What are the ethics of obtaining human tissue?
Primary cells can only be used for a finite amount of time (see “5 Things to Know About Primary Cells”).
To provide the highest quality primary human cells, we obtain our cells from donors.
We take the ethics of obtaining human tissue very seriously
We have the utmost respect for our donors and recognize that donating their tissue to science is a noble and selfless act.
Our cells come from individuals who are fully informed and have consented to tissue and organ donation.
The very highest quality tissues are always used for transplantation, without exception. We are fully aware that the primary goal of organ donation is to help save the lives of patients in need.
Tissue that is not recommended for transplantation usually comes to us, and even though it will not be used for medical purposes, we still comply with the same international standards as for transplant tissue. These include the following:
- 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, and donor documentation is securely maintained to ensure donor privacy.
- 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.
- 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.
- 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.
Lifeline Cell Technology® takes great care to ensure that our primary cells adhere to the highest research standards, so that they can be used for valuable cutting-edge research to solve complex medical problems and develop treatments for conditions ranging from asthma to skin cancer.
While the tissues we receive from donors may not directly save human lives, their use in research may ultimately result in alleviating the suffering of others in the future.