Medicine and Society
Nov 2020

What Is Ethically Informed Risk Management?

Alan J. Card, PhD, MPH, CPHQ, CPHRM
AMA J Ethics. 2020;22(11):E965-975. doi: 10.1001/amajethics.2020.965.

Abstract

Ethically informed risk management includes both the management of ethical risks and the ethical management of risks (professional ethics). This article aims to rekindle dormant discussion of professional ethics in health care risk management. It frames ethically informed risk management as a patient-centered and evidence-based practice, aligns its scope with that of biomedical ethics, and proposes specific ethical duties to guide risk management practice. It provides a starting point for more robust debate and the development of ethical standards for health care risk managers.

Introduction

There are 2 key avenues for applying ethical reasoning in health care risk management: the management of ethical risk and the ethical management of risk. The management of ethical risks (eg, related to advance directives, disclosure of accidental harm) has been the focus of significant attention in the risk management literature.1,2,3,4,5,6,7,8 The ethical management of risk (ie, professional ethics in risk management) has not been entirely ignored (see especially Kapp9) but has received far less attention and rarely appears to be a primary focus of ethical analysis.

The field of health care risk management has 3 foci, each of which has clear—and sometimes conflicting—ethical implications. It began as an insurance-focused response to the malpractice crisis of the 1970s and soon evolved to include legal and regulatory compliance. By the mid-1980s, its focus had expanded to include tackling clinical and patient safety risks through systems improvement.10 Outside the health care context, these 3 functions—risk finance, legal and regulatory compliance, and safety improvement—arose from very different traditions, each with its own ethos, praxis, and literature.11,12,13 Health care risk management encompasses the 3 in a single chimeric profession.14

Among risk managers, only attorneys have the benefit of a widely accepted code of ethics.15 Neither the strictures nor the freedoms (within those strictures) of legal ethics apply to the rest of the risk management community, however, and while the American Society for Healthcare Risk Management briefly promoted a code of ethics for all risk managers,16 it no longer does.

I will therefore focus on nonattorney risk managers. These professionals face significant moral dilemmas in the course of their work and would probably benefit from a code of professional ethics that speaks to their concerns in a relevant and principled way. In part, such a code would help provide clarity in sticky ethical situations, but, perhaps more consequentially, it would provide a potent defense against pressure (from administrators, clinicians, or even patients) to take unethical actions.17,18 If such a code of ethics were adopted, then—to paraphrase Latham18—when you hired a risk manager, you would get the code. It would serve as a de facto part of the employment contract, delineating the scope of action that risk managers would—and would not—take.18

It is not possible to construct a code of professional ethics from whole cloth in an article of this length, nor is it a task for a single author. I hope, however, to help begin a conversation about which ethical principles ought to guide an ethical code for health care risk management. 

Purposes of Risk Management

On the face of it, risk managers pursue 2 different and sometimes conflicting goals: protecting patients and protecting the health care organization. Tracing the history of health care risk management, one could argue that the driving force behind the emergence of the profession was the need to protect health care organizations from legal liability.10 As usual, the truth is more complicated, and the rationale for a profession’s birth does not necessarily paint a clear picture of its later life.18 Even accepting this premise, however, the need to protect health care organizations would still be just the starting point for analyzing the ethical basis of risk management practice. There are 2 key questions: What socially and ethically desirable purpose is served by protecting the organization? And what does this imply about the ethical duties of a risk manager? It is not enough to say, “My ethical duty is to perform the job I’m paid to do”; the ends served by that work must, themselves, be ethically sound (eg, managing risk for a violent criminal enterprise is unethical because of the organization’s role in society).

What, then, is the socially and ethically desirable purpose that is served by protecting a health care organization? It is to serve the mission of health care: to improve the health (or at least the health trajectories) of patients.19 Health care organizations also do other things, of course; some are organized to make a profit, and all serve an important role as employers. But those facts are also true of ice cream shops. The special privileges of health care organizations, which allow them to tinker with the mechanics of life itself, are given to them by society because these organizations provide care to improve health.

Thus, to the extent that health care risk management exists to protect health care organizations, it does so in service of a mission to promote and protect patients’ health. Risk managers accomplish this mission both directly (eg, through patient safety improvement) and indirectly, by protecting the organization’s financial and operational ability to deliver on its mission(eg, loss prevention).20 The patient-centered outlook derived from the health care mission should be a foundational principle of professional ethics for nonattorney risk managers.

Another purpose of risk managers as risk managers is to deliver excellence and effectiveness in the management of risk. Health care organizations pursue their mission primarily by delivering clinical care; they could as easily employ another clinician rather than a risk manager. To justify that opportunity cost, risk managers must ensure that they deliver the greatest practicable value through their work. Achieving this goal calls for practice that is evidence-based21 and constantly advancing rather than benchmark-based and complacent in the status quo. It also calls for making the most of the unique and specialized skills that the risk management profession brings to the table: systemic risk assessment and participatory systems design. Risk managers should, to the best of their ability, spend their time actually managing risks rather than simply collecting, categorizing, and communicating those risks. By themselves, these activities do nothing to protect the health and safety of patients. It is only by informing the design, implementation, and sustainability of effective solutions that they have any impact on outcomes.

Ethically Informed Risk Management

Here, I propose specific principles that might inform professional ethics in health care risk management. They are not intended as the elucidation of any grand moral theory but rather as the starting point for developing a “practice model”22 for ethical, patient-centered practice in health care risk management and as a public profession of the standards to which that practice should be held.

I begin by applying to risk management the 4 principles of Beauchamp and Childress,23 which play a prominent role in contemporary clinical ethics (see Table).24,25 Aligning the principles of risk management ethics with those most often referenced by clinicians creates a shared ethical vocabulary and helps establish the legitimacy of the broader suite of principles among patients and other stakeholders.

Table. The 4 Principles23 Applied to Risk Management
Principle Definition Application in Risk Management
Beneficence The obligation to provide benefits, prevent harm, and balance benefits against the risk of harm Address not only physical and economic benefits or harms, but all other harms, including psychological harm and avoidable suffering.26,27,28,29
Nonmaleficence The obligation to avoid actively causing harm (“first do no harm”), as opposed to the broader obligation to prevent harm from being caused Apart from disclosure/apology and compensation programs,27,30,31 current literature provides scant support for assessing how risk management practice can inflict (or avoid inflicting) harm.
Justice An obligation to pursue the fair allocation of benefits, risks, and costs according to morally relevant criteria
  • Concerns about distributive justice underlie recognition of inequities in patient safety and quality of care32,33,34,35,36,37,38,39,40,41 and apportionment of blamewhen an adverse event occurs.42,43,44
  • Concerns about procedural justice have been addressed through the just culture45,46 approach, in which staff are not blamed for problems attributable to their work systems.
  • Concerns about restorative justice underlie disclosure/apology and compensation programs.27,30,31

Respect for
Autonomy

 A duty to (1) refrain from attempting to control and constrain the autonomous actions of others and (2) actively support autonomous decision making, especially by disclosing relevant information. Risk management literature addresses support for clinicians and health care organizations in deciding how heavily to weigh patient autonomy in health care decision making.3,5,9 For risk managers, respect for autonomy also pertains to interactions with the health care workforce, which has received far less attention.

These 4 principles represent prima facie duties, which means they are binding obligations except when they conflict with one another—in which case, a balance must be struck between them (eg, balancing beneficence and autonomy in the case of a minor who requires a blood transfusion that is proscribed by the parents’ religion). Unfortunately, there is no checklist or algorithm to ensure the “right” balance is struck. If all ethical duties cannot be perfectly satisfied, the risk manager must attempt to find a solution that best satisfices47 (sufficiently satisfies) those requirements in context.

Additional Principles

In the context of biomedical ethics, Beauchamp and Childress argue that the 4 principles (along with a few simple rules, such as truth telling) are a sufficient basis for moral reasoning.23 Even within the systems-focused realm of health care risk management, one could probably use these principles to infer and justify each of the additional principles I will discuss below. In the context of supporting a practice model for risk management ethics, however, it is probably worth highlighting these more specific duties. The principles below are proposed as a supplementary set of prima facie obligations, with the aim of specifying key aspects of the 4 principles to better develop what Beauchamp would call the particular professional morality of health care risk management.48

Patient-centered practice. As I argued earlier, the ethical duties of risk managers ultimately rest upon the foundation of the health care mission: to improve the health trajectories of patients. Everything else flows from this mission. Because risk managers’ scope of practice encompasses the systems level and not just dyadic interactions, patient-centered practice includes respect for the needs of patients in the aggregate (ie, the population of patients served by the organization’s mission) as well as the particular patients and families involved in any given situation. Similarly, because risk managers sit at the intersection of clinicians, administrators, patients, and families, they owe ethical duties to all of these stakeholders. The principle of patient-centered practice offers important guidance on how risk managers should uphold respect for autonomy, beneficence, justice, and nonmaleficence by explicitly privileging their ethical duties to patients.

Participatory design. Risk management is, at its heart, a design discipline. Its purpose is to design (or redesign) systems to reduce negative risk and leverage positive risk (ie, potential opportunities) in the service of the health care mission. Current practice focuses primarily on risk assessment (problem exploration), leaving risk control (the design of interventions to improve outcomes) as an afterthought. This oversight leads to predictable and—given the alternatives—frankly unethical failures of the risk management process, especially with regard to patient safety risks.49,50,51,52,53,54,55,56,57,58 Because health care organizations are complex adaptive systems characterized by what Plsek and Greenhalgh refer to as “individual agents with freedom to act in ways that are not always totally predictable, and whose actions are interconnected so that one agent’s actions changes the context for other agents,”59 the intervention design process can only hope to be safe and effective if it is informed by stakeholder participation (including that of patients60 as well as staff).

What, then, is the socially and ethically desirable purpose that is served by protecting a health care organization? 

In addition to ethical motivations related to outputs and outcomes, participatory design (or co-design or co-production) is also motivated by the ethical implications of design as a process (eg, procedural justice and respect for autonomy).61,62,63,64,65 As Robertson and Wagner state: “Perhaps the core principle of Participatory Design is that people have a basic right to make decisions about how they do their work and indeed any other activities where they might use [the products of design].”65 In health care risk management, self-determination implies a need to include the voices of patients and families who have historically been excluded from the design process60 and also to genuinely engage with staff in the design—not just the implementation—of interventions.

Competence, diligence, and evidence-based practice. Risk managers have an ethical obligation not only to do good, but also to do good well. Failures of competence and diligence have real impacts on the health care mission that, at a minimum, have implications for justice, beneficence, and nonmaleficence. Health care risk management practice has been built primarily on good intentions, expert opinion, and (often underexamined) consensus standards of practice rather than on evidence58—a foundation for practice that is no longer seen as morally acceptable in other areas of health care.66

To meet their obligations under this principle, risk managers must move toward a practice based on evidence and excellence. Examples of practice changes that might support this principle include adopting evidence-based approaches for risk control,50,51,57,58,67,68 adopting proactive disclosure and settlement, and reducing or deimplementing69,70 practices that have not proven effective, such as overuse of retrospective risk assessment at the expense of prospective risk assessment54,71,72,73,74 or excessive focus on categorizing and reporting risks in ways that do not inform action.75,76,77,78

Respect for privacy. Respect for privacy is well-integrated into risk management practice—so much so that the code of silence can cause risk managers harm.29 This principle remains worth mentioning, however, because it is important to public acceptance of risk management and because risk managers should be reminded to consider risks to patient privacy when new sources of risk (eg, emerging technologies)79,80,81 present themselves.

Equity. Equity is clearly implied by the principle of justice, but pervasive inequities in the distribution of patient safety risks, benefits of improvement initiatives,32,33,34,35,36,37,38,39,40,41 and the burden of blame in safety investigations (eg, preferentially blaming lower-status members of the clinical team)42,43,44 warrant the recognition of a stand-alone principle.

Honesty and transparency. Finally, risk managers should aim for the highest practicable level of honesty and transparency. Although a duty of honesty is likely to be noncontroversial, the loss-prevention aim of risk management might cause some to balk at a duty of transparency due to a belief that disclosing patient harm or ongoing risks (whether to patients or staff) might cause harm to the organization. Nevertheless, respect for autonomy (of both patients and health care workers) dictates that risk managers enable informed decision making by being transparent about risks and actual harms. Fortunately, these 2 aims—honesty and transparency, on one hand, and loss prevention, on the other—are not necessarily at odds, as demonstrated by the industry’s experience with programs aimed at proactively disclosing and apologizing for adverse events and offering compensation to those affected.7,30,60,82,83,84

Conclusion

The practice of health care risk management is a constant exercise in balancing ethical duties and their conflicts. Currently, risk managers face these dilemmas alone, without the support of an agreed-upon set of ethical principles, much less a formal code of ethics. This circumstance might make risk managers less effective in defending ethical decisions, which not only impairs their ability to support the health care mission but also can lead to a sense of futility and ethical failure.29 This paper does not attempt to develop a formal code of ethics, but it does propose an ethical foundation for risk management practice and hopefully will rekindle the discussion of what constitutes ethically informed risk management.

Read More

References

  1. Banja JD. Disclosing medical error: how much to tell? J Healthc Risk Manag. 2003;23(1):11-14.

    View Article PubMed Google Scholar
  2. Banja J, Sumler M. Overriding advance directives: a 20-year legal and ethical overview. J Health Care Risk Manag. 2019;39(2):11-18.
    View Article PubMed Google Scholar

  3. Helm H, Hyatt J, Sine DM. Risk management and the transgender hospital admission. PSQH. November 14, 2019. https://www.psqh.com/analysis/risk-management-and-the-transgender-hospital-admission/. Accessed May 20, 2020.

  4. Hyatt J. Maintaining the privacy of a minor’s sexual orientation and gender identity in the medical environment. J Healthc Risk Manag. 2015;35(1):31-36.
    View Article PubMed Google Scholar
  5. Sine D, Sharpe V. Ethics, risk, and patient-centered care: how collaboration between clinical ethicists and risk management leads to respectful patient care. J Healthc Risk Manag. 2011;31(1):32-37.
    View Article PubMed Google Scholar
  6. Swisher KN. Developing an ethical model for risk management. Perspect Healthc Risk Manage. 1991;11(4):11-18.
    View Article PubMed Google Scholar
  7. Wolk SW, Sine DM, Paull DE. Institutional disclosure: promise and problems. J Healthc Risk Manag. 2014;33(3):24-32.
    View Article PubMed Google Scholar

  8. Youngberg BJ, ed. Principles of Risk Management and Patient Safety. Sudbury, MA: Jones & Bartlett Learning; 2011.

    Google Scholar

  9. Kapp MB. Are risk management and health care ethics compatible? J Healthc Risk Manag. 1991;11(1):2-7.

    View Article PubMed Google Scholar
  10. Kuhn AM, Youngberg BJ. The need for risk management to evolve to assure a culture of safety. Qual Saf Healthc. 2002;11(2):158-162.
    View Article PubMed Google Scholar
  11. Sims JW. American law of maritime personal injury and death: an historical review. Tulane Law Rev. 1980;55(4):973-1009.
    Google Scholar
  12. Wang J. Maritime risk assessment and its current status. Qual Reliab Eng Int. 2006;22(1):3-19.
    View Article Google Scholar
  13. Herschaft JA. Not your average coffee shop: Lloyd’s of London—a twenty-first-century primer on the history, structure, and future of the backbone of marine insurance. Tulane Marit Law J. 2005;29(2):169-185.
    Google Scholar

  14. American Hospital Association Certification Center. Certified professional in healthcare risk management candidate handbook and application. https://documents.goamp.com/Publications/candidateHandbooks/AHA-CPHRM-handbook.pdf. Effective June 2017. Accessed September 17, 2020.

  15. Bennett EJ, Gunnarsson HW; American Bar Association. Annotated Model Rules of Professional Conduct. 9th ed. Chicago, IL: ABA Book Publishing; 2019.

  16. American Society for Healthcare Risk Management. ASHRM code of ethics. Perspect Healthc Risk Manage. 2009;11(4):38-38.
  17. Kipnis K. The elements of code development. Am J Bioeth. 2005;5(5):48-50.
    View Article PubMed Google Scholar
  18. Latham SR. The (low) life of ethics codes. Am J Bioeth. 2005;5(5):46-48.
    View Article PubMed Google Scholar
  19. Card AJ. Moving beyond the WHO definition of health: a new perspective for an aging world and the emerging era of value-based care. World Med Health Policy. 2017;9(1):127-137.
    View Article Google Scholar
  20. Card AJ. The underlying narrative of risk management. J Healthc Risk Manag. 2017;37(2):6-7.
    View Article PubMed Google Scholar
  21. Card AJ, Ward JR, Clarkson PJ. Getting to zero: evidence-based healthcare risk management is key. J Healthc Risk Manag. 2012;32(2):20-27.
    View Article PubMed Google Scholar

  22. Wood BL. Biopsychosocial. In: L’Abate L, ed. Paradigms in Theory Construction. New York, NY: Springer Science+Business Media; 2012:31-66.

    Google Scholar

  23. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 3rd ed. Oxford, UK: Oxford University Press; 1989.

    Google Scholar
  24. Gillon R. Medical ethics: four principles plus attention to scope. BMJ. 1994;309(6948):184-188.
    View Article PubMed Google Scholar

  25. Schöne-Seifert B. Danger and merits of principilism: meta-theoretical reflections on the Beauchamp/Childress-approach to biomedical ethics. In: Rehmann-Sutter C, Düwell M, Mieth D, eds. Bioethics in Cultural Contexts: Reflections on Methods and Finitude. Dordrecht, The Netherlands: Springer; 2006:109-119.

    Google Scholar
  26. Card AJ, Klein VR. A new frontier in healthcare risk management: working to reduce avoidable patient suffering. J Healthc Risk Manag. 2016;35(3):31-37.
    View Article PubMed Google Scholar
  27. Bell SK, Etchegaray JM, Gaufberg E, et al. A multi-stakeholder consensus-driven research agenda for better understanding and supporting the emotional impact of harmful events on patients and families. Jt Comm J Qual Patient Saf. 2018;44(7):424-435.
    View Article PubMed Google Scholar
  28. Card AJ. Physician burnout: resilience training is only part of the solution. Ann Fam Med. 2018;16(3):267-270.
    View Article PubMed Google Scholar
  29. Holden J, Card AJ. Patient safety professionals as the third victims of adverse events. J Patient Saf Risk Manag. 2019;24(4):166-176.
    View Article Google Scholar
  30. Kachalia A, Sands K, Van Niel M, et al. Effects of a communication-and-resolution program on hospitals’ malpractice claims and costs. Health Aff (Millwood). 2018;37(11):1836-1844.
    View Article PubMed Google Scholar
  31. Wojcieszak D, Banja J, Houk C. The Sorry Works! Coalition: making the case for full disclosure. Jt Comm J Qual Patient Saf. 2006;32(6):344-350.
    View Article PubMed Google Scholar
  32. Diamantidis CJ, Seliger SL, Zhan M, et al. A varying patient safety profile between black and nonblack adults with decreased estimated GFR. Am J Kidney Dis. 2012;60(1):47-53.
    View Article PubMed Google Scholar
  33. de Bruijne MC, van Rosse F, Uiters E, et al. Ethnic variations in unplanned readmissions and excess length of hospital stay: a nationwide record-linked cohort study.  Eur J Public Health. 2013;23(6):964-971.
    View Article PubMed Google Scholar

  34. Fiscella K, Sanders MR. Racial and ethnic disparities in the quality of health care. Annu Rev Public Health. 2016;37:375-394.

    View Article PubMed Google Scholar
  35. Swietek KE, Gaynes BN, Jackson GL, Weinberger M, Domino ME. Effect of the patient-centered medical home on racial disparities in quality of care. J Gen Intern Med. 2020;35(8):2304-2313.
    View Article PubMed Google Scholar

  36. Agency for Healthcare Research and Quality. 2018 National Healthcare Quality and Disparities Report. Rockville, MD: Agency for Healthcare Research and Quality; 2019. AHRQ publication 19-0070-EF. https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2018qdr-final.pdf. Accessed September 17, 2020.

  37. Brooks Carthon JM, Jarrín O, Sloane D, Kutney-Lee A. Variations in postoperative complications according to race, ethnicity, and sex in older adults. J Am Geriatr Soc. 2013;61(9):1499-1507.
    View Article PubMed Google Scholar
  38. Tsai CL, Sullivan AF, Gordon JA, et al. Racial/ethnic differences in emergency care for joint dislocation in 53 US EDs. Am J Emerg Med. 2012;30(9):1970-1980.
    View Article PubMed Google Scholar
  39. Jiang HJ, Andrews R, Stryer D, Friedman B. Racial/ethnic disparities in potentially preventable readmissions: the case of diabetes. Am J Public Health. 2005;95(9):1561-1567.
    View Article PubMed Google Scholar
  40. Main EK, Markow C, Gould J. Addressing maternal mortality and morbidity in California through public-private partnerships. Health Aff (Millwood). 2018;37(9):1484-1493.
    View Article PubMed Google Scholar
  41. Konetzka RT, Grabowski DC, Perraillon MC, Werner RM. Nursing home 5-star rating system exacerbates disparities in quality, by payer source. Health Aff (Millwood). 2015;34(5):819-827.
    View Article PubMed Google Scholar

  42. Wise J. Survey of UK doctors highlights blame culture within the NHS. BMJ. 2018;362:k4001.

    View Article PubMed Google Scholar

  43. Winning J. Learning to think-with: feminist epistemology and the practice-based medical humanities. Fem Encount. 2018;2(2):20.

    View Article Google Scholar

  44. Palmieri PA, Peterson LT. Attribution Theory and Healthcare Culture: Translational Management Science Contributes a Framework to Identify the Etiology of Punitive Clinical Environments. London, UK: Elsevier; 2009.

    Google Scholar
  45. Reason J. Achieving a safe culture: theory and practice. Work Stress. 1998;12(3):293-306.
    View Article Google Scholar
  46. Wachter RM, Pronovost PJ. Balancing “no blame” with accountability in patient safety. New Engl J Med. 2009;361(14):1401-1406.
    View Article PubMed Google Scholar

  47. Simon HA. The Sciences of the Artificial. 3rd ed. Cambridge, MA: MIT Press; 1996.

    Google Scholar
  48. Beauchamp TL. A defense of the common morality. Kennedy Inst Ethics J. 0003;13(3):259-274.
    View Article PubMed Google Scholar
  49. Card AJ, Ward J, Clarkson PJ. Successful risk assessment may not always lead to successful risk control: a systematic literature review of risk control after root cause analysis. J Healthc Risk Manag. 2012;31(3):6-12.
    View Article PubMed Google Scholar
  50. Card AJ, Simsekler MCE, Clark M, Ward JR, Clarkson PJ. Use of the Generating Options for Active Risk Control (GO-ARC) Technique can lead to more robust risk control options. Int J Risk Saf Med. 2014;26(4):199-211.
    View Article PubMed Google Scholar
  51. Card AJ, Ward JR, Clarkson PJ. Rebalancing risk management—part 2: the Active Risk Control (ARC) Toolkit. J Healthc Risk Manag. 2015;34(3):4-17.
    View Article PubMed Google Scholar
  52. Card AJ, Ward JR, Clarkson PJ. Rebalancing risk management—part 1: the process for active risk control (PARC). J Healthc Risk Manag. 2014;34(2):21-30.
    View Article PubMed Google Scholar
  53. Card AJ, Ward JR, Clarkson PJ. Trust-level risk evaluation and risk control guidance in the NHS East of England. Risk Anal. 2014;34(8):1471-1481.
    View Article PubMed Google Scholar
  54. Card AJ, Ward JR, Clarkson PJ. Beyond FMEA: the structured what-if technique (SWIFT). J Healthc Risk Manag. 2012;31(4):23-29.
    View Article PubMed Google Scholar
  55. Pham JC, Kim GR, Natterman JP, et al. ReCASTing the RCA: an improved model for performing root cause analyses. Am J Med Qual. 2010;25(3):186-191.
    View Article PubMed Google Scholar
  56. Hibbert PD, Thomas MJW, Deakin A, et al. Are root cause analyses recommendations effective and sustainable? An observational study. Int J Qual Health Care. 2018;30(2):124-131.
    View Article PubMed Google Scholar
  57. Vacher A, D’Hollander A, El Mhamdi S, et al. Effectiveness of a tool for structuring action plan after analysis of adverse event. Proc Hum Factors Ergon Soc Annu Meet. 2011;55(1):1631-1634.
    View Article Google Scholar

  58. Vacher A, El Mhamdi S, D’Hollander A, et al. Impact of an original methodological tool on the identification of corrective and preventive actions after root cause analysis of adverse events in health care facilities: results of a randomized controlled trial [published online ahead of print November 8, 2017]. J Patient Saf.

    View Article PubMed Google Scholar

  59. Plsek PE, Greenhalgh T. The challenge of complexity in health care. BMJ. 2001;323(7313):625-628.

    View Article PubMed Google Scholar

  60. Vincent CA, Coulter A. Patient safety: what about the patient? Qual Saf Healthc. 2002;11(1):76-80.

    View Article PubMed Google Scholar

  61. Greenhalgh T. How to improve success of technology projects in health and social care. Public Health Res Pract. 2018;28(3):2831815.

    View Article PubMed Google Scholar

  62. Asaro PM. Transforming society by transforming technology: the science and politics of participatory design. Accounting Manage Inf Technol. 2000;10:257-290.

  63. Greenhalgh T, Jackson C, Shaw S, Janamina T. Achieving research impact through co-creation in community-based health services: literature review and case study. Millbank Q. 2016;94(2):392-429.
    View Article PubMed Google Scholar
  64. Elden M. Sociotechnical systems ideas as public policy in Norway: empowering participation through worker-managed change. J Appl Behav Sci. 1986;22(3):239-255.
    View Article Google Scholar

  65. Robertson TJ, Wagner I. Ethics: engagement, representation and politics-in-action. In: Jesper Simonsen TR, ed. Routledge International Handbook of Participatory Design. Abingdon, UK: Routledge; 2013:chap 4.

    Google Scholar

  66. Stone E. Evidence-based medicine and bioethics: implications for health care organizations, clinicians, and patients. Perm J. 2018;22:18-030.

    View Article Google Scholar
  67. Card AJ, Ward JR, Clarkson PJ. Generating Options for Active Risk Control (GO-ARC): introducing a novel technique. J Healthc Qual. 2014;36(5):32-41.
    View Article PubMed Google Scholar
  68. Card AJ. The Active Risk Control (ARC) Toolkit: a new approach to designing risk control interventions. J Healthc Risk Manag. 2014;33(4):5-14.
    View Article PubMed Google Scholar

  69. Prusaczyk B, Swindle T, Curran G. Defining and conceptualizing outcomes for de-implementation: key distinctions from implementation outcomes. Implement Sci Commun. 2020;1:43.

    View Article PubMed Google Scholar

  70. Prasad V, Ioannidis JP. Evidence-based de-implementation for contradicted, unproven, and aspiring healthcare practices. Implement Sci. 2014;9:1.

    View Article PubMed Google Scholar
  71. Smith A, Boult M, Woods I, Johnson S. Promoting patient safety through prospective risk identification: example from peri-operative care. Qual Saf Health Care. 2010;19(1):69-73.
    View Article PubMed Google Scholar

  72. Ward J, Clarkson J, Buckle P, Berman J, Lim R, Jun T. Prospective Hazard Analysis: Tailoring Prospective Methods to a Healthcare Context. Cambridge, UK: Engineering Design Centre, University of Cambridge; 2010. https://www.birmingham.ac.uk/Documents/college-mds/haps/projects/cfhep/psrp/finalreports/PS035-RevisedPHAFinalReportv11withToolkitJuly2010.pdf. Accessed September 17, 2020.

  73. Card AJ, Harrison H, Ward J, Clarkson PJ. Using prospective hazard analysis to assess an active shooter emergency operations plan. J Healthc Risk Manag. 2012;31(3):34-40.
    View Article PubMed Google Scholar
  74. Peerally MF, Carr S, Waring J, Dixon-Woods M. The problem with root cause analysis. BMJ Qual Saf. 2017;26(5):417-422.
    View Articles PubMed Google Scholar

  75. Macrae C, Stewart K. Can we import improvements from industry to healthcare? BMJ. 2019;364:l1039.

    View Article PubMed Google Scholar
  76. Macrae C. The problem with incident reporting. BMJ Qual Saf. 2016;25(2):71-75.
    View Article PubMed Google Scholar
  77. Leistikow I, Mulder S, Vesseur J, Robben P. Learning from incidents in healthcare: the journey, not the arrival, matters. BMJ Qual Saf. 2017;26(3):252-256.
    View Article PubMed Google Scholar

  78. Mitchell I, Schuster A, Smith K, Pronovost P, Wu A. Patient safety incident reporting: a qualitative study of thoughts and perceptions of experts 15 years after “To Err Is Human.” BMJ Qual Saf. 2016;25(2):92-99.

    View Article PubMed Google Scholar
  79. Nebeker C, Orozco-Linares R, Crist K. A multi-case study of research using mobile imaging, sensing and tracking technologies to objectively measure behavior: ethical issues and insights to guide responsible research practice. J Res Adm. 2015;46(1):118-134.
    Google Scholar

  80. Nebeker C, Murray K, Holub C, Haughton J, Arredondo EM. Acceptance of mobile health in communities underrepresented in biomedical research: barriers and ethical considerations for scientists. JMIR Mhealth Uhealth. 2017;5(6):e87.

    View Article PubMed Google Scholar
  81. Nebeker C, Harlow J, Espinoza Giacinto R, Orozco-Linares R, Bloss CS, Weibel N. Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives. AJOB Empir Bioeth. 2017;8(4):266-276.
    View Article PubMed Google Scholar

  82. Conway J, Federico F, Stewart K, Campbell M. Respectful management of serious clinical adverse events. 2nd ed. Cambridge, MA: Institute for Healthcare Improvement; 2011. https://www.macrmi.info/files/7813/6784/6262/IHIRespectfulManagementofSeriousClinicalAdverseEventsOct11.pdf. Accessed September 17, 2020.

  83. Federico F. Disclosure: Challenges and Opportunities. Forum. 2003;23(2):2-3.

  84. American Society for Healthcare Risk Management. Disclosure of Unanticipated Events: The Next Step in Better Communication with Patients. Chicago, IL: American Society for Healthcare Risk Management; 2003.

    Google Scholar

Editor's Note

Background image by Ryoko Hamaguchi.

Citation

AMA J Ethics. 2020;22(11):E965-975.

DOI

10.1001/amajethics.2020.965.

Conflict of Interest Disclosure

The author(s) had no conflicts of interest to disclose.

The viewpoints expressed in this article are those of the author(s) and do not necessarily reflect the views and policies of the AMA.