Ethics rules to safeguard human trials

Guideline introduces review standards for life sciences, medical research

China has released a guideline that provides a uniform set of ethical review standards for medical institutions, colleges and research institutions planning to conduct life sciences and medical research involving humans.

The guideline, released by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the National Administration of Traditional Chinese Medicine on Monday, has expanded the scope of research requiring ethical reviews and clarified the supervision accountability of various authorities.

Officials and experts said that the release of the guideline is a timely and vital move to dismantle barriers between government departments and address ethical gray areas in research.

"Research in the fields of modern biomedical and life sciences tends to integrate with each other more closely, posing challenges for government authorities holding independent supervision power," said Zhai Xiaomei, executive director of the Chinese Academy of Medical Sciences' research center for bioethics. "Over the years, professionals in China have been appealing for a more integrated oversight system to address challenges."

Zhai said a landmark reform occurred in July 2019 when the central authority announced that a national science and technology ethics committee would be established, heralding the start of a series of efforts to enforce uniform and comprehensive regulations concerning ethical review.

"The new guideline is a step in alignment with China's current principle in rolling out ethical reviews and gathers four government departments together to formulate and enforce a standard set of rules," she said.

The commission released a similar document regulating ethical reviews in 2016, but that only applied to biomedical research in different levels of medical and health institutions.

"With China's increasing investment into the field of scientific innovation and the development of its biotechnology, more higher education institutions and research facilities have participated in life sciences and medical research involving human beings," said the commission.

Compared with previous rules, the new guideline also allows for the setting up of a commission system so that facilities without ethical review boards can grant ethical review power to more capable institutions to "ensure full coverage of ethical review", said the commission.

According to a survey released by the China Association for Science and Technology in 2020, 87.5 percent of medical institutions have ethics regulatory bodies, but the figure was only 17.6 percent for universities, 5.4 percent for research institutions and 1 percent for companies.

"Some institutions might carry out only two to three such projects each year, and some are simply unable to find qualified experts to form a board," said Zhai. "So this commission mechanism can help solve the dilemma facing these facilities."

The document also proposes setting up regional ethical review boards to improve the efficiency of ethical assessments. "For enterprises intending to carry out such research, they can rely on the commission system to complete the required procedures," it said.

The guideline said an ethical review board should launch assessments and issue opinions within 30 days of accepting a review application. Emergency requests for ethical reviews should be processed immediately and review requests submitted amid an acute epidemic should be given feedback within 72 hours.

The guideline also specifies a series of steps to be taken to seek informed consent from research participants with disabilities or limited mobility.

"Special groups have always been a focus of ethical reviews," said the commission. "The guideline has laid out requests for giving special protections for children, pregnant women, the elderly and people with intellectual or mental disabilities."

"Such protection for vulnerable groups has always been a focus of ethical review in China and the new guideline makes further improvements," Zhai said.

As China's ethical review system has been improving continuously through recent years, Zhai said the next step is to step up training to ensure that review board members are capable and can help solve substantial issues.

"Ethics in research is a complicated and sometimes case-by-case topic that requires careful value judgment and a balance of multiple factors," she said. "It is important to improve abilities to analyze and resolve ethical issues."