How to Conduct Research with Human Embryonic Stem Cells

Before you begin hESC research, consider these questions:

• Where it will take place?
• Who will work on the project?
• Who will fund the project?
• What equipment will be used?
• What cell lines will be used?
• How will research personnel obtain cell culture training?
• How will research personnel, including yourself, obtain ethics training?

Read UCSD Guidelines for Human Embryonic Stem Cell Research and review Frequently Asked Questions.

• Note: Principal investigators, get in touch with your department MSO when considering any stem cell research, especially with hESCs. Your department MSO can help you follow guidelines for separation of stem cell research costs and implementing appropriate laboratory procedures to maintain compliance with university policies and guidelines.

To conduct work in the UC San Diego Human Embryonic Stem Cell Core Facility, contact Director Karl Willert, (858) 822-3235.

Principal investigators whose work uses hESC, and all research personnel (including students, postdocs, volunteers, and employees) who work with these cells should obtain information and/or training in stem cell research, policy, and ethics.

1. Embryonic Stem Cell Research Oversight (ESCRO) Committee approval
   • Both federally eligible and non-federally eligible pluripotent cell lines require review and approval of the ESCRO Committee.
2. Institutional Review Board (IRB) approval of protocol or amendment
   • IRB reviews all new hESC research applications regardless of the origin of the cell line, and regardless of whether cells will be used in human projects.
3. Institutional Animal Care and Use Committee (IACUC) approval
   • IACUC must approve your test plan if you plan to use vertebrate animals in your ESCRO experiment. You will also need to identify on the ESCRO face page which vivarium will house your animals.
4. Institutional Biosafety Committee (IBC) approval
   • You will need prior approval for a Biohazardous Use Authorization (BUA) if you are establishing a new lab and plan to use biohazardous materials.
   • If you have an existing approved BUA and wish to add other materials, you must submit an amendment and obtain approval.
   • Use of human embryonic stem cells in-vivo requires concurrent active BUA and IACUC approval.
   • CAL-OSHA categorizes human embryonic stem cells under the Bloodborne Pathogens Standard and requires participants to undergo initial bloodborne pathogen training as well as annual safety refresher courses to work with stem cells.
   • Check with Environment, Health & Safety if you are unsure of the requirements that your lab must meet to work with human embryonic stem cells.

1. Federal monies may not be used for personnel, supplies, or other resources to research Pluripotent Cells that are not on the NIH Human Pluripotent Stem Cell Registry.
2. Review the guidelines to separate costs for work on federally funded stem cell projects to answer questions regarding critical hESC distinctions.

1. Complete the UCSD Material Transfer Agreement (MTA) to obtain the hESC material.
2. Researchers can also obtain hESC materials from NIH Human Pluripotent Stem Cell Registry, as well as HUES stem cell lines from Harvard University.

To receive hESC materials, you must:

• Meet Office of Contract and Grant Administration MTA requirements, or receive other written acknowledgment
• Submit completed MTA paperwork requesting the source of the cell line
• Submit an MTA for every principal investigator, even if viable cells are obtained from another researcher at UCSD