Per HRP-309 Ancillary Review Matrix review by the Stem Cell Research Oversight Committee (SCRO) occurs after and outside IRB review. 

Studies that derive cell lines from a subject’s samples should include commercial products language in the consent document. 

Refer to the UW Madison’s Policy on Use of Human Fetal Tissue in Research. Research using de-identified fetal material does NOT require IRB review. Research that uses human fetal tissue or that focuses on either a fetus, or human fetal tissue, in-utero or ex-utero cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities. 

Refer to  HRP-413 Non-Viable Neonates, HRP-414 Neonates of Uncertain Viability, and HRP-044 SOP: Not Otherwise Approvable Research, Interventional research enrolling neonates cannot be conducted by VA investigators while on official VA duty, at VA facilities, or at VA-approved off-site facilities; prospective observational or retrospective studies are permitted. 

Refer study teams to the University’s Data Stewardship, Access, and Retention Policy for questions about data retention.  In addition to the University’s requirements, the Principal Investigator will need to comply with any other contractual records retention obligations (e.g., terms of a grant). 

Researchers should also consider whether data needs to be retained to:

• allow evaluation/defense/prosecution in instances of research misconduct 
• permit access to others at the UW, such as graduate students or collaborators, who have reasonable need access to it
• support intellectual property protections 

Note that it is the PI who determines which elements of project data are retained, how this data is identified or de-identified, when identifiers may be destroyed (including when is the “earliest opportunity consistent with the conduct of the research” for a waiver of authorization under HIPAA), and how it is disseminated and used. Also, it is the responsibility of the investigator in collaboration with their department/school/college to preserve data at the UW through the retention period if the investigator is leaving the University and no one else is taking over the study.   Please see this guidance if study personnel are leaving the institution and plan to take copies of research data with them.