UCSF Process for Submitting Human Embryonic Stem Cell Lines to NIH Registry

Background

NIH Guidelines for Human Stem Cell Research, effective July 7, 2009, established an NIH Human Embryonic Stem Cell Registry listing human embryonic stem cells (hESCs) eligible for use in NIH funded research. Only hESCs that have been reviewed and deemed eligible by the NIH in accordance with the Guidelines may be used in NIH supported research.

NIH Form 2890 is provided for the purposes of submitting information about hESC lines to the NIH, along with assurances and supporting documentation of compliance with the NIH Guidelines. NIH Form 2890 is a web-based form only and must be submitted electronically through eRA Commons.

Purpose

The purpose of this guidance document is to codify the UCSF process, including roles and responsibilities for submission of Human Embryonic Stem Cell Lines for use in NIH Funded Research, and to ensure that submissions comply with NIH guidelines. If hESC lines are approved for use in NIH funded research, the stem cell lines, and provider information if the lines are available for distribution, will be posted on the NIH Human Embryonic Stem Cell Registry.

Roles and Responsibilities

Principal Investigator (PI) reviews NIH guidelines and requirements for submission of hESCs to NIH and completes NIH Form 2890 in eRA Commons with required certification and assurance letter.

Signing Official (SO) is the UCSF designated official with authority to approve submission of NIH Form 2890, including required certification and assurances. For the purposes of this approval process, UCSF has designated the Director, Human Research Protection Program, or their designee.

Additional Officials (AOs) assist PIs with questions regarding rights and/or restrictions pertaining to the hESC, e.g., ownership, deriver or licensee or permission of the same to submit for use in NIH research.  AOs include the Executive Director, Industry Contracts Division and Executive Director, Office of Technology Management and Advancement, or their designees.

Process

1. PI reviews NIH guidelines and drafts NIH Form 2890 (instructions to complete Form 2890) in eRA Commons and prepares UCSF letter (UCSF Template Letter for Certification, Assurances and Signatures Required for NIH hESC Registry Request) using the provided template: https://irb.ucsf.edu/sites/g/files/tkssra6501/f/UCSF%20template_SO_letter%20for%20NIH%20hESCs.doc
2. PI must attest that they are the owner, deriver or licensee or have written permission of the same to submit the hESC line to the NIH Human Embryonic Stem Cell Registry on the UCSF template letter. If necessary, PI consults AOs regarding rights or ownership pertaining to the hESC.
3. PI must confirm that any materials translated into English were accurately translated by an individual independent of UCSF who is fluent in English, and the original language of the translated documents.
4. PI sends a copy of the completed NIH Form 2890, UCSF letter, and an email confirming that the consent of both parents for the donation of the embryo tissue used to create the hESC line for research purposes was obtained to the SO for review.
5. PI and SO review the completed NIH Form 2890 and certifications and assurances required by NIH and sign the UCSF letter (letter must be on UCSF letterhead).
6. SO completes and signs an attestation letter (Signing Official Certification and Assurance for hESC Registry Request) indicating that the information provided by the PI in NIH Form 2890 is complete and accurate: https://irb.ucsf.edu/sites/g/files/tkssra6501/f/UCSF%20NIH%20hESC%20Signing%20Official%20Letter.docx
7. PI uploads the signed UCSF letter and the SO attestation letter in eRA Commons NIH Form 2890 in the Supporting Information section and submits the request to NIH.
8. SO, or their designee, uploads a copy of the signed UCSF letter, the signed SO attestation letter, as well as the email from the PI confirming the consent of both parents for the donation of embryo tissue for the creation of hESC lines for research purposes was obtained, in the Internal Documents section for the IRB approved study in the IRB system.