Committee Overview
Introduction
The British Chinese Medicine Ethics Committee (BCMEC) is an independent academic and professional ethics body hosted by Shulan College of Chinese Medicine (UK).
The Committee is established to uphold ethical standards in Traditional Chinese Medicine (TCM) education, clinical practice, and research conducted within the United Kingdom and in international collaborations involving UK-based institutions.
Guided by internationally recognised principles of medical ethics, including respect for human dignity, informed consent, risk–benefit assessment, and data protection, the Committee provides ethical review, guidance, and oversight for TCM-related activities that involve human participants.
Through ethical governance, professional guidance, and education, the Committee aims to promote responsible, transparent, and culturally informed practice of Traditional Chinese Medicine within the UK and internationally.
英国中医伦理委员会是在英国兰中医学院（Shulan College of Chinese Medicine, UK）支持下设立的，具有独立审查与决策职能的学术与专业伦理机构。
本委员会旨在维护和提升英国范围内及英国机构参与的国际合作中，中医教育、临床实践与科研活动的伦理规范与专业标准。
委员会依据国际医学伦理通行原则（包括尊重人格尊严、知情同意、风险与获益评估及数据隐私保护等），对涉及人体参与的中医相关项目提供伦理审查、专业指导与持续监督。
通过建立清晰的伦理治理框架、开展伦理教育与咨询服务，本委员会致力于推动中医在英国及国际范围内的规范化、专业化与可持续发展。
Mission
-
To safeguard the rights, safety and wellbeing of research participants and patients
-
To promote ethical, responsible and evidence-informed TCM research and practice
-
To support doctoral studies, clinical research and international collaboration in TCM
-
To enhance public trust and professional integrity in Chinese Medicine
-
保障中医科研与临床中 研究对象与患者的权益、安全与尊严
-
促进 符合国际伦理标准的中医循证研究与临床实践
-
支持 博士研究、临床试验及国际中医合作项目
提升中医行业的 专业性、公信力与国际认可度
Disclaimers
The British Chinese Medicine Ethics Committee operates as an independent academic and professional ethics body hosted by Shulan College of Chinese Medicine (UK).
It does not replace or act as a UK Health Research Authority (HRA) Research Ethics Committee and does not review Clinical Trials of Investigational Medicinal Products (CTIMPs).
英国中医伦理委员会在伦理审查中保持独立性，不隶属于亦不替代英国卫生研究管理局（HRA）研究伦理委员会，亦不审查药物临床试验（CTIMPs）。
Ethical Principals
The British Chinese Medicine Ethics Committee (BCMEC) is guided by internationally recognised ethical principles applicable to human research and professional clinical practice worldwide.
These principles underpin all ethics review, guidance, and approval decisions made by the Committee.
英国中医伦理委员会（British Chinese Medicine Ethics Committee，BCMEC）遵循适用于全球人体研究与专业临床实践的国际公认伦理原则。这些原则构成委员会开展所有伦理审查、伦理指导及伦理批准决策的根本依据。
1
Respect for Autonomy
尊重自主性
-
Participation must be voluntary, free from coercion or undue influence
-
Individuals must be provided with clear, understandable information to enable informed decision-making
-
Participants retain the right to withdraw from research or treatment at any time without disadvantage
-
Informed consent is considered a continuous process, not a single event.
-
研究与临床参与必须基于自愿原则，不得存在任何形式的强迫或不当影响
-
研究对象应获得清晰、易于理解的信息，以支持其作出知情、自主的决定
-
参与者有权在任何阶段无任何不利后果地退出研究或治疗
-
知情同意被视为一个持续的过程，而非一次性行为
2
Balance of Risk and Benefit
风险与受益平衡
-
Risks must be minimised and proportionate to the expected benefits
-
Benefits may be direct (to participants) or indirect (to scientific knowledge or clinical practice)
-
Studies involving more than minimal risk require clear justification and enhanced safeguards
-
所有潜在风险必须被尽可能降低，且应与预期受益相称
-
研究受益可以是直接的（对参与者），也可以是间接的（对科学知识或临床实践）
-
涉及超过最小风险的研究，必须具有明确的伦理合理性，并采取强化保护措施
3
Avoidance of Harm
避免伤害
-
Physical, psychological, social, and cultural harms must be carefully considered
-
Preventive measures must be in place to reduce foreseeable harm
-
Research must not expose participants to unjustified or avoidable risk
-
应全面评估并审慎考虑身体、心理、社会及文化层面的潜在伤害
-
必须采取适当的预防性措施以减少可预见的风险
-
研究不得使参与者暴露于不合理或可避免的风险之中
4
Justice and Fairness
公正与公平
-
Participant selection must be justified and non-discriminatory
-
No group should bear disproportionate risks or be unfairly excluded from potential benefits
-
Vulnerable populations require additional ethical protections
-
研究对象的选择应具有伦理合理性，不得存在歧视性做法
-
不应让任何特定群体承担不成比例的风险，或被不公正地排除在潜在受益之外
-
对弱势群体的研究须提供额外的伦理保护措施
5
-
Personal data must be collected only where necessary
-
All data handling must comply with UK GDPR and the Data Protection Act 2018
-
仅在必要情况下收集个人信息
-
所有数据处理活动必须符合**英国《通用数据保护条例》（UK GDPR）及《2018 年数据保护法》**的相关要求
6
Integrity
诚信与专业责任
-
Research must be conducted honestly, transparently, and responsibly
-
Conflicts of interest must be declared and appropriately managed
-
Ethical approval must be obtained before the commencement of research activities
-
研究必须以诚实、透明、负责的方式开展
-
所有利益冲突必须如实申报，并得到适当管理
-
所有研究活动必须在获得伦理批准后方可开始
By adhering to these principles, the British Chinese Medicine Ethics Committee (BCMEC) seeks to protect the dignity, rights, and welfare of research participants and patients; uphold high standards of academic, clinical, and professional integrity; and support the responsible advancement of Chinese medicine within an ethical and internationally recognised framework.
伦理承诺声明
秉持上述伦理原则，英国中医伦理委员会（BCMEC）致力于：保护研究参与者与患者的尊严、权利与福祉；维护学术、临床及专业实践的高标准诚信；并在符合伦理与国际公认规范的前提下推动中医的负责任发展。
Ethical Framework & Legal Compliance
BCMEC conducts all ethics reviews in accordance with the following principles and regulations:
-
Declaration of Helsinki (World Medical Association)
-
International Conference on Harmonisation – Good Clinical Practice (ICH-GCP), where applicable
-
UK General Data Protection Regulation (UK GDPR)
-
Data Protection Act 2018
-
Core principles of human research ethics applicable to non-NHS research
Non-NHS Statement
BCMEC is not an NHS Research Ethics Committee and does not replace NHS REC approval.
The Committee provides ethics review only for non-NHS, academic, private, or professional research and clinical activities.
英国中医伦理委员会在伦理审查中严格遵循以下国际与英国标准：
-
《赫尔辛基宣言》（世界医学会）
-
ICH-GCP 临床研究规范（如适用）
-
英国《通用数据保护条例》（UK GDPR）
-
《2018 年数据保护法》
-
适用于非 NHS 研究的人体研究伦理基本原则
非 NHS 声明
本委员会不属于 NHS 研究伦理委员会，亦不替代 NHS REC 的法定职能。
BCMEC 仅对非 NHS 体系下的学术、私立及行业相关研究与临床活动提供伦理审查与支持。
Committee Board
Committee Composition
Chair:Shiwei Zhou
Deputy Chair: Hong ye Zheng
Chinese Medicine Clinical Expert(s): Hua hong Liang
Research Methodology or Statistics Expert(s) :De Yuan Wang
Medical / Biomedical Expert(s): Ahemed Shabbir
Ethics or Legal Advisor(s): Anna Han
Lay Member(s) / Public Representative(s): Kevin Howarth
委员会组成
主席：周时伟
副主席：郑宏业
中医临床专家：梁华虹
研究方法或统计学专家：王德元
医学 / 生物医学专家：Ahemed Shabbir
伦理学或法律顾问：Anna Han
公众代表:Kevin Howarth
Ethic Review Application
What We Review
-
Doctoral and Master’s research projects in Chinese Medicine and Integrative Medicine
-
Randomised Controlled Trials (RCTs) in Chinese medicine
-
Clinical observational studies and case series
-
Research involving non-pharmacological Chinese medicine therapies (e.g. acupuncture, tuina)
-
Clinical research involving Chinese herbal medicine (non-NHS drug trials)
-
International collaborative research projects
-
Teaching- and student practice-related research involving human participants
审查范围
-
博士 / 硕士研究课题（TCM / Integrative Medicine）
-
中医随机对照试验（RCT）
-
临床观察研究、病例系列研究
-
中医非药物疗法研究（针灸、推拿等）
-
草药临床研究（非 NHS 药物试验）
-
国际合作研究项目
-
教学与学生实践研究（如涉及人类受试者）
Review Process
All ethics applications submitted to the British Chinese Medicine Ethics Committee (BCMEC) are reviewed in accordance with established ethical principles and Committee procedures.
Step 1: Submission
Applicants are required to submit a completed ethics application form together with all required supporting documents to the BCMEC Secretariat. Only applications that include all mandatory documentation will proceed to the next stage of the review process.
第一步：提交申请
申请人须向英国中医伦理委员会（BCMEC）秘书处提交完整填写的伦理申请表，并同时递交所有必需的支持性文件。只有在所需材料全部齐全的情况下，申请方可进入后续审查流程。
Step 2: Administrative Screening
Upon receipt of an application, the Secretariat conducts an initial administrative screening to confirm that all required documents have been submitted, and that all forms are complete and appropriately signed. Applications that are incomplete or do not meet submission requirements will be returned to the applicant for correction before they are forwarded for ethical review.
第二步：行政初审
委员会秘书处在收到申请后，将进行初步的行政审查，以确认所有必要文件均已提交、所使用的模板符合委员会要求，且表格内容填写完整并已妥善签署。如申请材料不完整或未符合提交要求，秘书处将退回申请，要求申请人在进入正式伦理审查前进行补充或更正。
Step 3: Ethics Committee Review
Applications that successfully pass the administrative screening are reviewed by members of the Ethics Committee who possess appropriate academic and clinical expertise. The review assesses the application’s compliance with BCMEC ethical principles and includes consideration of the balance between potential risks and benefits, the adequacy of informed consent procedures, the protection of participant safety and welfare, and the measures in place to ensure confidentiality and data protection. Additional ethical issues may also be considered where relevant.
第三步：伦理委员会审查
通过行政初审的申请将由具备相应学术与临床专业背景的伦理委员会成员进行审查。审查内容包括但不限于研究是否符合BCMEC 的伦理原则、风险与受益的合理平衡、知情同意程序的充分性、研究参与者的安全与福祉保障，以及隐私保护与数据安全措施。委员会亦可根据具体研究情况考虑其他相关伦理问题。
Step 4: Ethics Decision
Following the completion of the ethics review, the Committee reaches a formal decision and, where applicable, provides written feedback to the applicant outlining the outcome of the review and any required actions
第四步：伦理审查决定
在完成伦理审查后，委员会将作出正式审查决定，并在适当情况下向申请人提供书面反馈，说明审查结果及所需采取的后续行动。
Application Form
Thank you for considering BCMEC for research ethics review.
Here is the ethic application form, which contains all the information you will need to make an application.
[BCMEC-ETHICS APPLICATION FORM.docx]
Review outcomes
Approved
The study meets BCMEC ethical requirements. An Ethics Approval Letter will be issued and the research may begin.
Conditionally Approved
The study is ethically acceptable but requires minor revisions or clarification. The research may only begin after the required changes have been reviewed and confirmed.
Revisions Required
The study requires substantial revision before it can be approved. The revised application must be resubmitted for further ethical review. The research must not begin at this stage.
Not Approved
The study does not meet BCMEC ethical standards and may not proceed under BCMEC approval. Written feedback will be provided.
Important Note
Research must not begin until ethics approval has been formally granted.
审查结果说明
已批准：研究符合 BCMEC 的伦理要求。委员会将出具伦理批准函，研究可正式开始。
有条件批准（需小幅修改）：研究在伦理上总体可接受，但需进行小幅修改或补充说明。只有在相关修改经确认后，研究方可开始。
需修改后重新审查（重大修改）：研究需进行实质性修改后方可获得批准。修订后的申请需重新提交进行伦理审查，在此阶段研究不得开展。
未批准：研究未达到 BCMEC 的伦理标准，无法在本委员会伦理批准框架下开展。委员会将提供书面反馈说明。