Superseded. These 2016 Measures were replaced on February 18, 2023 by the Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans. DCC keeps this structured summary for reference; it is not a translation of the full text.
Promulgated by: National Health and Family Planning Commission (国家卫生和计划生育委员会, predecessor of the National Health Commission).
Document No.: NHFPC Order No. 11 (中华人民共和国国家卫生和计划生育委员会令第11号).
Adopted at the Commission’s executive meeting on September 30, 2016. Promulgated October 12, 2016. Effective December 1, 2016.
Scope
The 2016 Measures governed ethics review of “biomedical research involving humans” conducted by healthcare institutions at all levels (Article 2). The defined activities (Article 3) were research on human physiology, psychology, pathology, disease etiology and treatment using modern physical, chemical, biological, traditional Chinese medicine or psychological methods; experimental research on the human body using new medical technologies or products; and epidemiological, sociological or psychological collection, recording, use, reporting or storage of human samples, medical records, behavior and other research materials. Universities and research institutes were not within scope unless they were also healthcare institutions — a gap the 2023 Measures closed.
Structure and key contents
The Measures ran to seven chapters and 50 articles.
Supervision architecture (Chapter I). The NHFPC supervised ethics review nationally and established a National Medical Ethics Expert Committee; the National Administration of Traditional Chinese Medicine ran a parallel committee for TCM research; provincial health authorities established provincial medical ethics expert committees to guide, inspect and evaluate institutional committees (Articles 5–6).
Ethics committees (Chapter II). Every healthcare institution conducting in-scope research had to establish an ethics committee and could not conduct such research without one (Article 7). Committees needed at least seven members drawn from biomedicine, ethics, law and sociology plus outside lay members, with gender diversity and ethnic-minority representation where relevant; members served five-year renewable terms and could engage non-voting independent consultants (Articles 9–10). Committees had to be filed with the institution’s practice-registration authority within three months and registered on the medical research registration system, with annual reports due by March 31 (Article 14). Members signed confidentiality agreements (Article 13).
Ethics review (Chapter III). Article 18 set six ethical principles — informed consent, risk control, no charge and compensation, privacy protection, statutory compensation, and special protection for children, pregnant women, persons with intellectual disabilities and persons with mental disorders. Applications required a form, investigator and institutional credentials and funding source, the protocol and supporting data, and the informed-consent form (Article 19). Review focused on thirteen points including investigator qualifications, scientific validity, risk–benefit ratio, informed-consent adequacy, confidentiality measures for personal information, fair inclusion and exclusion, compensation, conflicts of interest and public-opinion risk (Article 20). Decisions — approve, disapprove, approve after modification, re-review after modification, suspend or terminate — required agreement of more than half of all members at a meeting (Article 23). A simplified procedure was available for minor amendments and minimal-risk studies (Article 24). Approved projects had to be registered on the medical research registration system before starting (Article 25), serious adverse events reported promptly (Article 26), and follow-up review conducted by at least two designated members (Article 27). Multi-center studies could use a collaborative mechanism led by the lead institution’s committee (Article 29), and foreign institutions or individuals cooperating with domestic healthcare institutions had to apply to the domestic partner’s committee (Article 30).
Informed consent (Chapter IV). Written consent was required, with oral consent and process records where the subject could not sign (Article 33); guardians consented for persons without or with limited civil capacity (Article 34). Article 36 listed seven mandatory elements of the consent form. Re-consent was required when the protocol, scope or content changed, when identifiable samples previously collected for diagnosis or treatment were reused for research, and when identifiable biobank samples or clinical history were reused (Article 38). Article 39 allowed committees to waive signed consent where identifiable materials or data were used but the subject could no longer be found and no privacy or commercial interest was involved, or where a sample donor had already consented to use in all medical research.
Supervision and liability (Chapters V–VI). Local health authorities conducted routine supervision on nine listed items (Article 40). Institutions that conducted research without an ethics committee faced orders to rectify, warnings and fines of up to RMB 30,000, with disciplinary action against responsible persons (Article 45); committees and investigators faced rectification orders, circulated criticism and warnings for listed violations (Articles 46–47), with civil and criminal liability preserved (Article 49).
What the 2023 Measures changed
The 2023 Measures kept the architecture but changed the reach and the data rules. They extend coverage from healthcare institutions to universities and research institutes; replace “subjects” (受试者) with “research participants” (研究参与者), expressly including anyone who supplies biological samples, information data, health records or behavior; add a 30-day review clock and a 72-hour emergency track; add explicit exemptions from ethics review for research on lawfully obtained public data, anonymized data, existing samples within their consent scope, and biobank cell lines (Article 32); expand the consent form to twelve elements including data sharing and secondary use; require institutions supplying samples or data to enterprises to fix scope and use by agreement (Article 28); replace the fine-based penalties with administrative penalties under general law plus entry in the research-integrity dishonesty database; and tie high-risk studies to the cross-sector Science and Technology Ethics Review Measures. The 2016 Measures ceased to apply on February 18, 2023.