UW-Madison Policy for Full Committee or Expedited Panel Review of Studies Using Human Embryo and or Human Pluripotent Stem Cells
Adopted By: Stem Cell Research Oversight Committee (SCRO)
Adoption Date: October 27, 2010
Revised: May 10, 2017
POLICY
I. Definitions
A. Full SCRO Committee review means that the application is reviewed at a SCRO Committee meeting with a quorum present and any action taken on the application is done via a majority vote of members present.
B. Expedited panel review means that the review is carried out by the SCRO Committee Chair or by one or more SCRO Committee members designated by the Chair. In reviewing the research, the expedited reviewer(s) may exercise all of the authorities of the SCRO Committee except that the reviewer(s) may not disapprove the research. The expedited reviewer(s) may also bring the application to the full SCRO Committee for review when he or she determines that full SCRO Committee review is appropriate.
II. Review by the Full SCRO Committee
A. Per UW-Madison's Policy for Human Embryo and Human Pluripotent Stem Cell Research, all research on campus involving campus faculty or staff that involves the following must be submitted to the SCRO Committee for review and approval:
1. The use of hESCs or their derivatives; or
2. the introduction of hPSCs, or their derivatives, obtained from a non-embryonic source, into non-human animals at any embryonic, fetal, or postnatal stage, if an expected effect is that human cells will be integrated into the central nervous system, testes, or ovaries of the animal; or
3. all research that (a) involves pre-implantation stages of human development, human embryos, or embryo-derived cells or (b) entails the production of human gametes in vitro when such gametes are tested by fertilization or used for the creation of embryos; or
4. the storage or disposition of human embryos or gametes obtained for the purposes of stem cell research.
B. All applications submitted to the SCRO Committee for initial or continuing review of research involving human embryo and or human pluripotent stem cells will be reviewed by the full SCRO Committee, except for those applications that qualify for expedited review. See III.A. below.
C. Applications for changes of protocol will be reviewed by the full SCRO Committee, except for those applications that qualify for expedited review. See III.B. below.
D. The SCRO Committee uses a primary reviewer system for all reviews by the full Committee. At least two primary reviewers, who are SCRO Committee members, are assigned to each application for review.
E. The assignments are made by the SCRO Committee staff and reflect the expertise of the primary reviewers. The SCRO Committee staff also checks for conflicts of interest between primary reviewers and research protocols. See, SCRO Committee Conflict of Interest Policy.
F. The assigned primary reviewers conduct the in-depth review of the protocol application and all provided materials, and lead the discussion of the application at the full SCRO Committee meeting. All other SCRO Committee members, including any alternate members substituting for a SCRO Committee member, are expected to review the provided materials in enough depth to be familiar with them and be prepared to discuss them at the convened meeting.
III. Expedited Review
A. Those initial and continuing review applications that qualify for expedited review include:
1. In vitro studies using an NIH approved cell line(s); and
2. In vitro studies using a cell line(s) previously approved by the SCRO Committee and listed on UW-Madison's hESC Registry [https://kb.wisc.edu/gsadminkb/page.php?id=33286].
B. Those changes of protocol that qualify for expedited review include:
1. Changes in personnel;
2. Changes in funding source;
3. Other changes that do not affect the research type, research design or research question.