Clinical Research Law: The Participant's Legal Regime
The law of clinical research in Georgia, from the participant's side, is governed by the Law on Patient Rights: it is there that the entire machinery of informed consent regulating the use of a patient in research and teaching is written. One boundary must be drawn plainly: the organization of research, its phases and the ethics committee are subject to separate legislation — the subject of this page is the rights the patient holds under the law itself. The Declaration of Helsinki and the international standards of clinical practice are significant reference points, but non-Georgian: the participant's consent is carried by the Georgian law.
The anchor norm is Article 26: a patient's informed consent is necessary for the patient to be used as an object of teaching, and that consent precedes the use. The use of recipients of support and of minor patients in research is regulated by another law — like any medical intervention, it is lawful only where the machinery of consent is respected.
When Research Use Does Not Require Consent
The law names two exceptions where use for teaching purposes is possible without the patient's consent: first, information existing in the patient's medical documentation, where it does not allow identification of the patient; second, material obtained in the course of treatment and diagnostics — urine, blood, other tissues — where the patient's anonymity is ensured. Outside this boundary, any research use requires consent.
The practical question is always the same: can the data or the biological material be identified? If the answer is positive or doubtful, the full regime applies — information and consent; the degree of anonymization is precisely the technical boundary at which the responsibility of the medical institution and the researcher begins.
The Written-Consent List and the Right to Refuse
Article 22 sets the general rule: a mandatory condition of providing medical service is the informed consent of the patient — or, for a minor or a person unable to take an informed decision, of a relative or legal representative — and that consent precedes the service. Written consent is required by a defined list: any surgical operation, abortion, sterilization, catheterization of great vessels, hemodialysis and peritoneal dialysis, extracorporeal fertilization, transplantation of a human organ and the use of human tissue or cells, genetic testing, gene therapy, radiation therapy, chemotherapy of malignant tumors, transfusion of blood or its components, and every other case where the provider considers written consent necessary. A research intervention fits this logic as an intervention carrying additional burden.
Article 23 is the counterweight of consent: a patient who is capable and able to take an informed decision may refuse medical service at any stage of treatment and stop a service already begun; the patient must be exhaustively informed of the expected consequences of refusal or termination. For research this means the right to withdraw after joining is as lawful as refusal to join — and informing about the consequences is the provider's duty.
Prior Will and the Representative's Decision
Article 24 gives the patient the right of a prior written will: the patient may express consent or refusal today as to resuscitation, life-sustaining or palliative treatment to be conducted when unconscious or deprived of decision-making capacity, where that condition is caused by the terminal stage of an incurable disease or by a disease that will inevitably cause severe disability. The accompanying right is to nominate in advance the person who will decide when these circumstances exist.
Article 25 governs the cases where the decision belongs to another: where the decision of the relative or representative of a minor or incapable patient contradicts the patient's health interests, the provider may challenge it in court. In an emergency where the representative cannot be found and delay means death or significant deterioration of health, the provider decides in the patient's interests; the same rule applies where the representative refuses urgent assistance.
Frequently Asked Questions
Below we summarize the questions most often asked about clinical research and participants' rights. The law also regulates exceptions: the patient’s consent is not necessary where the study uses information from medical documentation that does not allow identification of the patient, or material obtained in the course of treatment and diagnostics in which the patient’s anonymity is ensured. The use of recipients of state support and of minor patients as study objects is referred to separate legislation, and the rules on consent to mandatory tuberculosis examination are governed by a special law.
Where does the lawfulness of research begin?
With informed consent: a patient may be used as an object of teaching only with consent, and the consent precedes the use.
When may data be used without consent?
Only where documentation information does not allow identification, or biological material is anonymous.
Can a participant leave a study?
Yes — the patient may refuse at any stage and stop a begun service, after exhaustive information about the consequences.
Who decides for an incapable patient?
A relative or legal representative; on conflict with the patient's interests — the court; in emergencies — the provider.
How We Help on Legal.ge
On Legal.ge we work with research organizers and participants alike: we audit consent forms, assess the degree of anonymization, draft information texts, and defend the participant's interests at every stage. Contact us — we will cover the legal side of your research in full.