If it were not for human testing, we would never have developed cures for many dangerous diseases. Similarly, if we hadn’t done dangerous testing, we would never have had a number of beneficial technologies. Therefore, there is a tolerable risk that allows such dangerous acts to be carried out with impunity. In this article, we will look at exactly what permissible risk means and what conditions must be followed.
Permissible risk is one of the circumstances precluding unlawfulness. It is a situation in which an act that might otherwise be considered criminal is justified by certain circumstances that are set out in the law.
Imagine, for example, a situation where you broke someone’s car window to get inside. That, without context, would clearly be an unlawful act. However, given the circumstances of the act, it would not be a criminal offence – the car is parked by a clearing in the sun and the temperature in the shade reaches 30 degrees, there is a child locked in the car, you do not have your phone with you and there is no one around to help.
In total, there are five types of circumstances precluding illegality:
Tip: Read about the other circumstances precluding illegality in our article.
Permissible risk gives professionals in the course of their work the opportunity to act in a way that may jeopardise or violate an interest protected by criminal law. However, this conduct is only permitted if it is sufficiently beneficial to society, if the persons at risk have consented and if there is no other safe way to achieve the same positive outcome. Such conduct will not be considered a criminal offence if the person acted on the basis of the knowledge and information available at the time.
The following conditions must be met for an act to be considered a tolerable risk :
The conduct must be aimed at achieving a positive result that benefits society as a whole. This may include, for example, scientific research that will bring people a cure for a dangerous disease, new technology, etc. Actions must therefore be motivated not just by personal gain but by socially beneficial goals.
Example: The development of a vaccine against a dangerous virus, such as SARS-CoV-2 causing COVID-19, required rapid testing in human volunteers to make the vaccine available to the public as quickly as possible. The risk of side effects was present, but the societal benefit of protecting against a pandemic was extremely important.
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This condition emphasises that an action that involves some risk is only permissible if there is no other way to achieve the same beneficial result without risk. In other words, a person should consider other, safer courses of action before taking a risky course of action.
Example: In engineering development, for example, when developing new types of aircraft engines, it is often necessary to conduct tests under extreme conditions that pose a risk. If there is no other way to test the engine under these conditions, this risk is considered acceptable.
Acceptable risk applies to persons acting within the scope of their occupation, profession, position or function. This means that their actions are part of their professional duties, whether they are doctors, scientists or other professionals.
Example: A doctor who performs experimental surgery is acting within the scope of his or her expertise. He or she must carefully assess the risks and benefits of the procedure and decide whether the surgery is in the best interests of the patient.
This means that the higher the risk, the more significant the expected societal benefit must be. If the risk is high but the benefit is only marginal, the action cannot be considered acceptable.
Example: When developing a new medical technique, such as transplanting organs from genetically modified animals into humans (xenotransplantation), there is a significant risk of failure or adverse reactions. However, if the procedure offers the possibility of saving a human life where no other options exist, this risk is considered acceptable.
If an action threatens the life or health of a specific person, that person must consent to the action. This consent must be informed, which means that the person must be fully aware of the risks and consequences of the action.
The consent must be in accordance with other legal provisions. This means that even if the person consents, the conduct must not violate other legal standards that would preclude or limit that consent. For example, consent cannot be given by a person under the age of 18 or by an insane person.
Example: A patient participating in a clinical trial of a new medicine must be informed of the possible risks and side effects. Only after this informed consent can he/she be included in the trial.
Tip: Read about the two most common types of circumstances that exclude illegality – necessary defence and extreme emergency.
Conduct must not be inconsistent with the principles of humanity, which means that it must respect the fundamental human rights and dignity of all persons involved. Any cruel, inhuman or degrading treatment is unacceptable.
Conduct must also be consistent with the generally accepted moral and ethical standards of society. This means that it must not be contrary to the public interest, must be carried out with respect for human dignity and should not contravene normal moral standards.
Example: the dignity and rights of patients must be respected in the development of new treatments. Any experiment that would lead to the unethical treatment or humiliation of patients would be unacceptable, even if it had the greatest potential to bring about scientific progress.
Actions must be consistent with the current state of scientific, technical or other expert knowledge available at the time. The person must have access to this information and apply it correctly to the situation he or she is addressing.
This also means that if, in the course of the research, new knowledge emerges that poses a higher risk, the researcher is not responsible for it because he or she did not know about it beforehand. Therefore, it is still an acceptable risk in this case.
Example: If an engineer designs a bridge based on the technical standards and scientific knowledge in force at the time, but it later turns out that better but unknown technologies existed at the time, the engineer is not liable for risks that were not known at the time.
Permissible risk allows professionals to act in a way that might normally be criminal if the specific circumstances justify such action. Key conditions include social utility, impossibility of achieving the result otherwise, professional conduct, proportionality of risk to benefit, informed consent of persons at risk, respect for humanity and ethical standards, and acting on the basis of contemporaneous knowledge. This concept ensures that risky activities are carried out responsibly and with the best interests of society in mind, while protecting the basic human rights and dignity of all involved.
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