PSCI认证咨询|为患者与受试者及捐赠者建立信息安全访问管理系统

Ethics

Suppliers shall conduct their business ethically and act with integrity. The Ethics elements include:

1. ANTI-BRIBERY ANDCORRUPTION

All forms of bribery, corruption*, extortion and embezzlement are prohibited. Suppliers shall not pay or accept bribes or participate in other illegal inducements in business or government relationships,or through the use of intermediaries. Suppliers shall ensure they have adequate systems in place to prevent bribery and comply with applicable laws.

2. FAIR COMPETITION

Suppliers shall conduct their business consistent with fair and vigorous competition and in compliance with all applicable anti-trust laws. Suppliers shall employ fair business practices including accurate and truthful advertising.

3. ANIMAL WELFARE

Animals shall be treated humanely with pain and stress minimized. Animal testing should be performed after consideration to replace animals, to reduce the numbers of animals used, or to refine procedures to minimize distress. Alternatives should be used wherever these are scientifically valid and acceptable to regulators.

4. DATA PRIVACY AND SECURITY

Suppliers shall safeguard and make only proper use of confidential information to ensure that company, worker, patient, subject* and donor* privacy rights are protected. Suppliers shall comply with applicable privacy and data protection laws and ensure the protection, security and lawful use of personal data.

5. PATIENT SAFETY AND ACCESS TO INFORMATION

Suppliers shall ensure that adequate management systems are in place to minimize the risk of adversely impacting on the rights of patients, subjects and donors, including their rights to health and to access information directly.

6. CONFLICTS OFINTEREST

Suppliers shall take reasonable care to avoid and manage conflicts of interest. Suppliers are expected to notify all affected parties if an actual or potential conflict of interest arises.

*We use the term “corruption” in these Principles to refer to the abuse of entrusted power for private gain, the term “subject” to refer to any person who participates as a subject in scientific and medical experimentation or product testing, and the term “donor” to refer to any person who donates tissues, cells, organs and any other body parts for research purposes.

道德

供应商应以道德、诚信的方式开展业务。道德原则包括以下要素：

1.反贿赂和腐败

禁止一切形式的贿赂，腐败*，敲诈勒索以及挪用公款。供应商不得在业务或政府关系中或通过使用中间人，来支付或接受贿赂或参与其他非法诱因。供应商应确保已建立适当的系统来防范贿赂并遵守适用法律。

2.公平竞争

供应商应在公平、有力的竞争中开展业务，并遵守所有适用的反垄断法。供应商应采用公平的商业实践，包括准确、真实地开展广告活动。

3.动物福利

动物应接受人道的对待，最大限度地减少其痛苦与压力。进行动物试验前应考虑使用其它方式代替动物试验、减少动物的使用数量，或改进流程以最大限度地减少其痛苦。在科学证明了有效并且监管机构能够接受的情况下，应采用替代方法。

4.数据私密性和安全性

供应商应保护并仅适当使用机密信息，以确保公司、员工、患者、受试者*和捐赠者*的隐私权得到保护。

供应商应遵守适用的隐私和数据保护法律，并确保对个人数据的保护、安全与合法使用。

5.患者的安全和对信息的访问

供应商应确保建立适当的管理系统，以最小化对患者、受试者和捐赠者的权利（包括其健康权和直接获得信息的权利）产生不利影响的风险。

6.利益冲突

供应商应采取合理的措施避免及管理利益冲突。如果出现实际或潜在的利益冲突，供应商应通知所有受影响的相关方。

*本原则中的“腐败”一词指代滥用委托权力谋取私利，“受试者”一词是指作为受试者参加科学和医学实验或产品测试的人，“捐赠者”一词是指为研究目的捐赠组织、细胞、器官和任何其他身体部位的人。