In the twentieth century, scientific progress has, on the one hand, undoubtedly contributed to increased prosperity and improved the health of humanity. On the other hand, however, scientific activity was a source of frequent violations of human rights. It was mainly the dramatic experiences of this period that forced humanity to rethink its approach to bioethical issues. On the wave of these events, a number of international agreements and national acts were created to regulate when, who can conduct and be subjected to medical experiments, and on what terms. In Poland, legal regulations concerning this matter can be found in the Act on the Profession of Physician and Dentist, the Helsinki Declaration regulating clinical research, the Penal Code and the Constitution of the Republic of Poland.
What is a medical experiment
The concept of scientific experimentation appears in Article 39 of the most important act in force in our country. The Constitution categorically prohibits any experimentation on anyone who has not given his or her voluntary consent. The provision emphasises that this also applies to medical experiments.
Paweł Sarnecki, in his commentary on the Constitution edited by Professors Lech Garlicki and Marek Zubik, writes that: A scientific experiment can be considered to be the induction of a specific human behaviour by artificial means in order to determine the course of that behaviour, its effects and, in particular, to verify certain research hypotheses. A medical experiment consists of inducing such behaviour by interfering with human physiological processes. Experiments, whether medical or non-medical, must never contain a deliberate risk of negative consequences for those subjected to the experiment. A medical experiment is therefore anything that goes beyond routine medical procedures.
We can divide medical experiments into therapeutic and research experiments. The aim of the former will be to improve the patient's condition or to make an appropriate diagnosis. The Law on the Profession of Physician and Dentist describes them as: the introduction of new or only partially tested diagnostic, therapeutic or preventive methods with the aim of achieving a direct benefit to the health of the person affected. It can be carried out if the methods used so far are not effective or if their effectiveness is not sufficient. This category includes, for example, administering medication and undergoing medical treatment.
A research experiment, on the other hand, is intended to advance medical knowledge. The law mentions that it can be carried out on both a sick and a healthy person. Here, in addition to the classic scientific experiments performed at universities, all tests of drugs and other substances that may later be administered to patients should also be included.
It is also a medical experiment to carry out tests on biological material, including genetic material, taken from a person for scientific purposes.
The performance of an experiment is, in criminal law, one of the circumstances exempting an act prohibited by a criminal statute from illegality. Under this branch of law, it is very strongly emphasised that in order for an action to be considered a medical experiment, it is necessary that the expectation of achieving a substantial benefit, the advisability and the manner of carrying out the experiment are reasonable in the light of the current state of knowledge.
- Pillar writes that: any action taken by a medical practitioner during a therapeutic experiment must of course, as in the case of any other non-experimental therapeutic act [...] be performed at the level required by the rules of medical science and their performance is assessed in this context on a general basis.
Commentators also emphasise the need for an appropriate balance between expected benefits and risks. As a rule, the potential improvement in the condition of the person undergoing the experiment, or the increase in knowledge, should outweigh what the person risks. The Medical and Dental Professions Act puts it as follows: Conducting a research experiment is permissible when participation is either risk-free or the risks are minimal and not disproportionate to the possible positive results of such an experiment.
With regard to the probability taken into account in assessing a particular situation, it is a popular thesis in dogma that when the expected benefit is very significant and the potential harm is small, the experiment is permissible, even if the probability of benefit is less than the probability of harm.
Another equally important requirement for an experiment to be considered properly conducted is the opinion of a bioethics committee. As M. Paszkowska notes: All acts of international and Polish law, referring to the issue of medical experimentation on a human being, make the admissibility of its conduct dependent primarily on the consent of the person participating in it. On the other hand, some of these acts, which constitute their more recent generation, also make the admissibility of a medical experiment conditional on the consent of another subject or subjects and, in particular, on a positive assessment of the project by a special ethics committee.
Patient consent and exceptions to it
As mentioned above, any experiment should be performed after obtaining prior consent from the experimental participant. This is the only requirement that the Constitution places before experiments. Consent must be preceded by the provision of precise information as to the nature, risks and expected results. This must be expressed in writing. According to the law, an experiment may not be performed on: a conceived child, an incapacitated person, a soldier and any other person in a hierarchical relationship limiting the freedom to freely give consent, and a person deprived of liberty or subjected to detention. Polish law recognises that the above groups must be given special care and that their exceptional situation does not allow any experiments to be conducted on them even they or their guardians have agreed to participate.
The situation of minors is regulated exceptionally, although not so strictly. Participation in a research experiment by a participant who is a minor is allowed when the following conditions are cumulatively met:
- the expected benefits are of direct relevance to the health of the minor subjected to the research experiment or other minors of the same age group;
- the research experiment will result in a significant expansion of medical knowledge;
- there is no possibility of conducting such an experiment with comparable effectiveness involving an adult.
In the case of exceptional situations, it is also possible to conduct an experiment without the consent of the participant. These exceptions will apply to therapeutic rather than research experiments. A total of six conditions must be met for this:
- the participant is incapable of giving his or her consent to take part in that experiment;
- there is a case of urgency and it is not possible, due to the need for immediate action, to obtain consent for participation in a therapeutic experiment from the legal representative of the subject or a court authorisation within a sufficiently short period of time;
- an experiment of comparable effectiveness cannot be carried out on persons not in a situation of urgency;
- the participant has not previously objected to participating in such an experiment;
- the participant in a therapeutic experiment conducted in a non-urgent situation and, if applicable, his or her legal representative shall be given all relevant information concerning participation in the experiment as soon as possible;
- authorisation to participate in the therapeutic experiment has been sought or granted by the court referred to in Article 25(7).
Bioethics Committee
According to the Act on the Profession of Physician and Dentist, the Minister of Health appoints Bioethics Commissions to independently control the clinical trials conducted. This means that each stage of a medical experiment should be approved and supervised by a Bioethics Committee. Bioethics committees can be established, among others, at hospitals and medical boards, etc. Persons with high moral authority, high specialist qualifications and significant experience in medical experimentation cases shall be appointed to the bioethics committee. Members of the bioethics committee are appointed by the district medical council, the rector of a university providing education in medical or health sciences, the director of a research institute supervised by the minister responsible for health matters or the director of an institute of the Polish Academy of Sciences belonging to the Faculty of Medical Sciences.
Finally, the Bioethics Committee issues an independent opinion at the request of the clinical research organiser, which is the clinical research administrator. The Bioethics Committee issues its opinions in the form of resolutions taking into account ethical criteria, the advisability of the project and the feasibility of the project.
Summary
In the modern world, doctors and scientists are bound by very strict requirements for conducting experiments on human beings. Due to the complexity of the matter, the legislator had to make use of general clauses when regulating experiments. A certain assumption can be made that the legislator, by using general clauses and indefinite phrases, assumes that it is the supervising authority that, in the event of any doubt, will decide whether something is a medical experiment and whether the experiment complies with the applicable legal status.
Aleksandra Sobisz-lawyer,
Stanisław Skrzypek- legal assistant
Kordowska Law Group, Rytel
Advocates and Legal Advisers sp.p.
The Network for Health project is implemented with a grant from the Active Citizens Programme - National Fund financed by Iceland, Liechtenstein and Norway through the EEA Funds..