Highlights
- •Although the realization of the alarming frequency, harm, and costs of errors in clinical care has led to error management systems being widely implemented, there have been no similar efforts to manage errors or failures in academic investigator-initiated clinical research.
- •Errors and failures frequently occur in clinical research and can negatively impact research quality, potentially contributing to significant wasted resources and patient harm. There is an urgent need to implement error management in academic clinical research.
- •Specific strategies that can assist error management in clinical research include error reporting systems so that lessons can be learnt, a systematic approach to disclosing errors to clinical research participants, and emotional support being proactively offered to investigators involved in errors.
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Subscribe to Journal of Clinical EpidemiologyReferences
- To err is human: building a safer health system.The National Academies Press, Washington, D.C.2000
- Massachusetts coalition for the prevention of medical errors. When things go wrong: responding to adverse events. A consensus statement of the harvard hospitals. Massachusetts Coalition for the Prevention of Medical Errors, Boston, MA2006
- A trial on unruptured intracranial aneurysms (the TEAM trial): results, lessons from a failure and the necessity for clinical care trials.Trials. 2011; 12: 64
- Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada.Trials. 2021; 22: 844
- Errors and error management in biomedical research.in: Hagen J.U. How could this happen? Managing errors in organizations. Springer, Cham2018: 149-160
- A laboratory critical incident and error reporting system for experimental biomedicine.PLoS Biol. 2016; 14: e2000705
- Tolerating bad health research: the continuing scandal.Trials. 2022; 23: 458
- Human error: models and management.BMJ. 2000; 320: 768-770
- Criminalization of medical error: who draws the line?.ANZ J Sug. 2007; 77: 831-837
- How does the law recognize and deal with medical errors?.J R Soc Med. 2009; 102: 265-271
- Human error.Cambridge University Press, Cambridge1990
- Open disclosure standard: a national standard for open communication in public and private hospitals, following an adverse event in health care.Australian Commission on Safety and Quality in Health Care, Sydney2008
- Disclosing and reporting medical errors: cross-sectional survey of Swiss anaesthesiologists.Eur J Anaesthesiol. 2015; 32: 471-476
- Investigators' sense of failure thwarted transparency in clinical trials discontinued for poor recruitment.J Clin Epidemiol. 2022; 145: 136-143
- Prevalence, characteristics, and publication of discontinued randomized trials.JAMA. 2014; 311: 1045-1051
- Participants left uninformed in some halted medical trials.New York Times, New York, NY2007
- Evaluating the implementation of a national disclosure policy for large-scale adverse events in an integrated health care system: identification of gaps and successes.BMC Health Serv Res. 2016; 16: 648
- Health care professionals as second victims after adverse events: a systematic review.Eval Health Prof. 2013; 36: 135-162
- The emotional impact of medical error involvement on physicians: a call for leadership and organisational accountability.Swiss Med Wkly. 2008; 138: 9-15
- Relationship between increased personal well-being and enhanced empathy among internal medicine residents.J Gen Intern Med. 2005; 20: 559-564
- Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study.JAMA. 2006; 296: 1071-1078
- Association of resident fatigue and distress with perceived medical errors.JAMA. 2009; 302: 1294-1300
- Suffering in silence: a qualitative study of second victims of adverse events.BMJ Qual Saf. 2014; 23: 325-331
- The natural history of recovery for the healthcare provider “second victim” after adverse patient events.Qual Saf Health Care. 2009; 18: 325-330
- Implementing the RISE second victim support programme at the Johns Hopkins Hospital: a case study.BMJ Open. 2016; 6: e011708
- Cost-benefit analysis of a support program for nursing staff.J Patient Saf. 2020; 16: e250-e254
- How to develop a second victim support program: a toolkit for health care organizations.Jt Comm J Qual Patient Saf. 2012; 38: 235-240
- Caring for our own: deploying a systemwide second victim rapid response team.Jt Comm J Qual Patient Saf. 2010; 36: 233-240
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Declaration of interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Competing interests: The authors do not have any competing interests to declare.
Author Contributions: SM conceived and drafted the paper based on his previous doctoral research on medical errors and recent research regarding clinical research with MB. SM was responsible for the overall content as the guarantor who has accepted full responsibility for the work. MB critically revised the manuscript. All authors read and approved the final version of the manuscript.