11 June 2013

Healthcare and Research Ethics Need Improvement P2

Part 1 of 2 parts

With the second article, the authors bring forward a new ethical framework for the integration of research with practice in what the Institute of Medicine (IOM) calls a learning healthcare system. “The framework includes seven obligations, six of which fall on health professionals and institutions, and the 7th on patients:
  1. Respect the rights and dignity of patients
  2. Respect the clinical judgment of clinicians
  3. Provide optimal care to each patient
  4. Avoid imposing nonclinical risks and burdens on patients
  5. Address health inequalities among populations
  6. Conduct continuous learning activities that improve the quality of clinical care and health care systems
  7. Contribute to the common purpose of improving the quality and value of clinical care and health care systems”

The framework does incorporate both medical and research ethics and includes new obligations. The authors do acknowledge that the revised traditional concepts will affect the roles of healthcare providers and patients. The authors have tackled some long-standing problems with inequalities in health outcomes and in the evidence base for clinical decision-making. Among the examples of unfair inequalities the authors say should be addressed by obligation five is the scarcity of evidence for managing chronic illness in pregnant women, as compared to other adults with the same conditions. Women, and their children, would be well served by a healthcare system that continually learns from patient care.

The framework challenges previous thinking in research and clinical ethics. It calls for an ethical obligation on the part of clinicians, administrators, payors and purchasers to conduct research to improve health care quality and value, and on patients to contribute to such research. The authors write, "Just as health professionals and organizations have an obligation to learn, patients have an obligation to contribute to, participate in, and otherwise facilitate learning," that will improve the quality of the healthcare system. This is not a blanket obligation, regardless of risk. Some kinds of medical research, such as early testing of drugs still unapproved by the Food and Drug Administration, are not included and should always proceed only with the express, voluntary informed consent of the patient.

The patient obligation is to be focused on research that poses no additional risk beyond what patients face in clinical care. This would exclude research that compares different types of treatments, for example, surgery to medical management. The authors add that the framework includes obligations to avoid imposing nonclinical risks and burdens on patients, and to protect their rights and interests.

This may be the key when the authors say that extraordinary opportunities for learning are lost in our current system, because physicians and researchers face significant hurdles in capturing the rich information generated from thousands of daily medical encounters with patients due to overly burdensome oversight and consent rules. The new framework is intended to help reduce these hurdles.
The authors also state that they expect their articles will spark debate, and hope they will move the transformation to a learning healthcare system forward, both in its ethical underpinnings and in practice. They write, "We claim no more than a start on a subject that merits extensive investigation, and we welcome suggestions and commentary moving forward…We are in the early days of a progressive realization of a lofty aspirational goal, but given the preventable harm, waste, and uncertainty about clinical effectiveness in health care, efforts to accelerate learning should be given high priority."

My personal feeling is that the realignment of ethics is long overdue and with the increase in technology, much clinical research needs to be researched from the daily medical records of patients. This may be where valuable research can be gleaned.

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