The following information was sent this week to investigators who are involved in stem cell research from William S. Mellon, Associate Dean for Research Policy at UW-Madison. We are including the full notice here, for your reference.

Dear campus stem cell investigator:

As we await news from the federal government on possible regulatory changes following the Presidents executive order removing barriers to responsible stem cell research, our procedures for oversight of stem cell research remain in place at UW-Madison. Recall that the campus adopted a stem cell policy and guidelines on May 2007, which reflect those published by the National Academy of Sciences. This email is intended to provide information to you concerning: (A) Stem cell research oversight at UW-Madison; (B) Researcher obligations; and (C) Consequences for failing to complete training and undergo SCRO Committee review.

A. Stem Cell Research Oversight At UW-Madison: Since August 2008 the UW-Madison Stem Cell Research Oversight (SCRO) committee has been reviewing protocols (www.grad.wisc.edu/admin/committees/scro; click on Electronic
Submission in the menu on the left-hand side of the page). It is campus policy, announced previously and discussed at town hall meetings on campus, that all stem cell research ongoing before September 1, 2008 and all new stem cell research since that time be submitted to the SCRO for review and if necessary receive approval before being conducted. Additionally, UW-Madison requires all researchers listed on an application submitted to the Stem Cell Research Oversight (SCRO) Committee to complete online stem cell ethics and policy training
(www.grad.wisc.edu/research/wkshop/index.html#SCR) before the application will be reviewed. These provisions apply to all research on campus or involving campus faculty or staff that involves either: 1. the use of human embryonic stem cells or their derivatives; or 2. the introduction of human pluripotent stem cells, 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.

B. Researcher Obligations: If you are currently engaged in either of these categories of stem cell
research that has not been reviewed by the SCRO committee you should complete the training and begin the electronic application process immediately. If you are planning to begin new stem cell research, you should file an application to the committee and await approval before beginning your research. This can be done electronically at https://rcr.gradsch.wisc.edu/irbwebkit/Login.asp. If you have a question about the online application contact Heather Mc Fadden, Office of Research Policy, 608-890-2648, hnmcfadden@bascom.wisc.edu. The deadline for completion of stem cell training and submission of stem cell protocols is June 1, 2009. In order to ensure that all research is reviewed in compliance with campus stem cell policy, the university is instituting consequences for failing to undergo appropriated SCRO review by the JUNE 1st DATE.

C. Consequences for Failing to Complete Training and Undergo SCRO Committee Review: The university will provide no support for extramural activities involving stem cell research on behalf of principal investigators who do not fulfill their responsibilities under the campus stem cell policy. Specifically, the university will not: 1. Submit a stem cell-based grant proposal or other project application to sponsors for extramural projects; 2. Execute stem cell award agreements; 3. Establish accounts for spending extramural funds for new or continuing stem cell projects; and 4. Process other stem cell-related documents such as material transfer agreements. Any protocol or application submitted via RSPs WISPER system will ask whether the research involves “Use of human embryonic stem cells OR transplantation of human pluripotent stem cells into animals with possible CNS integration or germline transmission.” Responses to this question will be checked against a database of protocols reviewed and approved by the SCRO committee.

I hope that you understand that this is not intended to be punitive, but rather to ensure that we are undertaking research that has been reviewed with respect to ethical principles of stem cell research.

Sincerely,

William S. Mellon, Associate Dean for Research Policy