Guidance for the use of de-identified fetal material in research
This document provides guidance for the use of de-identified human fetal material in research.
Requests to obtain and use de-identified fetal material in research must be reviewed and approved by the Stem Cell Research Oversight (SCRO) committee chair or designee to ensure it meets the requirements of the NIH Policy on Informed Consent for Human Fetal Tissue Research.
- Investigators planning to use de-identified fetal material in research should contact Heather Mc Fadden
- The review requires the following information:
- Description and source of material
- Assurance: Neither the PI nor lab members working with the tissue will knowingly acquire, receive, or transfer any human fetal tissue for valuable consideration.
- Attestation from the health care provider or a third-party supplier, that informed consent was obtained at the time of tissue collection.
- A blank copy of the consent form used to obtain the material without identifiers.
- The documents will be reviewed and either approved, returned to the study team for more information, or denied if information cannot be provided, or if IRB review and approval is needed.
- Once approved, tissue can be procured, and research initiated.