Article 27. Responsibilities of Departments affiliated to the Ministry of Health
1. The Administration of Science Technology and Training affiliated to the Ministry of Health has the responsibility to:
a) disseminate and provide guidance on the implementation of this Circular;
b) update the list of RECs that have notified their establishment on the website of the Administration of Science Technology and Training within 15 days from the receipt of the REC establishment notification;
c) carry out periodic or unscheduled inspections of compliance with regulations of this Circular by RECs;
d) if it is found that a REC fails to comply with regulations laid down in this Circular, remove it from the list published on the website of the Administration of Science Technology and Training.
dd) suspend or request a competent authority suspend operation of a REC if it is found that such REC violates the regulations set forth in this Circular, thereby affecting the protection of rights, safety and well-being of research subjects.
2. Departments affiliated to the Ministry of Health have the responsibility to:
a) cooperate with the Administration of Science Technology and Training in disseminating and providing guidance on the implementation of this Circular.
b) cooperate with the Administration of Science Technology and Training in carrying out periodic or unscheduled inspections of compliance with regulations of this Circular by RECs.
Article 28. Responsibilities of Departments of Health of provinces and central-affiliated cities and health authorities of ministries
Departments of Health of provinces and central-affiliated cities and health authorities of ministries have the responsibility to:
1. disseminate and provide guidance on the implementation of this Circular to units under their management.
2. carry out periodic or unscheduled inspections of compliance with regulations of this Circular by RECs established by the entities under their management.
3. request the Administration of Science Technology and Training affiliated to the Ministry of Health to suspend operation of RECs if it is found that such RECs violate the regulations set forth in this Circular, thereby affecting the protection of rights, safety and well-being of research subjects.
Article 29. Responsibilities of entities establishing RECs
An entity establishing the REC has the responsibility to:
1. disseminate and organize the implementation of this Circular at the entity.
2. promulgate its Regulation on organizational structure and operation of the REC by realizing regulations specified in this Circular.
3. assess the compliance with regulations of law, Regulations on organizational structure and operation and SOPs of the REC.
4. maintain the compliance with regulations of this Circular by its REC.
5. receive and respond to complaints about the REC from researchers, research subjects and concerned parties.
6. notify and update REC activities on its website within 10 working days from the date on which the REC establishment decision is obtained.
7. send a notification of establishment within 15 days from the date on which the REC establishment decision is obtained according to the Appendix 01 hereof to the Administration of Science Technology and Training affiliated to the Ministry of Health.
Article 30. Effect
1. This Circular comes into force from March 15, 2020.
2. The Circular No. 45/2017/TT-BYT dated November 16, 2017 of the Minister of Health is null and void from the effective date of this Circular.
Article 31. Responsibility for implementation
The Director of the Administration of Science Technology and Training, Chief of the Ministry Office, Chief Inspector of the Ministry, General Directors and Directors of Departments affiliated to the Ministry of Health, heads of affiliates of the Ministry of Health, and relevant organizations and individuals are responsible for the implementation of this Circular.
Difficulties that arise during the implementation of this Circular should be promptly reported to the Administration of Science Technology and Training affiliated to the Ministry of Health for consideration./.
Tìm kiếm
Thông tư 4/TT-BYT (Bản Pdf)
Thông tư 4/TT-BYT (Bản Word)