Patients in health care systems are suffering for a lack of clear federal regulatory guidance in support of low-risk quality improvement research, according to a "viewpoint" article by health and policy experts in the Journal of the American Medical Association (JAMA).
"The Office for Human Research Protections, the Office for Civil Rights, and the US Food and Drug Administration should provide more complete and coordinated advice," to avoid institutions making unnecessarily restrictive decisions on what research can go forward because of uncertainty about what regulations allow, thus impeding much-needed medical research, the article says, under the heading "Time for a Change."
Looking specifically at the generally low- or no-risk type of research known as comparative effectiveness research, the viewpoint asks: what level of oversight is necessary? The authors offer recommendations for both the current health policy landscape and a hopeful vision of "harmonized regulation" in transparent, data-driven health care systems of the future.
"Our federal regulatory system is critical in protecting patients when research poses risks or threats to their wellbeing. But our regulations also need to have flexibility to allow different oversight options for research that alters patients' care very little yet has the opportunity to improve care enormously," says Nancy Kass, co-author of the viewpoint and the Deputy Director for Public Health at the Johns Hopkins Berman Institute of Bioethics.
"All clinical care carries risk, and to assume that research automatically imposes additional risks beyond those the same patient would otherwise have experienced in clinical care may overinflate the risks of research and underestimate the risk of not conducting these evaluations," the viewpoint states.
Joining Kass in the opinion is Richard Platt, a research physician trained in infectious diseases, of Harvard Medical School and Pilgrim Health Care Institute, and Deven McGraw, a health care lawyer and privacy expert, of the Center for Democracy and Technology.
The authors highlight the paradox of stringent research regulations for studies evaluating changes in how healthcare is organized coexisting alongside the lack of oversight when "administrative" decisions are made to health system operations. Such administrative clinical decisions are not considered research and thus are not subject to review, patient consultation or other transparency yet can have considerable impact on patients' experience and successful treatment. The authors use the example of changing the ratio of nurses to patients, which could have profound effects on patient outcomes.
The viewpoint also stresses the importance of patient engagement in oversight and in the research process. The engagement of patients and other stakeholders will be critical to collecting and using data in ways that seem respectful and acceptable to patients.
"Ethics has a central role to play in ensuring that patients in our health care system are safe and are treated with respect. We must uphold these commitments both through research oversight and care delivery, so that policy, clinicians and patients are working in harmony to find the most effective, safe and respectful solutions," Kass says.
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