The
Medical School Office of Research has shifted from the monthly publication of “Research News” to a weekly edition. Please bookmark the important links below and consider setting up email alerts to stay abreast of the latest information not only from our organization, but from UMOR.
Events around us are continuously evolving, and our team is committed to keeping you informed and supporting our research community to the utmost of our ability.
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News Affecting Your Research Operation
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Yesterday, UMOR hosted a virtual Research Town Hall, which featured updates on the entire U-M research enterprise from Dr. Rebecca Cunningham, Dr. Steven Kunkel, and other U-M research leadership.
CLICK HERE to view the video recording of the virtual event in MBox (download if your connection is too slow to preview).
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COVID-19 Clinical Research Biorepository
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To coordinate COVID-19 patient sample collection, distribution, and tracking, the
Clinical Trials Support Office is working with the
Central Biorepository to centralize the collection of COVID-19 residual clinical samples and research blood draws and blood processing.
Principal investigators interested in obtaining access to these samples must submit proposals to the UMOR
COVID-19 Research Prioritization Committee and receive IRB approval. For researchers interested in accessing samples:
- Submit a UMOR COVID-19 Research Prioritization form
- Submit an IRB application
- After UMOR priority designation, interested PIs will receive a form to provide details regarding sample needs and contact information
- After IRB approval, investigators can reach out for sample* pick up consistent with their IRB approval
*Samples are dependent on availability.
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COVID-19 Trials Feasibility Review Committee Established
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SignNow Software Now HIPAA and FDA 21 CFR Part 11 Compliant
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SignNow Software is now HIPAA and FDA 21 CFR Part 11 compliant for patient signatures. Study Coordinators are no longer required to have patients sign the HIPAA Permission to Use SignNow form before signing informed consent documents.
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OHRP Issues Guidance on COVID-19
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On April 8, 2020, the federal Office for Human Research Protections (OHRP) issued
guidance for institutional review boards (IRBs) and the research community on the coronavirus pandemic. The guidance provides information about the following topics:
- Public health activities and clinical activities;
- Excluded public health activities;
- Legally required reporting;
- Requirements when eliminating apparent immediate hazards to participants;
- Proposing and reviewing study changes; and
- Whether suspensions must be reported to OHRP.
The guidance indicates that previously issued U.S. Food and Drug Administration (FDA)
guidance on clinical trials during the COVID-19 pandemic is consistent with the regulations at 45 CFR 46, even if the research is not also regulated by the FDA. Additionally, it states that 2018 OHRP
guidance, “Effects of Disasters on Human Research Protections Programs,” may be applicable during the COVID-19 pandemic.
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Commercialization Guide Offers Biomedical Researchers Online Support
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The
Fast Forward Medical Innovation team put together a list of
resources that can help you continue to move your research project down the commercialization pathway while you’re not physically in the lab.
You’ll find instructional videos on commercialization concepts and industry interaction tips, funding opportunities, and links to websites that can help you continue to move your research project down the commercialization pathway.
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Maintaining Compliance and Oversight During COVID-19 Pandemic
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Researchers can utilize self-assessment tools to ensure research documentation is complete and complies with federal and institutional requirements. The Office of Research Compliance Review has a variety of self-assessment tools available on their
website.
Contact the Office of Research Compliance Review (
[email protected]) for consultation on how to optimize the use of these tools.
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Changes to ULAM Animal Husbandry Staffing
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Consistent with practices that are already in place on the clinical side, the
Unit for Laboratory Animal Medicine (ULAM) initiated the division of husbandry staff into two teams on Monday, April 13, 2020. These changes will allow ULAM to maintain the same high standards of animal welfare, while further safeguarding our animal care staff from the spread of COVID-19.
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HITS Develops New Tools Supporting Remote Work
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To reduce Service Desk wait times, HITS has created several tools to provide answers to common Work from Home questions:
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New COVID-19 Well-Being Help Center
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During the COVID-19 pandemic, it is important for Michigan Medicine faculty, staff, and learners, as well as members of the larger community, to take care of themselves.
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Fast Grants for COVID-19 Research
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Foundation Relations has forwarded information about "Fast Grants" for COVID-19 research. These grants are $10k-$500k, and award decisions are made in under 48 hours. The principal investigator must already be working on a project that could help with the COVID-19 pandemic within the next six months.
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Funding Resources for COVID-19 Projects
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These web-based funding resources help researchers pursue funding related to COVID-19:
In addition to these websites, below you'll find this week's roundup of funding opportunities.
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10:00AM-11:00AM, Wednesday, April 22
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12:00PM-12:45PM, Thursday, April 23
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Looking for additional information about changes to training & events? Visit...
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To better navigate the complexities of the U-M biomedical research enterprise, visit the
Research Project Lifecycle
. This interactive tool provides an overview of the resources available to you, not only within the Medical School Office of Research but also across the University. The "stops" along this lifecycle are highlighted above, and more information is available
online
.
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