独立运作的研究伦理审查机制，为生命科学伦理敏感研究提供专业保障
联盟伦理审查委员会（简称"伦审会"）是在联盟理事会授权下独立运作的专业审查机构，在行政上不隶属于启元生命科学研究院，亦不受秘书处日常管理约束，以确保审查意见的独立性与权威性。委员会依据《赫尔辛基宣言》、香港《人体生物医学研究操守守则》及国际医学科学组织委员会（CIOMS）相关伦理指南，结合亚太地区实际情况，制定并执行本委员会的审查规范。
伦审会的核心职能是对联盟资助课题中涉及伦理审查的研究项目出具独立审查意见，审查意见作为联盟是否继续支持该项目的重要参考依据之一。此外，伦审会亦接受非联盟资助、但希望获得独立第三方伦理审查意见的外部科研项目提交申请。
伦审会的设立是卓健生命科学与健康发展联盟区别于其他同类学术组织的核心特色之一，也是联盟承诺以严谨态度推动"负责任的科学"这一理念的具体体现。
委员会的全部审查工作以以下六项核心原则为基础
所有涉及人类受试者的研究须充分尊重受试者的人格尊严与自主决策权，知情同意程序必须真实、完整、可理解。
研究设计须在合理范围内将受试者及社会公众的潜在获益最大化，并以可量化方式论证研究的社会价值。
研究方案须采取充分措施规避、减少对受试者身体、心理及社会层面的潜在伤害，风险须与预期获益相称。
受试者招募标准须科学合理，不得对弱势群体施加不当利诱，研究成果的获益须向参与研究的群体公平传递。
涉及个人生物信息、基因数据及健康记录的研究须遵守严格的数据保护规范，明确数据存储、使用与销毁的全生命周期管理方案。
研究者须向伦审会如实披露研究设计的全部相关信息，包括潜在的利益冲突，委员会审查结论须可溯源、可解释。
七名委员，跨学科构成，确保审查视角的多元性与专业性
委员会重点审查涉及以下伦理敏感领域的研究项目
所有以人类个体为直接研究对象的干预性研究，包括但不限于药物或器械的人体安全性与有效性测试、行为干预研究、侵入性生物标本采集研究，以及以患者群体为对象的回顾性临床研究（涉及个人可识别信息时）。委员会审查的核心关注点包括知情同意程序的充分性、受试者的安全保障措施、利益分配安排及研究结束后的随访计划。
涉及人类基因组编辑（含体细胞与生殖细胞层面）、遗传物质转移、基因诊断及遗传咨询的研究项目，均须提交伦理审查。委员会将重点评估基因编辑的技术安全性证据、脱靶风险的评估方案、遗传信息的保密与使用限制，以及是否存在对后代遗传影响的充分论证。对于涉及人类胚胎或生殖细胞的研究，委员会将依据国际最高审慎标准进行审议。
所有以评估新型药物、生物制品、医疗器械或治疗方案为目的、在人体中开展的系统性试验研究，无论处于哪个试验阶段，均须在开始招募受试者前完成伦理审查。委员会的审查内容涵盖试验设计的科学合理性、受试者纳入与排除标准、风险监控与不良事件报告机制、试验暂停与终止标准，以及安慰剂对照组设计的伦理正当性。
利用人工智能、机器学习或大数据分析方法处理个人健康数据、医学影像或基因组数据的研究项目，以及将AI辅助决策工具应用于临床诊断或治疗推荐的研究，须就数据来源合法性、算法公平性与偏见风险、患者知情同意及数据跨境传输等方面接受伦理审查。数字健康与移动医疗领域的研究亦须关注数字弱势群体的权益保护问题。
标准审查周期为30个工作日，全程规范透明
申请人填写《伦理审查申请书》，并按要求准备全套申请材料（详见申请指南），发送至伦理审查专用邮箱 ethics@zalshd.com。伦理审查委员会受理人员于3个工作日内回复收件确认函，并告知材料完整性初步判断。
伦理审查委员会受理人员对申请材料进行形式完整性审核，重点核查必备材料是否齐全、申请人资质是否符合要求、研究类别是否在审查范围内，以及研究设计描述是否达到可供专家评审的信息深度。形式审查不通过者，受理人员将书面告知缺项并给予一次补充机会，补充期限为10个工作日。
伦理审查委员会受理人员将材料分发给不少于3名委员（按研究领域专长匹配），委员进行独立审阅并在内部审议会议上进行集体讨论。委员会采取多数表决制确定审查意见类别。如委员认为申请材料存在重大信息不足，可要求申请人补充说明或出席答辩，此情况下审查周期相应顺延，但总周期不超过60个工作日。
委员会以整体名义出具正式《伦理审查意见书》，意见类别分为四种：（1）批准——研究可按既定方案开展；（2）有条件批准——须按委员会要求修改方案后方可开展；（3）暂缓审议——须申请人补充重要信息后重新提交；（4）不批准——研究存在无法接受的伦理风险，委员会建议终止。意见书由委员会主席署名，加盖联盟公章，作为正式书面文件发送至申请人。
审查时限说明：标准审查周期为收到完整材料后30个工作日内完成全程并出具意见书。因申请人补充材料、申请人答辩或委员会内部重大分歧需扩大审议规模等情况导致的延期，委员会将提前书面告知申请人，并说明预计完成时间。
提交完整、规范的申请材料是高效完成审查的基础
申请伦理审查前，请先阅读以下常见问题解答
An independently operated research ethics review mechanism protects ethically sensitive life science research.
The ZALSH Ethics Review Committee is an independent professional review body authorized by the Council. It is not administratively subordinate to Qiyuan Life Sciences Institute and is not controlled by the Secretariat's daily operations, ensuring independent and authoritative opinions.
The committee follows the Declaration of Helsinki, Hong Kong guidance on human biomedical research conduct, CIOMS ethical guidelines, and regional practice across Asia-Pacific. Its core duty is to issue independent review opinions for alliance-funded projects involving ethical review and for external research projects seeking third-party ethics review.
The committee reflects the alliance's commitment to responsible science and is a key institutional feature distinguishing ZALSH from comparable academic organizations.
All review work is grounded in six ethical principles.
Research involving human participants must fully respect dignity and autonomous decision-making. Informed consent must be truthful, complete, and understandable.
Study design should maximize potential benefit to participants and the public within reasonable limits and demonstrate social value with measurable evidence.
Protocols must take adequate steps to reduce physical, psychological, and social risks, with risk proportionate to expected benefit.
Recruitment criteria must be scientifically justified, avoid undue inducement to vulnerable groups, and ensure fair transmission of research benefits.
Research using biological information, genetic data, or health records must define strict data storage, use, sharing, and destruction controls.
Researchers must disclose all relevant study information and potential conflicts of interest. Committee conclusions must be traceable and explainable.
Seven interdisciplinary members ensure professional and diverse review perspectives.
The committee focuses on research projects involving ethically sensitive fields.
Interventional studies directly involving humans, including drugs, devices, behavioral interventions, invasive specimen collection, and retrospective clinical research involving identifiable information. Review focuses on consent, safety, benefit sharing, and follow-up plans.
Projects involving human genome editing, genetic material transfer, genetic diagnosis, or genetic counseling must be submitted. Review focuses on safety evidence, off-target risk, genetic information confidentiality, and possible intergenerational impact.
All systematic human studies evaluating new drugs, biologics, medical devices, or treatment plans must complete ethics review before participant recruitment. Review covers study design, inclusion and exclusion criteria, risk monitoring, adverse event reporting, and placebo control justification.
Studies using AI, machine learning, or big data to process personal health data, medical images, or genomic data must address data legality, algorithm fairness, consent, and cross-border data transfer. Digital health studies must also protect digitally vulnerable groups.
The standard review period is 30 working days and follows a transparent workflow.
Applicants complete the ethics review application form and submit all required materials to ethics@zalshd.com. Ethics Review Committee intake staff reply within 3 working days with receipt confirmation and an initial completeness check.
The secretariat checks whether required materials are complete, applicant qualifications meet requirements, the study falls within scope, and the research design provides sufficient information for expert review.
Materials are assigned to at least three committee members matched by expertise. Members conduct independent review and deliberate collectively. If major information is missing, applicants may be asked to supplement or attend a defense.
The committee issues a formal ethics review opinion in one of four categories: approved, conditionally approved, deferred pending additional information, or not approved. The written opinion is signed by the chair and sent to the applicant.
Timeline note: The standard review cycle is completed within 30 working days after complete materials are received. Delays caused by supplements, applicant defense, or expanded deliberation will be communicated in writing.
Complete and standardized materials are essential for efficient review.
Please review the common questions before applying for ethics review.
For questions about review scope, application materials, or the review process, contact the Ethics Review Committee intake staff. We will reply within 3 working days.
ethics@zalshd.com