The revised Code of Medical Ethics on genetic testing. There is a comment from the ethics committee

• The Medical Ethics Committee of the Supreme Medical Council presented its commentary on the amended provision of the Code of Medical Ethics regarding genetic testing
• The dynamics of development of this research is so great that it is necessary to take a position on many ethical issues or dilemmas related to conducting research on genes, genome and inheritance - the Commission pointed out
• Article 61 is based on the fundamental values ​​of medicine: respect for autonomy, biological integrity, patient safety and social justice.

Another commentary of the Medical Ethics Committee of the Supreme Medical Council on the amended KEL has been published, which concerns the issue of genetic testing. Article 61 reads:

1. A physician may only conduct genetic testing for health or related research purposes after obtaining the patient's informed consent and providing him with the opportunity for a genetic counseling.
2. A physician may intervene in the human genome only for preventive or therapeutic purposes.
3. A physician is not allowed to participate in activities aimed at causing heritable genetic changes in a human being.

As emphasized in the commentary, "the spectacular progress of molecular biology and the development of genetic research have created social, ethical and legal problems. The dynamics of the development of this research is so great that it is necessary to take a position on many ethical issues or dilemmas related to conducting research on genes, genome and inheritance."

The Commission also reminds us that genetic testing is becoming increasingly useful in the prevention, diagnosis and treatment of many diseases. Therefore, given the ever-increasing possibilities of determining the molecular etiology of diseases, detecting the carriage of genetic mutations in healthy individuals and genetic predispositions to certain diseases, providing competent genetic advice is the duty of a physician. The legal aspect concerning genetic testing is included in the "Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine".

"Tests predicting genetic diseases or tests that can be used to identify the carrier of the gene responsible for the disease, and tests that can detect genetic predisposition or susceptibility to a disease, may only be carried out for health purposes or for scientific research related to health purposes, and are subject to appropriate genetic counseling" - the Ethics Committee of the National Medical Council quotes the provision.

The provision of paragraph 1 of Article 61 emphasizes three conditions for the legality and ethicality of genetic research, namely:

• health or scientific purpose,
• informed consent,
• genetic consultation – in accordance with the guidelines of the Polish Society of Human Genetics, crucial for the interpretation of results and protection of the patient against erroneous self-assessment.

Thus, the cited provision is an expression of respect for the patient's autonomy and protection of their genetic privacy. The patient's informed consent must be preceded by full and understandable information about the nature and possible effects of the test. The obligation to provide genetic counseling is also reflected in the provisions of international law, and consultation before and after the test is crucial for the patient to be able to make an informed decision and understand the implications of the results obtained. This requires maintaining particular sensitivity and confidentiality.

At the same time, the provision of Article 61 paragraph 2 excludes genetic interventions for non-medical purposes (e.g. "improving" a human being), allowing them only when they serve to prevent or treat a disease. This is in line with applicable international standards.

Potential medical interventions in genetic material that may lead to changes in the genome are specified in Article 13 of the aforementioned Convention: "An intervention aimed at modifying the human genome may be carried out solely for preventive, therapeutic or diagnostic purposes and only if its purpose is not to induce heritable genetic changes in the offspring."

It should be noted that potential interventions in the genetic material of somatic cells may in the future potentially serve to reverse genetically damaged molecular pathways, and thus create completely new therapeutic possibilities. This provision limits the possibility of genetic interference to cases justified by the health interest of the patient - e.g. gene therapy in the treatment of rare diseases. However, it excludes eugenic actions that improve features unrelated to health (e.g. intelligence, appearance). This is an implementation of the principle of proportionality and non-interference in the biological integrity of a human being, confirmed, among others, in Article 13 of the Bioethics Convention - the Commission cites in the commentary.

In turn, paragraph 3 of Article 61 clearly prohibits interventions that may lead to genetic changes passed on to offspring (so-called germline editing), which is in line with widely accepted international standards (e.g. the position of WHO, UNESCO) and reflects the precautionary approach of medical ethics towards the irreversible effects of interference in the human germline. In addition, it means a ban on participating in experiments or procedures that aim to change hereditary DNA. As stated, this is crucial for maintaining public trust in medicine.

However, research on the modification of reproductive cells not intended for fertilization may only be conducted in vitro and after obtaining the approval of the appropriate ethics committee.

In its comments, the Commission also cited ethical principles in genetic counselling (WHO recommendations):

• Full respect for the rights of consulted individuals and families, including in the decisions they make, protection of their genetic data and the right to obtain full, accurate and objective information.
• Protecting family integrity.
• Providing individuals and families with full access to all their health information.
• Protecting individuals and families against unlawful actions by employers, insurers and schools.
• Informing individuals and families about the possibility of inappropriate use of their genetic data by other people and institutions.
• Raising the awareness of consultees about their moral obligation to inform their relatives about the likelihood of being exposed to genetic risk.
• Making the consulted person aware that concealing information about being a carrier of a gene mutation may have serious consequences for the planned marriage and that passing on this information to the spouse is particularly important in the case of planning children.
• Raising the awareness of consultees about their moral obligation to disclose their genetic disease if it poses a threat to public safety.
• Genetic counseling should include information presented in a way that is as objective as possible.
• Genetic counseling should be non-directive, except in situations where there is a possibility of treating the disease.
• Both children and young people should, wherever possible, participate in decisions that directly affect them.
• The counsellor has an obligation to re-contact the person or family whenever there are indications to do so.

Article 61 of the Code of Medical Ethics:

• is based on the fundamental values ​​of medicine: respect for autonomy, biological integrity, patient safety and social justice,
• refers to the most dynamically developing field of modern medicine – genetics, including gene therapy and molecular diagnostics,
• genetic test results must guarantee the confidentiality of the data obtained. They cannot be used for commercial or demographic purposes,
• Genetic knowledge may not be used for discriminatory purposes.

The guiding principle that must be remembered and followed in conducting research in the field of genetics and molecular biology is: "the interest and well-being of the human being prevails over the exclusive interest of society or science". This knowledge requires from the physician not only clinical awareness, but also ethical awareness, social sensitivity and knowledge of changing international standards - concluded the Medical Ethics Committee of the NRL.

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