More than ever, our health care system can learn much about prevention, diagnosis, and treatment of illness due to an increased interest in comparative effectiveness studies and practice-based research, and the availability of data from large health information systems. But, in the opinion of DPM’s Dr. Richard Platt and his co-authors, such approaches are inhibited by assuming that evaluation automatically creates higher risks to patients than usual care.
Presented in the article are a number of recommendations that could be considered within existing regulations:
Government agencies dealing with human research protection should provide more detailed information about permitted activities and precedents to assist IRBs in their decision-making. IRBs tend to err on the side of over-restriction because of their own uncertainty about the law.
Certain health care operations should be redefined, so that routine and continuous evaluation of health care processes are not classified as “research” and thus subjected to strict research regulations.
The risk-based approach to evaluating research studies needs to be modified. Potential risks and burdens to patients in a study to better learn about the efficacy of a treatment need to be compared to the risks of care to patients without the benefit of such an evaluation.
The authors point out that systematically assessing care can result in significant opportunities to improve health outcomes and that research policies should enable, rather than inhibit, this potential.
To read the Viewpoint article, click here.