Information for Faculty
and Research Administrators

FAQ
What do I need to do to start
research with human Embryonic Stem Cells?

1. Plan the Research
   Consider the research you plan to conduct
1. where it will take place
2. who will work on the project
3. who will fund the project
4. what equipment will be used
5. what cell lines will be used
6. how will research personnel obtain cell culture training
7. how will research personnel, including yourself, obtain ethics training
   
   
2. Review Applicable Campus Guidelines
   Review the UCSD Guidelines for Human Embryonic Stem Cell Research at http://research.ucsd.edu/ESCRO/guidelines.html, and Frequently Asked Questions at http://research.ucsd.edu/ESCRO/faqs.html
   
   
3. Consider Usage of
   Human Embryonic Stem Cell Core Facility
   If you are considering conducting work in the Human Embryonic Stem Cell Core Facility, contact the Director, Karl Willert at kwillert@ucsd.edu or (858)822-3235 http://stemcells.ucsd.edu/facility.asp
   
   
4. Obtain approval of Research Protocol from ESCRO
   All projects involving the use of hESCs, both federally and non-federally approved lines, require the review and approval of the ESCRO Committee. http://research.ucsd.edu/ESCRO/submit.html
   
   
5. Obtain approval of protocol or amendment from IRB
   All research with hESCs must be reviewed regardless of the origin of the cell line, and regardless of whether cells will be used in a project that also includes human subjects. http://irb.ucsd.edu/howto.shtml#newapp
   
   
6. Obtain approval of Research Protocol tfrom IACUC
   If vertebrate animals are involved in your research, IACUC approval is also required. http://IACUC.ucsd.edu. You will also need to identify on the ESCRO face page which vivarium will house your animals.
   
   
7. Obtain IBC Approval (Institutional Biosafety Approval)
   If you are establishing a new lab and plan to use Biohazardous materials you will need to have a Biohazardous Materials Authorization (BUA) approved prior to commencing work. If you have an existing approved BUA and wish to add other materials, you must submit an amendment and obtain approval. http://blink.ucsd.edu/Blink/External/
   Topics/How_To/0,1260,12116,00.html
   
   Additional approvals are required for use of Radioisotopes, Lasers, and Controlled Substances.
   
   If you plan to use human embryonic stem cells in-vivo, you must have concurrent active BUA and IACUC approval.
   
   CAL-OSHA recognizes human embryonic stem cells as being covered under their Bloodborne Pathogens Standard. Therefore, there is a requirement to participate in annual training. Training information can be found at http://blink.ucsd.edu/Blink/External/Topics/
   Policy/0,1162,11375,00.html
   
   Please check with EH&S if you are unsure of the requirements that your lab must meet. http://blink.ucsd.edu/Blink/External/Topics/
   Policy/0,1162,14533,00.html
   
   
8. Obtain the materials
   Receipt of Human Embryonic Stem Cell materials must comply with the Office of Contract and Grant Administration (OCGA) Material Transfer Agreement (MTA) requirements, or other written acknowledgement.
   
   To obtain the necessary Material Transfer Agreement, complete the UCSD MTA process and obtain a copy of the Provider MTA from the provider’s website. Go to http://materialtransfer.ucsd.edu. Follow the directions for receiving materials to complete the MTA process. All hESC providers require a formal agreement.
   
   You must complete paperwork to request an MTA from the source of the cell line. Every PI will need an MTA even if viable cells are obtained from another researcher at UCSD.
   
   To obtain a list of federal-registry lines, links to obtain cells and the MTA request form go to http://stemcells.nih.gov/research/registry/
   
   For HUES stem cell lines available from Harvard, use www.mcb.harvard.edu/melton/HUES to get registration requirements and forms for obtaining the cells.
   
   
9. Complete Ethics Training
   Research personnel with responsibilities for research using Human Embryonic Stem Cells should have applicable information and/or training in stem cell research, policy, and ethics. Obtain ethics training for yourself and all those who will work on the project. http://research.ucsd.edu/ESCRO/ethics_training.html
   
   
10. Plan for Adequate Separation of Research Costs
    Research involving Human Embryonic Stem Cells that are not listed on the NIH Human Embryonic Stem Cell Registry may not be conducted using personnel, supplies or other resources funded by federal monies.
    Make plans to separate costs for work on ineligible lines from costs and funding for all federal projects. Guidelines and FAQ for this process will be issued in June, 2007.
    
    
11. Work with Your Department MSO
    Investigators should get in touch with their department MSO when considering any stem cell research, especially with hESCs. The Department MSO can help you assure that guidelines for separation of research costs are followed, and that appropriate procedures are implemented in your laboratory to maintain compliance with applicable University policies and guidelines. This section may require further edits pending discussions with the MSOs and other members of the UCSD community. Additional controls that may be required include an annual assertion from the MSOs of compliance with cost accounting standards and other applicable University policies, appropriate separation of research costs, and physical control of the environment.