclose the information to at-risk relatives. However, both active and passive non-disclosure in families occurs: choosing not to communicate the information or failing to communicate the information despite intention to do so, respectively. The ethical obligations to prevent harm to at-risk relatives and promote the duty of care by genetic health professionals is in conflict with (...) Privacy laws and professional regulations that prohibits disclosure of information to a third party without the consent of the proband. In New South Wales, Australia, amendments to Privacy legislation permits such disclosure to living genetic relatives with the process defined under guidelines although there is no legal duty to warn. This study assessed NSW GHP’s awareness and experience of the legislation and guidelines. Methods: An online survey collected demographics; theoretical knowledge; clinical scenarios to assess application knowledge; attitudes; confidence; experience with active non-disclosure. A link to correct answers was provided after completion. Knowledge scores above the median for non-parametric data or above the mean for parametric data were classified as ‘good’ or ‘poor’. Chi square tests assessed associations between confidence and knowledge scores. Results: While many of the 37 participants reported reading the guidelines, there was limited awareness of their scope and clinical application; that there is no legal duty to warn; and that the threat does not need to be imminent to warrant disclosure. No association between confidence and ‘good’ theoretical or applied clinical knowledge was identified. Uncertainty of their professional responsibility was identified and in the several case examples of active non-disclosure that were reported this uncertainty reflected the need for further understanding of the guidelines in regard to the processes required before disclosure was initiated. Conclusions: There is a need for further education and training about the guidelines associated with the legislation that would be relevant to support disclosure. The findings may inform future strategies to support introduction of policy changes in other jurisdictions where similar regulatory regimes are introduced. (shrink)

While an ethical obligation to report findings of clinical research to trial participants is increasingly recognised, the academic debate is often vague about what kinds of data should be fed back and how such a process should be organised. In this article, we present a classification of different actors, processes and data involved in the feedback of research results pertaining to an individual. In a second step, we reflect on circumstances requiring further ethical consideration. In regard to a concrete research (...) setting—the one of clinico-genomic research—we discuss what kinds of difficulties have to be faced when returning individual research results to trial participants. In a last step, we elaborate on a stepwise model to trigger the individual feedback process. Hence, this paper gives guidance on how to feedback individual research results in a specific research setting and responds at the same time to new challenges in the debate on the duty to return individual research findings. (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)

The disclosure policies of scientific journals now require that investigators provide information about financial interests relevant to their research. The main goals of these policies are to prevent bias from occurring, to help identify bias when it occurs, and to avoid the appearance of bias. We argue here that such policies do little to help achieve these goals, and we suggest more effective alternatives.

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in (...) the informed consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward. (shrink)

The article examines the effects of non-financial disclosure on corporate social responsibility. We conceptualise trade-offs between two ideal types in relation to CSR. Whereas self-regulation is associated with greater flexibility for businesses to develop best practices, it can also lead to complacency if firms feel no external pressure to engage with CSR. In contrast, government regulation is associated with greater stringency around minimum standards, but can also result in rigidity owing to a ‘one-size-fits-all’ approach. Given these potential trade-offs, we (...) ask how mandatory non-financial disclosure has been shaping CSR practices and examine its potential effectiveness as a regulatory instrument. Our analysis of 24 OECD countries using the Asset4 database shows that firms in countries that require non-financial disclosure adopt significantly more CSR activities. However, we also find that NFD regulation does not lead to lower levels of corporate irresponsibility. Furthermore, our analysis demonstrates that, over time, the variation in CSR activities declines as firms adopt increasingly similar practices. Our study thereby contributes to understanding the impact of government regulation on CSR at firm level. We also discuss the limits of mandatory NFD in addressing regulatory trade-offs between stringency and flexibility in the field of corporate social responsibility. (shrink)

In an explicit attempt to reduce physician paternalism and encourage patient participation in making health care decisions, the informed consent doctrine has become a foundational precept in medical ethics and health law. The underlying ethical principle on which informed consent rests — autonomy — embodies the idea that as rational moral agents, patients should be in command of decisions that relate to their bodies and lives. The corollary obligation of physicians to respect and facilitate patient autonomy is reflected in the (...) rules that have been created to implement consent procedures, especially those requiring disclosure of relevant information.However, there are many practical impediments to patient self-determination in health care decisionmaking. Well-meaning physicians often lack the time to live up to the ideal of facilitating genuine, informed deliberation with and by their patients, and many lack the motivation or skill to do so successfully. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Each year individuals are required to execute millions of authorizations for the release of their health records as a condition of employment, applying for various types of insurance, and submitting claims for benefits. Generally, there are no restrictions on the scope of information released pursuant to these compelled authorizations, and the development of a nationwide system of interoperable electronic health records will increase the amount of health information released. After quantifying the extent of these disclosures, this article discusses why it (...) is important to limit disclosures of health information for nonmedical purposes as well as how it may be possible to do so. (shrink)

Along with many jurisdictions, Australia is struggling with the unique issues raised by genetic information in the context of privacy laws and medical ethics. Although the consequences of disclosure of most private information are generally confined to individuals, disclosure of genetic information has far-reaching consequences, with a credible argument that genetic relatives have a right to know about potential medical conditions. In 2006, the Privacy Act was amended to permit disclosure of an individual's genetic information, without their (...) consent, to genetic relatives, if it was to avoid or mitigate serious illness. Unfortunately, additional amendments required for operation of the disclosure amendment were overlooked. Public Interest Determinations —delegated legislation issued by the privacy commissioner—have, instead, been used to exempt healthcare providers from provisions which would otherwise make disclosure unlawful. This paper critiques the PIDs using documents obtained under the Freedom of Information Act—specifically the impact of both the PIDs and the disclosure amendment on patients and relatives—and confidentiality and the procedural validity of subordinate laws regulating medical privacy. (shrink)

A premise of this paper that despite an emphasis on professional distance the occurrence of self-disclosure is inevitable in the practice of youth work, yet there is little in-depth discussion in the literature, which recognises or reflects this. We utilise literature from counselling and psychotherapy which highlights the pervasive and unavoidable nature of self-disclosure within therapeutic relationships. In doing so we argue that not only is self-disclosure inevitable in youth work, but that decisions about whether or not (...) particular disclosures are right or wrong are difficult, arguing that they need to be reflected upon and explored in their particular context. We suggest some boundaries for self-disclosure, as well as offer a model within which to begin to distinguish aspects of self-disclosure. This it is hoped will help maintain both effective and professional relationships with young people, but maintain that this still requires the professional judgement of youth workers. In so doing self-disclosure is recognised as not only inevitable but as a useful aid to youth work practice. (shrink)

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)

Mi propósito en este trabajo es reconsiderar una de las lecturas más relevantes y provocativas que se han hecho sobre John Dewey en el mundo de habla hispana. En la primera parte reconstruyo las circunstancias que rodearon la difusión, interpretación y traducción de las obras de Dewey en el México de mediados de los años 1940, y en concreto las razones que llevaron a que la visión sociológica que José Medina Echavarría quiso dar de Dewey fuera finalmente desplazada por la (...) filosófica de José Gaos. En la segunda parte analizo la traducción y lectura que Gaos hizo de Experience and Nature de Dewey, teniendo muy presente sus comparaciones con Sein und Zeit de Heidegger . Finalmente, propongo algunas críticas a la visión que Gaos transmite de Dewey como un pensador carente de un tipo de "soberbia diabólica" propia de la verdadera gran filosofía. The purpose of this work is a reconsideration of one of the most relevant and provocative readings of John Dewey written in the Hispanic World. In the first part I reconstruct the circumstances which surrounded the publicity, interpretation and translation of John Dewey's works in the Mexico of the middle 1940's, particularly the reasons why the sociological reading of Dewey that José Medina Echavarría proposed was finally displaced by the metaphysic perspective of José Gaos. In the second part I reconsider Gaos' own translation and interpretation of Experience and Nature, taking in consideration his comparisons with Heidegger's Sein und Zeit . Finally I analyze critically Gaos' view of Dewey as a thinker whose philosophy lacked the "diabolical arrogance" that true great philosophy would seem to require. (shrink)

Background Biomarker research is gaining increasing attention focusing on the preclinical stages of the disease. Such interest requires special attention for communication and disclosure in clinical contexts. Many countries give dementia a high health policy priority by developing national strategies and by improving guidelines addressing disclosure of a diagnosis; however, risk communication is often neglected. Main text This paper aims to identify the challenges of disclosure in the context of dementia prediction and to find out whether existing (...) clinical guidelines sufficiently address the issues of disclosing a dementia diagnosis and of disclosing the risk of developing dementia in asymptomatic and MCI stage. We will examine clinical guidelines and recommendations of three countries regarding predictive testing and diagnostic disclosure in dementia and Mild Cognitive Impairment to show their potentials and limits. This will provide a background to address ethical implications of predictive information and to identify ways how to proceed further. We will start by examining the guidelines and recommendations by focusing on what there is already and what is missing regarding the challenges of disclosing dementia prediction and MCI. Then, we will highlight the novel ethical issues generated by the shift to identify preclinical stages of the disease by biomarkers. We will argue for the need to develop guidelines for disclosing a risk status, which requires different considerations then disclosing a diagnosis of dementia. Finally, we will make some suggestions on how to address the gap and challenges raised by referring to German Stakeholder Conference, which presents us a good starting point to the applicability of involving stakeholders. Conclusions This paper underlines the need to develop empirically based guidelines that address the ethical and social strategies for risk communication of dementia prediction by genetic as well as non-genetic biomarkers. According to our analysis, the guidelines do not address the new developments sufficiently. International efforts should aim for specific guidelines on counseling, communicating risk and disclosing results. We argue that guidelines on disclosure should be developed by involving various stakeholders and should be informed by socio-empirical studies involving laypersons’ needs and wishes regarding risk communication. (shrink)

The purpose of this article is to problematise a particular social transparency and disclosure regulation in the UK, that transcend national boundaries in order to control slavery in supply chains operating in the developing world. Drawing on notions from the regulatory and sociology literature, i.e. transparency and normativity, and by interviewing anti-slavery activists and experts, this study explores the limitations of the disclosure and transparency requirements of the UK Modern Slavery Act and, more specifically, how anti-slavery activists (...) experience and interpret the new regulations and the regulators’ implementation of the regulation. This research found limited confidence among anti-slavery activists regarding the Act’s call for transparency in relation to the elimination of slavery from global supply chains. The research also found that the limits of the transparency provisions within the Act appear to hinder the attainment of normativity. This study provides new and unique insights into the critical role that social activists play in exposing the lack of corporate transparency and failures of responsibility to protect workers within global supply chains. (shrink)

The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the disclosure requirement for advance research (...) directives. We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level. (shrink)

The reasons for judgment by the Supreme Court of Canada on the appeal in Mabior (2012 SCC 47) fail to address or resolve a number of significant questions. The reasons acknowledge the fundamental role of sexual consent in protecting sexual autonomy, equality, and human dignity, but do not use the law of consent as a tool to assist the Court in crafting a fresh approach to the issue on appeal. Instead the Court adopts the same general approach to analysis of (...) the elements of aggravated sexual assault committed by fraud it used in 1998 in Cuerrier. Fifteen years later, it should be possible to re-conceptualize the problem in a more straightforward manner that reflects Charter values, fundamental common law principles, recent developments in sexual assault law, and the limitations and uncertainties of current HIV treatment and diagnosis. -/- Ironically, the two pronged legal test ultimately proposed by the Court -- non-disclosure of HIV-positive status and a “realistic possibility of transmission,” is likely to give false confidence to individuals who adhere to a regime of anti-retroviral treatment, use good quality latex condoms, and routinely conceal their HIV-positive status from their sexual partners. Research shows that HIV viral loads fluctuate widely in response to a myriad of factors. An inevitable consequence of reliance on the Mabior test will be accused who are shocked to find themselves charged under s. 273, charges that would not apply had they disclosed their HIV-positive status to their sexual partner(s). There are further practical consequences. Non-disclosure will tend to increase the risk of transmission because non-HIV-positive sexual partner(s) will not fully appreciate the actual hazards of improper condom use. As a direct result, careless sexual practices will be more common. And finally, the decision will not contribute to reducing the social stigma that haunts the lives of those who are HIV-positive -- even those who are skilled at deceit. That stigma will not be reduced or eliminated by a ruling that can be seen as tacitly validating stigmatization and fear by appearing to permit infected individuals to pretend they are not HIV-positive when they know or suspect this to be false. Deceit harms the human dignity of the deceived and deceiver alike, and does nothing to build authentic social trust and cohesion. For all these reasons, the problem on appeal in Mabior requires a different approach. This article proposes one. (shrink)

The secure release of identity attributes is a key enabler for electronic business interactions. Users should have the maximum control possible over the release of their identity attributes and should state under which conditions these attributes can be disclosed. Moreover, users should disclose only the identity attributes that are actually required for the transactions at hand. In this paper we present an approach for the controlled release of identity attributes that addresses such requirements. The approach is based on the (...) integration of trust negotiation and minimal credential disclosure techniques. Trust negotiation supports selective and incremental disclosure of identity attributes, while minimal credential disclosure guarantees that only the attributes necessary to complete the on-line interactions are disclosed. (shrink)

Corporate sustainability reports are supposed to provide a complete and balanced picture of corporate sustainability performance. They are, however, usually voluntary and thus prone to interpretation and even greenwashing tendencies. To overcome this problem, the Global Reporting Initiative (GRI) provides standardized reporting guidelines challenging companies to report positive and negative aspects of an organization’s sustainability performance. However, the reporting of “negative aspects” in particular can endanger corporate legitimacy if perceived by the stakeholders as not being in line with societal norms (...) and values. Starting from the theoretical lenses of economics-based disclosure theories and socio-political theories of disclosure, the focus of this study therefore was to analyze the communicative legitimation strategies companies use to report “negative aspects,” i.e., negative ecological and social impact caused by corporate activity. Using qualitative content analysis of GRI-oriented sustainability reports from companies listed on the US Dow Jones Industrial Average Index and on the German DAX Index, we identified six legitimation strategies. We discuss these strategies regarding to symbolic and substantial management of legitimacy. We show that symbolic legitimation strategies aiming at modifying the perception of legitimizing stakeholders dominate in the reports at hand. Such persuasion, however, does not meet the requirement of impartiality as postulated by the GRI guidelines. Building upon this conclusion we propose a concise characterization of “negative aspects” and develop a GRI-compliant schema of reporting about them. In doing so, we offer a way to improve the overall “balance” of sustainability reporting contributing to a true and fair view in sustainability disclosure. (shrink)

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the (...) cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups. (shrink)

Children with HIV are dependent on taking continuous medication and care, and family preparation is required when disclosing HIV. This study aimed to unveil families’ experiences with HIV disclosure to children under 13 years old. Eight family members who have disclosed HIV to seropositive children were interviewed in‐depth and individually. The fieldwork took place at a public paediatric outpatient hospital in Rio de Janeiro. The results showed that the family members’ discourse highlighted two ways of knowing their own condition (...) and disclosing the condition of the children with HIV. First, they needed to address the communication of bad news and discover their own HIV status through their children's disease. Second, the disclosure was a process constituted by four stages: preparing for disclosure, identifying the time, deciding how and where to tell, and instilling silence after disclosure. They also recognized that nurses had a role in the process as part of an interprofessional team. Nurses can develop advocacy care and empower family members in the preparation of safe HIV disclosure. By systematizing and institutionalizing the care advocacy process, nurses may enable caretakers and children to participate in their therapeutic management, improving adherence to the treatment and self‐care with autonomy. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.2 (2001) 165-168 [Access article in PDF] UPMC Presbyterian Policy and Procedure Manual Guidelines for Disclosure and Discussion of Conditions and Events with Patients, Families and Guardians* I. Introduction and Background In the course of hospital care, an extensive amount of clinical information is generated. It includes diagnostic findings, treatment options, responses to interventions, and professional opinions. The information can be positive or (...) negative. Clinical events may or may not be caused by clinicians and consequently may be iatrogenic (caused by medical treatment), nosocomial (occurring in the hospital) or natural events.In accordance with the informed consent policy (#4011), Patients' Bill of Rights (# 0154, Section II H), and the Guidelines on Forgoing Life Sustaining Treatment (#4007), patients have the right to information regarding their condition and care. Physicians and other caregivers are obligated to provide accurate information as expeditiously as possible. While it is usually easy to provide positive information, negative information is more difficult to disclose, especially when the cause is iatrogenic."Therapeutic privilege" has been invoked to explain why certain negative information might be withheld. By invoking therapeutic privilege, the physician refrains from full disclosure to protect the patient from the effects of receiving the information itself. The use of therapeutic privilege is increasingly being called into question because it decreases patient autonomy and reduces trust.The following recommendations are provided to clinicians to help guide delivery of sensitive information, positive and negative. Specific recommendations [End Page 165] are provided for situations where the information is about an unfavorable or adverse event, or where the information might best be characterized as "bad news." II. Definitions Unfavorable event or unfavorable condition. For the purposes of these guidelines, an unfavorable condition is an occurrence or diagnosis that results in or is likely to result in a significant negative outcome, and/or a significant alteration in the care plan.An unfavorable event in this context is not the same as a sentinel event, which in policy #4025 is defined as, "a serious, unexpected, adverse patient event which has resulted in, or if repeated would have a significant probability of resulting in, loss of life or serious physical or psychological injury, that is judged to be a warning of an underlying problem involving hospital facilities, policies, procedures, systems or personnel."Adverse Event. An unfavorable event for the purposes of these guidelines is also distinguished from the FDA definition of the term "adverse event", which is a reportable negative effect of a drug or device potentially resulting in death, hospitalization, or medical or surgical intervention. (See policy #4022 Safe Medical Device Act.)Examples of unfavorable events or conditions for the purpose of these guidelines include a new diagnosis of cancer, a perioperative myocardial infarction, or unintended delivery of an incorrect medication that results in clinical change.Examples of events not covered by these guidelines are intravenous saline infiltration and medication dosing errors that have no clinical impact on care.Iatrogenic. Event caused by the treatment of a healthcare provider. III. Guidelines and Principles It is appropriate that UPMC Presbyterian support basic principles for patient and family notification regarding all clinical events and conditions, including unfavorable ones. Physicians must be honest because that is a cornerstone of the patient-physician relationship, and because it fosters patient autonomy.UPMC Presbyterian supports the following AMA position regarding patient information: [End Page 166] It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and to be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician's mistake or judgement. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care. Ethical responsibility includes informing patients of changes in their diagnoses... (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)

Sometimes medical errors should not be disclosed. We report a case of semen samples exchange, during a homologous artificial insemination procedure, where a bioethics consultation was required. The bioethics consultation addressed ethical and legal elements in play, supporting non-disclosure to some of the subjects involved. Through a proper methodology, gathering factual and juridical elements, a consultant can show when a moral dilemma between values and rights—privacy versus fatherhood, in our case—is unsubstantial, in a given context, because of the groundlessness (...) of the value or the right itself. However, being the error elicited by organizational factors, a broader ethical pronouncement was needed. Under such circumstances, ethical evaluation should engage in a sort of ‘ethical-based root-cause analysis’, linking ethical principles to quality aims and showing the opportunity to integrate ethical methodology in healthcare management. From this perspective, errors may become an incentive to promote high-quality organizations, attending to the central value of person even through the organizational process. (shrink)

Children with HIV are dependent on taking continuous medication and care, and family preparation is required when disclosing HIV. This study aimed to unveil families’ experiences with HIV disclosure to children under 13 years old. Eight family members who have disclosed HIV to seropositive children were interviewed in‐depth and individually. The fieldwork took place at a public paediatric outpatient hospital in Rio de Janeiro. The results showed that the family members’ discourse highlighted two ways of knowing their own condition (...) and disclosing the condition of the children with HIV. First, they needed to address the communication of bad news and discover their own HIV status through their children's disease. Second, the disclosure was a process constituted by four stages: preparing for disclosure, identifying the time, deciding how and where to tell, and instilling silence after disclosure. They also recognized that nurses had a role in the process as part of an interprofessional team. Nurses can develop advocacy care and empower family members in the preparation of safe HIV disclosure. By systematizing and institutionalizing the care advocacy process, nurses may enable caretakers and children to participate in their therapeutic management, improving adherence to the treatment and self‐care with autonomy. (shrink)