CTSA Program Webinar Wednesday, July 22, 2020 2:00 PM – 3:00 PM ET
Agenda Time Topic Presenter Welcome 2:00 PM – 2:10 PM Michael G. Kurilla, M.D., Ph.D. NCATS and CTSA Program Updates Pablo Cure, M.D., MPH 2:10 PM – 2:15 PM Competitive Revisions Updates Program Director, Division of Clinical Innovation NCATS NIH Jane Atkinson, D.D.S. Consuelo Wilkins, M.D. Paul Harris, Ph.D. 2:15 PM – 2:50 PM TIN Updates Danny Benjamin, M.D., Ph.D. Dan Hanley, M.D. Trial Innovation Network (TIN), NCATS NIH Susanna McColley, M.D. Report from “An Un -Meeting on Lifespan and Life Course Associate Clinical Director of Child Health 2:50 PM – 3:00 PM Research: Integrating Strategies” Translational Sciences Institute Northwestern University Feinberg School of Medicine 3:00 PM Adjourn 2
CTSA Program Updates Michael Kurilla
Opportunities & Administrative Updates 4
NIH Rapid Acceleration of Diagnostics (RADx) Initiative https://www.nih.gov/research-training/medical-research-initiatives/radx • Support innovative technologies to make more rapid SARS-CoV-2 tests (in the millions) available in US by late Summer or Fall in support of safe return to normal life • National call for scientists and organizations to bring their innovative ideas for new COVID-19 testing approaches and strategies • Technologies, devices, and strategies
RADx Components • RADx-Tech : Innovative point-of-care and home-based tests; improve clinical laboratory tests that can directly detect the virus. https://www.nibib.nih.gov/radx-initiative-covid-19-testing/FAQ • RADx-UP : Understand factors associated with disparities in COVID-19 morbidity and mortality in underserved populations and to lay the foundation to reduce disparities • RADx-rad : Support new, non-traditional approaches, including rapid detection devices and home-based testing technologies, that address current gaps in COVID- 19 testing • RADx-ATP : Increase testing capacity and throughput by identifying existing and late stage testing platforms for COVID-19 that are far enough advanced to achieve rapid scale-up or expanded geographical placement in a short amount of time; efforts will focus on scaling up technologies and improving existing high-throughput platforms
RADx-UP New Funding Opportunities • Community-Engaged Research Testing Research Projects Limited Competition Emergency Competitive Revisions NOT-OD-20-121 Due: August 7, 2020 • Community-Engaged Research on COVID-19 Testing Emergency Competitive Revisions NOT-OD-20-120 Due: August 7, 2020; September 8, 2020 • Social, Ethical, and Behavioral Implications (SEBI) Research on COVID-19 Testing Emergency Competitive Revisions NOT-OD-20-119 Due: August 7, 2020; September 8, 2020 • RADx-UP Coordination and Data Collection Center RFA-OD-20-013 Due: August 7, 2020
Human Subjects Research (HSR) Studies Process Change • Additional Temporary Change to New Domestic KL2 Scholar projects that involve HSR (effective July 9, 2020) • Formal Prior Approval requirements are suspended for domestic COVID-19-related and non-COVID KL2 Scholar HSR Category 2 studies (not a clinical trial and are minimal risk or exempt). • Category 2 studies may begin after entry into the eRA HSS along with NCATS- specified documentation and email notification of NCATS at NCATS_CTSA_Pilot_HS@mail.nih.gov . • All UL1 Pilots and KL2 Scholar projects that include Category 1 studies (greater than minimal risk or a clinical trial) or include a foreign component continue to require formal Prior Approval.
HSR Requirement Reminders https://ctsa.ncats.nih.gov/governance-guidelines/guidelines/new-projects-with-human-subjects-research/ • Harmonized UL1 Pilot and KL2 Scholar project requirements (at least temporarily) • Email notification of NCATS for Process Types Standard & Expedited Prior Approval: NCATSPriorApprovalRequest@mail.nih.gov • Notification & HSS Study Entry: NCATS_CTSA_Pilot_HS@mail.nih.gov • • Addendum and Instructions for PIs and SOs version 1.0 is required ( here ) Critical to expedite review and approval • The form has not been updated with temporary changes; follow the • instructions that match your HSR study categories and process types.
Current HSR Study Categories & Process Types UL1 Pilot or KL2 Project Mechanism Category 1 Category 2 Study Risk Greater Than Minimal Risk Minimal Risk or Exempt Category or Clinical Trial (non-Clinical Trial) Study Focus Non-COVID COVID-19 Non-COVID COVID-19 Process Standard Prior Expedited Prior Notification & Notification & Type Approval Approval HSS Study Entry HSS Study Entry
Upcoming Webinars • August: Cancelled – BUT… • … we need your input for the Oct. webinar • September 23 webinar: Dr. Kurilla’s annual “State of the CTSA Program” (tentative) • October 28 webinar: Focus on human subjects-related topics • Submit your questions/issues to the CLIC suggestion box by October 5 • Also submit best practices that address common problems and you’d like to share
Competitive Revision Awards Pablo Cure
CTSA Program Competitive Revision Awards PAR-19-337 Purpose: Solicit UL1 competitive revision applications for the demonstration, and/or dissemination, and/or implementation of highly innovative and impactful translational science projects that address the goals of the CTSA Program, have been tested and validated at a specific hub or institution, and are beyond the original scope of the approved parent project Funding Cooperative Agreement Instrument: Eligibility: Active UL1 parent awards (not in NCE) Award Budget: $750,000/year in direct costs excluding consortium/contractual F&A costs Project period: 1 to 3 years provided it is within the remaining project period of the UL1 award September 25, 2019; September 25, 2020; September 27, 2021 Due Dates: 30 days prior to the application due date Letter of Intent: Application Please refer to PAR-19-337 for complete instructions. Instructions: Review and Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NCATS Selection:
Eligibility • Parent award (UL1) must be active (i.e. not be in an extension period), and the research proposed in the supplement must be accomplished within the remaining active project period for the existing UL1 parent award. • Projects with a total proposed duration of less than one year will not be accepted. • Requested project period may be from 1-3 years provided it is within the remaining project period of the current UL1 award.
Examples of the types of projects that would be considered for support under this FOA include, but are not limited to: • Demonstration, and/or dissemination, and/or implementation of new activities and/or capabilities successfully developed at one hub to be tested at other hubs. • Efforts to promote the sharing of resources and capabilities across different CTSA Program hubs. • Efforts to disseminate expert knowledge and create that expert capacity at additional CTSA Program hubs. • Sharing and/or expansion of a platform developed and demonstrated to be impactful in the translational science space at a single hub that will be adopted at multiple hubs. • Expansion of consortium-wide capabilities. Proposed capability has been tested/validated and has led to a measurable impact at the local hub.
Page Limitations All page limits described in the SF424 Application Guide and the Table of Page Limits must be followed. Note: We recommend applicants to use a different application title than the Parent UL1 grant title in their competitive revision applications. This to avoid duplication in cases where more than one application is submitted by the same hub. Only one competitive revision application to a UL1 hub may be funded per year.
Research Strategy • Addressing a systemic barrier in clinical and translational science • Evidence that the proposed capability is ready for use and dissemination • Capability Dissemination and Implementation Plan • Evaluation and Sustainability Plan • Program Director/Principal Investigator
Common Mistakes • Failure to follow SF424 Instructions: • For studies that will include the use of previously collected biospecimens, data or records, lack of description regarding the source of these materials, whether these can be linked with living individuals, and who will be able to link the materials. • For Human Subjects Research Claiming Exemptions: lack of justification of why the research meets a specific exemption category. • Lack of description regarding the process for obtaining informed consent • Lack of description regarding planned strategies for protecting against or minimizing all potential risks identified, including strategies to manage and protect the privacy of participants and confidentiality of research data. • Inclusion plans that are not justified or with insufficient details (i.e plans for inclusion of children, inclusion of women and minorities). • Failure to recognize observational research on users as Human Subject Research (45 CFR 46). • Failure to include in the Research Strategy a Dissemination and Implementation Plan and/or Evaluation and Sustainability Plan
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