The Italian code of medical deontology recently approved stipulates that physicians have the duty to inform the patient of each unwanted event and its causes, and to identify, report and evaluate adverse events and errors. Thus the obligation to supply information continues to widen, in some way extending beyond the doctor-patient relationship to become an essential tool for improving the quality of professional services.

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)

BackgroundBetween the need for transparency in healthcare, widely promoted by patient’s safety campaigns, and the fear of negative consequences and malpractice threats, physicians face challenging decisions on whether or not disclosing medical errors to patients and families is a valid option.We aim to assess the knowledge, attitudes and practices (KAP) of physicians in our center regarding medical error disclosure.MethodsThis is a cross-sectional self-administered questionnaire study. The questionnaire was piloted and no major modifications were made.A day-long training workshop consisting (...) of didactic lectures, short and long case scenarios with role playing and feedback from the instructors, were conducted. Physicians who attended these training workshops were invited to complete the questionnaire at the end of the training, and physicians who did not attend any training were sent a copy of the questionnaire to their offices to complete. To assure anonymity and transparency of responses, we did not query names or departments.Descriptive statistics were used to present demographics and KAP. The differences between response\s of physicians who received the training and those who did not were analyzed with t-test and descriptive statistics. The 0.05 level of significance was used as a cutoff measure for statistical significance.ResultsEighty-eight physicians completed the questionnaire (55 attended training (62.50%), and 33 did not (37.50%)). Sixty Five percent of physicians were males and the mean number of years of experience was 16.5 years. Eighty-Seven percent (n = 73) of physicians were more likely to report major harm, compared to minor harm or no harm. Physicians who attended the workshop were more knowledgeable of articles of Jordan’s Law on Medical and Health Liability (66.7% vs 45.5%,p-value = 0.017) and the Law was more likely to affect their decision on error disclosure (61.8% vs 36.4%,p-value = 0.024).ConclusionFormal training workshops on disclosing medical errors have the power to positively influence physicians’ KAP toward disclosing medical errors to patients and possibly promoting a culture of transparency in the health care system. (shrink)

Defined as patients who ‘lack decision-making capacity and a surrogate decision-maker’, the unrepresented present a major quandary to clinicians and ethicists, especially in handling errors made in their care. A novel concern presented in the care of the unrepresented is how to address an error when there is seemingly no one to whom it can be disclosed. Given that the number of unrepresented Americans is expected to rise in the coming decades, and some fraction of them will experience a (...) medical error, creating protocols that answer this troubling question is of the utmost importance. This paper attempts to begin that conversation, first arguing that the precarious position of unrepresented patients, particularly in regards to errors made in their care, demands their recognition as a vulnerable patient population. Next, it asserts that the ethical obligation to disclose error still exists for the unrepresented because the moral status of error does not change with the presence or absence of surrogate decision-makers. Finally, this paper concludes that in outwardly acknowledging wrongdoing, a clinician or team leader can alleviate significant moral distress, satisfy the standards of a genuine apology, and validate the inherent and equivalent moral worth of the unrepresented patient. (shrink)

Recent literature on the ethics of medical error disclosure acknowledges the feelings of injustice, confusion, and grief patients and their families experience as a result of medical error. Substantially less literature acknowledges the emotional and relational discomfort of the physicians responsible or suggests a meaningful way forward. To address these concerns more fully, I propose a model of medical error disclosure that mirrors the theological and sacramental technique of confession. I use Aquinas’ description of moral (...) acts to show that all medical errors are evil, and some accidental medical errors constitute venial sins; all sin and evil should be confessed. As Aquinas urges confession for sins, here I argue that confession is necessary to restore physicians to the community and to provide a sense of absolution. Even mistakes for which physicians are not morally culpable ought to be confessed in order to heal the physician–patient relationship and to address feelings of professional distress. This paper utilizes an Episcopal theology of confession that affirms verbal admission and responsibility-taking as freeing and relationally restoring acts, arguing that a confessional stance toward medical error both leads to better outcomes in physician–patient relationships and is more compassionate toward physicians who err. (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)

Next SectionThis article proposes that knowledge of cultural expectations concerning ethical responses to unintentional harm can help students and physicians better to understand patients’ distress when physicians fail to disclose, apologise for, and make amends for harmful medical errors. While not universal, the Judeo-Christian traditions of confession, repentance, and forgiveness inform the cultural expectations of many individuals within secular western societies. Physicians’ professional obligations concerning truth telling reflect these expectations and are inclusive of the disclosure of medical error, (...) while physicians may express a need for self-forgiveness after making errors and should be aware that patients may also rely upon forgiveness as a means of dealing with harm. The article recommends that learning how to disclose errors, apologise to injured patients, ensure that these patients’ needs are met, and confront the emotional dimensions of one’s own mistakes should be part of medical education and reinforced by the conduct of senior physicians. (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)

Medication error is the most common and consistent type of error occurring in hospitals. This article attempts to explore the ethical issues relating to the nursing management of medication errors in clinical areas in Macau, China. A qualitative approach was adopted. Seven registered nurses who were involved in medication errors were recruited for in-depth interviews. The interviews were transcribed and analyzed using content analysis. Regarding the management of patients, the nurses acknowledged the mistakes but did not disclose the (...) incidents to patients and relatives. Concerning management of the nurses involved by senior staff, most participants experienced fairness, comfort and understanding during the process of reporting and investigation. The ethical issues relating to the incidents were discussed, particularly in the Chinese context. There is a need for further study relating to the disclosure of medication incidents to patients and some suggestions were made. (shrink)

We investigate the effectiveness of corporate social responsibility disclosure in protecting corporate reputation following financial restatements. As expected under legitimacy theory, firms can signal their legitimacy via nonfinancial disclosure after the negative effects of financial restatements. Our results show that restating firms make substantial improvements to overall CSR disclosure quality by changing their standalone reports to a more conservative tone, increasing readability and report length, even though they strategically disclose less forward-looking and sustainability-related content. Such improvements are (...) more pronounced in restating firms with prior low-quality CSR disclosure. Moreover, restating firms with CSR disclosure have smaller forecast errors than non-CSR disclosers, yet the change in CSR disclosure after restatements does not further improve analyst forecast accuracy. Finally, we find that compared with nondisclosers, restating firms with CSR disclosure suffer smaller firm value losses. Overall, the evidence supports the view that consistent CSR reporting alleviates reputational damage and plays an insurance-like or value protection role during crisis periods. (shrink)

BackgroundHospitals face a disclosure dilemma when large-scale adverse events affect multiple patients and the chance of harm is extremely low. Understanding the perspectives of patients who have received disclosures following such events could help institutions develop communication plans that are commensurate with the perceived or real harm and scale of the event.MethodsA mailed survey was conducted in 2008 of 266 University of Washington Medical Center (UWMC) patients who received written disclosure in 2004 about a large-scale, low-harm/low-risk adverse event (...) involving an incomplete endoscope cleaning process. The survey measured patients’ satisfaction with this disclosure, their concerns about healthcare outcomes, and their recommendations for future communication, given similar circumstances.ResultsSurveys were received from 127 of 266 (48 percent) of eligible respondents; 98 percent thought that UWMC was right to inform them about this event, and mean satisfaction with the disclosure was 7.7 on a 0 to 10 scale. Of the 127 respondents, 64 percent were somewhat or very concerned that the endoscope cleaning problem might cause them health problems; 60 percent reported their impressions of UWMC’s honesty and integrity had increased; 31 percent said their perceptions of the quality of care had increased; 94 percent agreed that institutions should tell patients about any error in their care, even when the risk of harm was low, although 28 percent agreed that such notifications would make them anxious. Respondents who reported concern that the event could cause them health problems were less likely to be satisfied with the institution’s disclosure. Patients cited their right to know information material to their own health and healthcare as an important reason for disclosure.ConclusionRecipients of disclosure of a large-scale, low-harm/low-risk event overwhelmingly supported being told of the event and endorsed notification of patients for similar events in the future. Although informing patients may cause concern for some, institutions should ensure their disclosure policies and procedures reflect their patients’ preferences. (shrink)

This book is a collection of original, interdisciplinary essays on the topic of medical error. Given the complexities of understanding, preventing, and responding to medical error in ethically responsible ways, the scope of the book is fairly broad. The contributors include top scholars and practitioners working in bioethics, communication, law, medicine and philosophy. Their contributions examine preventable causes of medical error, disproportionate impacts of errors on vulnerable populations, disclosure and apology after discovering medical errors, and ethical (...) issues arising in specific medical contexts, such as radiation oncology, psychopathy, and palliative care. They also offer practical recommendations for respecting autonomy, distributing burdens and benefits justly, and minimizing injury to patients and other stakeholders. Ethics and Error in Medicine will be of interest to a wide range of researchers, students, and practitioners in bioethics, philosophy, communication studies, law, and medicine who are interested in the ethics of medical error. (shrink)

Imagine this scenario: a bank customer walks up to an ATM to withdraw cash from her account. While entering her PIN, she accidentally presses the '3' key at the same time as the 'Clear' key. Instantly $100 comes out of the cash dispenser! Curious, she checks the receipt and seeing that the money did not from her account, she tries the same operation. Again, $100 comes out of the cash dispenser. At this point she has two options, A: she can (...) continue to take advantage of this obvious flaw and tell her friends, or B: she can report this problem to the bank, telling no one else. While Kantian ethics might require the latter, the issue becomes much grayer when it comes to computer software vulnerabilities. Many variables exist to cloud the ethical judgment of a software flaw's discoverer. The question becomes: is it better to report any vulnerability that could cause catastrophic problems or to make the vulnerability information public in order to simultaneously compel the software vendor to address the problem while giving the vendor's customers a chance to prepare for potential exploitation? Software companies are facing this dilemma on a regular basis. There are dozens of websites, newsgroups, and e-mail lists dedicated to the task of sharing vulnerability information, whether condoned by the software company or not. The issue increases in severity as vulnerable software becomes ubiquitous across global networks. The public release of vulnerability information is often the first drop of the monsoon that is the malicious network worm. How this information is controlled and disseminated is critical to the stable operation of millions of computer systems and networks across the globe.Modern software with network capability is fundamentally complex and can span thousands of lines of source code for one small part of the package. Without proper testing and quality assurance, many bugs and errors slip through. Software development requires these iterations of coding and bug fixing to produce stable and polished final products. Larger and more complex software gives a greater chance for a bug to remain undiscovered. Yet, since major vulnerabilities have appeared in relatively smaller projects, proper code audit and testing are critical regardless of the size of a software package or the amount of source code required to produce it. If bugs or security vulnerabilities are not discovered and fixed by the software manufacturers, it is inevitable that they will be discovered by outside researchers.This breeds the ethical conundrum of what the researchers do with the information once it has been discovered. Foundational to disclosure, regardless of the ideology, is the notion of providing useful protective information to the most appropriate audience. Many suggest that disclosure is about doing the 'greatest good' for the greatest number of people, which is an obvious adherence to the ethical principle of Utilitarianism. There are numerous parties involved in the network security process such as software vendor, security researcher, system administrator, and even malicious attacker: all whose intentions reflect on the ethical principles behind their actions. (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)

This study explores the rationality behind firms’ decision to admit or deny their involvement in bribery when responding to confidential surveys conducted by international agencies. Specifically, we posit that firms’ reluctance to provide accurate information about their engagement in bribery is at least to some extent contingent on certain situational factors. In other words, we claim that this behavior is context dependent. The paper uses the notions provided by the theory of planned behavior to understand the way in which the (...) corruption of the legal environment, the intensity of market competition, and identification risk influence firms’ decision to lie about their involvement in bribery. To test these notions, we use databases from the fifth wave of the EBRD-World Bank Business Environment and Enterprise Performance Survey, country-level data from the Kauffman Foundation and macroeconomic information from the World Bank database. We run ordinary least squares with geographic region-clustered standard errors on data from 30 countries and 6122 individual firms during the period 2012–2013. Consistent with our expectations, the results indicate that firms operating within more corrupt legal environments, facing more competition, and bearing a higher risk of being identified are less likely to deny their involvement in bribery. We conclude that not all firms have the same incentives to lie about their participation in bribery, and therefore, identifying the drivers of this heterogeneity may help policymakers better assess the reliability of bribery information collected through confidential surveys. (shrink)

Disclosure of near miss medical error (ME) and who should disclose ME to patients continue to be controversial. Further, available recommendations on disclosure of ME have emerged largely in Western culture; their suitability to Islamic/Arabic culture is not known.

This article argues that positioning disclosure as a primary remedy in addressing the ethical problems posed by conflicts of interest in medicine and health is an error. Instead, bioethical resources should be devoted to the problems associated with sequestration, defined as the elimination of relationships between commercial industries and health professionals in all cases where it is remotely feasible. The argument begins by arguing that adopting Andrew Stark’s conceptual framework for COIs leads to advantages in understanding COIs and (...) in ordering priorities for intervention. The article then draws on prior work establishing that COIs are, under ordinary epidemiologic standards, properly regarded as population health hazards. This justifies attention to possible remedies, of which disclosure generates by far the most analysis. Such primacy is unwarranted given the extensive evidence suggesting that disclosure as a remedy for COIs is at best ineffective. ‘At best’ is justified because the evidence also shows that disclosure may have a perverse effect, intensifying biased behaviors. Expending significant attention on an ineffective or even deleterious intervention is unjustified and also crowds out devotion of resources to the real problems that attend sequestration. Therefore, disclosure ought to be regarded as a lower priority among possible COI interventions. (shrink)

Jones, Kate The quality of communication and the authenticity of interaction are undoubtedly tested in the midst of difficult and challenging circumstances. When patient harm occurs, and health care outcomes fall well below governing best practice standards, the way in which this is managed has a lasting impact on patients and their families. This is true whether or not the problem was due to an error, or a failed plan of treatment, and was unintentional and unforseen.

A general consensus has been reached in health care organizations that the disclosure of medical errors can be a very powerful way to improve patients and physicians well-being and serves as a core component to high quality health care. This practice strongly encourages transparent communication with patients after medical errors or unanticipated outcomes. However, many countries, such as Brazil, do not have a culture of disclosing harmful errors to patients or standards emphasizing the importance of disclosing, taking responsibility, apologizing, (...) and discussing the prevention of recurrences. Medical error is not discussed or approached during medical school. The stigma of error has a strong connection with value judgments, and emotional support for physicians does not exist. This paper suggests that open communication with the patient is essential. Guidance about error disclosure from health care organizations would be helpful for quality and patient safety and for health care professionals in countries like Brazil. (shrink)

The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to (...) prevent autonomy-undermining ignorance. The problem with the standard account, we argue, is that it fails to distinguish between different forms of ignorance–in particular, error and suspending ignorance–that have very different effects on individuals’ ability to provide valid consent. While error often undermines our ability to provide valid consent, suspending ignorance, we argue, does not. Once the moral weight of this distinction is appreciated, it becomes apparent that valid informed consent requires far less knowledge than suggested by the standard account. (shrink)

A general consensus has been reached in health care organizations that the disclosure of medical errors can be a very powerful way to improve patients and physicians well-being and serves as a core component to high quality health care. This practice strongly encourages transparent communication with patients after medical errors or unanticipated outcomes. However, many countries, such as Brazil, do not have a culture of disclosing harmful errors to patients or standards emphasizing the importance of disclosing, taking responsibility, apologizing, (...) and discussing the prevention of recurrences. Medical error is not discussed or approached during medical school. The stigma of error has a strong connection with value judgments, and emotional support for physicians does not exist. This paper suggests that open communication with the patient is essential. Guidance about error disclosure from health care organizations would be helpful for quality and patient safety and for health care professionals in countries like Brazil. (shrink)

A general consensus has been reached in health care organizations that the disclosure of medical errors can be a very powerful way to improve patients and physicians well-being and serves as a core component to high quality health care. This practice strongly encourages transparent communication with patients after medical errors or unanticipated outcomes. However, many countries, such as Brazil, do not have a culture of disclosing harmful errors to patients or standards emphasizing the importance of disclosing, taking responsibility, apologizing, (...) and discussing the prevention of recurrences. Medical error is not discussed or approached during medical school. The stigma of error has a strong connection with value judgments, and emotional support for physicians does not exist. This paper suggests that open communication with the patient is essential. Guidance about error disclosure from health care organizations would be helpful for quality and patient safety and for health care professionals in countries like Brazil. (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)

BackgroundExperience with open disclosure and its study are restricted to certain western countries. In addition, there are concerns that open disclosure may be less suitable in non-western countries. The present study explored and compared the in-depth perceptions of the general public and physicians regarding open disclosure in Korea.MethodsWe applied the COREQ checklist to this qualitative study. We conducted 20 in-depth interviews and four focus group discussions with 16 physicians and 18 members of the general public. In-depth interviews (...) and focus group discussions were performed according to semi-structured guidelines developed according to a systematic review of open disclosure. We conducted a directed content analysis by analyzing the verbatim transcripts and field notes in accordance with the predetermined guidelines.ResultsOpen disclosure perceptions were summarized in terms of the “five Ws and one H”. All physician and general public participants acknowledged the normative justifiability of open disclosure. The participants mostly agreed on the known effects of open disclosure, but the physicians had negative opinions on its expected effects, such as decreased intention of the general public to file lawsuits and increased credibility of medical professionals. Generally, the participants thought that open disclosure is required for medical errors causing major harm. However, the physicians and general public had conflicting opinions on the need for open disclosure of near misses. Most physicians did not know how to conduct open disclosure and some physicians had bad experiences due to inappropriate or incomplete open disclosure.ConclusionPhysicians and the general public in Korea acknowledge the need for open disclosure. Guidelines according to the type of patient safety incident are required to encourage physicians to more readily conduct open disclosure. Furthermore, hospitals need to consider organizing a dedicated team and hiring experts for open disclosure. (shrink)

BackgroundIn this study, medical errors are defined as unintentional patient harm caused by a doctor’s mistake. This topic, due to limited research, is poorly understood in Malaysia. The objective of this study was to determine the proportion of doctors intending to disclose medical errors, and their attitudes/perception pertaining to medical errors.MethodsThis cross-sectional study was conducted at a tertiary public hospital from July- December 2015 among 276 randomly selected doctors. Data was collected using a standardized and validated self-administered questionnaire intending to (...) measure disclosure and attitudes/perceptions. The scale had four vignettes in total two medical and two surgical. Each vignette consisted of five questions and each question measured the disclosure. Disclosure was categorised as “No Disclosure”, “Partial Disclosure” or “Full Disclosure”. Data was keyed in and analysed using STATA v 13.0.ResultsOnly 10.1% intended to disclose medical errors. Most respondents felt that they possessed an attitude/perception of adequately disclosing errors to patients. There was a statistically significant difference when comparing the intention of disclosure with perceived disclosures. Most respondents were in common agreement that disclosing an error would make them less likely to get sued, that minor errors should be reported and that they experienced relief from disclosing errors.ConclusionMost doctors in this study would not disclose medical errors although they perceived that the errors were serious and felt responsible for it. Poor disclosure could be due the fear of litigations and improper mechanisms/procedures available for disclosure. (shrink)

Research and practice of Voluntary Earnings Disclosure (VED) as a strategy are limited, notwithstanding its evidenced contribution to firm value. An emerging VED profile is identified, characterised and evaluated. Firms applying it regularly provide VED between quarterly earnings announcements. This profile is compared with the prevailing approach of issuing VED when warranted by events and/or when serving firm or management ad hoc interests. These firms' VEDs are found to be more regular, frequent, timely, and often with confirming content. Their (...) VED events, usually midquarter updates, are often prescheduled and specifically named using period-related terms. These controllable characteristics qualify it as a strategy, termed 'Period-Driven VED', in distinction from 'Event-Driven VED'. The period-driven VED strategy is found to improve a firm's information environment through a reduced information gap, measured by abnormal stock returns, lower analysts' forecast error and dispersion, and fewer surprises around earnings-release dates. The firm's improved information environment leads to lower cost of capital, as evidenced by prior theoretical and empirical research, enhancing firm value. (shrink)

This article explores Dietrich Bonhoeffer’s writings on truth telling with reference to the problem of medical error in the US, the UK, and other developed nations, with particular attention to physicians’ resistance to disclosing their own mistakes to injured patients and their families. The brief essay ‘What Is Meant by “Telling the Truth”?’ and its historical context — Bonhoeffer’s imprisonment and interrogation in 1943 — is proposed as a text for medical ethicists and others seeking to overcome the barrier (...) of the ‘hidden curriculum’ within the culture of medicine, which encourages medical students and physicians to conceal their errors and to fear disclosure. (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)

BackgroundIn this study, medical errors are defined as unintentional patient harm caused by a doctor’s mistake. This topic, due to limited research, is poorly understood in Malaysia. The objective of this study was to determine the proportion of doctors intending to disclose medical errors, and their attitudes/perception pertaining to medical errors.MethodsThis cross-sectional study was conducted at a tertiary public hospital from July- December 2015 among 276 randomly selected doctors. Data was collected using a standardized and validated self-administered questionnaire intending to (...) measure disclosure and attitudes/perceptions. The scale had four vignettes in total two medical and two surgical. Each vignette consisted of five questions and each question measured the disclosure. Disclosure was categorised as “No Disclosure”, “Partial Disclosure” or “Full Disclosure”. Data was keyed in and analysed using STATA v 13.0.ResultsOnly 10.1% intended to disclose medical errors. Most respondents felt that they possessed an attitude/perception of adequately disclosing errors to patients. There was a statistically significant difference when comparing the intention of disclosure with perceived disclosures. Most respondents were in common agreement that disclosing an error would make them less likely to get sued, that minor errors should be reported and that they experienced relief from disclosing errors.ConclusionMost doctors in this study would not disclose medical errors although they perceived that the errors were serious and felt responsible for it. Poor disclosure could be due the fear of litigations and improper mechanisms/procedures available for disclosure. (shrink)

The objective of this research is to investigate the effects of corporate governance scores and environmental, social, and governance scores (ESG) on firms’ cost of capital in emerging countries. The sample consists of 800 firm-year observations collected from Thomson Reuters. We analyze the data using panel-corrected standard errors (PCSE) regressions, which correct for heteroskedasticity issues and contemporaneous errors in the data. When moderated with emerging market variable, our findings indicate that in the financial sector, corporate governance and ESG score is (...) negatively associated with cost of capital. Nonetheless, in the nonfinancial sector, no evidence is found on the effect of corporate governance and ESG on cost of capital. Our findings indicate that emerging countries, different institutional, ownership, and legal structural has an effect on corporate governance and ESG implementation. (shrink)

When a health care professional contacts a health care attorney for advice about how to deal with a medical error involving a patient, what is the most ethically appropriate response? Honesty is the best policy; the ethical health lawyer should advise the client to tell the patient the truth. This advice is neither naïve nor impractical, as we will show. More importantly, it is without question the right thing to do for a number of sound reasons. It may not (...) be a natural inclination or an easy task to accomplish; several countervailing factors discourage health professionals from telling patients the truth about medical errors. However, we will argue that resistance to truthful disclosure can and should be overcome by rational arguments that also take into consideration the psychodynamics of the patient-health professional relationship. (shrink)

Efforts to decrease errors in health care are directed at prevention rather than at managing a situation when a mistake has occurred. Consequently, nurses and other health care providers may not know how to respond properly and may lack sufficient support to make a healthy recovery from the mental anguish and emotional suffering that often accompany making mistakes. This article explores the conceptualization of mistakes and the ethical response to making a mistake. There are three parts to an ethical response (...) to error: disclosure, apology and amends. Honesty and humility are discussed as important virtues that facilitate coping and personal growth for the health care provider who is involved in mistakes. In conclusion, a healthy view of nursing practice and mistake making is one that prevents error but, when prevention is not possible, accepts fallibility as part of the human condition and achieves the best possible outcome for all. (shrink)

Nurses make mistakes in practice despite the culturally based expectation of perfection. Such a disparity between reality and expectation calls members of the profession to question the current attitudes toward mistakes in practice. Two explanatory models of the origin of mistakes are presented. The Perfectibility Model holds that any error or harm is caused by an individual practitioner's lack of knowledge or motivation. The Faulty Systems Model offers a broader explanation of human error. I conclude that a Faulty (...) Systems Model is more comprehensive and more effective for managing mistakes. Integrating the Faulty Systems Model into practice and education can result in more ethically fitting responses to errors and ultimately better outcomes for nurses, institutions and patients. (shrink)

Understanding the impact of robot errors in child-robot-interactions (CRI) is critical, as current technological systems are still limited and may randomly present a variety of mistakes during interactions with children. In this study we manipulate a task-based error of a NAO robot during a semi-autonomous computational thinking task implemented with the Cozmo robot. Data from 72 children aged 7–10 were analysed regarding their attitudes towards NAO (social trust, competency trust, liking, and perceived agency), their behaviour towards the robot (self- (...) class='Hi'>disclosure, following recommendations), as well as their task performance. We did not find quantitative effects of the robot’s error on children’s self-reported attitudes, behaviour, or task performance. Age was also not significantly related to either social attitudes or behaviours towards NAO, although there were some age-related differences in task performance. Potential reasons behind the lack of statistical effects and limitations of the study with regards to the manipulation of robot errors are discussed and insights into the design of future CRI studies provided. (shrink)

Highlights of this edition include: / Important new material addressing federal privacy regulations, disclosure of medical errors, limits on residents'...

This article analyzes the relationship between corporate social responsibility (CSR) decoupling and financial market outcomes. CSR decoupling refers to the gap between CSR disclosure and CSR performance. More specifically, we analyze the effect of CSR decoupling on analysts’ forecast errors, cost of capital, and access to finance. We also examine the moderating effect of forecast errors on relationships between CSR decoupling and cost of capital and access to finance. For a sample of U.S. firms consisting of 7,681 firm-year observations (...) for the period 2006–2015, our empirical evidence supports the idea that a wider gap results in higher analysts’ forecast errors, a greater cost of capital, and reduced access to finance. In addition, our results show that forecast errors enhance the effect of the CSR decoupling on cost of capital and access to financial resources. We also note that external monitoring, in the form of greater analysts’ coverage, reduces CSR decoupling. (shrink)

Health care institutions must decide whether to inform the patient of a medical error. The barriers to disclosure are an aversion to admitting errors, a concern about implicating other practitioners, and a fear of lawsuits and liability. However, admission of medical errors is the ethical thing to do and may be required by law. When examined, the barriers to such disclosures have little merit, and, in fact, lawsuits and liability may actually be reduced by informing the patient of (...) medical errors. Therefore, a health care institution should implement a written policy providing for disclosure of medical errors, using a process such as that outlined in the article. (shrink)

Individuals care about and guard their privacy intensely in many areas. With respect to patient medical records, people are exceedingly concerned about privacy protection, because they recognize that health care generates the most sensitive sorts of personal information. In an age of advancing technology, with the switch from paper medical files to massive computer databases, privacy protection for medical information poses a dramatic challenge. Given high-speed computers and Internet capabilities, as well as other advanced communications technologies, the potential for abuse (...) is much greater than ever before. At every stage in the process of collection and storage, dangers can arise, including entry errors, improper access, exploitation, and unauthorized disclosure. Secondary use and aggregation of data are all far easier, faster, and less expensive, and thus pose additional threats to an individual's control over the disposition of medical information. (shrink)

Summary We offer a novel historical-philosophical framework for discussing experimental practice which we call ‘Generating Experimental Knowledge’. It combines three different perspectives: experimental systems, concept formation, and the pivotal role of error. We then present an historical account of the invention of the Scanning Tunnelling Microscope (STM), or Raster-Tunnelmikroskop, and interpret it within the proposed framework. We show that at the outset of the STM project, Binnig and Rohrer—the inventors of the machine—filed two patent disclosures; the first is dated (...) 22 December 1978 (Switzerland), and the second, two years later, 12 September 1980 (US). By studying closely these patent disclosures, the attempts to realize them, and the subsequent development of the machine, we present, within the framework of generating experimental knowledge, a new account of the invention of the STM. While the realization of the STM was still a long way off, the patent disclosures served as blueprints, marking the changes that had to be introduced on the way from the initial idea to its realization. (shrink)

Anesthesiology training programs are tasked with equipping trainees with the skills to become medically and ethically competent in the practice of anesthesia and to be prepared to obtain board certification, yet there is currently no standardized ethics curriculum within anesthesia training programs in the United States. To bridge this gap, and to provide a validated ethics curriculum to meet the aforementioned needs, in July 2021, a survey was sent to anesthesia scholars in the field of biomedical ethics to identify key (...) areas that should be included in such an ethics curriculum. The responses were rated on a Likert scale and ranked. This paper identifies the top ten topics identified as high priority for inclusion in an anesthesiology training program and consequently deemed most relevant to meet the educational needs of graduates of an anesthesiology residency: (1) capacity to consent; (2) capacity to refuse elective versus lifesaving treatment; (3) application of surrogate decisionmaking; (4) approach to do not resuscitate (DNR) status in the operating room; (5) patient autonomy and advance directives; (6) navigating patient beliefs that may impair care; (7) “futility” in end-of-life care: when to withdraw life support; (8) disclosure of medical errors; (9) clinical criteria for “brain death” and consequences of this definition; and (10) the impaired anesthesiologist. (shrink)

Zealous nudging can deteriorate into paternalistic bullshitting. To the extent that William Simkulet’s paper is a reminder against that danger, it does us good service.1 Simkulet, however, makes the far bolder claims that nudging just is bullshitting and that—since bullshitting deviates from truthfulness, and truthful disclosure is essential for valid consent—nudging invalidates informed consent. These bolder claims involve a set of errors. The problem starts with Simkulet’s formal definition of ‘bullshit’, which says that conveying x while intending one’s audience (...) to believe y is sufficient for bullshit. This, however, is not true since the bullshitter’s not caring whether x is true is constitutive of bullshitting, and hence a necessary condition. Why, we then ask, must such lack of care be the case with the doctor who nudges? It is at least prima facie easy and intuitive to think of scenarios in which the ethical doctor is staunchly committed to telling the truth while simultaneously acting on additional motives regarding the expected effects of what is said. If the doctor cares about saying only truths, he is not a bullshitter. Having communicative motivations that transcend the trivial motive of transmitting the truth of the literal content of what is said is normal and indeed normative in conversations of regular people.2 …. (shrink)

The practice of evidence based medicine has changed the role of the physician from information dispenser to gatherer and analyser. Studies and controlled trials that may contain unknown errors, or uncertainties, are the primary sources for evidence based decisions in medicine. These sources may be corrupted by a number of means, such as inaccurate statistical analysis, statistical manipulation, population bias, or relevance to the patient in question. Regardless of whether any of these inaccuracies are apparent, the uncertainty of their presence (...) in physician information should be disclosed to the patient. These uncertainties are not, however, shared by physicians with patients, and have caused a direct increase in patient responsibilities and mistrust. Only when disclosure of uncertainty becomes commonplace in medical practice will the physician/patient relationship evolve to a level of greater understanding and satisfaction for both the physician and patient. (shrink)