Academic journal article Northwestern University Law Review

Promoting Free Speech in Clinical Quality Improvement Research

Academic journal article Northwestern University Law Review

Promoting Free Speech in Clinical Quality Improvement Research

Article excerpt

INTRODUCTION

There is merit to having a body of peers review the value of proposed and ongoing research from an ethical perspective. However, the current structure of the Institutional Review Board ("IRB"), the local body designated by the federal government to review research with human subjects,1 is ill-suited to address the great diversity of research that is generally conducted. The Office of Human Research Protections ("OHRP"), the federal agency of the Department of Health and Human Services created to supervise research with human subjects, primarily designed the structure of the IRB with biomédical research in mind. However, the enabling Common Rule regulations, 45 C.F.R. § 46,2 sweep broadly, reaching any systematic investigation involving human subjects "designed to develop or contribute to generalizable knowledge."3

The Common Rule presents significant free speech barriers to clinical quality-improvement research ("CQIR"), the evaluation and dissemination of efforts to improve the quality of the delivery of health care. Application of the Common Rule to CQIR has the potential to affect negatively the quality of care patients receive, by preventing quality improvement work from being produced in the first place or by inhibiting its dissemination. This Paper will review the free speech issues raised by CQIR. Applying the Common Rule to CQIR undermines First Amendment principles because it is insufficiently tailored to meet the minimal risk presented by CQIR.4 The government fails to have a compelling state interest in regulating research that presents no greater risk than that encountered in everyday life. Moreover, stretching the regulations to encompass CQIR violates the principle of unconstitutional conditions. Lastly, application of the Common Rule to CQIR violates equal protection by selectively restricting the rights of administrators of academic institutions to disseminate their quality improvement work. The ideal solution would be a change in the regulations eliminating minimal risk human subjects research from IRB review.5 Barring such changes, quality-improvement investigators should be prepared to defend and articulate First Amendment rights as IRBs impose unnecessary regulatory review.

I. THE PURSUIT OF QUALITY IN MEDICINE

The pursuit of quality has been of growing importance for medicine with the recognition of the hidden dangers, inequities, and inefficiencies of the healthcare system.6 Medicine has turned to insights from industry, where quality-improvement methodologies were first developed, and incorporated these quality-improvement approaches into the daily practice of medicine. Quality improvement in the practice of medicine, or clinical quality improvement ("QI"), is best understood as the systematic management of clinical operations to produce immediate, beneficial change. QI is continuous and ongoing, occurring in iterative cycles of planning, implementation, and analysis. It is inherently embedded into the routine acts of caring for patients.7

QI bears some resemblance to traditional biomédical research in that both involve the use of data methodologically to come to conclusions about how best to provide care. However, a primary distinction is that biomédical research generally involves the study of an agent or intervention devoid of the particular setting. For example, whether or not beta blocker medications prolong life after a heart attack is a question of empirical science that has been convincingly demonstrated. Rather than answering this first order question of whether an agent is effective for some purpose, QI aims to determine the second order question of how best to implement this knowledge into daily practice. In the example above, the key question for QI is what is the best approach to improve the standard processes of routine care so that beta blockers are prescribed after a heart attack in all patients without a contraindication.

Determining what system-based interventions are best suited for implementation are questions for QI. …

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