Table 2 Laws and regulations on genetic research in China

The Interim Procedures for Human Genetic Resources Management by NHFPC & MST in 1998

Covers research, development and transfer of genetic materials, rules and procedures of application and approval;

Requires informed consent from donors and relatives for international collaborations but does not mention IRB review and specific content about informed consent;

States that genetic resources and related information should be protected as state secrets of science and technology, does not mention sample reuse and research information feedback to individual donors.

The Good Clinical Practice by CFDA in 2003

To ensure that clinic trials of new medicines are scientifically reliable, protect subjects’ right and safety;

conforms to Declaration of Helsinki, follows principles of justice, respect and beneficence/non-maleficence;

Clear requirement to protect the benefits of subjects by appropriate IRB reviews and informed consent about the clinic trial;

The definition of clinical trial refers research “on human body” that may be literally inapplicable to genetic research;

The requirement of informed consent does not mention particular issues of consent for genetic research, which at least should include consent for future use of samples, feedback and withdrawal from research.

The Ethical Review of Biomedical Research Involving Human Subjects by NHFPC in 2007

Rules for duties and jurisdictions of IRB, clearly states the constitution of IRB;

Stipulates ethical principles of IRB review with standard procedures;

Clearly requires protection of privacy, subjects can quit at any time without any condition, re-consent shall be obtained if research protocol has been changed;

The definition of research still literally problematic in genetic research context;

Not provides details about feedback and withdrawal method that fits genetic research.

The Tort Liability Law of the People’s Republic of China by NPC in 2010

Protects legitimate rights and interests of civil subjects in general, explicitly ensures citizens’ right to life, to health as well as the right of privacy. Especially in the chapter of compensation for medical damage it notes health care organizations and medical professionals should protect patients’ privacy and shall bear the liability for tort if patients get damaged due to privacy leaking or the disclosure of patients’ medical records.