Frequently Asked Questions - General Application Questions
- What is the rationale for the numbering system chosen for the ESCRO record #? For example, what does E007-001 mean?
- What is meant by “full,” “moderate,” and “minimal (administrative)” review and approval?
- When should I submit a new application?
- If my research will use differentiated progeny of hESCs and are no longer pluripotent, do I need to submit a new application?
Each researcher who submits a human embryonic stem cell (hESC) proposal for ESCRO approval will receive a unique researcher identification # (e.g. E007, E standing for ESCRO). That number will comprise the first half of every record number for all applications submitted by that researcher. The “001” portion of the example referenced above refers to the unique proposal that has been submitted by the researcher. For example, if Dr. Smith submits an application to study in vitro development of pre-existing anonymized hESC lines, the ESCRO record # would be E007 (representing Dr. Smith as PI) followed by 001 (representing the unique in vitro proposal) or E007-001. If Dr. Smith submits a second proposal, for example, one proposing to incorporate hESC lines into non-human animals, this new proposal would be E007 (representing Dr. Smith as PI) followed by 002 (representing the unique chimerism proposal) or E007-002. A third application would be numbered E007-003, and so forth.
When full ESCRO review and approval have occurred, the full convened ESCRO Committee has reviewed and approved your proposal. Categories of research that may require full ESCRO review are described in section V.D.2 of GIM-36. ESCRO meets once each month to review hESC proposals.
When administrative ESCRO review occurs, the ESCRO office and ESCRO Chair have reviewed and approved your proposal. Categories of research that may require minimal ESCRO review are described in section V.D.3 of GIM-36. The anticipated turnaround time from submission date to final ESCRO approval date is less than the time required for full review items. The ESCRO Chair will determine when moderate ESCRO review is needed.
Moderate review will involve 3 subcommittee reviewers in addition to the ESCRO Chair review. Although GIM-36 does not specifically describe what categories of research may require moderate review, this type of review is left to the discretion of the ESCRO Chair.
Please review sections V(D) and V(E) of GIM-36 for guidance on when to submit a new ESCRO application.
Please contact the ESCRO Office at firstname.lastname@example.org or at 206-685-7010 with any questions.
ESCRO does not require further review and approval of your hESC research if you have established that the differentiated hESCs are no longer pluripotent. For example, your previous ESCRO application involved inducing the differentiation of hESCs and you have now grown the cells over many passages using media conditions that ensure the loss of pluripotency. These growth conditions are published and are widely accepted by the scientific community as demonstrating that pluripotency of the hESCs no longer exists. Finally, you have shown that your differentiated hESCs no longer express pluripotency markers but rather express markers of a differentiated cell type. If these criteria are met, your research with these cells no longer requires ESCRO review and approval.
If you are no longer working with the original pluripotent hESC lines, please work with the ESCRO office to close your existing ESCRO application.