Clinical research, Key terms of research ethics - Bioethics

Clinical trials

Key terms of research ethics

The Belmont report and a number of other important bioethics documents have made a fundamental difference between scientific research ( research ) and medical practice.

The concept of practice, as articulated in the Belmont Report, "refers primarily to interventions that are solely aimed at improving the health of an individual patient or client and on which a successful outcome is reasonably expected. The goal of medical or behavioral practice is to establish a diagnosis, conduct preventive treatment or therapy for specific individuals. "

At the same time, the term & quot; research & quot; Used to refer to activities that are aimed at testing the hypothesis, it allows you to draw conclusions and thereby obtain generalized knowledge (expressed, for example, in theories, principles or the establishment of connections). The study is usually described in a formal protocol in which the goal is formulated and a number of procedures are set to achieve this goal. "

It is important to understand these key concepts, because there are many intermediate or little-defined options for action in the medical field, which can lead to considerable confusion in terms.

Not every research that is conducted in the health care system falls under the strict concept of scientific research. For example, various kinds of research (data collection, analysis of statistics, observations, etc.) that are conducted to improve the quality of medical care, improve the use of medical resources, improve the level of public services, increase the safety of assistance, etc., are used for internal practical use and do not imply an increase in scientific knowledge (and, accordingly, scientific publication) and are not strictly scientific research.

The main features that distinguish scientific research from current medical practice, include the following.

1. The purpose of medical practice is the improvement of health, the specific benefit for the patient (groups, etc.). The purpose of the study is the increase in scientific knowledge (which has a generalized character).

2. Medical practice is focused on the benefit of this particular patient at present; research - for the benefit in the future (when the received scientific knowledge will be put into practice).

3. The results of scientific research are presented in the form of theories, hypotheses, etc. (ie in scientific form), and also should be published. Other forms of research activity (for example, with practical purposes) do not have these properties.

4. Medical practice must strictly follow the patient's well-being and protect it from harm; At the same time, scientific research can deliberately create uncertainty and even some risk (in order to acquire new knowledge).

It should be noted that medical practice and scientific research can be carried out simultaneously , when, for example, patients receive medical care and at the same time they participate (as volunteers) in the testing of new medicinal products preparations. In such a situation, a doctor can simultaneously act as both a doctor and a research scientist, which complicates his activities and can lead to a conflict between his professional roles. The simultaneous provision of medical care and the conduct of scientific research on the same individuals is an important problem of medical ethics.

There is another area of ​​activity, in a sense intermediate between practice and research in the strict sense of the word. These are situations of deviation from generally accepted medical practice or the use of untested (insufficiently verified) medical methods. This type of activity can not be considered a scientific investigation in the strict sense of the word.

This area of ​​activity is referred to as "untested practice," "experimental practice," "therapeutic innovation."

Generally speaking, this activity is a special case of the more general concept of "experimentation" (English, experimentation), which in itself is not sufficiently defined. Experimentation is a kind of search aimed at gaining experience, creating new practices, and so on. From scientific research it is distinguished by the absence of clear formal procedures, and from medical practice by that it can carry more risk and less than the expected benefit for the patient.

Thus, we can distinguish three important areas of activity in medicine:

1) normal, or proven, medical practice;

2) scientific research;

3) experimental practice, or therapeutic innovation.

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