Hospitals in Michigan can continue to use infection checklists because they are not harming human subjects, HHS Office for Human Research Protections ruled.
Checklists to ensure appropriate procedures are followed can help to reduce the rate of catheter-related infections in intensive-care units, which is a quality improvement initiative that poses little risk to patients, according to the Office for Human Research Protections. The office had halted the checklist practice in Michigan hospitals after learning they were implementing a list developed through a Johns Hopkins University study, sparking contention with medical providers who said the checklist was not research.
HHS regulations provide great flexibility and should not have inhibited this activity, said the office's Acting Director Ivor Pritchard in a written statement.
HHS said it will work with its offices and medical providers to improve communications for future quality projects. Were reviewing the application of (regulations) to evidence-based quality improvement activities, like the Johns Hopkins project, and whether any changes are needed to encourage such work while safeguarding the rights and welfare of human subjects in research, a spokesman said. -- by Jean DerGurahian
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