Clinically trialed objects in medical examination and treatment in Vietnam

Clinically trialed objects in medical examination and treatment in Vietnam

Pursuant to Article 94 of the Law on Medical Examination and Treatment 2023, clinically trialed objects include:

- New healthcare techniques or methods.

- Medical equipment that is ranked highly above-average or high in the risk rating adopted by the Government before being registered for free sale in Vietnam.

Conditions of participants in clinical trials in healthcare in Vietnam

Pursuant to Article 95 of the Law on Medical Examination and Treatment 2023, Conditions of participants in clinical trials in healthcare are stipulated as follows:

- Persons who meet the professional requirements of a clinical trial of new technique or method, medical equipment in use in medical examination and treatment activities (hereinafter referred to as clinical trials) and voluntarily participate in clinical trials.

- In order to participate in a clinical trial, the participant who is a person who loses his/her capacity to perform civil acts, has impaired cognition or difficulties in behavior control or limited capacity to perform civil acts; the minor patient shall be required to seek the consent from his/her representative or guardian under civil law.

- If the participant in a clinical trial is the one specified in clause 2 of this Article above; a pregnant or lactating woman, the research profile shall need to clarify reasons for recruitment and proper actions for protection of the participant, unborn babies or the infants who are being breast-fed by the mother participating in the clinical trial.

Clinically trialed objects in medical examination and treatment in Vietnam (Internet image) 

Rights and obligations of participants in clinical trials in Vietnam

Pursuant to Article 96 of the Law on Medical Examination and Treatment 2023, rights and obligations of participants in clinical trials are as follows:

- A participant in a clinical trial shall reserve the following rights:

+ Have access to full and accurate information about the clinical trial and potential risks before the clinical trial is initiated;

+ Receive any compensation for any damage caused by the clinical trial;

+ Have the confidentiality of his/her personal information relating to the clinical trial protected;

+ Gain exemption from any liability when unilaterally terminating his/her participation in the clinical trial;

+ File complaints, denunciations or take legal actions against any violation of laws committed by entities or persons whose new techniques, methods or medical equipment need to be clinically trialed.

- Participants in clinical trials shall be obliged to comply with the instructions specified in the approved clinical trial profiles.

Rights and responsibilities of testing bodies in Vietnam

Pursuant to Article 98 of the Law on Medical Examination and Treatment 2023, it stipulates the rights and responsibilities of testing bodies as follows: 

- Testing bodies shall reserve the following rights:

+ Take steps in accepting conduct of clinical trials in accordance with law;

+ Import and purchase chemicals, reference materials, specimens of medications and medical equipment needed for a clinical trial;

+ Use findings from a clinical trial in accordance with entities and persons whose new techniques, methods or medical equipment need to be clinically tested.

- Testing bodies shall assume the following responsibilities:

+ Take responsibility for the completeness, accuracy and reliability of clinical trial findings;

+ Bear responsibility for the safety of clinical trial participants and compensate them for any risk that they may incur through the testing body’s fault in accordance with laws;

+ Ensure authenticity and objectivity during a clinical trial.

Mai Thanh Loi

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