Volume 27, Issue 7 (10-2020)                   RJMS 2020, 27(7): 97-108 | Back to browse issues page

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Forouzandeh M, Hashemi A, Bahmani F. Distinguishing between clinical practice and clinical research: A Review of definitions and ethical issues. RJMS. 2020; 27 (7) :97-108
URL: http://rjms.iums.ac.ir/article-1-6232-en.html
Department of Medical Ethics, Iran University of Medical Sciences, Tehran, Iran , fbahmanimd@gmail.com
Abstract:   (664 Views)
Background: Although clinical research and clinical practice are closely related, distinguishing the boundaries between them is an important issue debated by contemporary bioethicists. Some commentators have criticized drawing a sharp line between research and practice (1, 3 & 4), but most experts and policy makers in the field of biomedical ethics, believe that the distinction between the two in clinical settings leads to increased scientific credibility of research and greater protection of patients' rights and safety (2, 18). They argue that blurring the boundaries between clinical practice and clinical research is an ethical mistake (6, 7). Despite significant efforts that have been undertaken in recent years to implement and enforce research ethics in Iran, the need to training in the field of basic concepts of research ethics and ethical justifications for the codes and guidelines of research ethics exists yet.  The purpose of this study is to address this gap in the literature. The first part of this paper deals with a brief history of research ethics that gave rise to the formation of boundaries debates and led to the publication of the Belmont Report. Then, a set of relevant definitions and criteria required to conceptually and practically distinguish between research and clinical practice are presented. Finally, the ethical dimensions of this distinction are reviewed as an argument in favor of the moral requirement to maintain the boundaries between clinical research and clinical practice for the various parties involved in clinical research.
Methods: Relevant publications were selected through a MEDLINE search. The key phrases used were clinical research or clinical practice plus distinction, boundaries or distinguishing. The main textbooks of research ethics and medical ethics, both electronic and paper types, were included in the search. International and national research ethics documents and guidelines were obtained via the organizational websites. 
Results: This study has yielded several results with possible implications for the different parties involved in clinical research. First, through a close look at the nature of unethical human research studies that took place in the 1970s and prompted the U.S. policymakers to rethink research ethics governance and gave rise to creation of the Belmont Report (5, 8), it can be concluded that the mere issuing of research ethics guidelines in the absence of ethical oversight of research leads to a failure in protection of human subjects in clinical research. Recognizing and maintaining a sharp boundary between research and practice is the basic requirement of a thorough research oversight and providing precise definitions for the terms, clinical research and clinical practice, is the prerequisite to distinguish this boundary (14).
Secondly, Activities that are designed initially with the aim of producing or contributing to the production of “generalizable knowledge” and have the form of a research methodology that have been described in an research proposal and have been scientifically (14, 15), methodology and ethically validated can be labeled as research. These research activities are deemed clinical research If they involve a human participant (7, 13). Such interventions that are intended to increase the well-being of a patient without undergoing a peer-review, although considered to generate “new knowledge”, are still considered as clinical practice because the knowledge gained is not generalizable, even though new (7).
Thirdly, the issue of research-practice distinction can be discussed from various ethical aspects. On the practical level there are several issues involving both the physician/researcher and the patient/research participant. The roles and responsibilities of the physician and that of the researcher cannot be a single set of roles and responsibilities, as these two roles each have their own moral implications and duties, which may be in conflict at times (17, 18). Clinicians are committed to make clinical decisions according to the best interests of the patients, while researchers commit themselves to the research protocol (2, 6, and 7). Adopting distinct approaches to clinical research and clinical practice will also help physicians better distinguish their dual role of physician and researcher and manage potential conflicts of interest.
Blurred boundaries between research and practice also leads to therapeutic misconception for Patients /research participants. Therapeutic misconception is a situation in which patients do not recognize that they are participating in a clinical research although being disclosed by the clinician/researcher (19). The therapeutic misconception may also occur to the minds of the clinicians, and the result is their reluctance to disclose to the patients that they are participating in a clinical research, when feeling far from regulatory agencies.  As research interventions are often unapproved, they pose an increased risk to research participants, as well as additional burden and cost. So, failure to understand the research process seriously infringes the patients’ rights to safety, quality care, and autonomy (10).
How research and practice are distinguished also affects the actions taken on the policy level. It is of great importance that research ethics committees and policy making bodies make distinction between research and practice in clinical settings. Historically the most important trigger to acknowledge the issue of separate clinical research and clinical practice was the need to clearly define which activities should undergo oversight in the clinical realm where the professional norms does not require oversight on the practice of licensed clinicians (6). The general rule originally stated in the Belmont report is that whenever there is a research component in an activity, that activity should be monitored for the protection of human subjects (14).
National Research ethics guidelines play an important role in shaping the attitudes of different parties involved in clinical research, toward their roles and responsibilities in research. As research ethics scholars have argued, using the notion of “therapeutic research” in the early versions of the declaration of Helsinki by the World Medical Association led to a "misunderstanding" in clinical research ethics and the violation of patients' rights (1). Although “therapeutic research” was a common concept in the classical research community, but also was reinforced by policy-making institutions; this conceptual error according to Howard Brady, an expert in the field of medical ethics, had prevented a correct and ethical understanding of "research with human subject" for years (11).
A review of national biomedical research ethics guidelines issued by the “National Committee for Ethics in Biomedical Research” at the Iranian Ministry of Health and Medical Education, reveals a lack of basic definitions and clarifications. In some instances, like in the “General ethics guidelines for medical research including human subjects,” some provided definitions increase the ambiguity; however, some criteria for distinguishing between research and practice can implicitly be derived from the text. Codes number 10, 11, 26, and 28, which explain the researcher's ethical responsibilities toward the participants - a responsibility that is not defined for clinicians- implicitly set out the criteria for research-practice distinction (16).
Conclusion: The issue of boundaries between research and practice in clinical settings is ethical in nature.  Although considerable efforts have been made to develop national biomedical research ethics guidelines in Iran, a comprehensive approach to providing the definitions of basic concepts and the underlying theoretical framework in the field of biomedical research ethics still seems lacking.
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Type of Study: review article | Subject: Medical

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