Epidemiology and public health. Ethical problems of epidemiology

The concept maintenance "epidemiology" and its development stages. Social aspect and ethical problems of epidemiology. Protecting the rights and dignity of the human clinical trials and medical practice. The fundamental principles of medical research.

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Chair of clinical pharmacology and evidence medicine.

Discipline of " evidence -based medicine».

Course 3

Speciality 051301 «General medicine».

THE INFORMATION-DIDACTIC BLOCK

ON « evidence -based medicine »

TO PRACTICAL LESSON № 15.

Theme: «Epidemiology and public health. Ethical problems of epidemiology»

Epidemiology and public health

The causal relationship between factors of the phenomena is inaccessible to direct feeling, it opens mind of the learning person ”.

I.M.Sechenov.

Now became obvious that the researches devoted to diagnostics, the prevalence, a natural current, treatment and preventive maintenance of the illnesses, based on epidemiological methods, give the most valuable information for acceptance of clinical decisions. Publications of results of randomized clinical tests, researches a case-control, meta - analyses make an essential share of articles in the most influential medical magazines all over the world. Epidemiological research of an etiology and pathogenesis of illnesses is aimed at revealing of communication of an exposition to potentially harmful condition (risk factor) with disease. This research is spent in the conditions of real-life system of rendering of the medical and social help, in conditions when such important factors, as the limited working day, family support and many other things operate. Research is under construction so that to exclude influence of these resulting factors and to reveal communication if the such exists.

Public health (public health) name a science and practice of decrease in death rate, disease and life prolongation. For achievement of these purposes there is a wide spectrum of methods. Their well-founded application, unfortunately, didn't become till now an obligatory rule in activity medical and social services the same as there was no rule use only the methods of diagnostics checked up in tests and treatment in clinic.

The charter of World Health Organization defines 1968 health - as a condition of full physical, social and spiritual or psychological well-being, and not just absence of illnesses and defects.

Health levels:

1. Individual health

2. Family health

3. Health of groups of the people united by any sign

4. Population health

Health measuring instruments:

1. A health index (not ill / ills for a year)

2. Health potential

3. Balance of health

4. Health resources

Risk factors:

Primary - smoking, alcohol, hypodinamic, stresses

Secondary - a hypercholesterolemia, hyperlipidemia, an arterial hypertensia, rheumatism, allergies, a diabetes, an immunodeficiency

The concept maintenance «epidemiology»

The word "epidemiology" occurs from the Greek words "epi" ("among"), "demos" ("people") and "logos" ("a science about"). Initially Russian word meaning epidemiology - полюдье. Further the set of definitions of epidemiology was offered:

epidemiology or the science about epidemics studies the reasons of influence and development of epidemics, finds out the conditions favoring to their distribution and plans ways of struggle against them, based on the science and practice data. (D.K.Zabolotnyj, 1927г.)

Epidemiology - a science about epidemics or, more truly, about laws of epidemic process. (L.V.Gromashevsky, 1949y.)

Epidemiology - a science about mass diseases among people.

(V.A.Bashenin, 1958г.)

Epidemiology - a science studying the reasons, conditions and mechanisms of formation of disease for the purpose of a substantiation of measures of preventive maintenance and an estimation of its efficiency. (V.D.Beljakov, 2000г.)

One of the best definitions gives Last JM (1988г.).

Epidemiology - a science studying features of distribution and the reason of occurrence of diseases in a society, for the purpose of application of the received knowledge for the decision of problems of public health services. It includes some the key terms reflecting important principles of this discipline:

1. A science epidemiology - independent scientific discipline, with special methods of scientific research;

2. Distribution - epidemiology is engaged in studying of frequency and features of distribution of infectious and noninfectious illnesses in concrete groups of the population.

3. Frequency includes not only absolute number of the such phenomena, but also the indicators reflecting risk of disease in concrete group of the population;

4. The indicator (number of the phenomena, divided for the size of group) is very important for epidemiologists as he allows to spend well-founded comparisons between various groups of the population.

Features of distribution come to light at the analysis of diseases on time, an occurrence place, and also under personal characteristics of the diseased - multidimensional display of the biomedical phenomenon is studied:

1. Dynamics of occurrence of illnesses on years, months, and during epidemic - on days and even hours - time of occurrence of illnesses;

2. Occurrence of illnesses in space, for example, among city and agricultural population, among workers of the certain enterprises or pupils of certain schools - a place of occurrence of illnesses.

3. The personal characteristic of the diseased (phenomenon structure):

Such demographic characteristics concern them as age, race, a floor, marital status and economic and social situation;

And also features of behavior and presence or absence of influence of harmful factors.

The analysis of illnesses on time, a place, etc. features of occurrence name descriptive by epidemiology which should answer on questions: what disease has arisen (a preventive maintenance problem); who, where and when was ill. Analytical epidemiology studies causality, trying to answer questions, why and as there was a disease, i.e. the reasons of occurrence of disease (etiology), and also for revealing of risk factors of occurrence of disease:

* Comparing among themselves groups of people to various indicators of disease and disease among persons with distinctions in demographic, immunological, genetic, behavioural, professional and other features (which name risk factors).

* the Analysis gives the grounds enough for carrying out of fast and effective social interventions in epidemiological processes.

* Researches with application of methods retrospective and prospective analysis of the hypotheses formulated for an explanation of results of spent supervision.

* the Studying directed on an estimation of the nature of a causal relationship between an exposition of harmful factors of environment and arising biological effects from health of the person, by check of scientific hypotheses.

The retrospective analysis - a method in which indicators of a state of health of various groups of the population in preceding years are analyzed. Detection in group of patients of the greatest share of persons which have undergone to influence of the studied factor, in comparison with control group specifies in communication presence between development of disease and action of this factor. The prospektivnyj analysis - method E.I., in which indicators of a state of health of various groups of the population in the long term (from day in day and years) are analyzed.

Development stages of epidemiology (by academ. V.D.Beljakov, 1995y)

Stage

The characteristic

1. To bacteriological from Hyppocrat to the XIX-th century middle.

population

2. Bacteriological

center

From the middle of a XIX-th century till 50th years ХХ century

population

Epidemiology - the basic science of public health services

Thus today, epidemiology it is a biomedical science which is engaged in research of factors and the conditions defining frequency and distribution of diseases and physical inability among the population (fundamental science on studying of causality of an illness). The Object of science are the biomedical phenomena proceeding in social on a way of existence the Person! Now epidemiology covers all kinds of diseases, whether it be sharp or chronic, somatic or mental, infectious or noninfectious and all pathological conditions at the person. Epidemiology studies the reasons and conditions of formation of disease of the population by the analysis of its distribution on territory, among various groups of the population and in time (system methodology of medicine), and also carries out scientifically-practical activities public public health services which basis results of the epidemiological researches used for working out of intersectoral strategy and tactics of preventive maintenance of diseases (make an expert in the form of sanitary- epidemiological supervision (monitoring).

The obtained new epidemiological data should be used for preventive maintenance of illnesses and propagation of a healthy way of life (new knowledge). The essence of practice of public public health services is applied epidemiology.

In public public health services quantitative receptions epidemiology are used at:

1. A substantiation of problems of preventive maintenance on nosological classes and groups of illnesses and concerning separate illnesses;

2. Estimations of needs and requirements of preventive maintenance;

3. A formulation, estimations and a substantiation of hypotheses about risk factors (the epidemiological diagnosis);

4. Estimations intermediate and the end results of social interventions (a continuity of epidemiological researches).

Directions of modern epidemiology

1) regulation of development of health services by an establishment of the size and distribution of the problems connected with illnesses (health);

2) revealing causal and other factors which presume to combat these diseases or to influence them;

3) to develop a method of definition of efficiency of the actions spent with a view of struggle against illnesses and improvement of health of a society.

Social aspect of epidemiology

Influential forces of a modern society have accelerated a recognition of methods and possibilities clinical эпидемиологии. Medical aid cost has reached such level at which even the richest groups of the population not in a condition оп to pay all desirable types of service. It is shown that use of new clinical methods is completely not necessarily accompanied by respective alterations of clinical outcomes; hence, the standard or expensive kinds of treatment are useful to the patient not all. Ways of more careful estimation of the clinical data which heads of public health services can use are now developed. There was «a common opinion that medical aid should be based on results of strict researches and be estimated on results taking into account financial expenses which the society presumes». Besides, concrete patients are even more often considered as a component of the big groups of similar patients; It helps not only to do more exact individual forecasts, but also to choose the most expedient way of use of the limited medical resources for the optimum help probably большему to number of people.

Ethical problems of epidemiology

The informed consent of patients in the clinical

Tests and medical practice.

Key element of qualitative clinical practice (GCP) in protection of the rights of the person at carrying out of biomedical researches at the person is reception of the informed consent at test assumed about the subject, and in case of participation in research of the person not capable independently to give such consent, reception of the proxy informed consent at its lawful representative.

The base ethical principle formulated in the Helsinki declaration of the World medical association (Helsinki 1964y., reconsidered in 1996г.), the freedom in choosing and respect for independence of the human person are defined. However in variety of cases the individual informed consent can be sewn up by not enough perfect form of the rights and advantage of the person. The reason of similar imperfection age, intellectual, mental or social immaturity of the person of the subject of test that predetermines a summer residence of the unconscious consent can be.

In difficult cases for an exception of possibility of a summer residence of the unconscious consent independent protection of the person of the subject of research is predetermined from Ethical committee which duties include consideration and approval of the text and procedure of reception of the informed consent.

Recognition of responsibility of all international community for observance of human rights during reception of the proxy informed consent is the fact of working out of strict recommendations and rules of the information consent the various authorized international organizations (World Health Organization, the European ethical committee, the European forum on qualitative clinical practice, etc.).

The prime rule caused by definition «the informed consent», is devoted the maintenance and an essence of the given information.

So, the information for the potential participant of biomedical research should contain:

the fact of participation in research;

the purpose and research methods;

prospective duration;

expected advantage of participation and refusal;

prospective risk or inconveniences:

alternative therapy;

confidentiality;

responsibility of the researcher on medical aid rendering;

financial conditions of research, in particular data on full indemnification in case of harm from research or death: the information on independence of the decision of the subject of research to participate in research or to refuse participation at its any stage without loss of possibility of medical aid.

The special attention in the information block is given to an explanation of positions about an advantage and risk parity. Speaking about prospective advantage, it is necessary to stop not only on advantage of participation in test, but also on advantage of tap of research in process of carrying out by it if that is made under the decision of the researcher.

At a statement of factors of prospective risk it is necessary to list all known studying at the given stage the undesirable phenomena. The special attention is given to materials about influence of investigated means on pregnancy and a fruit. Thus given data shouldn't have intimidating character, and only to give the objective information necessary for acceptance of the adequate decision.

To the potential participant of research, except the information on advantage and risk, it is necessary to give accurate representation about inconveniences and possible restrictions (in a diet, a daily routine, a way of life and so forth) if those are caused by participation in research.

Confidentiality is understood as strict observance of the Helsinki declaration on the rights of the subject of biomedical research to independence of the person and anonymity of the data. In this connection in the informed consent all guarantees on maintenance of the minimum access to the personal data of the patient should be reflected.

In section about indemnification not only accurately it is underlined that the subjects of the research who has received physical sufferings as a result of the participation in research, have the right on financial (or another) indemnification which repays a temporary either constant damage, or disability, but also the concrete standard base and indemnification source (the insurance of the sponsor, the state etc.) is defined. Thus it is necessary to give an explanation that indemnification isn't given when the damage is caused by the consequences expected or connected with illness if those don't differ from the consequences observed in usual practice.

The researcher concerning procedure of reception of the informed consent is obliged:

* to give all information necessary for the adequate informed consent;

* to give full possibility of the answer to questions;

* to exclude possibility of unreliable information, illegal influence and intimidation;

* to accept the consent only after the subject has received adequate knowledge of the facts and consequences of the participation in research and had appropriate possibility to solve a question on participation:

* as a key rule to receive from each prospective subject of research the signed form as the proof of the informed consent;

* to receive the new informed consent from each participant if there were significant changes in conditions or research procedures.

The text of the informed consent should be presented in a native language and with use of the words accessible to level of perception of the potential subject of research.

At reception of the informed consent it is necessary to stipulate and motivation questions to participation in research -- stimulus to participation. Subjects of research can receive a payment for the inconveniences, spent time, indemnification for additional expenses and free health services from payment. However the payment shouldn't be so high, and the health services so unique that it could induce to take part in research illogically. All payments, indemnifications and given health services for subjects of research should be approved by ethical committee.

In addition to the above general recommendations, there is a regulation of rules and requirements, certain of specific investigation contingent. These requirements are defined in the following rules in relation to specific contingents.

Thus,children investigations may be held if:

* Children can not be adequately replaced by adults;

* The aim of the study - to provide the knowledge necessary just for children's health;

* Parents or legal representatives of each child gave Plenipotentiary satisfactory agreement;

* acceptance of each child was obtained in accordance with its ability for consent, denial of the child to participate in the investigation always recognized, except as a result of participation in the study a child can receive therapy, which does not alternatives;

* the risk is less than the possible benefits, attainabling in investigation and the importance of knowledge acquired;

* the treatment benefits , achieved through participation in investigation research at least exceeds that of any alternative therapy.

Pregnant or nursing mothers, as a rule, not be subjects of the non-clinical studies, except those that are built to protect or preserve the health of pregnant or lactating women or the fetus or newborn child, and where the other women can be appropriate research subjects. Such studies can be classified studies to identify the defect fetal development; treatment of conditions associated with or aggravated by pregnancy (vomiting, hypertension, diabetes, etc.), or to prevent risk of perinatal transmission of HIV from mother to fetus (HIV infection, hepatitis).

Consequently, the main argument and a justification of participation pregnant and lactating women in the CI is that they do not lose the opportunity to benefit.

In studies involving people with mental and behavioral disorders also need complete confidence that:

* These people can not be replaced by the subjects without these solutions violate ;

* The aim of the study - to provide the knowledge necessary to treat people with mental and behavioral disorders;

* consent of each subject was obtained in accordance with its ability to give consent, the refuse to participate in the study always recognized. In case of failure subject to the decision the agreement receive from its legal representative;

* degree of risk as a result of participation in the study is less than the possibility success and significance of acquired knowledge;

* the success of treatment, which can be achieved as a result of participation in the study must be greater than any alternative therapy.

The independent considiration requires the research persons from developing countries (among members of the Ethics Committee must be persons who are deeply knowledgeable customs and traditions of this community and others), investigations on prisoners, the procedure for conducting epidemiological studies (obtaining consent from govermental or departmental organizations).

The act of certifying the procedure of informed consent, to serve as evidence of the signing of a special consent form (sample attached).

TheconsentForm:

*The number of research center.

*The number of research.

* The number of patients in this study.

* The name of the protocol.

* The name of the researcher.

* The name of an independent witness.

Please to note:

1. I confirm that I read and understood the information contained in the information sheets dated specific number ( the reference number

version…) for the above study.

2. I understand that participation in research is voluntary and that I am free to refuse from participation in the study at any time without losing the ability of itself legitimate right to medical care

……………………(- )

3. I am ready to allow the access to my medical documents, but I'am

understand that the strict confidentiality of the data will be provided. The purpose

access to documents - control study, which will provide the right correctness of its implementation……………… (-)

4. I agree to participate in the above study…………….. (-)

Name of patient Date Signature

Name of person Date Signature

received the consent

(If different from researcher)

Name of researcher Date Signature

Note. The date and signature are placed by each party to the procedure itself. According to the modern requirements to write the two copies of the consent form. The one copy remains for the patient - one for the file researcher. Now are considerating the question about the need for a third consent form, which will be keep in hospital clinic materials of scientific research institute.

All of the above, primarily concerned with the CI, new drugs, vaccines and examination methods . But should'nt ignore the importance of objective information and its adequate understanding and perception, as the confidence contact between the doctor and the patient in routine medical practice. It is difficult to exclude the fact that even official drug or examination method of in each case may be first used for each specific patient and the success of therapy is often difficult to predict.

Hence, as in CI, a doctor's usual practice of medicine requires the patient explanation of the effect of the therapy, the disclosure of the nature of adverse events and opportunities for prevention, drug combinations, specific diets, features and limitations in the mode at the time of treatment or examination. Equally, as in CI and in medical practice the nature of the disease, psyhcological, social, economic position of the patient their effect on perception and adequate follow doctor's recommendations. The expounded arguments in favor of the concept of providing value information and research ethical relations the investigator and the subject of research, doctors and patients give hope that the materials on informed consent, given in the presenting paper will be equally useful for physicians, researchers and physicians whose practice Health.

The Helsinki Declaration of World Medical Association.

The new Helsinki Declaration edition - a major international instruments designed to ensure the ethical regulation of medical research involving human subjects - was adopted in 1952 session of the General Assembly of the World Medical Association, held in October 2000 in Edinburgh (Scotland ). The credibility of this document extremely high, because its main provisions formed the basis for many national legislations. The Revision of the Helsinki Declaration and the adoption of the new edition, without conventionally have a significant impact on the practice of medical studies leading.

The new version is radically different from the previous one. From 32 declaration articles only three remained unchanged, and 8 articles are absolutely new. The most important are following changes :

* Extended the application declaration, which includes now research conducted at the Human Origin biomaterials (Art. 1);

* introduced a norm that requires special measures to protect vulnerable groups; significantly expanded the volume of information that the investigator must submit to the ethics committee, in addition, the researchers imposed the obligation to pass the ethical committee the information that he may to require the monitoring already ongoing research;

* fundamentally new requirement is that the purpose of investigation should be such that those groups or population among which the study is conducted to have the benefit from that. (Article 19);

* in accordance with Art. 22 substantially increases the amount of informa tion, which the subject will to give, informing satisfactory agreement, and also to strict the requirements for consent registration are given by the oral;

* to introduce new rules relating to both the author and publisher connection with the publication of research results: it is necesssary to publish not only positive but also negative results, the publication should indicate not only a place of study, but also someone who sponsored research (Article 27);

* Art. 29 restricts the use of placebo only in that cases, where there are no effective methods of prevention, diagnosis or treatment;

* the basic norm is introduces in Art. 30. It is a question that tested patients must be guaranteed the receipt the treatment after research of treatment, which in the course of the study proved its effectiveness. This requirement is particularly important for research in developing countries, as has been a widespread practice, when the inhabitants of those countries participating in the research, assumes the risk associated with the study of new medications, but after investigation they could not get the same funds have already demonstrated their effectiveness, but are usually very expensive.

The World Medical Association developed the Helsinki declaration as a document containing principles to guide doctors and other professionals in providing to scientific research involving human subjects, as object. Under the medical research involving human in case of object. For medical research with participation of humans as object meaning scientific research with the use of specific materials of the human body or specific data about a person.

The protecting and improving people's health - the main duty of a doctor. The knowledge of the doctor and his mind should be directed to perform this duty.

The Geneva Declaration of the World Medical Association holds with binding for each doctor words: "I am motivated primarily by considerations of health of my patient." International Code of Medical Ethics states: "In the provision of medical assistance as a result of which may be weakened fisi cal or mental condition of the patient, the doctor acts in the interest of the patient."

The progress of medical science based on scientific research, whitch ultimately, should include experimental work involving human subjects as an object.

For medical research involving human health and welfare of people participating in a research study, have priority over the interests themselves science and society. epidemiology сlinical trial medical

The main task of medical research involving human subjects as the object of improving the prevention, diagnosis and treatment of work and understanding of the etiology and pathogenesis of disease. Even if proven prevention methods, diagnostics and treatment proved to be the best side, not necessary to conduct scientific work constantly to improve them to enhance their effectiveness, efficiency, affordability and quality.

In current medical practice and in medical research studies ¬ repetition, most prophylactic, diagnostic and treatment activities related to risk and high loads for patients and subjects.

Medical research must meet ethical standards, ensuring respect for all human beings and protect their health and rights. Some categories of people, attracted to in research, are at increased risk and need are of special protection measures. Must be constantly mindful of the needs and requirements of those people who are disadvantaged in terms of material and the availability of copper assistance. Particular attention should be given to participants in medical research that can not self respect consent or to refuse to participate in scientific research Research Institute, forced to agree to participate under duress, can not extract personal benefit from participation in scientific research, as well as those when scientific research is connected with the ongoing treatment of chickens catfish.

Researchers should be aware of the ethical, legal and normative requirements that apply to scientific research on the man in their countries, as well as between the respective national norms.

The fundamental principles of any scientific research.

In the medical research duty doctor - to ensure the safety of life, health, privacy and the protection of the reliability dignity of research participants.

Medical research involving people in facilities shall comply with generally accepted principles of research, based on a thorough knowledge of modern medical literature and information from other sources available, take into account the results of extensive laboratory investigations Exploration and, if necessary, research on animals.

For research should be sufficient precautions to protect the environment, while conducting research on animals to observe triangle requirement of humane treatment of animals.

The order of each scientific experiment involving human should be recorded in detail in the form of a protocol. The protocol is a specially appointed ethics committee to consider watching, preparing comments, make recommendations and, if necessary, approval of a protocol. The ethics committee operates independently of the researchers, sponsor ditch and from outside influence in any other form. Committee's work is structed in accordance with applicable laws and regulations of the country in which the experiment is conducted. The ethics committee empowered to conduct ongoing monitoring of clinical trials. The researcher must submit to the ethics committee of the progress of works, especially when there are serious side effects Comrade. In addition, the investigator must submit to the ethics committee information concerning the sponsors of the order of financing Conference on Financing, branches, research institutions, as well as by conflicts of interest and ways to encourage participation scientific research.

The protocol must necessarily contain a statement under confirmatory ethical principles, and an indication that the work will be conducted in full accordance with the provisions of this Declaration.

Medical research involving human subjects may be pro made only by persons possessing the necessary scientific training, and supervision of medical staff specialists in the region of clinical medicine. Responsibility for the lives and health of the participant research is always a medical specialists, and not on the face of participating in the study, despite the fact that the person gave consent to participate in the study.

Each medical research project must be laborious work on a detailed assessment of the predictability risk factors and the stress on a person involved in the investigation, in comparison with foreseeable benefits to the participant research and for other patients. This provision does not exclude denotes participation in scientific research in healthy volunteers good. The order of the research should be available for public inspection.

Physicians should abstain from engaging in research projects experiments with human participants, unless they are confident that the risks associated with their implementation, have not been properly assessed and that the management of rice can not be implemented effectively. Physicians should cease any investigation if, in his view, the risks associated to the study, is too large compared with the in positive result or if there is clear proof of to achieve a favorable and positive results.

Medical research involving human subjects conducted only if the relevance of the goal justifies the possibility risks and burdens on the people involved in the study. This provision is particularly important with respect to healthy volunteers, involved in research.

Conducting medical research is justified only under the condition that people involved in its conduct, can benefit from the outcomes.

Persons engaged in medical research, must be voluntary and informed the researcher electric project.

Must respect the right of persons participating in the study, to protect their own interests. Should take all necessary measures to protect the privacy of members of the scientific research sequence, the confidentiality of patient information and to minimize the impact of research on the physical and integrity of the party as well as protect their rights as individuals.

When conducting any medical research each of its potential participant must be adequately inform on the purposes of scientific research, the methods used, sources of financing , potential conflicts of interest, links to other scientific institutions, about the anticipated benefits and possible risks GOVERNMENTAL related to the research, as well as the work with which the participant may encounter in the course of the study. Participants in the study should also be made aware of the fact that he has the right at any time refuse to participate and to withdraw previously given consent to participate in the study without negative consequences for him. After the doctor to make sure that potential participants understand and took note of this information, from the participant should obtain voluntary and informed consent, preferably in writing. If agreement can not be submitted in writing, you can get an oral agreement this which should be documented in the presence of witnesses.

When obtaining informed consent from participant research physician should be particularly careful in the case, if the study participant is dependent on him and if he can give consent under duress. In such a case, tea party's consent must be obtained by other knowledgeable physician not involved in the investigation and do not have any relation to this research participant.

If the study participant has been declared incapacitated by law, us to minors or not capable of giving consent because of their physical or mental condition, the researcher necessarily obtain informed consent of his legal representative in accordance with applicable law. Such members are not involved in research if the medical investigation not directed at improving their health and if the medical research can be conducted with the assistance of able-bodied participants.

If the person incapable by law, for example, a minor, unable to give consent to participate in the study, researchers loops must obtain the consent of that person in addition to the consent of his legal representative.

Research involving persons whose consent is not possible for obtain (including the consent of a legal representative or with says this in advance) may be conducted only if the physical or mental condition that prevents obtaining informed consent is a necessary characteristic of the research group of individuals. Specific reasons for bringing to study of Persons with states that do not allow us to obtain integral molded consent should be stated in the protocol used sequence, which is submitted for consideration and approval of the Ethics Committee. The protocol should specify that the consent to participate in the study will be obtained as soon as possible on the subject or his legal representative.

Authors and publishers of publications have ethical obligations.

When publishing results of research the authors are required to report accurate and reliable information on the results. Both positive and negative results of studies should be published or presented in a public form. The publications hould also give information on funding sources, branches, research institutions and about possible conflicts of interest. Reports of experimental studies that do not meet the principles of this Declaration should not be accepted for publication.

Additional principles concerning the medical research conducted in conjunction with medical care.

The doctor may conduct medical research at the same time

with medical care only insofar as this study is justified in terms of its contribution to the prevention, diagnosis and treatment of diseases. In conducting medical theoretical studies in conjunction with medical care, additional standards apply to protect the integral of patients participating in studies.

Positive results, risks, burden on the subjects and the effectiveness of the new method should be evaluated in comparison with the most advanced to date methods of prevention, diagnosis and treatment.

Upon completion of the study, every patient should forget party granted access to the best methods of preventive, diagnostic and therapeutic services, identified by the study doctor is obliged to fully inform the patient about those of medical care, which have relation to the investigation. Patient refusal to participate in research under any circumstances should not affect the relationship between doctor and patient. In the absence of proven methods of prevention, diagnostics and treatment or for their lack of effectiveness, the physician may, after obtaining informed consent from the patient apply untested or new prophylactic, diagnoustical, and therapeutic measures, if in the opinion of the doctor, they give hope to save the life of the patient, the restoration of his health or alleviating the severity of the disease. If possible, these measures should be the goal of research aimed at assessing the safety and effectiveness. In all such cases, the new information received must be documented over and under excitation possibilities, is published. It should be guided by other relevant principles of this Declaration.

The final control of knowledge

1. What is epidemiology?

2. What is called public health?

3. What is the significance of social epidemiology?

4. Protecting the rights and dignity of the human clinical trials and medical practice?

5. What are the fundamental principles of any scientific research?

6. What are the fundamental principles of conducting research in children, pregnant and nursing mothers?

7. What are the fundamental principles of conducting research involving persons with mental and behavioral disorders ?

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