| RegulationforEthicalReviewofClinicalResearchofTraditionalChineseMedicine |
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| 時間：2012-11-16 00:00:00 |
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| Chapter 1 General Principles
1. This regulation is promulgated to regulate the ethical review of clinical research of traditional Chinese medicine, to respect the rights and protect safety of the human subjects involved in clinical research, in accordance with ‘Law of the People/'s Republic of China on Progress of Science and Technology’, ‘Regulations of the People’s Republic of China Traditional Chinese Medicine’, ‘Regulations on Management to Medical Institutions’.
2. Ethical review of clinical research of traditional Chinese medicine involving human subjects should abide by this regulation.
Chapter 2 Ethics Committee
3. State and provincial regulatory authority of traditional Chinese medicines are responsible for establishing expert ethics committees. As requested and entrusted by regulatory authorities respectively, through discussion, the expert ethics committees provide advice on policy making for critical ethics issues, conduct ethical review for important research projects, supervise the ethics committees within respective areas, organize workshop and seminar on research ethics.
4. Institutions that conduct clinical research of traditional Chinese medicines, including healthcare sectors, research institutes, medical colleges, are responsible for establishing institutional ethics committees (EC) and providing essential resources to support the ECs for carrying out their responsibilities. The establishment of ECs should report to the related health authority for keeping on record.
5. The composition and operation of ECs should be independent, competent, multidisciplinary and transparent. The review decision-making should not be influenced by any individual or entity that conducts, sponsors, or hosts the research its reviews.
6. ECs should be composed of at least 5 members including individuals with expertise in medical science (including traditional Chinese medicine) and legal matters, lay people whose primary background is not in health and medicine, and people who are not affiliated with the institute which will conduct the research under the review, with balanced gender distribution. The EC members could be selected via recruitment or recommendation.
7. Members of ECs should be willing to publicize his/her full name, profession, and affiliation. EC members should sign a confidentiality agreement regarding information on research, research participants and other related matters. Members should comply with the policy on conflict of interests management.
8. EC should establish specific quorum requirements for reviewing an application. The minimum number of members required to compose a quorum should be more than half the members and no less than five with a fair gender distribution, include members with expertise in medical science, lay people, and members affiliated and non-affiliated with the institute.
9. When necessary, ECs may call upon independent consultants without voting right, to provide special expertise to the EC on proposed research protocols.
10. ECs should develop and provide initial training and continuing education programs to EC members to update their knowledge of laws and regulations, research ethics principles, guidelines and standard operating procedures for ethical review.
11. ECs should establish policies, term of reference and standard operating procedures (SOPs), which clearly state the authority under which the committee is established, the organizational structure, the functions and duties of EC. SOPs should cover the review process, and clearly define the procedures, responsible personnel and detailed instructions.
12. ECs are responsible for ethical review of clinical research of traditional Chinese medicine which is conducted by their own institutions. ECs may also conduct ethical review of traditional Chinese medicine research submitted by other institutions as entrusted.
13. ECs are authorized to approve or disapprove a clinical research on traditional Chinese medicine, to conduct follow-up review of the approved ongoing research, and to terminate or suspend its prior approval of the research.
Chapter 3 Ethical Review
14. The following documents should be submitted to ECs for review before initiating the research.
14.1 The protocol (indicating version number and date)
14.2 Informed consent form (indicating version number and date)
14.3 Material to be used (including advertisements) for the recruitment of potential research participants (if any);
14.4 Case report from / diary cards, and other questionnaires intended for research participants;
14.5 Investigator/'s Brochure（if any）
14.6 Principle Investigator’s current curriculum vitae
14.7 Any significant decisions made by other ECs
15. ECs should review the scientific validity and ethical acceptability of the research in accordance with the applicable laws and regulations. The essential review elements and requirements are as follow:
15.1 Research design and conduct:
15.1.1 Research should accord with accepted scientific principles, and be based on a thorough knowledge of long-term clinical practice and experience of traditional Chinese medicine, and adequate evidences from laboratory and animal experimentation when necessary. The nature of traditional Chinese medicine as complex compounds should be taken into consideration.
15.1.2 Research design should be applicable to the purpose. The investigational intervention should be tested against those of the best current proven intervention except in the following circumstances: the use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm.
15.1.3 The investigator(s) should have suitable qualifications and experience, sufficient time, appropriate resource and facilities to conduct the proposed research.
15.2 Risks and benefits: risks should be minimized to the extent possible and are reasonable in relation to the anticipated benefits of the study. The well-being of the individual research subject must take precedence over the interests of science and society.
15.2.1 Research that holds out the prospect of direct benefit for the individual subject must be justified by the expectation that they will be at least as advantageous to the individual subject, in the light of foreseeable risks and benefits, as any available alternative. Risks of such /'beneficial/' interventions or procedures must be justified in relation to expected benefits to the individual subject.
15.2.2 Risks of research that do not hold out the prospect of direct benefit for the individual must be justified in relation to the expected benefits to society.
15.3 Subject recruitment: Equitable distribution of burdens and benefits in the selection of groups of subjects in research. The individual research subject is representative for the population of target disease.
15.4 Informed consent form must provide certain information as below:
15.4.1 A statement that it is a clinical research, not a clinical treatment; with explanation of the purposes of the research, the procedures to be followed, including all invasive procedures, the expected duration of the subject/'s participation, and the alternative treatment that may be available to the subjects;
15.4.2 A description of any reasonably foreseeable risks or discomforts, as well as any potential benefits to the subject; when there is no direct benefit to the subject, the subject should be made aware of this;
15.4.3 The payment and the anticipated expense, if any, to the subject for participating in the trial.
15.4.4 The records identifying the subject will be kept confidential, to the extent permitted by the applicable laws and/or regulations. The regulatory authority and the EC will be granted direct access to the subject/'s original medical records.
15.4.5 The compensation and/or treatment available to the subject in the event of trial-related injury.
15.4.6 That the subject/'s participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
15.4.7 The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury.
15.5 Informed consent process: the elements for informed consent are full disclosure, adequate comprehension and voluntary choice. The language and expression used are understandable to the subjects. There should be a full description of the process for obtaining informed consent, including the identification of those responsible for obtaining and signing consent.
15.6 Care and protection of research subjects: the suitability of the investigator(s)’s qualifications and experience for the proposed study; the medical care to be provided to research participants during and after the course of the research; the provisions for compensation/treatment in the case of the injury of a research participant attributable to participation in the research.
15.7 Protection of research subjects’ privacy and confidentiality: the measures taken to ensure the confidentiality and security of personal information and privacy concerning research participants are appropriate; a description of the persons who will be allowed to access to personal data of the research subjects including medical records and biological samples;
15.8 Research involving vulnerable persons: the research could not be carried out equally well with less vulnerable subjects;
The research is intended to obtain knowledge that will lead to improved diseases or other health problems characteristic of, or unique to, the vulnerable class.
The risks attached to research that do not hold out the prospect of direct health-related benefit will not exceed those associated with routine medical risks of such persons, unless an ethical review committee authorizes a slight increase over this level of risk ;
When the prospective subjects are either incompetent or substantially unable to give informed consent, their agreement will be supplemented by the permission of their legal guardians or other appropriate representatives.
15.9 Research involving specific population or community: the impact and relevance of the research on the specific population or community; the extent to which the research contributes to capacity building, such as the enhancement of local healthcare, research, and the ability to respond to public health needs.
16. Criteria for approving clinical research of traditional Chinese medicine are:
16.1 Appropriate risk management to address anticipated risks
16.2 The risks to the subjects are reasonable in relation to the anticipated benefits
16.3 Fair selection and recruitment of subjects
16.4 Full disclosure in informed consent form and appropriate informed consent process
16.5 When necessary, the constitution of a data safety monitoring board (DSMB) described in the protocol to ensure the subjects safety
16.6 Appropriate protection of subjects privacy and confidentiality
16.7 Special protection measures for vulnerable subjects
17. ECs’ review procedures include convened review, emergency convened review and expedited review. EC members should be given enough time in advance of the meeting to review the relevant documents.
18. ECs should make the review decision only after thorough discussion of the research proposed by vote. When making decisions, ECs should ensure documents required for a full review complete, review elements discussed thoroughly, quorum present, and conflict of interests managed.
19. Review decisions can be: approval, modification required prior to its approval, modification required and re-submitted for review, disapproval, terminate or suspend its prior approval.
20. ECs should have written minutes for convene review and promptly notify in writing the applicant concerning review decision/opinion.
20.1 As for research proposed requiring modification or re-submit, ECs should confirm the modification or clarification acceptable before issue the approval.
20.2 In the case of “disapproval” or “terminate or suspend prior approval”, ECs should clearly state reasons for its decision/opinion. If the applicants disagree with the decision, they can submit the appeal to the EC.
21. ECs should follow up the progress of all approved studies—from the time that the approval decision is taken until the termination or completion of the research.
Follow-up review includes amendment review, annual review or continuing review, serious adverse events review, non-compliance review, review of study closed or termination. ECs may conduct site visit when necessary.
22. Research proposal with no more than minimal risk may be applicable for expedited review. Expedited review can be conducted by 1 or 2 members. If the two reviewers have different opinion or negative decision, the research proposal should be submitted for convened review. Research proposals approved through expedited review should be notified to the full board during the meeting.
23. Ethical review of multicenter studies should be consistent and in a timely manner. Cooperative review procedure could be adopted across the sites. EC could approve, disapprove or terminate the research conducted by its own institution.
24. Multinational research protocol should be submitted to ECs in the country of sponsor organization, as well as national or local ECs in the host country for ethical review.
25. ECs should keep protocol files for each research proposal reviewed. Documents that should be filed and archived include but may not be limited to are all materials submitted by an applicant, review records, the decision and any advice or requirements sent to an applicant, continuing review records. Documents should be archived for a minimum period of 5 years following the completion of a study.
Chapter 4 Supervision and Management
26. State and provincial regulatory authorities of traditional Chinese medicine are responsible for the supervision and management of ethical review practice, which include whether an EC is established as required in an institution that carries out clinical research of traditional Chinese medicine, whether ECs conduct ethical review in accordance with the ethical review principles, and whether the review elements and procedures comply with relevant regulations and guidelines.
27. Any individual or organization has the right and obligation to report any unethical activities or misbehavior in clinical research of traditional Chinese medicine to relevant EC or regulatory authority, and any concerns with EC’s non-compliance could be reported to the regulatory authority.
28. Once ECs violate the regulations or any applicable laws or policies, regulatory authorities at different levels should take appropriate actions, including public reprimand, warning, mandatory correction required. ECs would be suspended to conduct ethical review in serious cases.
As for any unethical behaviors in conduct of clinical research of traditional Chinese medicine, the affiliated institution and regulatory authority have the power to take actions, including public reprimand, terminate the project, and withdraw relevant license. If there is any violation of the law, the case shall be transferred to judicial process.
Chapter 5 Supplementary Provisions
29. The State Administration of Traditional Chinese Medicine is responsible for the interpretation of the regulation.
30. The regulation will come into effect since the releasing date.
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