Message to UW–Madison colleagues

(sent October 23, 2019)

Dear Colleagues,

As you may be aware, the NIH has issued new guidance for competitive grant applications due September 25, 2019 or after, that involve the use of human fetal tissue (HFT). The University continues to work at a national level to better understand the impact of this guidance and provide feedback to federal officials and others about its implications. This guidance does not affect research with human embryonic stem cells.

For those interested in submitting applications involving the use of HFT, we recommend you review the guidance carefully. You can also find NIH FAQs at: https://grants.nih.gov/grants/human-fetal-tissue-research-faqs.htm

Some key points of the guidance include:

Ethics Advisory Board

Beginning September 25, 2019, research proposals involving HFT will be evaluated by a federal ethics advisory board. As of October 23, 2019. this advisory board had not yet been convened, which could delay funding of submitted grants since new proposals and competitive renewals are on hold until this new mechanism is in place. Already funded grants are allowed to continue.

New Required Information for Grant Applications

Investigators must now submit detailed information about why the proposed research cannot be accomplished using alternatives to HFT, as well as plans for treatment and disposal of HFT upon completion of the research. Additionally, investigators must submit a copy of the IRB-approved informed consent form used to obtain the HFT, including for already-acquired tissue.

Further, researchers must demonstrate that no enticements, benefits, or financial incentives were used at any level of the process to incentivize abortion or the donation of HFT. Researchers acquiring HFT from a tissue bank should work with the bank to obtain necessary documentation for the grant application.

Expansion/Trainees

Importantly, centers and core grants with discretionary funds will not be allowed to expand existing HFT funding or to add HFT to funded activities, including pilot projects. The guidance also states that training awards and individual fellowships may not propose research using HFT. Per a subsequent posting by NIH: “Trainees and fellows may not independently propose research using HFT. However, trainees and fellows can still conduct HFT research if it is part of a mentor or sponsor’s award and meets all policy requirements.”

Please be reassured that the university remains fully committed to advocating on your behalf and supporting your research. The institution will continue to help you navigate evolving requirements.

If you have any questions or concerns, please contact Heather Mc Fadden (heather.mcfadden@wisc.edu, 890-2468).

Media inquiries should be directed to: Interim Director of Research Communications Kelly Tyrrell (kelly.tyrrell@wisc.edu, 262-9772) or Manager of Strategic Communications in the Office of the Vice Chancellor for Research and Graduate Education Natasha Kassulke (natasha.kassulke@wisc.edu, 890-4728)

 

Anita Bhattacharyya

Assistant Professor, Cell and Regenerative Biology

Chair, UW Stem Cell Research Oversight Committee

 

Steven A. Ackerman

Interim Vice Chancellor for Research and Graduate Education

Professor of Atmospheric and Oceanic Sciences