Frequently Asked Questions - Amendment Form
Some examples of when an amendment form should be submitted include, but are not limited to, the items listed below:
• Change in PI
• Request for additional cell lines;
• Request to modify the scientific experiments in a significant way (see response to question 3 below);
• Request to change the source, procurement procedure, or privacy protections for the donation of embryos or gametes.
Some amendments are eligible for administrative or expedited approval and some require full committee or stringent review for approval. These distinctions are described in UW policy GIM-36, section V, subsections D3 and D2, respectively.
Some examples of when an amendment is NOT required are, but are not limited to, the items listed below:
• Change in contact information;
• Change in source information;
• Change in location.
Some examples of significant changes to scientific experiments are, but are not limited to, the items listed below:
• Employing new methods for the derivation of hESC lines from gametes, embryos, or fetal tissue;
• Implementing distinct transplantation or analysis protocols when introducing hESC or hESC-like lines into humans or animals;
• Altering the proposed methods for generating human embryos from hESC or hESC-like lines;
• Changes that require oversight of other UW compliance offices. For example: if your original ESCRO approved record involved transplant of hESC-lines into the eyes of adult humans but you are now interested in performing this same type of transplant in children, this proposed activity will require IRB review and approval and will also require submission of a significant amendment form for ESCRO review and approval.
Please contact the ESCRO Office at firstname.lastname@example.org or at 206-685-7010 with any questions.