Guideline on ethical review standards released

China released a guideline on Monday providing a uniform set of ethical review standards for medical institutions, colleges and research institutions planning to conduct life sciences and medical research involving human beings.

The guideline was jointly released by the National Health Commission, Ministry of Education, Ministry of Science and Technology and National Administration of Traditional Chinese Medicine.

Compared with the previous regulation on ethical review published by the commission in 2016, the commission said the new document has expanded the scope of research requiring ethical review and clarified accountability for different authorities.

In addition, the new guideline allows setting up a commission system so facilities without ethical review boards can grant ethical review power to more capable institutions. The change aims to ensure full implementation of ethical review procedures.

It also specifies a series of steps to be taken to seek informed consent from research participants with disabilities or limited mobility, and lists conditions under which ethical reviews can be waived to reduce unnecessary burdens on researchers.

The guideline said an ethical review board should launch assessment and issue opinions within 30 days of accepting a review application. Reviews for emergency events should be conducted immediately and review requests submitted amid an acute outbreak should be given feedback within 72 hours.

The regulation takes effect immediately.