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)

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)

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)

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.

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)

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)

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)

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)

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.

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)

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)

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)

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)

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)

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)

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)

Health-care provider liability has again taken center stage in American political debate, but with an ironic twist. In the seventies, physicians wanted tort reform, but they measured such reform solely by a reduction in both the risk of being sued and the size of any judgment a plaintiff could win. Malpractice reforms in many states in the seventies therefore capped damages, reduced contingency awards to lawyers, and restricted other tort rules to limit plaintiff success. Today physicians are conflicted. They want (...) an increase in liability exposure — not for themselves, but for managed care plans. We have therefore ended up with a series of overlapping debates, with the same debaters taking contradictory positions. Should managed care organizations—until now protected by ERISA preemption from liability—be liable? Physicians say yes. But should physicians be protected from the threat of suit, which they argue acts as an in terrorem device that drives disclosure of medical errors into hiding? (shrink)

Health-care provider liability has again taken center stage in American political debate, but with an ironic twist. In the seventies, physicians wanted tort reform, but they measured such reform solely by a reduction in both the risk of being sued and the size of any judgment a plaintiff could win. Malpractice reforms in many states in the seventies therefore capped damages, reduced contingency awards to lawyers, and restricted other tort rules to limit plaintiff success. Today physicians are conflicted. They want (...) an increase in liability exposure — not for themselves, but for managed care plans. We have therefore ended up with a series of overlapping debates, with the same debaters taking contradictory positions. Should managed care organizations—until now protected by ERISA preemption from liability—be liable? Physicians say yes. But should physicians be protected from the threat of suit, which they argue acts as an in terrorem device that drives disclosure of medical errors into hiding? (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.2 (2001) 115-116 [Access article in PDF] The Ethics of Medical Mistakes: Historical, Legal, and Institutional Perspectives Introduction In late 1999, the Institute of Medicine (IOM) released its report on medical errors, To Err is Human: Building a Safer Health System. The report estimated almost 50,000 deaths per year nationally due to medical mistakes, making it a leading cause of death. (...) IOM speculated that more than half of the deaths related to medical error are preventable. The IOM report shocked the public and medical professionals alike, sparking a national discussion of how to make the health care system safer. This multifaceted issue has profound implications for all aspects of health care, from the very personal--e.g., the relationship of caregiver and patient--to the societal--e.g., a nation's responsibility to its citizens.On 15 May 2000, the University of Pittsburgh Medical Center hosted an ethics conference devoted to the topic of medical mistakes. The goal was to bring together experts from various disciplines, before an audience of both providers and patients, to discuss medical mistakes and their implications. In this issue of the Kennedy Institute of Ethics Journal, we present selected papers resulting from that conference. These papers reflect not only the original oral presentations, but also much of the discussion those presentations generated. Three key perspectives on the ethics of medical mistakes are offered: historical, legal, and institutional.Rosa Lynn Pinkus offers a revealing historical perspective on the ethics of medical mistakes. In analyzing the history of mistake reporting in neurosurgery, she shows how the notion of a mistake developed only as the notion of a standard of practice emerged. Although much of managed care is directed toward systematically fostering a standard of care, this pursuit is relatively new in health care. One might speculate that as more standards are created, mistakes--defined as deviations from standard practice--must increase. If deviation from standard practice is overly castigated, however, then needed innovation in practice may be stifled. Interestingly, as Pinkus discusses, medical malpractice suits quickly followed the emergence of practice standards, driving the initial open reporting of mistakes underground. [End Page 115]Taking up the issue of medical malpractice, Thomas May and Mark Aulisio consider the ramifications of the current malpractice system for mistake prevention. The current system, they argue, while failing to adequately achieve its purported goals of deterring medical mistakes and compensating victims, itself creates a climate that deters the open reporting of mistakes by engendering fear and shame in clinicians. According to May and Aulisio, this failure to report medical mistakes openly has serious ramifications. Chief among these is the inability to do root cause analysis of mistakes, and then, where possible, to implement safeguards to minimize the occurrence of future mistakes. Ultimately, both the prevention of medical mistakes and the goals of malpractice litigation itself will be better served if substantial malpractice reform is undertaken.Andy Thurman argues that even in the current climate institutions ought to have a policy (and practice) of admitting to and openly reporting medical mistakes. Thurman argues that doing so not only is the right thing to do, but is also in the interest of institutions. Interestingly, he contends that failing to admit and openly report mistakes is both at odds with the mission of health care institutions and puts them at higher risk of litigation, and liability. In light of this, Thurman then suggests an institutional process for handling medical mistakes.Michael DeVita concedes that disclosing mistakes is widely supported by the health professionals' principles of ethics, but argues that there are a number of factors that conspire to make doing so a very difficult task. In analyzing an index case, DeVita contends that platitudes about being honest are not nearly enough to foster honest behavior and that policies that offer specific guidance on handling unfavorable events are needed in health care institutions.Finally, we conclude with the policy on disclosure of unfavorable events (this terminology is chosen because it includes both iatrogenic and natural diseases and conditions) that resulted from... (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)

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)

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)

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)

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 (...) class='Hi'>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)

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)

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

In this chapter I explicate and evaluate the concept of medical error. Unlike standard philosophical approaches to analyzing medical phenom- ena in the abstract, I instead address medical error specifi cally within the context of an embodied social world. I illustrate how, as a deeply contex- tual concept, medical error is inextricably tied to the social conditions— and concrete, powerful interests—of the particulars in which it is found. -/- I begin with an analysis (...) that demonstrates the relational quality of medi- cal error, as a functional, outcome-oriented concept, evaluating the origin and context of the term’s emergence, and connecting it to a similarly contextual concept, “standard of care.” I move on to note the concern- ing implications of medical error identifi cation and measurement when viewed through an intersectional standpoint. To do so, I discuss what intersectional approaches can help reveal about our contemporary social world of medicine and public health. Intersectional approaches, as I will explain, focus on how intersections of social identity can unmask social structures that negatively impact groups and individuals. It appears, as -/- I will suggest, that disparities in social goods (e.g., social standing, edu- cation, wealth) complicate our identification of medical error, itself, and compound concerns of equity and access to medical goods for those who have diminished expectations for health. (shrink)

Kwaku Marfo, Danielle Garcia, Saira Khalique, Karen Berger, Amy LuMontefiore Medical Center, Bronx, NY, USABackground: Medication errors are a prime concern for all in healthcare. As such the use of information technologies in drug prescribing and administration has received considerable attention in recent years, with the hope of improving patient safety. Because of the complexity of drug regimens in renal transplant patients, occurrence of medication errors is inevitable even with a well adopted computerized physician order entering system. Our objective (...) was to quantify medication error type and frequency in an inpatient renal transplant unit.Methods: Systemic evaluation of all medication errors during an initial 10-day audit and a 28-day follow-up audit in an inpatient renal transplant unit. Each error was concurrently evaluated for potential to result in adverse patient consequences, error type and associated medication class.Results: A total of 103 clinically significant medication errors were detected during the 10-day and 28-day audit time periods. The most common errors were wrong medication dose ordered and wrong time of drug administration. Thirty-six out of 66 prescribing/ordering errors reached the patient.Conclusions: Even with utilization of computerized physician order entry system in an inpatient renal transplant unit, post-kidney transplant patients are at risk for adverse outcomes due to medication errors. The risk factors may be multifactorial and will require both organizational and technical approaches to resolve.Keywords: medication errors, CPOE, inpatient, renal transplant patients. (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)

This paper argues that epistemic errors rooted in group- or identity- based biases, especially those pertaining to disability, are undertheorized in the literature on medical error. After sketching dominant taxonomies of medical error, we turn to the field of social epistemology to understand the role that epistemic schemas play in contributing to medical errors that disproportionately affect patients from marginalized social groups. We examine the effects of this unequal distribution through a detailed case study of (...) ableism. There are four primary mechanisms through which the epistemic schema of ableism distorts communication between nondisabled physicians and disabled patients: testimonial injustice, epistemic overconfidence, epistemic erasure, and epistemic derailing. Measures against epistemic injustices in general and against schema-based medical errors in particular are ultimately issues of justice that must be better addressed at all levels of health care practice. (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)

Errors have been the concern of providers and consumers of health care services. However, consumers' perception of medical errors in developing countries is rarely explored. The aim of this study is to assess community members' perceptions about medical errors and to analyse the factors affecting this perception in one Middle East country, Oman.

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

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

Medical ethics is a realm where four important subjects of philosophy, medicine, theology and law are covered. Physicians and philosophers cooperation in this area will have great efficiency in the respective ethical rules formation. In addition to respect the autonomy of the patient, physician's obligation is to ensure that the medical intervention has benefit for the patient and the harm is minimal. There is an obvious conflict between duty of confidentiality and duty of mandatory reporting. Professional confidentiality is (...) one of the basic components in building a constant physician-patient relationship which nowadays, beside the novelty, it is the subject of discussion. Legal obligation of confidentiality is not absolute. In physician-patient relationship, keeping patient's secrets and maintaining confidentiality is a legal and ethical duty, and disclosure of such secrets is mainly through specific statutes. Thus, there are a number of situations where breach of confidentiality is permitted in different legal systems. One of the situations where breaching confidentiality is permitted is the medical mandatory reporting to the relevant authority which is in accordance with many countries' legal systems. Some situations are considered in many countries legal systems' such as notification of births and deaths, infectious diseases, child abuse, sport and relevant events, medical errors, drug side effects and dangerous pregnancies. In this paper, we will examine and discuss medical mandatory reporting and its ethical and legal aspects in the judicial and legal system of Iran and few other countries. Finally we will suggest making Medical Mandatory Reporting Law in Iran. (shrink)

Medical error is a leading problem of health care in the United States. Each year, more patients die as a result of medical mistakes than are killed by motor vehicle accidents, breast cancer, or AIDS. While most government and regulatory efforts are directed toward reducing and preventing errors, the actions that should follow the injury or death of a patient are still hotly debated. According to Nancy Berlinger, conversations on patient safety are missing several important components: religious (...) voices, traditions, and models. In After Harm, Berlinger draws on sources in theology, ethics, religion, and culture to create a practical and comprehensive approach to addressing the needs of patients, families, and clinicians affected by medical error. She emphasizes the importance of acknowledging fallibility, telling the truth, confronting feelings of guilt and shame, and providing just compensation. After Harm adds important human dimensions to an issue that has profound consequences for patients and health care providers. (shrink)

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)

In the mid-nineteenth century, healthcare delivery began transitioning from an individual, private payment model to a third-party payment model, dominated by the insurance industry. During the same time, productivity shifted from a transformational model, centered on the provider-patient relationship, to a transactional model, based on the distribution of services. The emergence of medical insurance and other third-party payers removed providers and patients from discussions about treatment plans, payment, and risk. This resulted in a weakening, if not fracturing, of the (...) provider-patient relationship. All healthcare providers enter their profession to care for people, yet what has most frequently been lost in the transformed relationship over the past century is context, communication, and trust—all elements of a relational ethic, or what ethicist and psychologist Carol Gilligan first described as, “the ethics of care.” This loss of relationality has led to a model of healthcare delivery that is fractured, isolated, and uncoordinated, with an epidemic of medical errors that by some estimates results in the death of approximately 400,000 individuals per year. Thus far, isolated foci on patient quality, outcomes, and safety have been feckless and unimpressive. However, new advanced payment models, such as value-based purchasing and patient-centered medical homes, have the potential to reduce medical error by addressing its root cause. In linking payment to factors such as context, communication, and trust, they bring relationality back into the healthcare system. This essay traces the historic devolution of the provider-patient relationship and the promise of new payment models to restore it. (shrink)

Hastings Center Report, Volume 52, Issue 1, Page 12-14, January/February 2022.

This paper addresses the concept of moral luck. Moral luck is discussed in the context of medical error, especially an error of omission that occurs frequently, but only rarely has adverse consequences. As an example, a failure to compare the label on a syringe with the drug chart results in the wrong medication being administered and the patient dies. However, this error may have previously occurred many times with no tragic consequences. Discussions on moral luck can (...) highlight conflicting intuitions. Should perpetrators receive a harsher punishment because of an adverse outcome, or should they be dealt with in the same way as colleagues who have acted similarly, but with no adverse effects? An additional element to the discussion, specifically with medical errors, is that according to the evidence currently available, punishing individual practitioners does not seem to be effective in preventing future errors. The following discussion, using relevant philosophical and empirical evidence, posits a possible solution for the moral luck conundrum in the context of medical error: namely, making a distinction between the duty to make amends and assigning blame. Blame should be assigned on the basis of actual behavior, while the duty to make amends is dependent on the outcome. (shrink)

This essay reviews and defines avoidable medical error, malpractice and complication. The relevant ethical principles pertaining to unanticipated medical outcomes are identified. In light of these principles I critically review the moral culpability of the agents in each circumstance and the resulting obligations to patients, their families, and the health care system in general. While I touch on some legal implications, a full discussion of legal obligations and liability issues is beyond the scope of this paper.

This special issue on ethics and error in medicine reinvigorates a conversation that has been substantially dormant for twenty years. The papers in this issue elaborate and update that conversation in significant ways, particularly with regard to vulnerable populations and the epistemology of medical error. But this first paper is largely conceptual, laying out the motivation for caring about medical error in the first place, exploring what medical error is, and proposing a moral (...) framework to help us think about it. This paper therefore sets up those that follow—while, at the same time, remaining largely neutral about the substantive views advanced by those authors. The papers are therefore complementary and form a... (shrink)