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  6. Medical Experiment Violation Defense

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MedicalExperimentViolationDefense

Are clinical trials legal in Georgia?

Yes, clinical trials are legal but require approval from an ethics committee and adherence to strict protocols.

What if the patient signed but didn't know the risks?

If the patient was not fully informed about the risks, their signature is invalid, and the doctor will be held liable.

Can experiments be conducted on children?

Only in exceptional cases, with parental consent, and if the research directly benefits the child's health.

How can I protect myself as a researcher?

It is essential to maintain perfect documentation and strictly adhere to GCP (Good Clinical Practice) standards.

Reading Time

3 min

Published

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Conducting illegal biomedical research (related to Article 135 of the Criminal Code of Georgia concerning organ trafficking contexts, or general provisions on health crimes) is a highly specific offense violating fundamental bioethics principles. Medical experiments or clinical trials on humans are strictly regulated by international conventions and Georgian legislation. Any research conducted without the patient's informed consent, or where the risk exceeds the expected benefit, is prohibited. Charges can be brought against doctors, researchers, or pharmaceutical companies testing new drugs or methods on humans without appropriate permits and adherence to ethical standards. This crime poses a threat to human life and health, and consequently, penalties are severe.

What does the Medical Experiment Violation Defense service cover?

Medical law specialists offer qualified defense based on deep knowledge of bioethics and legislation. Services include:

  • Research protocol analysis: Checking whether the study was approved by an ethics committee and complied with international standards (GCP - Good Clinical Practice).
  • Informed consent evaluation: Determining whether the patient received full information about risks and whether their consent was voluntary.
  • Risk-benefit balance: Conducting medical expertise to prove that the intervention was intended to save the patient and was not merely an experiment.
  • Regulatory interaction: Appealing findings from the Ministry of Health and the Regulation Agency.

Common Real-World Scenarios

Charges may arise in the following situations:

  • Use of unapproved drugs: A doctor uses an experimental drug on a patient that has not undergone registration or clinical trial phases.
  • Lack of consent: A procedure is performed on a patient for research purposes without their knowledge that they are participating in an experiment.
  • Data falsification: Falsifying research results to prove drug efficacy, leading to patient health damage.
  • Exploiting vulnerable groups: Conducting experiments on children, prisoners, or individuals with mental health issues without proper safeguards.

Georgian Legal Framework

The main regulator is the Law on "Health Care" (Chapter XIX - Biomedical Research). Criminal liability arises when safety norms and patient rights are violated. Specific articles (e.g., Art. 135 or bodily injury articles) apply depending on the outcome. Human cloning or genetic engineering misuse is also prohibited under this category. Court practice considers the Helsinki Declaration and the Bioethics Convention.

Process and Stages

The defense strategy includes:

  1. Documentation audit: Reviewing all consent forms and ethics committee minutes.
  2. Expert testimony: Inviting field specialists to justify the scientific value and necessity of the method used.
  3. Court defense: Arguing that the action aimed to treat the patient rather than cause harm.

Why choose a specialist on Legal.ge?

Illegal medical experiment cases require not just a lawyer, but a bioethics expert. Legal.ge gives you access to professionals who can protect medical personnel and research organizations from unfounded accusations. Find a qualified defender on Legal.ge.

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