Stem Cell Research and Therapy

Ethics and Regulatory Considerations of Stem Cell Research

- Lifecell Conference at Chennai Jan-2006 by Dr.Umesh Banakar

HIPAA and Federal Human Subject Research Protection: 
(Two Most Important Stem Cell Regulation Policies)

HIPAA - Health Insurance Portability and Accountability Act: 

HIPAA collects informed medical record information from the donors about the collected materials and also maintains the information about the recipient of the stem cell therapy. HIPAA also maintains records of the stem cells used in research. HIPAA has the right to disclose or use the information of the donor, which out any permission from the research investigator. 

Federal Human Subject Research Protection:

Federal Human Subject Research Protection collects voluntary informed consent from all the study and treatment participants. This act emphasizes prior permission from Institutional Review Board (IRB). In addition, a review of stem cell research and therapy is carried out on an annual basis where the results obtained; the associated risks and complications are evaluated in detail. 

Regulatory Board of New Jersey:

New Jersey has a multi-collaborated act governing the use of stem cell treatment and research and requires a case-by-case approval and review by IRB. 

Regulatory Board of California: 

• Independent Citizens’ Oversight Committee (ICOC) law governs the use of stem cell in California.
• Informed consent has to be obtained from the donor
• Control of use of human source in stem cell therapy
• Maintaining the privacy of human patients involved in stem cell treatment
• Restriction of financial transactions in stem cell therapy
• Maintaining time limit for conducting stem cell research
• Conflict of Interest
• Prohibits giving compensation
• Intellectual property rights of research in stem cells.