临床研究与生物伦理学杂志

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Remediation for Human Research Subjects Protections Non-Compliance: Concepts and Approaches

Jay Johnson

Approximating the extent of non-compliance regarding human research subjects protections is controversial. Nevertheless, based on recent research it can be conservatively estimated at about 1,163 cases per year in the United States alone; whereas, less conservative surveys estimate the problem is more widespread (approx.. 84% higher). Additionally, many notorious cases were preceded by earlier offenses, so there is recidivism. The conventional response to the problem is punitive, that is suspension and/or termination. This usually entails losing the research, research personnel, funding, and bad publicity and loss of the public’s confidence. Unlike punitive action, proponents for an alternative response, namely remediation, argue it offers prevention of recidivism, restoration of trust, and risk management because action plans are established. Yet, there are few if any reports on systems, models, or methodical approaches regarding practical aspects of remediation for human research subjects protection non-compliance. This article is a first yet critical step to fill that void of information in that it: provides a conceptual report on a general linear progression of steps to follow, a triage model or pathway to remediation, conducting a general assessment and specific inventory, visual displaying, causal identification, courses of action, prevention/education, and near zero defect accomplishment. The hope is that researchers can use the fundamental tool chest of ideas and methods described herein-if necessary, and hopefully that will never be the case—to tailor remediation efforts to their particular circumstances.