Chương V Thông tư 45/2017/TT-BYT: Điều khoản thi hành

Chapter V

IMPLEMENTATION CLAUSE

Article 37. Implementation

1. The Administration of Science Technology and Training affiliated to the Ministry of Health shall take charge and cooperate with relevant units affiliated to the Ministry of Health in:

a) disseminating, providing guidelines and inspecting the implementation of this Circular.

b) requesting the Minister of Health to suspend operation of any REC which is found violating regulations of this Circular, thereby affecting the protection of rights, safety and well-being of research participants.

c) issuing operation code to RECs and publishing it on the website of the Administration of Science Technology and Training affiliated to the Ministry of Health as prescribed in this Circular.

2. Departments of Health of provinces and central-affiliated cities shall disseminate, organize and inspect the implementation of this Circular at the authorities and unit under their management.

3. Entities establishing RECs shall:

a) disseminate and organize the implementation of this Circular within the entities.

b) promulgate Regulation on organizational structure and operation of the REC within the entities by realizing regulations specified in this Circular.

c) assess the compliance with regulations and SOPs of RECs and application of ethical principles set out in international guidelines and national standards by REC members.

d) when assessing operation of a REC, notify the scope, assessment method and interval to the REC at least 01 month prior to the date of starting to carry out assessment and notify assessment results to the REC to conduct activities pertaining to quality improvement.

dd) ensure the assessment is conducted by persons with appropriate qualifications and in an independent and objective manner.

e) consider and supervise corrective actions and precautions by RECs according to findings and recommendations from internal assessment and external assessment.

g) receive, handle and monitor complaints about the REC made by researchers, research subjects and other relevant parties (if any).

h) provide resources to RECs as prescribed in Article 14 of this Circular.

i) in December, submit a report on REC activities to the Administration of Science Technology and Training affiliated to the Ministry of Health according to the Appendix 10 hereof.

Article 38. Effect

This Circular comes into force from January 01, 2018.

Article 39. 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.

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