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. Lifeline Cell Technology obtains tissue and organ donations only from donors located in the United States.
2. No personally identifiable donor information is provided in connection with our cell offerings. To the best of our knowledge, use of human cells and tissue from de-identified donors does not meet the definition of human subject research and is therefore not subject to IRB oversight.
3. “Informed Consent” – Lifeline® ensures that the organ procurement organizations (OPOs) from which we acquire tissue donations obtain informed consent for commercial and research use of the donation. Some tissue/organ donations are obtained from OPOs that are governed by the Uniform Anatomical Gift Act (UAGA). Others have IRB approval for their donation and collection process. 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).
a. For clarity, the UAGA prohibits the sale and purchase of human organs. Consent forms provided by the OPOs clearly state that the donor or donor’s family will not receive compensation.
4. 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.
5. 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.
6. CFR- Code of Federal Regulations Title 21 – Lifeline complies with 21 CFR sections 1270 and 1271 as they apply to human tissue collection and use in research.
7. The donation and collection of blood is performed by blood banks in compliance with 21CFR606, The Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR).
8. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L. 104-191). Title 11 of the HIPPA, known as the Administrative Simplifications (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.
If you have any questions, please contact technical support.