Questions and Answers on Submitting a New Cell Line
Q: What materials should I consider including in my submission?
A: Relevant materials may include, for example, the consent for donation of embryos for research purposes, the consent for reproductive treatment (including the consent for cryopreservation of embryos, if applicable), and the research protocol or other document(s) demonstrating the relative timing of reproductive treatment and the donation of embryos for research purposes.
Q: I am an investigator using one of the human embryonic stem cell lines that I received from the NIH stem cell bank. Should I submit a "Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research"?
A: Unless your organization has the authority and/or rights pertaining to the human embryonic stem cell line (e.g., your organization is the owner, deriver or licensee or have written permission of the same to submit), you should not submit the request. You can see if a request has been submitted for the line you are using by checking http://grants.nih.gov/stem_cells/registry/pending.htm. (Draft requests can also be seen at http://grants.nih.gov/stem_cells/registry/draft_intent.htm.)
Q: What organization should submit the "Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research"?
A: The submitting entity should have the authority and/or rights pertaining to the human embryonic stem cell line (e.g., be the owner, deriver or licensee or have written permission of the same to submit). If you are not sure whether your organization should submit a request, seek appropriate advice from within your organization, such as from your organization's legal counsel.
Q: Who is the Signing Official in my organization?
A: The Signing Official should be an individual with direct or delegated authority to sign on behalf of the organization /submitting entity and verify that the information submitted on Form 2890 is correct. In some cases, this may be an individual who serves as a Signing Official for purposes of submitting grant applications to NIH. Please note that there are Assurance, Certification, and Authority boxes in NIH Form 2890 that should be checked by the Signing Official if he/she is submitting the form. If you are not a Signing Official, do not check the boxes, but provide, as one of the attached supporting documents, a letter signed by the Signing Official that provides the required certifications (see the sample letter in Form 2890).