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Ethical and Legal Standards for Primary Human Cells

Lifeline® is committed to the highest ethical and legal standards. Since its inception, Lifeline® has complied with the following standards for obtaining human tissue:

  1. “Informed Consent” – Lifeline® uses tissues for cell isolation only from individuals which are fully informed, consented donors Donor documentation is securely maintained to assure donor privacy following the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (please see item 5 below).
  2. The Declaration of Helsinki as developed by the World Medical Association stating ethical principles that provide guidance to physicians and other participants in medical research involving human subjects. Lifeline® only works through tissue acquisition networks, physicians and organ procurement organizations that are compliant with these standards.
  3. The Human Tissue Act as published on November 15th, 2004 by the government of the United Kingdom. This act aims to make consent a fundamental principle underpinning the use and storage of human tissue. Lifeline® or its tissue acquisition agents require informed consent documentation consistent with these principles.
  4. CFR – Code of Federal Regulations Title 21 – Lifeline® complies with 21CFR sections 1270 and 1271 as they apply to human tissue collection and use in research.
  5. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104-191). Title II of HIPAA, known as the Administrative Simplification (AS) provisions, requires the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers. The AS provisions also address the security and privacy of health data. Lifeline® is fully HIPPA compliant and uses a documented de-identification system.

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