Research monitoring by US medical institutions to protect human subjects: compliance or quality improvement?

• Published in: Journal of medical ethics 2013-04, Vol.39 (4), p.236-241
• Main Authors: de Jong, Jean Philippe, van Zwieten, Myra C B, Willems, Dick L
• Format: Article
• Language: English
• Subjects: Animal experimentation; Bioethics; Biomedical Research - ethics; Biomedical Research - standards; Compliance; Compliance certificates; Ethics committees; Guideline Adherence; Hospitals; Human subjects; Humans; Institutional review boards; Interviews; Interviews as Topic; Investigational drugs; Investigative reporting; Medical research; Medicine; Medicine, Experimental; Observational research; Philosophy; Policy Guidelines/Inst. Review Boards/Review Cttes; Quality Assurance, Health Care; Quality Improvement; Quality management; Quality of Health Care; Regulation; Regulation compliance audits; Research Ethics; Research facilities; Research Personnel; Research Subjects; Scientific Research; Surveys and Questionnaires; United States
• ISSN: 0306-6800; 1473-4257
• DOI: 10.1136/medethics-2011-100434

In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and evidence, institutions have had little guidance in setting up their programmes. To help institutions make the right choices, we used interviews and document analysis to study how and why 11 US institutions have set up their monitoring programmes. Although these programmes varied considerably, we were able to distinguish two general types. ‘Compliance’ programmes on the one hand were part of the institutional review board office and set up to ensure compliance with regulations. Investigators’ participation was mandatory. Monitors focused on documentation. Investigators could be disciplined, and could be obliged to take corrective actions. ‘Quality-improvement’ programmes on the other hand were part of a separate office. Investigators requested to be monitored. Monitors focused more on actual research conduct. Investigators and other parties received feedback on how to improve the research process. Although both types of programmes have their drawbacks and advantages, we argue that if institutions want to set up monitoring programmes, quality improvement is the better choice: it can help foster an atmosphere of trust between investigators and the institutional review board, and can help raise the standards for the protection of human subjects.