Abstract
BackgroundDespite their close relationship, clinical research and medical care have become separated by clear boundaries. The purpose of clinical research is to generate generalizable knowledge useful for future patients, whereas medical care aims to promote the well-being of individual patients. The evolution towards patient-centered medicine and patient-oriented research, and the gradual standardization of medicine are contributing to closer ties between clinical research and medical practice. But the integration of both activities requires addressing important ethical and methodological challenges.DiscussionFrom an ethical perspective, clinical research should evolve from a position of paternalistic beneficence to a situation in which the principle of non-maleficence and patient autonomy predominate. The progressive adoption of “patient-oriented informed consent”, “patient equipoise”, and “altruism-based research”, and the application of risk-based ethical oversight, in which the level of regulatory scrutiny is adapted to the potential risk for patients, are crucial steps to achieve the integration between research and care.From a methodological standpoint, careful and systematic observations should have greater relevance in clinical research, and experiments should be embedded into usual clinical practice. Clinical research should focus on individuals through the development of patient-oriented research. In a complementary way, the integration of experiments into medical practice through the systematic application of “point of care research” could help to generate knowledge for the individuals and for the populations.SummaryThe integration of clinical research and medical care will require researchers, clinicians, health care managers, and patients to reevaluate the way they understand both activities. The development of an integrated learning health care system will contribute to generating and applying clinically relevant medical knowledge, producing benefits for present and future patients.
Highlights
Despite their close relationship, clinical research and medical care have become separated by clear boundaries
The purpose of clinical research is to produce generalizable knowledge useful for future patients, while medical care aims to promote the well-being of individual patients [2]
This leap requires the reassessment of the “three solutions” (Table 1): 1. From researcher-oriented informed consent to patient-oriented informed consent: The purpose of the Informed Consent Document is to ensure that individual patients can control whether or not they participate in clinical research, and that they only participate if the research is consistent with their values, interests, and preferences [16]
Summary
Ethical barriers and potential solutions: from paternalistic beneficence to autonomy and non-maleficence Thirty five years ago, the Belmont Report established a formal distinction between clinical research and medical care [15] and emphasized the different purpose of both activities. The leap from the current model to a new model based on the principles of non-maleficence and autonomy may help to successfully integrate research and care. This leap requires the reassessment of the “three solutions” (Table 1): 1. One of the main factors that obstruct the integration of clinical research and medical care is the current regulation systems that require excessively detailed inform consent documents, even for trials comparing widely accepted treatments [20]. Patient-oriented informed consent (autonomy) and risk-based ethical oversight (no maleficence). “low risk conditions” may not be applicable to exploratory trials, which are aimed at increasing our understanding the potential therapeutic effects of a new drug. The integration between clinical research and medical care may not be feasible in such trials
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