Frequently Asked Questions - Additional Oversight
- What if my proposal requires IACUC and/or EH&S approval but I have not received an IACUC protocol # or EH&S protocol #?
- When do I need IRB approval?
- How do I know when the specimens I’ve received contain codes that are considered identifiable would require IRB review?
- Why am I asked about Office of Technology Transfer?
ESCRO review will occur concurrently with other Oversight Office reviews. If you have submitted an application to another Oversight Office but have not received an Oversight Office protocol # yet for that application, please email the ESCRO office (firstname.lastname@example.org) with the following information:
- Title of the application applicable to the hESC research
- Oversight Office that the application was submitted to
- Date of submission
Although the ESCRO office will work as much as possible with existing Oversight Offices to obtain protocol # information and approval information, some of the Oversight Offices cannot issue final approval until they receive confirmation of ESCRO review and approval. For example, if your proposal involves EH&S and/or IACUC, they cannot issue final approval until ESCRO has approved your protocol.
IRB review is required when the research involves human subjects. Human subjects can be people, human specimens (such as embryos), or data in which the subject’s identity is known or can be readily ascertained. Examples of human subjects research include:
- Interactions with living individuals, such as discussions with potential gamete donors. These interactions include the transplantation of human cells or test articles, such as differentiated cells derived from human embryos or human fetal tissue, into human recipients;
- Clinical research involving use of cells or test articles regulated by the Food and Drug Administration, such as drugs, devices, and biological products;
- Human cell lines where the donor(s) may be identified, including cells that retain links (such as a code).
If sponsors require verification that the research is not human subjects research, PIs must at the very least complete a Human Subject’s Division (HSD) form called the “Biological Specimens Determination” form. This form allows the HSD to make a formal determination that the project is not research involving human subjects. The Biological Specimens Determination Form is documentation that the researcher can then use for his or her funding source, regulatory bodies, etc.
Coded specimens may be considered identifiable and IRB review is required when you, the sponsor, or any other person involved in your study:
- Have any identifying information about the individuals from whom the specimens were obtained;
- Will or could acquire identifying information about the individuals from whom the specimens were obtained;
- Could acquire access to a code key or other information that links the specimens to the individuals from whom they were obtained;
- Could acquire identifying information about the specimen donors through a constellation of variables accompanying the specimens, such as an unusual pedigree describing a rare disease;
If you have questions about IRB review, please contact Arna Elezovic, Human Subjects Division, at 206-543-0098 or email@example.com.
ESCRO is attempting to serve as an information clearinghouse for Oversight Offices that may require that you submit an application. Office of Technology Transfer is listed in the table to merely serve as a prompt to remind you to consider contacting them in the event that any specimens or materials may be exchanged between you and collaborators.