What are the regulations on clinical trials? What are the principles and authority of approval of clinical trials in Vietnam?
Vietnam: What is a clinical trial?
Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.
Clinically trialed objects specified in Article 94 of the Law on Medical Examination and Treatment 2023 including:
- 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.
Participants in clinical trials in healthcare must fully satisfy the following conditions as prescribed in Article 95 of the Law on Medical Examination and Treatment 2023:
- 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.
What are the regulations on clinical trials? What are the principles and authority of approval of clinical trials in Vietnam? (Image from the Internet)
What are the rights and obligations of the parties participating in clinical trials in Vietnam?
(1) Participants in clinical trials have the rights and obligations specified in Article 96 of the Law on Medical Examination and Treatment 2023:
- 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.
(2) Rights and responsibilities of entities and persons whose new techniques or methods need to be clinically tested are specified in Article 97 of the Law on Medical Examination and Treatment 2023:
- Entities and persons whose new techniques or methods need to be clinically tested shall have the following rights:
+ Designate any body meeting facility and personnel requirements to conduct clinical trials;
+ Retain full ownership of clinical trial results.
- Entities and persons whose new techniques or methods need to be clinically tested shall have the following rights:
+ Compensate participants in clinical trials for any risk that may arise during the process of conduct of clinical trials in accordance with laws;
+ Enter into written contracts for clinical trials with testing bodies;
+ Have legal liability for quality and safety of new technique, method or medical equipment that they hand over for clinical trials.
(3) The rights and responsibilities of testing bodies under Article 98 of the Law on Medical Examination and Treatment 2023 are 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.
What are the principles and authority of approval of clinical trials in Vietnam?
Pursuant to Article 99 of the Law on Medical Examination and Treatment 2023 on the principles and authority of approval of clinical trials, specifically:
- Clinical trials shall be performed before application of a new technique or method, or marketing authorization of a medical device, except in the case of exemption from clinical trials or exemption from certain phases of a clinical trial.
- A clinical trial shall be conducted only after the profile of that clinical trial has passed the scientific and ethical evaluation by the Ethics Committee on Biomedical Researches referred to in clause 3 of this Article, and after it is approved in writing by the competent authority.
- Ethics Committee on Biomedical Researches is an independent committee set up to protect the rights, safety and health of the participants in clinical trials.
- Conduct of clinical trials, scientific and ethical evaluation of the clinical trial profiles and approval of clinical trials shall adhere to the following basic principles:
+ Respect, protect and uphold the self-determination rights of participants in clinical trials;
+ Ensure that research interests should prevail over risks incurred during clinical trials;
+ Ensure equal benefits and responsibilities; make sure that risks are evenly distributed among clinical trial participants;
+ Assure implementation of clinical trial stages and compliance with good practice in testing new techniques, methods or clinical testing of medical devices as instructed by the Minister of Health.
The Law on Medical Examination and Treatment 2023 will take effect from January 1, 2024
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