March 27, 2020
We are proud of the many ways Northwestern researchers have mobilized their programs to address the challenges we are confronting with the COVID-19 pandemic. These efforts include donating PPE, developing rapid diagnostics, initiating clinical trials to evaluate potential new therapeutics and vaccines, and producing a variety of DIY products intended to impact patient care. Indeed, our researchers and laboratories are a vital resource that can make significant contributions to the long-term mitigation of the virus. Thank you for all you do.
Many of you have asked for guidance with respect to the need for specific items, the supply chain processes used by our medical systems to introduce new items, and the regulatory steps required for hospitals to safely deploy new products. Our teams, together with Northwestern Memorial Hospital and the state government, have been working to understand these requirements. It is clear that many of the products and manufacturing processes now in development will require regulatory approval and coordination with hospital supply chain processes. We have established a working group to provide guidance to your teams, and have established the following points for your work related to COVID-19:
- You are encouraged to continue brainstorming, planning, and conducting research.
- Northwestern absolutely prohibits the production in its laboratories of items for human use without approval by the undersigned.
- Any sharing of parts, devices, prototypes, etc. with researchers at Northwestern and other universities must be done as a research collaboration and follow existing guidelines for Material Transfer Agreements and IACUC and IRB approvals.
- The University is eager to describe the important ways that our research is contributing to our public health system and the greater good of our community, but there are a number of important guidelines you should understand as you tell your stories.
- Please contact the Office of Global Marketing and Communications for opportunities to promote your work and to handle any outside media requests to cover your work.
- Email Jeri Ward, Bob Rowley, Jon Yates, Amanda Morris, Kristin Samuelson and/or Marla Paul within OGMC Media Relations to support your efforts.
- Sharing of parts, devices, prototypes, etc. with outside companies must be consistent with any intellectual property rights held by the University, and should be coordinated with INVO. In most cases, outside companies will be the most effective entities to manufacture and distribute our technologies.
- Finally, please notify your Associate Dean for Research and the VPR about any ongoing design/prototyping/fabrication/production projects in response to COVID-19. Our working group will coordinate with you and our partners to better understand the need, regulatory requirements and supply chain factors, and will consider approval for use of University resources in your project.
We know that many of you are working to strengthen our response to the COVID-19 pandemic, and that you are seeking guidance on the many complex issues that must be navigated to allow your work to benefit patients. The guidelines described above should be helpful, and we will continue to provide updates as needs change and as regulatory processes are revised in response to the pandemic. Please check the Office for Research website for updates.
Thank you for your important work and dedication during this very challenging time. We are proud of the many ways our research community is applying its knowledge and innovation to benefit the public.
Interim Vice President for Research
Stephanie M. Graham
Vice President & General Counsel