Ethical Review of Biomedical Research

4.1. Legal regulations protecting the security of the individual

Man, family, society, state, being a product of the long evolution of life on Earth, are governed by the laws of Nature and the laws of social (social) life. The experience of the development of mankind shows that the violation of the latter, as well as attempts to change them arbitrarily, sooner or later lead to chaos and decline, while taking into account and observing the laws is a condition for order and progress. The balance of all levels of interpersonal relations is achieved where and when three groups of social regulators operate in a coordinated and unswerving way – moral norms (“internal” regulators), moral norms (“public” regulators), norms of law (state regulators).

The fundamental difference between legal norms and norms of morality and morality is the general obligatory nature of legal norms, their establishment by the state and its protection by coercive force. The need to distinguish from all social norms – legal norms – is due to the historical experience of mankind, which has shown that in the life of society it is necessary to determine and control three main types of social behavior – people’s actions are unacceptable, actions are mandatory and actions are recommended (possible, permissible). The criterion for attributing this or that act to one of the three groups is the extent to which it contributes to the survival of the human community as a whole, since this is precisely the condition for the survival of individual individuals or their groups. Even before the emergence of the state and written law (legislation), some actions of people were prohibited as dangerous to the clan (for example, closely related incest threatening degeneration or the murder of a relative), others were considered mandatory (like the submission of ordinary members of the tribe to the leader or the need to share booty), others were encouraged (good hunting skills and efforts to pass them on to others). It was noted that the predominance in the actions of the members of a particular tribe of actions that are mandatory and recommended over forbidden (dangerous) contributed to its survival and development. Other tribes whose members acted without regard to these rules disappeared, becoming more vulnerable to external and internal dangers. It took many centuries for the “classification” of prohibited, obligatory and recommended human actions to acquire a harmonious form and become a necessary element of the daily life of society. Rules of law, their recognition, observance, protection and improvement have become guarantors of the effective survival and development of the entire human society. The three basic branches of law present in the legislation of any country – criminal, administrative and civil – are today a systematic presentation of hundreds and thousands of types of prohibited (criminal law), mandatory (administrative, state law) and permitted (civil law) behavior of citizens, legal entities, the state . If, on the threshold of the third millennium, we try to define in one word the group of states that have achieved the greatest humanitarian and technological progress, providing their citizens with the most favorable conditions for life and development, then this word will be “legal”. Just as the harmony of Nature is conditioned by the steady implementation of its laws, so the harmony of the modern state cannot be achieved otherwise than by the steady observance by all its subjects of the laws of social functioning, identified by millennia of social practice and now enshrined in the form of norms of national and international law.

So, from the generally accepted point of view, the rule of law is a legally enshrined (and therefore recognized, observed and protected by the state) instrument of ensuring security, primarily the personal security of a person. The rules of law in force in medical care are designed to ensure the personal safety of citizens who come into contact with the health care system.

Bearing in mind the interdisciplinary nature of bioethics, it is necessary to consider the relationship between ethics and law, since the legal status of a doctor and a patient, the degree of their legal protection often greatly influence the solution of emerging ethical problems. Unfortunately, not everything that is ethical is legal, and vice versa, not everything that is legal is ethical.

An important aspect in the relationship between a doctor and a patient in the course of providing medical services and in the process of research activities is legal responsibility . Legal responsibility should be understood as the obligation to be responsible for one’s professional actions in accordance with the current legislation, which requires, first of all, knowledge of the legal framework. On the one hand, this knowledge allows the doctor to ensure his protection in specific situations, for example, in certain kinds of conflicts with patients, on the other hand, it allows him to realize the imperfection of the law to resolve ethical issues in some situations, which are called incidental situations .

Health care plays an extremely important role in people’s lives. The rights enshrined in legislative acts in the field of life and health are fundamental human rights. That is why state and public mechanisms for guaranteeing the protection of these rights are in the center of attention of the world community.

At the international level, ethical and legal regulation in the field of bioethics is carried out on the basis of international normative documents . The system of legal regulation expresses the principles of both the therapeutic activity of the doctor and the participation of the doctor in research activities – in biomedical research.

The problem of ethical and legal regulation of biomedical research is dealt with by a number of international organizations: the UN, UNESCO, WHO, the Council of Europe, the European Union, the WMA, the International Council of Medical Scientific Societies (CIOMS), etc. The documents adopted by these organizations play an important role in determining the norms and rules of biomedical research. research.

In almost every area of biomedical research, the world community has developed its own point of view, which is reflected in the following international legal acts:

“Universal Declaration of Human Rights” (UN, 1948);

“Declaration of Geneva: International Medical Oath” (World Medical Association – WMA, General Assemblies 1948, 1968, 1983);

Declaration of Helsinki (WMA, General Assemblies 1964, 1975, 1983, 1989, 1996, 2000);

“International Code of Medical Ethics” (WMA, General Assemblies 1949, 1968, 1983);

“International Guidelines for the Ethics of Biomedical Research Involving Humans” (CIOMS, Geneva, 1993);

“Declaration to promote the rights of patients in Europe” (WHO, 1994);

“Guidelines for Good Clinical Practice”, prepared by the International Conference on Harmonization (ICH GCP, 1996);

“Convention for the Protection of the Rights and Dignity of the Person in Connection with the Application of Biology and Medicine”, adopted by the Council of Europe (1997) with subsequent “Additional Protocols”;

“Universal Declaration on the Human Genome and on Human Rights” (UNESCO, 1997);

Recommendations to Ethics Committees Reviewing Biomedical Research (WHO, 2000);

“Universal Declaration on Bioethics and Human Rights” (UNESCO, 2005) and a number of other documents.

Modern ethical and legal norms for conducting research with human participation are based on the provisions of the Nuremberg Code , adopted in 1947. For the first time, it demanded the informed consent of the subject to the experiment, the possibility of refusal and exit from the study at any stage, minimizing the risk to the patient, presented qualification requirements researcher.

The rational basis underlying most of the rules existing today regarding clinical trials involving humans was originally formed by philosophical thought of various directions, starting with classical philosophy. Particular attention is paid to it in the works of I. Kant on ethics based on natural necessity and the categorical imperative (“Fundamentals of the Metaphysics of Morality”).

However, a code of ethics for human research was developed only after the Second World War, when humanity was confronted with the clinical experiments of Nazi doctors on concentration camp prisoners, with the purely utilitarian (research effectiveness) justification for such experiments, and with the fact that these methods were used everywhere. This code, later called the Nuremberg Code, consists of ten (initially six) articles that define what constitutes legitimate research .

The first article of this code clearly states that the voluntary consent of a person is a fundamental condition . She defines consent – in the spirit of liberal philosophy and political theory – as “voluntary” if and when the person involved in the study as a subject:

· is able and has the right, according to the law, to give such consent;

· has the ability to exercise free choice and not be influenced by any elements of violence, deceit, fraud, cunning or other hidden forms of pressure or coercion;

possess knowledge sufficient to understand the essence of the experiment and make an informed decision.

The latter requires that before making an affirmative decision about the possibility of his participation in a particular experiment, the subject should be informed:

about the nature, duration and purpose of this experiment;

about the methods and methods of its implementation;

about all the expected inconveniences and dangers associated with the experiment,

· about the possible consequences for the physical or mental health of the subject, which may arise as a result of his participation in the experiment.

Despite the fact that the Nuremberg Code played a large role in the departure from the research practice of Nazi doctors, its legal status is still unclear. In medical research around the world, its principles are violated more often than they are respected. It is seen as something reserved for “bad doctors” and “good doctors” never engage in nasty practices.

If we look at how things stand with free choice (“has the ability to exercise free choice and not be influenced by …”) in research in the first half of the 20th century, and even post-war, it becomes obvious that the ethical principles of medical research are too often not respected. . Thus, all over the world, clinical studies and experiments are carried out on people in a helpless situation, without their knowledge and any benefit for them (the use of prisoners, incapacitated or mentally disabled people and even the general population, unaware that they are test subjects).

After the adoption of the UN Universal Declaration of Human Rights in 1948, the European Convention for the Protection of Human Rights and Fundamental Freedoms of 1950 and the implementation of their principles in national legislation and legal practice, the ideas of good clinical research and practice began to make their way into the national legislations of various countries, international medical forums and procedures of pharmaceutical companies.

In 1964, the International Medical Association adopted what is now, in its latest version, the standard for all discussion of research ethics and good clinical practice, the Declaration of Helsinki (Recommendations for Physicians Conducting Biomedical Research Involving Humans). The Declaration has been repeatedly revised in connection with the progress of the biomedical sciences and the expansion of the scope of research, as well as the development of the institution of ethical review of research projects. The latest version of the Declaration was adopted in 2000. Its main provisions have been embodied in the national legislations of a number of countries.

As you know, the goal of doctors is to protect people’s health. This means that the conscience of doctors also serves for the benefit of the implementation of this mission. The main postulate of the Declaration: “The health of my patient is my main concern.” Therefore, “the doctor, providing medical care that can subsequently alleviate the physical and mental condition of the patient, must act in the interests of the patient.”

According to the Declaration of Helsinki, biomedical research on humans should be based on the results of animal experiments and scientific literature data, should be carried out by qualified medical researchers, and the approval of the Ethics Committee must be obtained on the basis of providing it with full information about the study and its access to monitoring the progress of the study. . The physician is always responsible for the state of health of the subjects, regardless of whether the patient voluntarily consented to the experiment, the benefits and risks of the experiment should be comparable, but if the risk exceeds the potential benefits for the patient, the experiment should be stopped, since the interests of the subject always remain above the interests of science. The responsibility of the experimenter for the accuracy of published materials and observance of the rights of the subjects, the obligation to publish both positive and negative results, the protection of persons who are not able to give their consent to the study by obtaining such consent from legal representatives with the approval of the patients themselves are provided.

The document requires that benefits be obtained by those groups or populations in which this study was conducted, defines the amount of information provided to the patient for obtaining informed consent, regulates the use of placebo only in cases where there are no effective methods of prevention, diagnosis and treatment with which to compare it would be correct. The scope of ethical regulation, according to this document, extends to biomaterials of human origin and to personal data about the patient.

International legislation includes the definition of a number of terms that a physician must be familiar with when carrying out research activities, for example, be able to distinguish between medical practice and research, and when conducting research, understand the difference between therapeutic (clinical) research and non-therapeutic biomedical research involving people (non-clinical biomedical research). ).

The ethics of the experiment is also indirectly determined by such WMA documents as the Geneva Declaration (1948), the International Code of Medical Ethics (1983), the Twelve Principles for the Provision of Medical Care in any National Health System (1983), according to which the doctor undertakes to follow the ideals of humanity, conscientiously and with to fulfill his duty with dignity, to act only for the benefit of the patient, not to cause harm, in the interests of the patient to prescribe any treatment that is adequate from the point of view of modern standards. The WMA Declaration on the Human Genome Project (1992) sharply raises the question of the ethical and legal aspects of experiments. After gene mapping, when ways were opened for understanding genetic pathology and their possible prevention, the question arose of the possibility of using genetic information for non-medical purposes, discrimination in health insurance and employment, and the threat of eugenics. The medical community stands up for the protection of confidentiality of information, requires research to be carried out only on the basis of the full knowledge of patients and voluntary informed consent.

The legal instrument governing biomedical research is the Council of Europe Convention for the Protection of the Rights and Dignity of the Human Being with regard to the Use of Biology and Medicine, the Convention on Human Rights and Biomedicine, adopted in Oviedo (Spain) in 1997. For the sake of brevity, it is often called the Convention on bioethics.

This document is obligatory for execution by all members of this organization after its ratification. It contains provisions prohibiting research on human embryos (an additional protocol of 1998 prohibits human cloning), requiring careful treatment of the human genome (prohibition of discrimination based on genetic characteristics, restriction of intervention in the human genome only for preventive, diagnostic and therapeutic purposes and subject to conditions for the preservation of the genome of the heirs of a given person, the prohibition of choosing the sex of the unborn child, except when this is done to prevent the inheritance of a disease associated with the sex), as well as prohibiting the trade in organs and parts of the human body, the tactics of the behavior of a doctor who, in an emergency (emergency ) situation cannot obtain the consent of the patient or his representative for medical intervention, namely, action in the best interests of the patient, taking into account the wishes expressed by him in advance.

In the Republic of Belarus, a system of legal documents is also being created, which expresses the basic principles and norms of bioethics, including the ethics of biomedical research. This is reflected in the following documents:

1. Constitution of the Republic of Belarus (Articles 21, 24, 25, 45,46, 47)

2. Laws:

  • “On Health Care” (dated June 18, 1993 as amended by the Law of the Republic of Belarus of June 20, 2008)

· “On sanitary and epidemic well-being” (dated May 23, 2000 No. 397-З) ;

· “On medicines” (dated July 20, 2006 No. 161-З);

  • “On the donation of blood and its components” (dated January 31, 1995);
  • “On psychiatric care and guarantees of the rights of citizens in its provision” (dated July 1, 1999);
  • “On the safety of genetic engineering activities” (dated January 9, 2006);
  • “On transplantation of human organs and tissues” (dated March 4, 1997);
  • “On Amendments and Additions to the Law of the Republic of Belarus “On Transplantation of Human Organs and Tissues” (dated January 9, 2007), etc.

3. Bylaws:

Resolutions of the Council of Ministers of the Republic of Belarus “On the procedure for organizing work with citizens in the Ministry of Health and state healthcare organizations for issuing certificates or other documents” (dated 14.12.2005 N 1450); Ministry of Health of the Republic of Belarus “On the procedure for informing the population about the provision of medical care in healthcare organizations and on the procedure for referral for examination and treatment” (November 2, 2005 N 44); Ministry of Health of the Republic of Belarus “On Approval of the Model Internal Regulations for the Organization of Health Care for Patients” (dated June 14, 2002 No. 32), which determines the need for a respectful attitude towards medical personnel (if a patient violates internal regulations, this may be the basis for his discharge , although a day later, doctors are required to accept this patient so as not to violate his constitutional right to life); Ministry of Health of the Republic of Belarus “On approval of the Regulations on the procedure for holding consultations (conciliums) in healthcare organizations of the Republic of Belarus” (dated June 21, 2002 No. 34).

Instructions: for example, “Instruction on the procedure for sending citizens for examination and treatment” (2005), “Instruction on accreditation of healthcare institutions and certification of specialists for the right to conduct clinical trials of medicines, medical equipment and medical devices” (2004).

· Orders: for example, Order No. 254 of the Ministry of Health of the Republic of Belarus “On Approval of the Rules for Conducting Clinical Trials of Medicinal Products” (1999).

· methodological recommendations: for example, the methodological recommendations of the Ministry of Health of the Republic of Belarus “On the organization and work of the ethics committee” (2000).

4. Codes: labor , civil , administrative and criminal liability . The Code of Medical Ethics , approved in 1999 at the 1st Congress of Doctors of the Republic of Belarus, contains the rules of medical ethics and deontology, reflecting the principles of medical activity and the relationship between doctors and patients, and is based on the Law “On Health Care” of the Republic of Belarus. For physicians engaged in scientific activities, Section V “The Physician and the Progress of Medicine” is significant. The articles of this section of the code reflect the imperatives of conducting biomedical research, in which the object of research is a person. It should be noted that control over the execution of these articles is essentially entrusted to state bodies whose powers include the examination of biomedical research and their conduct, namely the Center for Expertise and Testing in Healthcare, ethics committees (local committees) at healthcare organizations accredited for the right conducting such tests, as well as ethical committees based on some institutions of the medical education system (for example, BSMU and BelMAPO). Public control over compliance with ethical norms and rules in the performance of work related to the participation of a person as an object of clinical trials is provided by the National Bioethics Committee established in April 2006 under the Ministry of Health of the Republic of Belarus.

5. Medical Oaths. How should a doctor treat legal and moral standards in his professional activities? Perhaps the most important thing is to observe the Hippocratic oath, because laws come and go, the socio-political structure of the state can change many times, and the medical oath and medical humanistic morality have been, are and will be.

The Hippocratic Oath says:

“I swear by Apollo the doctor, Asclepius, Hygia and Panacea and all the gods and goddesses, taking them as witnesses, to fulfill honestly, according to my strength and my understanding, the following oath and written obligation: to consider the one who taught me the medical art on an equal footing with my parents, to share with him with his wealth and, if necessary, help him in his needs, consider his offspring as their brothers, and this is an art, if they want to study it, to teach them free of charge and without any contract, instruction, oral lessons and everything else in the teaching to communicate to their sons and sons of his teacher and students bound by circumstance and oath according to medical law, but no one else.

I will direct the regimen of the sick to their advantage, according to my ability and my understanding, refraining from causing any harm and injustice. I will not give anyone a lethal drug that I ask for, nor will I show the way for such a design, just as I will not give any woman an abortifacient pessary. Purely and undefiled I will conduct my life and my art. Whatever house I enter, I will enter there for the benefit of the sick, being far from everything intentional, wrong and harmful, especially from love affairs with women and men, free and slaves.

So that during treatment (and also without treatment) I may not see or hear about human life, from what should never be divulged, I will keep silent about that, considering such things a secret. To me, who inviolably fulfills the oath, may happiness be given in life and in art, and glory to all people for eternity, but to the one who transgresses and gives a false oath, let it be the opposite!

It follows from the text of the oath that by introducing five key professional ethical requirements that are undoubtedly necessary in medical practice ( do no harm, keep the secrets entrusted to you, consult and help colleagues, remain morally pure, do not help the murder of the living ), it has the character of a tripartite deal: the doctor-Gods- professional community. Accordingly, in cases of its violation, responsibility will come (a) from the Higher Forces, to whom the oath was given, (b) in the form of condemnation from colleagues and (c) in the form of dishonor among healthy people and patients. As centuries-old experience has shown, this scheme of relations is quite reliable.

Subsequent codes and obligations of doctors, in essence, preserved and consolidated the main provisions of the Hippocratic Oath. Thus, the Oath of the Doctor of the Republic of Belarus says:

“Receiving with deep gratitude the title of doctor bestowed on me by medical science and practice, I swear before my teachers and colleagues:

– at any time to help every patient, regardless of his social origin, religion and nationality;

– always keep professional secrecy;

– constantly improve their medical knowledge and medical art, promote the development of medical science and practice with their work;

– apply, if the interests of the patient require it, for advice to their colleagues and never refuse them advice and assistance;

– to preserve and develop the noble traditions of domestic medicine;

– always remember the high calling of a doctor, the responsibility to the Belarusian people and the state.

I promise to carry fidelity to this oath through all my life.

Be First to Comment

Leave a Reply

Your email address will not be published.