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- UNL SROC Policy
- UNL SROC Flowchart
- UNL SROC New Project Application
- UNL SROC Change Request Application
- UNL SROC Continuing Review Application
In accordance with all federal guidelines, state legislation and the University of Nebraska Board of Regents policy, the University of Nebraska-Lincoln’s Scientific Research Oversight Committee (SROC) is responsible for the review and approval of research involving human embryonic stem cells (hESCs) and human fetal tissue (hFT). The SROC was formed utilizing the National Academies Guidelines for Embryonic Stem Cell Research Committees (ESCRO, referenced below). For the purposes of the research portfolio at UNL, hFT research is also included under the purview of the SROC.
The Human Embryonic Stem Cell Research Advisory Committee of the National Research Council and Institute of Medicine published Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research in 2008.
Section 2.0 (page 11) describes the establishment of an institutional ESCRO: “To provide oversight of all issues related to derivation and use of hES (human embryonic stem) cell lines and to facilitate education of investigators involved in hES cell research, each institution should have activities involving hES cells overseen by an Embryonic Stem Cell Research Committee (ESCRO).”
“An ESCRO committee should include independent representatives of the lay public as well as persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction and ethical and legal issues in hES cell research.” (In Nebraska, development of human stem cell lines is not permitted because creation or destruction of a human embryo is prohibited; therefore, assisted reproduction input is potentially less relevant than in states that do not have this prohibition.)
“It must have suitable scientific, medical and ethical expertise to conduct its own review and should have the resources needed to coordinate the management of various other reviews required for a particular protocol” (e.g., animal use, recombinant DNA, human subject research).
“But the ESCRO committee should not be a subcommittee of the IRB, as its responsibilities extend beyond human subject research.” (For example, in Nebraska, this includes ensuring that all hESC lines employed are federally approved.)
UNL SROC responsibilities:
- Provide oversight over all issues related to the use of hESC lines or hFT.
- Review and approve the scientific merit of research protocols that utilize hESCs or hFT.
- Review compliance of all in-house hESC or hFT research with all relevant regulations and guidelines.
- Maintain registries of hESC or hFT research conducted at the institution and hESC lines or hFT imported by institutional investigators.
- Facilitate education of investigators involved in hESC or hFT research.
- Seek alternatives to using hESC or hFT where possible.
The UNL SROC undertakes all of these tasks and reports its actions to the UNL Chancellor.
hESC and hFT research at UNL
Current protocols address a wide range of topics, from the very basic mechanisms that regulate stem cell self-renewal, which is the primary characteristic that distinguishes stem cells from all other cell types in the body, to potential applications of hFT in the prevention and treatment of HIV.
All studies utilizing hESCs or hFT must be reviewed and approved by the SROC and Institutional Review Board (IRB) to ensure compliance with all federal, state and university regulations.
- ONLY hESC lines from the NIH Human Embryonic Stem Cell Registry are allowed. hESC lines that are not on this registry are not allowed to be used for NU System research. The NIH Registration Number for a proposed stem cell line must be cited when submitting the application for hESC use to the SROC.
- No federally (NIH) approved hFT listing currently exists.
- No Nebraska State Tobacco Settlement or LB 606 funds can be used for research involving hESC or hFT.
What Training is Needed?
The SROC and IRB cannot approve new protocols, or re-approve existing protocols, until all listed personnel have been trained.
All research personnel must possess the necessary experience, skill and professional licensure. Personnel listed in any of the categories below are required to complete human embryonic stem cell (hESC) training under the human research curriculum, titled “Stem Cell Research,” through the Collaborative Institutional Training Initiative (CITI) program (https://www.citiprogram.org)
- Principal Investigator (PI)
This individual assumes overall responsibility for 1) development and submission of the application to the SROC; 2) the conduct of the research in full compliance with the protocol, SROC and IRB requirements, all applicable regulations, and state law; and 3) publication of the data. Only one PI can be named on the SROC application.
- Secondary Investigator(s) (SI)
These individuals share responsibility with the PI for 1) development and submission of the application to the SROC; 2) the conduct of the research in full compliance with the protocol, SROC and IRB requirements, all applicable regulations, and state law; and 3) the publication of the data.
- Participating Personnel
These individuals are not normally involved in the development and submission of the application to the SROC but will be participating in conducting the laboratory procedures.
UNL Institutional Official
Director of Research Compliance
Contact: 402-472-4491 or firstname.lastname@example.org