Stem Cell Research and Therapy

Ethics and Regulatory Considerations of Stem Cell Research

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

Regulatory approaches in United Kingdom and Canada:

Stem cell research and treatment is regulated by the AHRA agency, based on the Assisted Human Reproduction Act.

AHRA agency is responsible for:

• Licensing and permission granting for conducting stem cell therapy and research
• Inspection of the facilities for conducting stem cell therapy
• Maintaining a centralized registry for stem cell therapy
• First license will be given in 2007
• AHRA prohibits human reproductive cloning.

Issues regarding the use of Stem Cell Therapy:

• The functions of the stem cell research has to reviewed periodically 
• The power of the regulatory boards has to be governed by the federal and other international laws and regulation
• A centralized management is required for periodic report submission from all the regulatory boards, and all the regulatory boards should abide and report to this centralized review team.
• The issues of public consultation, education, research and training involved in stem cell research has to be integrated. 

NAS Guidelines:

• In April 2005, the National Academies NAS guideline was formed by an interdisciplinary embryo and stem cell research oversight committee. 
• The guidelines encourage ethical stem cell research and also allow private funding of human embryonic stem cell research. 
• The guidelines allow ethical collaboration between different states and institutes for conducting and exchange of valuable data for treatment on stem cell research. 
• NAS guidelines along with the IRB form several stem cell research committees to review stem cell research data and research reports. 
• NAS does not allow reproductive human cloning.