Academic journal article The Hastings Center Report

Can Research and Care: Be Ethically Integrated?

Academic journal article The Hastings Center Report

Can Research and Care: Be Ethically Integrated?

Article excerpt

Medical ethics assumes a clear boundary between clinical research and clinical medicine: one produces knowledge for the benefit of future patients, while the other provides optimal care to individuals right now. It also assumes that the two cannot be integrated without sacrificing the needs of the current patient to those of future patients. But integration could allow us to provide better care to everyone, now and in the future.

Historically, clinical medical research and clinical medical care were viewed as similar and as intertwined. Physicians considered research on patients to be an integral part of the care they delivered. (1) After all, the good physician constantly made observations and formulated and tested hypotheses; he turned to the literature and experimented with different treatments to find the one most efficacious for the patient in front of him. Moreover, he learned from these experiences to improve his treatment of future patients. On this model, both medical care and research were scientifically guided, therapeutically oriented activities conducted within the physician-patient relationship. (2)

In 1979, however, the Belmont Report disentangled research and care, defining clear boundaries between the two. (3) Central to the distinction was the idea that the purpose of clinical research is fundamentally different from that of clinical medicine: whereas medical care focuses on providing optimal care to individual patients, clinical research is primarily concerned with producing generalizable knowledge for the benefit of future patients. Other defining characteristics of clinical research include distinctive research methodologies--such as placebo controls, randomization, and blinding--that are anathema to medical care because they sacrifice personalization of care in order to minimize bias; the use of procedures that hold no prospect of medical benefit for the research participant but whose associated burdens and risks are justified in light of their scientific value; and a unique investigator-subject relationship that is best understood in contrast with the physician-patient relationship. (4)

Thirty years after Belmont, the sharp distinction between research and care is becoming increasingly blurred. Medical care and clinical research are extensively, deliberately, and routinely integrated in numerous settings. Significantly, this integration is occurring not just within the physician-patient relationship, but also at the level of health care systems. For example, use of electronic medical records within the Veterans Administration has furthered evidence-based practice and research by allowing clinical data to be aggregated for health services research. (5) Practice-based research networks, such as the "primary care practice-based research networks," hold the potential to enable the performance of randomized, controlled trials and other types of research in primary care offices nationwide. (6) This is a situation for which there is no historical precedent.

To a great extent, recent technological advances motivate and enable research-care integration. Health information technology, particularly electronic medical records, provides researchers access to patient data in a more comprehensive and less labor-intensive manner than ever before. It facilitates hypothesis formulation and testing, as well as the evaluation of millions of patients' experiences nearly in real time. (7) Cultural shifts, such as the growing appeal of evidence-based medicine and comparative effectiveness research, have also motivated research-care integration. Finally, there is perceived social value in integration. Integration offers an opportunity to improve medical care, to contain health care costs without sacrificing quality, to remove many barriers to effective research, and to increase patient satisfaction by enhancing access to promising treatments during periods of evidence development.

In 2007, the Institute of Medicine Roundtable on Evidence-Based Medicine wrote: "We must quicken our efforts to position evidence development and application as natural outgrowths of clinical care. …

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